Pre-Conference Evening Seminar:Implementing a Robust Strategy for ManagingeSubmissions in a Diverse Global Environment
18:00 - 20:30Global eSubmissions
Topics to be discussed include:
• Overview of the status of eSubmissions globallyincluding which countries are accepting eCTD,other types of eSubmissions or paper
• Reviewing whether the current degree of globalharmonisation in submission requirements willimprove
• Best practice for managing global submissions in asynchronised and harmonised way
• Understanding specific documentationrequirements in different regions and how thesecan be created successfully and efficiently
• Assessing varying expectations for submissioncontent and format in different regions
• Determining whether separate submissions mustbe made for the same registration in severalregions, or whether one submission will suffice
Participants
Suzie Henderson, Takeda Development Centre Europe,UK
Pre-Conference Evening Seminar: BestPractice for Conducting Multi-Regional ClinicalTrials in the Emerging Markets
18:00 - 20:30Emerging Markets Pre-Conference Evening Seminar
Multi-regional clinical trials (MRCT) are now beingconducted extensively in emerging markets with drugdevelopment being dramatically globalised in recentyears. Despite the advantages that come with MRCTincluding faster development processes and shorterapproval times, they do come with challenges.
This interactive evening seminar will provide attendeeswith a comprehensive insight into optimal MRCTdesign and conduct.
Topics to be discussed include:
• Case examples of successful MRCT design andconduct
• Understanding the key pros and cons of carryingout MRCTs
• Examining how to design MRCTs that successfullyaddress local population needs
• Showing how MRCTs can reduce approval time anddocumentation requirements for clinical trialapplications
• Overcoming coming key challenges experiencedwhen carrying out MRCT
Participants
Roger Joby, 1to1to1, UK
SESSIONSPRE-CONFERENCE EVENING SEMINARS - 17/10/2016
Global Pharmaceutical Regulatory Affairs Summit18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
TIME EMERGING MARKETS PRE-CONFERENCE EVENINGSEMINAR
GLOBAL ESUBMISSIONS
18:00 18:00 - Pre-Conference Evening Seminar: Best Practice forConducting Multi-Regional Clinical Trials in the EmergingMarkets
18:00 - Pre-Conference Evening Seminar: Implementing aRobust Strategy for Managing eSubmissions in a Diverse GlobalEnvironment
SCHEDULEPRE-CONFERENCE EVENING SEMINARS - 17/10/2016
Global Pharmaceutical Regulatory Affairs Summit18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
Registration
08:00 - 09:00Main agenda
Opening remarks from the Chairperson
09:00 - 09:10Main agenda
Overview of Russian National and EEUregistration process
09:10 - 09:45Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Exploring timelines with the Russian Federal LawNo. 429-FZ: Which amendments came into force 1July 2015, 1 January 2016 and 1 January 2017?
• Industry experience with interpretation andimplementation of the Russian amendments todate
• Comparing the Russian registration process withthe EEU process
Participants
Alexander Borisov, Teva LLC, Russia
Exploring the latest regulatory environment inBrazil and best strategies for productregistration
09:10 - 09:45Emerging Markets Stream 2: Latin America & Asia-Pacific
• Current regulatory environment and any recent orupcoming changes
• Working successfully with ANVISA• Comparing regulatory requirements in Brazil to
Europe• Overcoming the challenge of translating
regulations from local language and increasedtimelines
• Evaluating labelling requirements and expectationsin Brazil
Participants
Stefano Accorsi, CHIESI FARMACEUTICI S.p.A., Italy
Flash update: The EU eSubmissions Roadmap -what is upcoming, timelines and impact onindustry?
09:10 - 09:25Global eSubmissions
• Summary of the EU eSubmissions Roadmap• Outlining key timelines and milestones involved• Reviewing the impact on industry and expectations
that come with the Roadmap• Understanding and complying with EMA
requirements for eCTD baseline submissions
Participants
Melanie Ruppel, Boehringer Ingelheim Pharma GmbH& Co. KG, Germany
Interactive discussion session: Improvingcommunication between pharmacovigilance,labelling, regulatory affairs and riskmanagement to ensure compliant, relevant andtimely labelling updates
09:10 - 10:10Pharmaceutical Labelling
• Examining the extent to which labelling is driven bypharmacovigilance
• Assessing the risks to regulatory compliance ifseparate functions don’t communicate clearly
• Examining strategies to avoid working in silos• Optimising CMC and early gathering of documents
and data to streamline the process• Understanding the objectives of each stakeholder
and examining how these can become aligned
Participants
Patricia Lefebvre, Sanofi
Matthias Boedding, Merck Serono
Frederic Bouder,, Maastricht University
Simon Ashworth , Takeda Development Centre EuropeLtd.
EXTENDED ROUND TABLES SESSION: Updateand experiences with EU eCTD Module 1Specification v3.0 becoming mandatory from1st October 2016
09:25 - 10:20Global eSubmissions
The speaker will outline the latest status and changesimplicated by the EU eCTD Module 1 Specification v3.0which will become mandatory on 1st October 2016.Following the presentation, attendees will be split intosmaller groups to share experiences and challengesfaced so far with submissions using the updatedversion.
• Outlining the objectives and timelines involved withthe new eCTD Module 1 Specification
• Assessing industry experiences so far and any newprocesses or systems that need to be created
• Examining the review process of regulatoryauthorities and their expectations
• Understanding how vendors have adapted theirsystems to align with the new eCTD Module 1Specification
• Overcoming key challenges experienced andensuring business processes are not slowed down
Participants
Alastair Nixon, GlaxoSmithKline Research &Development Limited, UK
Exploring the new and upcoming Russian GMPinspection requirements for foreign drugs
09:45 - 10:20Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Clarifying GMP requirements in Russia andtimelines for coming into effect
• Reviewing the current status of the Russian GMPinspectorate
• Outlining how the GMP requirements will impactand challenge for foreign manufacturers
• Discussing whether GMP inspections areorganised yet and what documentation is missing
• Preparing inspection sites and communicatingwith the authority to agree inspection dates
Participants
Anna Zamakhaeva, Galderma, Russia
Brazil extended session
09:45 - 10:20Emerging Markets Stream 2: Latin America & Asia-Pacific
Attendees will be split into small groups for aninteractive discussion allowing them to shareexperiences with product registration and solutions tocommon problems in Brazil with other attendees.
Participants
Stefano Accorsi, CHIESI FARMACEUTICI S.p.A., Italy
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 1 - 18/10/2016
Global Pharmaceutical RegulatoryAffairs Summit
18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
Risk minimisation: Examining strategies toreduce medication errors through effectivelabelling
10:10 - 10:45Pharmaceutical Labelling
• Understanding regulatory expectations regardingrisk management
• Understanding the extent to which• insufficient labelling can be a source of adverse
events• Strategies for communicating the correct use of
the product to reduce the likelihood of medicationerrors happening
• Bridging the gap between pharmacovigilance andregulatory – labelling as a key risk minimisationmethodology
• Assessing the current challenge of communicatingrisk to patients through labelling
• Black box warning/black triangle
Participants
Dr Michael Forstner, Acino Pharma AG
TROUBLESHOOTING SESSION: Russia GMPrequirements
10:20 - 10:55Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
This extended interactive session providestheopportunity for attendees to ask questions andshare experiences related tolatest updates on RussianGMP requirements.
Participants
Anna Zamakhaeva, Galderma, Russia
Understanding the regulatory framework forregistration in Mexico
10:20 - 10:55Emerging Markets Stream 2: Latin America & Asia-Pacific
• Assessing the current regulatory environment andany recent or upcoming changes
• Clarifying the structure and activities of the NewMolecule Committee (NMC) and any upcomingchanges
• Outlining the need to repeat tests in Mexico as partof import testing and whether any exemptions aremade
• Comparing regulatory requirements in Mexico toEurope
Participants
Simone Granchi, Menarini Ricerche S.p.A., Italy
Practically implementing the mandatory use ofelectronic application forms (eAF) for allmedicines licensing procedure types
10:20 - 10:55Global eSubmissions
• Outlining latest progress, timelines and objectivesof eAF
• Discussing experiences and lessons learnt so farwith use of eAF for all medicines licensingprocedure types, including national procedures
• Overcoming key challenges faced so far withmandatory eAF use
• Outlining how eAF are performing to date includingany difficulties with opening and lengthy load uptimes
Participants
Karen Wittkopf, Boehringer Ingelheim GmbH & Co. KG,Ingelheim, Germany
Question and answer session
10:45 - 10:55Main agenda
Networking and morning coffee
10:55 - 11:25Main agenda
Assessing how drug interchangeability isdefined and established according toamendments introduced by Federal Law No.429-FZ
11:25 - 12:00Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Determining how the amendments introduce anddefine drug interchangeability
• Understanding how establishing a procedure fordetermining interchangeability will impact industry
• Exploring the criteria that must be covered in orderfor pharmaceuticals to be deemed interchangeable
Participants
Edelgard Rehak, Dr. Edelgard Rehak Consulting,Germany
Exploring the new regulation for variations inBrazil and third party reviews and therecognition model in Mexico
11:25 - 12:00Emerging Markets Stream 2: Latin America & Asia-Pacific
• Key concepts from the new regulation forvariations in Brazil and impact on industry
• Understanding how third party reviews and therecognition model in Mexico has resulted in areduction of approval times for certain products
Participants
Antonio Trejo Diaz, TEVA, USA
Latest updates and progress with the SingleSubmission Portal: The use of CESP and EMAGateway
11:25 - 12:00Global eSubmissions
• Assessing latest updates and timelines for a SingleSubmission Portal
• Understanding the impact a Single SubmissionPortal would have on industry and changes inprocedures
• Addressing concerns of integrating CESP with theEMA Gateway and whether more resources andtime will be required
• Determining how the current situation can beimproved and an ideal model for how it would work
• Regulatory agency perspectives and feedback
Participants
Karen Wittkopf, Boehringer Ingelheim GmbH & Co. KG,Ingelheim, Germany
Examining the latest updates from PRAC
11:25 - 12:00Pharmaceutical Labelling
• Assessing current pharmacovigilance legislationand clarifying key changes for industry
• Applying recommendations from PRAC to improvelabelling practices
• Clarifying evaluation of new adverse reactions• Examining the extent to which PRAC updates are
increasing and clarifying timelines for updates
Speaker to be confirmed
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 1 - 18/10/2016
Global Pharmaceutical RegulatoryAffairs Summit
18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
FLASH UPDATE: Implementing the RussianCTD format for registration dossiers underamendments introduced by the Federal LawNo. 429-FZ
12:00 - 12:15Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Assessing the upcoming requirement for theRussian CTD format and timelines forimplementation
• Outlining key challenges that industry will facefollowing the CTD format
• Determining how these challenges can beovercome
Participants
Anna Harrington Morozova, Regem Consulting
Navigating the regulatory framework forregistration in Chile
12:00 - 12:35Emerging Markets Stream 2: Latin America & Asia-Pacific
• Outlining the current regulatory environment andany recent or upcoming changes
• Case examples of successful registration in Chile• Reviewing documentation requirements and
timelines• Overcoming key regulatory challenges
Participants
Cathie Gongora, Sanofi Pasteur, France
Practically implementing strategies for eCTDonly DCP, MRP and National Proceduresubmissions
12:00 - 12:35Global eSubmissions
• Clarifying the objectives and timelines involvedwith eCTD only DCP, MRP and National Proceduresubmissions
• Sharing experiences and lessons learnt so far:What has the impact been on resources?
• Practically preparing and organising work formandatory eCTD format for National procedures by2018
• Outlining key pitfalls and challenges seen so farand how these have been overcome
Participants
Maike Diepen-Engisch, Teva, Germany
Practically meeting the authority expectationsregarding PRAC implementation timelines
12:00 - 12:35Pharmaceutical Labelling
• Clarifying what authorities are looking for regardingdecision making and labelling changes
• The PRAC referral procedure regarding safetyconcerns
• Analysing the importance of interaction with PRACduring the evaluation of an issue
• Strategies for keeping to proposed deadlineswithout violating Good Vigilance Practice andcompany SOPs
• Balancing regulatory compliance and keeping toauthority timelines with providing timely andaccurate information
Participants
Simon Ashworth , Takeda Development Centre EuropeLtd.
Quickfire Q&A Session
12:15 - 12:35Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
Led by speakers from the session
Networking lunch
12:35 - 13:35Main agenda
Latest regulatory updates in Ukraine includingthe recently adopted Ministry of Health’s OrderNo 452 which came into force September 2015
14:00 - 14:35Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Clarifying the status and timelines of the Ministryof Health’s Order No 452 since it entered into forceon 18 September 2015
• Determining key impacts of the Ministry of Health’sOrder No 452 on industry
• Outlining requirements for GMP compliance inUkraine and how the Ministry of Health’s Order No452 will impact this
• Reviewing the extent to which Ukraine is similar toEuropean regulations
Participants
Mariana Novozheniuk, Bayer Pharma AG, Germany
Evolving regulatory landscape in Latin America- comparison of regulatory requirements inChile, Brazil and Caribbean markets
14:00 - 14:35Emerging Markets Stream 2: Latin America & Asia-Pacific
• Exploring regulatory requirements in Chile, Braziland Caribbean markets
• Comparing how requirements differ
Participants
Rohit Kulkarni, Regulex Consulting Ltd., UK
Flash perspective: Industry perspective on thepractical use of the new PSUR repository
14:00 - 14:15Global eSubmissions
• Sharing experiences of use of the new PSURrepository so far
• Exploring the key challenges faced and how thesehave been overcome
• Assessing the advantages the PSUR Repositorybrings for regulatory authorities and industry
Participants
Chantal Le Floch, Servier, France
Regulatory feedback: Assessing the regulatorylandscape for pharmaceutical labelling
14:00 - 14:35Pharmaceutical Labelling
• Pharmacovigilance legislation and clarifying keychanges for industry
• Recommendations to improve labelling practices• Clarifying evaluation of new adverse reactions• Assessing current challenges for regulators
regarding pharmaceutical labelling
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 1 - 18/10/2016
Global Pharmaceutical RegulatoryAffairs Summit
18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
THOUGHT EXCHANGE between the audienceand industry representatives
14:15 - 15:10Global eSubmissions
During this interactive session, regulatory authoritiesand industry experts will comment on their keyexperiences and challenges faced to date in EUTelematics. Attendees will then have the opportunityto ask questions and take part in group discussionaddressing some of the following topics:
• What have experiences been so far with the EUeCTD Module 1 Specification v3.0 and how has thisimpacted day-to-day work?
• What lessons have been learnt to date with use ofeAF for all medicines licensing procedure types,including national procedures?
• What impact will a Single Submission Portal haveon industry?
• What are the main concerns of integrating CESPand the EMA Gateway?
• What have experiences been so far with use of thePSUR repository?
• How have industry been implementing eCTD onlyDCP, MRP and National Procedure submissions todate?
Participants
Alastair Nixon, GlaxoSmithKline Research &Development Limited, UK
Melanie Ruppel, Boehringer Ingelheim Pharma GmbH& Co. KG, Germany
Chantal Le Floch, Servier, France
Magda Andrițoiu, Alvogen, Romania
Maike Diepen-Engisch, Teva, Germany
EXTENDED Q&A SESSION: Sharingexperiences with registration in Ukraine andquestions on the latest regulatory updates
14:35 - 15:10Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
This extended Q&A discussion will provide attendeeswith an additional chance to get their questionsanswered and share experiences and challengesrelated to product registration in Ukraine.
• What key impacts of the Ministry of Health’s OrderNo 452 have been seen and experienced?
• What are some of the key challenges experiencedwhen registering products in Ukraine?
• How have these challenges been overcome?
Participants
Mariana Novozheniuk, Bayer Pharma AG, Germany
Examining and implementingpharmacovigilance and risk managementactivities in Latin America
14:35 - 15:10Emerging Markets Stream 2: Latin America & Asia-Pacific
• Exploring which countries have increasingrequirements for pharmacovigilance
• Best practice for managing pharmacovigilanceactivities in Latin America
• Reviewing requirements in place for PSURs,tracking and reporting
• Clarifying requirements for Risk ManagementPlans in Latin America
• Outlining the degree to which Latin America hasaligned requirements to Europe and the US
Participants
Lisa Ruiz, AbbVie Inc., USA
Examining and implementingpharmacovigilance and risk managementactivities in Latin America
14:35 - 15:10Pharmaceutical Labelling
• Exploring which countries have increasingrequirements for pharmacovigilance
• Best practice for managing pharmacovigilanceactivities in Latin America
• Reviewing requirements in place for PSURs,tracking and reporting
• Clarifying requirements for Risk ManagementPlans in Latin America
• Outlining the degree to which Latin America hasaligned requirements to Europe and the US
Participants
Lisa Ruiz, AbbVie Inc., USA
Networking and afternoon tea
15:10 - 15:40Main agenda
Exploring the regulatory framework and beststrategies for product registration inKazakhstan
15:40 - 16:15Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Current regulatory environment in Kazakhstan andany recent or upcoming changes
• Assessing the registration process and bestpractice for submitting a MAA
• Outlining Kazakhstan’s involvement in the EurasianUnion and impact on product registration
• Reviewing requirements for, and complying withGMP inspections in Kazakhstan
Participants
Anna Harrington Morozova, Regem Consulting
Regulatory requirements and challenges forbiosimilars registration in Latin America
15:40 - 16:15Emerging Markets Stream 2: Latin America & Asia-Pacific
• Assessing current regulatory requirements anddefinitions in place for biosimilars
• Region-specific requirements that are differentfrom EU/US
• Case examples of successful biosimilarsregistration in Latin America
• Focus on Brazil• Understanding expectations for ethnically relevant
clinical data for biosimilars
Participants
Thomas Kirchlechner, Sandoz GmbH, Austria
Latest update on EMA Policy 0070 onpublication and access to clinical trial data,and how this will impact Regulatory Operationsfunctions:
15:40 - 16:15Global eSubmissions
• Background to EMA Policy 0070• Assessing the latest status and timelines for
implementation• Understanding the EMA External Guidance• Redaction considerations, working with redactions
in PDF• Redaction proposals and final redactions in eCTD
format• Sharing experiences, concerns and challenges to
date
Participants
Alastair Nixon, GlaxoSmithKline Research &Development Limited, UK
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 1 - 18/10/2016
Global Pharmaceutical RegulatoryAffairs Summit
18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
The Need for Quality Management and ProcessControl in a Pharma Artwork Studio
15:40 - 16:40Pharmaceutical Labelling
• Reviewing the benefits of a QMS in a GMP artworkstudio
• Implementing a GMP compliant artwork process• Assessing Global Quality Standards to ensure
compliance• Identifying how Asset Management and Workflow
Technologies improve effectiveness• Controlling the artwork process to ensure
efficiency and transparency• Understanding The Customer/Vendor relationship
to improve collaboration
Participants
Suzanne Ivory , Perigord
Latest updates and practical experiences withthe Eurasian Union
16:15 - 16:50Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Current status of the Eurasian Union following the1 January 2016 date of coming into force
• Examining expectations for a common procedureof registration and dossier format
• Understanding how the Eurasian Union will work inpractice including when European documents canbe used and additional requirements
• Exploring the extent to which the Eurasian Union issimilar to the European Union
Participants
Galina Senchukova, Sanofi Pasteur Eurasia, Russia
LATAM COLLABORATION ZONE
16:15 - 17:25Emerging Markets Stream 2: Latin America & Asia-Pacific
Round table 1: Brazil
Round table 2: Chile
Round table 3: Adapting to requirements in emergingmarkets focusing on LATAM
Round table 4: Comparison of regulatory requirementsin Chile, Brazil and Caribbean markets
Participants
Stefano Accorsi, CHIESI FARMACEUTICI S.p.A., Italy
Cathie Gongora, Sanofi Pasteur, France
Andrea Herrmann, Merck KGaA, Germany
Rohit Kulkarni, Regulex Consulting Ltd., UK
Regulatory agency perspective: Feedback,plans and practical advice for eCTDsubmissions
16:15 - 16:50Global eSubmissions
• Outlining current agency priorities and future plans• Exploring where focus has been made on the EU
eSubmissions Roadmap• Reviewing expectations and requirements for
industry eCTD submissions• Feedback on common errors and observations
from eCTD submissions• Assessing agency readiness for mandatory eCTD
and the adoption of eCTD v4.0
Participants
Triin Mäesalu, State Agency of Medicines, Estonia
Managing the end to end labelling process:optimising internal processes and oversight forefficient and compliant labelling
16:15 - 16:50Pharmaceutical Labelling
• Creating a robust and reliable system to monitorlabel modifications and changes globally
• Tracking deviations from a global perspective:strategies to ensure oversight over the entireprocess
• Ensuring quality control of labelling content andartworks
• Balancing the need to get information out quicklyand complying from a regulatory standpoint
• Bundling labelling updates to drive up efficiencies
Participants
Lynsey Flitton, AbbVie
Navigating regulatory requirements andexploring successful marketing strategies forbiosimilars in Russia and CIS countries
16:50 - 17:25Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Exploring current regulatory requirements in placefor biosimilars
• Reviewing the criteria for biosimilarity and howsimilar a product must be to be considered abiosimilar
• Understanding expectations for extrapolatingindications for biosimilars
• Best practice for successful biosimilarsregistration and marketing strategies in Russia andCIS countries
• Case examples of commercial successes
Participants
Roman Ivanov, BIOCAD, Russia
Building a regulatory publishing team anddefining processes for electronic submissions
16:50 - 17:25Global eSubmissions
• Successfully building a regulatory publishing team• Ensuring processes for electronic submissions are
defined
Participants
Magda Andrițoiu, Alvogen, Romania
End of conference day one and networkingdrinks
17:25 - 17:25Main agenda
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 1 - 18/10/2016
Global Pharmaceutical RegulatoryAffairs Summit
18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
TIME MAIN AGENDA EMERGING MARKETS STREAM1: RUSSIA, CIS, TURKEY,MIDDLE EAST & AFRICA
EMERGING MARKETS STREAM2: LATIN AMERICA & ASIA-PACIFIC
GLOBAL ESUBMISSIONS PHARMACEUTICAL LABELLING
08:00 08:00 - Registration
09:00 09:00 - Opening remarks from theChairperson
09:10 - Overview of Russian Nationaland EEU registration process
09:45 - Exploring the new andupcoming Russian GMP inspectionrequirements for foreign drugs
09:10 - Exploring the latest regulatoryenvironment in Brazil and beststrategies for product registration
09:45 - Brazil extended session
09:10 - Flash update: The EUeSubmissions Roadmap - what isupcoming, timelines and impact onindustry?
09:25 - EXTENDED ROUND TABLESSESSION: Update and experienceswith EU eCTD Module 1 Specificationv3.0 becoming mandatory from 1stOctober 2016
09:10 - Interactive discussionsession: Improving communicationbetween pharmacovigilance,labelling, regulatory affairs and riskmanagement to ensure compliant,relevant and timely labelling updates
10:00 10:45 - Question and answer session
10:55 - Networking and morningcoffee
10:20 - TROUBLESHOOTINGSESSION: Russia GMP requirements
10:20 - Understanding the regulatoryframework for registration in Mexico
10:20 - Practically implementing themandatory use of electronicapplication forms (eAF) for allmedicines licensing procedure types
10:10 - Risk minimisation: Examiningstrategies to reduce medicationerrors through effective labelling
11:00 11:25 - Assessing how druginterchangeability is defined andestablished according toamendments introduced by FederalLaw No. 429-FZ
11:25 - Exploring the new regulationfor variations in Brazil and third partyreviews and the recognition model inMexico
11:25 - Latest updates and progresswith the Single Submission Portal:The use of CESP and EMA Gateway
11:25 - Examining the latest updatesfrom PRAC
12:00 12:35 - Networking lunch 12:00 - FLASH UPDATE:Implementing the Russian CTDformat for registration dossiers underamendments introduced by theFederal Law No. 429-FZ
12:15 - Quickfire Q&A Session
12:00 - Navigating the regulatoryframework for registration in Chile
12:00 - Practically implementingstrategies for eCTD only DCP, MRPand National Procedure submissions
12:00 - Practically meeting theauthority expectations regardingPRAC implementation timelines
13:00
SCHEDULEREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMA LABELLING DAY 1 - 18/10/2016
Global Pharmaceutical Regulatory Affairs Summit18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
TIME MAIN AGENDA EMERGING MARKETS STREAM1: RUSSIA, CIS, TURKEY,MIDDLE EAST & AFRICA
EMERGING MARKETS STREAM2: LATIN AMERICA & ASIA-PACIFIC
GLOBAL ESUBMISSIONS PHARMACEUTICAL LABELLING
14:00 14:00 - Latest regulatory updates inUkraine including the recentlyadopted Ministry of Health’s Order No452 which came into forceSeptember 2015
14:35 - EXTENDED Q&A SESSION:Sharing experiences with registrationin Ukraine and questions on the latestregulatory updates
14:00 - Evolving regulatory landscapein Latin America - comparison ofregulatory requirements in Chile,Brazil and Caribbean markets
14:35 - Examining and implementingpharmacovigilance and riskmanagement activities in LatinAmerica
14:00 - Flash perspective: Industryperspective on the practical use ofthe new PSUR repository
14:15 - THOUGHT EXCHANGEbetween the audience and industryrepresentatives
14:00 - Regulatory feedback:Assessing the regulatory landscapefor pharmaceutical labelling
14:35 - Examining and implementingpharmacovigilance and riskmanagement activities in LatinAmerica
15:00 15:10 - Networking and afternoon tea 15:40 - Exploring the regulatoryframework and best strategies forproduct registration in Kazakhstan
15:40 - Regulatory requirements andchallenges for biosimilarsregistration in Latin America
15:40 - Latest update on EMA Policy0070 on publication and access toclinical trial data, and how this willimpact Regulatory Operationsfunctions:
15:40 - The Need for QualityManagement and Process Control ina Pharma Artwork Studio
16:00 16:15 - Latest updates and practicalexperiences with the Eurasian Union
16:50 - Navigating regulatoryrequirements and exploringsuccessful marketing strategies forbiosimilars in Russia and CIScountries
16:15 - LATAM COLLABORATIONZONE
16:15 - Regulatory agencyperspective: Feedback, plans andpractical advice for eCTDsubmissions
16:50 - Building a regulatorypublishing team and definingprocesses for electronic submissions
16:15 - Managing the end to endlabelling process: optimising internalprocesses and oversight for efficientand compliant labelling
17:00 17:25 - End of conference day oneand networking drinks
SCHEDULEREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMA LABELLING DAY 1 - 18/10/2016
Global Pharmaceutical Regulatory Affairs Summit18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
Opening remarks from the Chairperson
09:00 - 09:10Main agenda
Case study: Best practice for normativedocument preparation
09:10 - 09:45Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Clarifying what needs to be included in thenormative document
• Overcoming the challenges of sample andstandard importation
• Reviewing the relationship between CTD formatand the normative document
• Outlining the importance of communicating withlocal affiliates to ensure the process is transparent
• Examining the pros and cons of working with aCRO for normative document preparation
Participants
Anna Litsiou, Astellas, The Netherlands
Product registration and latest regulatoryupdates in China: Challenges and opportunities
09:10 - 09:45Emerging Markets Stream 2: Latin America & Asia-Pacific
• · Exploring recent and upcoming changes to theregulatory environment in China
• · Outlining how changes to regulatory requirementsare impacting industry
• · Examining exactly what is required for MAAsubmissions, variations and renewals
• · Overcoming tight deadlines for compliance withlocal pharmacopeia
• · Reviewing whether China leans more towardsEurope or US-like requirements
Participants
Joe Zhou, Genor BioPharma, China
Ministry of Health perspective: Latest updatesand progress for eCTD submissions in Oman
09:10 - 09:45Global eSubmissions
• Outlining plans, guidance and timelines for eCTD inOman
• Addressing pilot project findings and outcomes• Examining the technical specification and
validation criteria for eCTD submissions in Oman• Sharing practical advice for migrating from EU or
US eCTD to Oman• Highlighting the remaining challenges for the
implementation of eCTD in Oman
Participants
Mohanned El Khider, Ministry of Health, Oman
Industry case study: Practically Implementinglabelling updates to achieve global levelapproval
09:10 - 09:45Pharmaceutical Labelling
• Assessing the challenges and opportunities ofcountry-specific labelling and localisation oflabelling
• Understanding what local labelling is based on/country dependencies/country of origin
• Understanding how to effectively track labellingamendments globally
• Strategies for adding a new adverse event onto thelabel and overcoming the challenge of workingwith different timelines
• Improving cooperation and communicationbetween headquarters and affiliates
• Examining key differences between the US and EU•
Participants
Bas Van Heijst,, Astellas
Practically conducting clinical trials in Russiaand the impact of separating clinical trials fromregistration procedures under Federal Law No.429-FZ
09:45 - 10:20Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
Participants
Anna Litsiou, Astellas, The Netherlands
China extended session
09:45 - 10:20Emerging Markets Stream 2: Latin America & Asia-Pacific
Attendeeswill be split into small groups for aninteractive discussion allowing them toshareexperiences with product registration and solutions tocommon problems inChina with other attendees.
Participants
Joe Zhou, Genor BioPharma, China
Kamani Gopalakrishna , Boehringer Ingelheim PharmaGmbH & Co. KG, Germany
Ching Li, Biotest Pharma GmbH, Germany
Assessing the importance of translation andreadability when updating labelling globally
09:45 - 10:20Pharmaceutical Labelling
• Managing the differences and overcoming versioncontrol issues
• Human Factors vs. User-testing: Meeting EU andUS readability requirements
• Global, ‘common’ package leaflets: Rationale forcreation. Strategies for dealing with Globalrequirements
• Dependent markets: Relevance of ‘lead’ countryLegislation and Guidelines for the Dependentmarket
Participants
Paul Soul-Williams, AbbVie
Saudi FDA perspective: Latest updates andprogress for eCTD submissions in Saudi Arabia
09:45 - 10:20Global eSubmissions
• Reviewing plans, timelines for eCTD in SaudiArabia and any guidance available
• Practical advice for successful eCTD submissionsin Saudi Arabia
• Assessing the eCTD implementation challenges inSaudi Arabia
Participants
Abdullah Abdulaziz Alduraibi, Saudi FDA, Saudi Arabia
Latest updates and progress for eSubmissionsin Jordan
10:20 - 10:55Global eSubmissions
• Examining plans, timelines for eCTD in Jordan &any guidance available
• eSubmission and tracking system in Jordan• Exploring the remaining challenges for the
implementation of eCTD in Jordan
Participants
Wesal Haqaish, Jordan FDA, Jordan
Clinical trials of medicines: Current regulatoryenvironment and updated local regulations inUkraine
10:20 - 10:55Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
Participants
Nataliia Bogdan, Independent Speaker (previously –Central Regulatory Authority), Ukraine
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 2 - 19/10/2016
Global Pharmaceutical RegulatoryAffairs Summit
18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
Case study: Best strategies for successfulproduct registration in India
10:20 - 10:55Emerging Markets Stream 2: Latin America & Asia-Pacific
• Case examples of successful product registrationin India
• Understanding exactly what is required for MAAsubmissions, variations and renewals in India
• Reviewing and managing submission timelines inIndia
• Overcoming key regulatory challenges experienced
Participants
Kamani Gopalakrishna , Boehringer Ingelheim PharmaGmbH & Co. KG, Germany
Pharmaceutical Labelling presentationdelivered by Schlafender Hase
10:50 - 11:25Pharmaceutical Labelling
Networking and morning coffee
10:55 - 11:25Main agenda
Examining latest updates and sharingexperiences with submitting eCTD in Australia
11:25 - 12:00Global eSubmissions
• Current status, agency updates and timelines foreCTD in Australia
• Assessing key findings and expectations from theTGA
• Successfully submitting to the regulatory agency• Sharing experiences from AU eCTD submissions
and comparing with EU eCTD submissions
Participants
Nathalie Mueller-Andriamboavonjy, Incyte, Switzerland
INTERACTIVE ROUNDTABLES: Sharingexperiences with conducting local clinicaltrials in Russia and CIS
11:25 - 12:00Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Sharing experiences with implementing therequirements in place for local clinical trials
• Success stories with conducting local clinical trials• What challenges and pitfalls have been seen with
local clinical trials?• How have these challenges been overcome?
Participants
Alex Dranov, Dr. Willmar Schwabe, GmbH & Co. KG,Germany
Anna Litsiou, Astellas, The Netherlands
Exploring the regulatory framework andconsiderations for successful productregistration in South Korea
11:25 - 12:00Emerging Markets Stream 2: Latin America & Asia-Pacific
• Current regulatory environment in South Korea andany upcoming changes
• Determining what is required for MAA submissions
Participants
Eric Ducamp, Ipsen, France
Panel discussion: Overcoming the challengesof implementing global level updates -improving communication and cooperation
11:25 - 12:00Pharmaceutical Labelling
• Assessing strategies to improve communicationbetween internal teams to ensure a streamlinedapproach to global labelling
• Understanding the importance of culturaldifferences when communicating withheadquarters and affiliates
• Managing the end to end labelling process on aglobal level
Speakers from the morning session
China: Latest updates and sharing experienceswith submitting eCTD
12:00 - 12:35Global eSubmissions
• Assessing plans for eCTD in China and anyguidance available
• Discussing the timelines for eCTD implementationin China
• Exploring the remaining challenges for theimplementation of eCTD in China
• Comparing requirements and expectations inChina with EU eCTD submissions
Participants
Carolline Petersen, Novo Nordisk A/S, Denmark
Reviewing labelling requirements andovercoming challenges in Russia and the CISmarkets
12:00 - 12:35Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Exploring requirements in place for labelling inRussia and CIS countries
• Overcoming key labelling challenges
Participants
Giovanna Ferrari, Pfizer, UK
Clarifying Taiwan’s regulatory framework andpractical advice for product registration
12:00 - 12:35Emerging Markets Stream 2: Latin America & Asia-Pacific
• Current regulatory environment in Taiwan and anyupcoming changes
• Determining what is required for MAA submissions• Overcoming key regulatory pitfalls experienced in
Taiwan
Participants
Cécile Vareilles, Ipsen, France
Reviewing labelling requirements andovercoming challenges in Russia and the CISmarkets
12:00 - 12:35Pharmaceutical Labelling
• Exploring requirements in place for labelling inRussia and CIS countries
• Overcoming key labelling challenges
Participants
Giovanna Ferrari, Pfizer, UK
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 2 - 19/10/2016
Global Pharmaceutical RegulatoryAffairs Summit
18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
Networking lunch
12:35 - 14:00Main agenda
Examining the current status of the FalsifiedMedicines Directive and the current challengesbeing faced by industry
14:00 - 14:35Pharmaceutical Labelling
• Short assessment FMD+DR• NMVO foundation• NMVS implementation• Lessons learned
Participants
Johan Verhaeghe, Medicines for Europe
RUSSIA AND CIS COLLABORATION ZONE
14:00 - 15:10Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
Save your questions from the session and join a roundtable dedicated to your region of choice. Join thespeaker and other attendees as they shareexperiences on the challenges faced in a highlyinteractive environment.
Round table 1: Russia
Round table 2: Ukraine
Round table 3: Kazakhstan
Round table 4: Eurasian Union
Participants
Alex Dranov, Dr. Willmar Schwabe, GmbH & Co. KG,Germany
Edelgard Rehak, Dr. Edelgard Rehak Consulting,Germany
Mariana Novozheniuk, Bayer Pharma AG, Germany
Anna Harrington Morozova, Regem Consulting
Galina Senchukova, Sanofi Pasteur Eurasia, Russia
Reviewing latest regulatory progress in theASEAN countries and impact on industry
14:00 - 14:35Emerging Markets Stream 2: Latin America & Asia-Pacific
• Outlining key recent regulatory updates from theASEAN countries and harmonisation efforts
• Evaluating the status of the ACTD format andupdates on harmonisation
• Overcoming the challenge of different agencyrequirements including expectations for stabilitydata
Participants
Inês Pinto, Actelion Pharmaceuticals Ltd., Portugal
Examining the latest progress towards eCTDsubmissions in Thailand
14:00 - 14:35Global eSubmissions
• Latest changes to the Mod1 specifications• Lessons learned• Setting example for ASEAN region?
Participants
Jens Pantke, F. Hoffmann-La Roche Ltd. Switzerland
Case study: Successful product registrationand latest regulatory requirements in Japan
14:35 - 15:10Emerging Markets Stream 2: Latin America & Asia-Pacific
• Examining latest regulatory requirements andupdates in Japan
• Understanding the registration milestones• Outlining local clinical trial requirements• Reviewing similarities with regulatory pathways
and timelines to Europe and the US
Participants
Lamine Messaoudi, International Regulatory ConsultGroup, USA
Spotlight Presentation -Please contactAlexander Zenonos for more information:[email protected] or call +44(0) 20 701 77742
14:35 - 15:05Pharmaceutical Labelling
Outlining latest updates on the new US Module1 v2.3 and practical implications for industry
14:35 - 15:10Global eSubmissions
• Reviewing latest updates from the FDA andtimelines for mandatory use of the new version
• Practical advice for complying with US Module 1v2.3 and eCTD Validation Criteria v3.1requirements
• Overcoming practical challenges presented by USModule 1 v2.3 and eCTD Validation Criteria v3.1
• Understanding how FDA requests for eCTDsubmissions compare to Europe and keydifferences
Participants
Olga Alfieri, Eisai, USA
Networking and afternoon tea
15:10 - 15:40Main agenda
Serialisation workshop: Examining strategiesto overcome labelling challenges resultingfrom increasing serialisation and codingrequirements
15:40 - 16:50Pharmaceutical Labelling
• An overview of the Falsified Medicines Directive:how will this impact serialisation requirements?
• Highlighting Commission Delegated Regulation(EU) 2016/161
• Assessing different ways of implementingserialisation on products
• Examining serialisation requirements around theglobe
• Serialisation in the US: examining the status so farand understanding the lessons learnt - Avastin
Participants
Horst Kastrup, MEDA Pharma GmbH & Co. KG
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 2 - 19/10/2016
Global Pharmaceutical RegulatoryAffairs Summit
18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
Implementing a revised ICH GCP in EmergingMarkets: Developing EU & FDA RiskManagement Plans Appropriate to EmergingMarkets
15:40 - 16:15Emerging Markets PLENARY SESSION
• Developing a systematic approach to riskmanagement for medicinal products developedacross regulatory regions
• The ICH revision and the importance of EU andFDA guidances for emerging markets
• Specific approaches to evaluating proportionaterisk in emergingmarkets
• The role of the sponsor and the role of the CRO inRisk Based Monitoring in emerging markets
• A perspective-based approach to risk managementin implementing and monitoring clinical trials inemerging markets
Participants
Francis P. Crawley, Good Clinical Practice Alliance –Europe (GCPA), Belgium
Presentation to be delivered by NNIT
15:40 - 16:15Global eSubmissions
Health agency interactions in emergingmarkets across the globe; availablepossibilities, timings of advice and its impacton overall regulatory strategy
16:15 - 16:50Emerging Markets PLENARY SESSION
• Mandatory vs optional health agency interactions• Different options available to get advice• How to prepare – role of local affiliates• Regional / local cultural aspects to be considered
Participants
Ayaz Khan, Grünenthal GmbH, Germany
GLOBAL eSUBMISSIONS COLLABORATIONZONE
16:15 - 17:25Global eSubmissions
Save your questions from the session and join a roundtable dedicated to your region of choice. Join thespeaker and other attendees as they shareexperiences on the challenges faced in a highlyinteractive environment.
Participants
Wesal Haqaish, Jordan FDA, Jordan
Mohanned El Khider, Ministry of Health, Oman
Nathalie Mueller-Andriamboavonjy, Incyte, Switzerland
Jens Pantke, F. Hoffmann-La Roche Ltd. Switzerland
Carolline Petersen, Novo Nordisk A/S, Denmark
Out of industry perspective: Developing acommon corporate culture across establishedand emerging markets
16:50 - 17:25Emerging Markets PLENARY SESSION
• Corporate culture: what is it and how do we share itthroughout the company and with affiliates?
• Developing communication strategies forimplementing and sharing a risk-based approachto clinical trials
• Achieving a culture of science and a culture ofethics within a robustbusiness model
• Breaking down silos and implementing asuccessful information transfer system acrosscorporate groups and with affiliates
Participants
Chie Misumi, Intercultural Communication Specialist
Case study: Successfully outsourcingregulatory publishing and overcoming keychallenges – one year on
17:25 - 18:00Global eSubmissions
• Sharing practical experiences with outsourcing andthe pros and cons
• Identifying which activities should be outsourcedand which should be retained in house
• Insourcing versus outsourcing• Ensuring organisational structure and roles
successfully accommodate the chosen sourcingmodel
Participants
Richard Knowles, Ipsen Biopharm Limited, UK
End of conference day two
17:25 - 17:25Main agenda
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 2 - 19/10/2016
Global Pharmaceutical RegulatoryAffairs Summit
18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
TIME MAIN AGENDA EMERGING MARKETSPLENARY SESSION
EMERGING MARKETSSTREAM 1: RUSSIA, CIS,TURKEY, MIDDLE EAST &AFRICA
EMERGING MARKETSSTREAM 2: LATINAMERICA & ASIA-PACIFIC
GLOBAL ESUBMISSIONS PHARMACEUTICALLABELLING
09:00 09:00 - Opening remarks fromthe Chairperson
09:10 - Case study: Bestpractice for normativedocument preparation
09:45 - Practically conductingclinical trials in Russia and theimpact of separating clinicaltrials from registrationprocedures under Federal LawNo. 429-FZ
09:10 - Product registrationand latest regulatory updatesin China: Challenges andopportunities
09:45 - China extendedsession
09:10 - Ministry of Healthperspective: Latest updatesand progress for eCTDsubmissions in Oman
09:45 - Saudi FDA perspective:Latest updates and progressfor eCTD submissions in SaudiArabia
09:10 - Industry case study:Practically Implementinglabelling updates to achieveglobal level approval
09:45 - Assessing theimportance of translation andreadability when updatinglabelling globally
10:00 10:55 - Networking andmorning coffee
10:20 - Clinical trials ofmedicines: Current regulatoryenvironment and updated localregulations in Ukraine
10:20 - Case study: Beststrategies for successfulproduct registration in India
10:20 - Latest updates andprogress for eSubmissions inJordan
10:50 - PharmaceuticalLabelling presentationdelivered by Schlafender Hase
11:00 11:25 - INTERACTIVEROUNDTABLES: Sharingexperiences with conductinglocal clinical trials in Russiaand CIS
11:25 - Exploring theregulatory framework andconsiderations for successfulproduct registration in SouthKorea
11:25 - Examining latestupdates and sharingexperiences with submittingeCTD in Australia
11:25 - Panel discussion:Overcoming the challenges ofimplementing global levelupdates - improvingcommunication andcooperation
12:00 12:35 - Networking lunch 12:00 - Reviewing labellingrequirements and overcomingchallenges in Russia and theCIS markets
12:00 - Clarifying Taiwan’sregulatory framework andpractical advice for productregistration
12:00 - China: Latest updatesand sharing experiences withsubmitting eCTD
12:00 - Reviewing labellingrequirements and overcomingchallenges in Russia and theCIS markets
13:00
SCHEDULEREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMA LABELLING DAY 2 - 19/10/2016
Global Pharmaceutical Regulatory Affairs Summit18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
TIME MAIN AGENDA EMERGING MARKETSPLENARY SESSION
EMERGING MARKETSSTREAM 1: RUSSIA, CIS,TURKEY, MIDDLE EAST &AFRICA
EMERGING MARKETSSTREAM 2: LATINAMERICA & ASIA-PACIFIC
GLOBAL ESUBMISSIONS PHARMACEUTICALLABELLING
14:00 14:00 - RUSSIA AND CISCOLLABORATION ZONE
14:00 - Reviewing latestregulatory progress in theASEAN countries and impacton industry
14:35 - Case study: Successfulproduct registration and latestregulatory requirements inJapan
14:00 - Examining the latestprogress towards eCTDsubmissions in Thailand
14:35 - Outlining latestupdates on the new USModule 1 v2.3 and practicalimplications for industry
14:00 - Examining the currentstatus of the FalsifiedMedicines Directive and thecurrent challenges being facedby industry
14:35 - Spotlight Presentation-Please contact AlexanderZenonos for more information:[email protected] call +44 (0) 20 701 77742
15:00 15:10 - Networking andafternoon tea
15:40 - Implementing a revisedICH GCP in Emerging Markets:Developing EU & FDA RiskManagement PlansAppropriate to EmergingMarkets
15:40 - Presentation to bedelivered by NNIT
15:40 - Serialisation workshop:Examining strategies toovercome labelling challengesresulting from increasingserialisation and codingrequirements
16:00 16:15 - Health agencyinteractions in emergingmarkets across the globe;available possibilities, timingsof advice and its impact onoverall regulatory strategy
16:50 - Out of industryperspective: Developing acommon corporate cultureacross established andemerging markets
16:15 - GLOBALeSUBMISSIONSCOLLABORATION ZONE
SCHEDULEREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMA LABELLING DAY 2 - 19/10/2016
Global Pharmaceutical Regulatory Affairs Summit18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
TIME MAIN AGENDA EMERGING MARKETSPLENARY SESSION
EMERGING MARKETSSTREAM 1: RUSSIA, CIS,TURKEY, MIDDLE EAST &AFRICA
EMERGING MARKETSSTREAM 2: LATINAMERICA & ASIA-PACIFIC
GLOBAL ESUBMISSIONS PHARMACEUTICALLABELLING
17:00 17:25 - End of conference daytwo
17:25 - Case study:Successfully outsourcingregulatory publishing andovercoming key challenges –one year on
SCHEDULEREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMA LABELLING DAY 2 - 19/10/2016
Global Pharmaceutical Regulatory Affairs Summit18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
Opening remarks from the Chairperson
09:00 - 09:10Main agenda
WORKSHOP: Best practices for creating aCCDS suitable for global implementation
09:10 - 10:30Pharmaceutical Labelling
• Examining possible approaches to the structureand content of a CCDS
• Understanding commonalities and differences inlabelling requirements
• Managing creation of CCDS content andassignment of reference safety information
• Defining principles for implementation of CCDSinto local labelling
• Creating adequate documentation to supportsubmission of new or updated labelling to healthauthorities
Participants
Barbara Lachmann, Lachmann Consulting
Practical advice for product registration andregulatory updates from the Gulf CooperationCouncil (GCC)
09:10 - 09:45Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Reviewing the current regulatory environment inSaudi Arabia, Oman and the UAE
• Current regulatory updates and product registrationin Oman
• Outlining requirements for filing variations in theGCC
• Practical advice when registering in the GCCregion, including documentation requirements andtimelines
• Clarifying the current status of the centralisedregistration procedure in the GCC and overview ofhow it works
Participants
Abid Hussain, Saudi Pharmaceutical Industries – SPI,Saudi Arabia
Working globally and adapting to requirementsin emerging markets with a focus on LatinAmerica
09:10 - 09:45Emerging Markets Stream 2: Latin America & Asia-Pacific
• Sharing strategies for working globally andadapting to emerging market requirements
• Focusing on Latin America
Participants
Andrea Herrmann, Merck KGaA, Germany
Understanding the updated EMA timelines forIDMP Iteration 1 and impact of a phasedimplementation approach on industry
09:10 - 09:45Global eSubmissions
• Clarifying the current status and timelinesassociated with:
• Publication of EU Implementation Guides• Start of implementation of Iteration 1 for products
and substances• Enforcement of Iteration 1 for products and
substances• Assessing the scope of Iterations 1, 2, 3 and 4 and
the impact a phased approach will have on industry• Reviewing latest priorities and updates from the
EMA
Participants
Andrew P Marr, Marr Consultancy Ltd., UK
Latest regulatory updates and practicallyregistering in Jordan
09:45 - 10:20Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Reviewing the latest regulatory requirements andany recent updates
• Registering in Jordan, including documentationrequirements and timelines
• Outlining requirements for filing variations inJordan
• Understanding the degree of alignment toEuropean regulations
• Overcoming key regulatory challenges
Participants
Syndie Messager, Laboratorios Cinfa
Ensuring specific stability data requirementsare met in Latin America
09:45 - 10:20Emerging Markets Stream 2: Latin America & Asia-Pacific
• Outlining the specific dossier requirements forstability data in Latin America
• Case examples of stability data requested andprovided
• Overcoming challenges with specific stabilityrequirements and long timelines for studies
Participants
Meike Vanhooren, Pfizer, Germany
FDA perspective: Update on the GSRS and itsuse at FDA
09:45 - 10:20Global eSubmissions
Participants
Larry Callahan, FDA, USA
Reviewing current Africa regulatoryharmonisation initiatives and practical adviceon product registration
10:20 - 10:55Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Understanding latest harmonisation initiatives forregulatory requirements across Africa
• Key considerations for submission includingdocumentation requirements and how these varybetween different countries/regions.
• Collaborative registration procedure based on theapproval of a Stringent Regulatory Authority (SRA) -Experience from pilot of Janssen drugs in severalAfrican countries.
Participants
Mercè Caturla, Janssen Pharmaceutica N.V., Belgium
Reviewing labelling and packagingrequirements and overcoming challenges inAsia-Pacific
10:20 - 10:55Emerging Markets Stream 2: Latin America & Asia-Pacific
• Understanding the requirements for labelling andpackaging in Asia-Pacific
• Examining the use of multi-language labelling andpackaging in Asia-Pacific
• Successfully using standard export packageinserts
• Overcoming key challenges
Participants
Ching Li, Biotest Pharma GmbH, Germany
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 3 - 20/10/2016
Global Pharmaceutical RegulatoryAffairs Summit
18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
Presentation to be delivered by AMPLEXOR
10:20 - 10:55Global eSubmissions
Networking and morning coffee
10:55 - 11:25Main agenda
Overcoming challenges for successful productregistration in South Africa
11:25 - 12:00Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Current regulatory environment in South Africa andany upcoming or recent changes
• Best strategies for registering in South Africaincluding managing the long timelines involvedwith the approval process
• Overcoming the challenge of long approvaltimelines for registration of different productstrengths or forms
• Latest update on eCTD implementation in SouthAfrica and the 1 June 2016 deadline
• Outlining the extent to which submissions in SouthAfrica are similar to the European style
Participants
Merle Scher, Merck, South Africa
ASIA-PACIFIC COLLABORATION ZONE
11:25 - 12:35Emerging Markets Stream 2: Latin America & Asia-Pacific
Round table 1: China
Round table 2: India
Round table 3: South Korea
Round table 4: Taiwan
Round table 5: ASEAN countries
Participants
Joe Zhou, Genor BioPharma, China
Alan Chalmers, Pharma International, Switzerland
Kamani Gopalakrishna , Boehringer Ingelheim PharmaGmbH & Co. KG, Germany
Eric Ducamp, Ipsen, France
Cécile Vareilles, Ipsen, France
Inês Pinto, Actelion Pharmaceuticals Ltd., Portugal
Flash presentation: Case study – successfullypreparing for IDMP implementationirrespective of the delay
11:25 - 11:40Global eSubmissions
• Discussing the strategy taken with the IDMPproject following the updated EMA timelines
• Examining how the updated IDMP timelines can beleveraged to improve business operations
• Outlining any adjustments which were made andhow these were carried out
• Understanding the importance of steps that can betaken at this stage to ensure preparation andreadiness for a phased implementation approach
• Exploring whether any funding or staffing has beenscaled down and which parts of the project havebeen kept going
WORKSHOP: PART TWO: Best practices forcreating a CCDS suitable for globalimplementation
11:25 - 12:00Pharmaceutical Labelling
• Examining possible approaches to the structureand content of a CCDS
• Understanding commonalities and differences inlabelling requirements
• Managing creation of CCDS content andassignment of reference safety information
• Defining principles for implementation of CCDSinto local labelling
• Creating adequate documentation to supportsubmission of new or updated labelling to healthauthorities
Participants
Barbara Lachmann, Lachmann Consulting
Flash presentation: Case study – successfullypreparing for IDMP implementationirrespective of the delay
11:40 - 12:00Global eSubmissions
• Discussing the strategy taken with the IDMPproject following the updated EMA timelines
• Examining how the updated IDMP timelines can beleveraged to improve business operations
• Outlining any adjustments which were made andhow these were carried out
• Understanding the importance of steps that can betaken at this stage to ensure preparation andreadiness for a phased implementation approach
• Exploring whether any funding or staffing has beenscaled down and which parts of the project havebeen kept going
Participants
Quentin Grignet, GSK, Belgium
Outlining the regulatory framework in NorthAfrica and practical advice for market entry
12:00 - 12:35Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Assessing the current regulatory environment inNorth Africa and any recent or upcoming changes
• Exploring key considerations for submissionincluding documentation requirements andtimelines
• Successfully providing registration samples soauthorities can reproduce analytical methods used
• Overcoming other key regulatory challenges
Participants
Abdul Mateen, AstraZeneca, UK
Flash presentation: Case study – successfullypreparing for IDMP implementationirrespective of the delay
12:00 - 12:15Global eSubmissions
• Discussing the strategy taken with the IDMPproject following the updated EMA timelines
• Examining how the updated IDMP timelines can beleveraged to improve business operations
• Outlining any adjustments which were made andhow these were carried out
• Understanding the importance of steps that can betaken at this stage to ensure preparation andreadiness for a phased implementation approach
• Exploring whether any funding or staffing has beenscaled down and which parts of the project havebeen kept going
Participants
Costas Mistrellides, Regulatory Affairs Executive, UK
Company Core Data Sheet Industry case study
12:00 - 12:35Pharmaceutical Labelling
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 3 - 20/10/2016
Global Pharmaceutical RegulatoryAffairs Summit
18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
Flash presentation: Case study –understanding how the updated IDMPtimelines can be leveraged to improvebusiness operations
12:15 - 12:35Global eSubmissions
• Outlining the strategy taken with the IDMP projectfollowing the updated EMA timelines
• Exploring how the updated IDMP timelines can beleveraged to improve business operations
• Reviewing any adjustments which were made andhow these were carried out
• Highlighting the importance of steps that can betaken at this stage to ensure preparation andreadiness for a phased implementation approach
• Discussing whether any funding or staffing hasbeen scaled down and which parts of the projecthave been kept going
Participants
Jakob Juul Rasmussen, Independent Consultant,Denmark
Networking lunch
12:35 - 14:00Main agenda
Case study: Overcoming the challenge of GMPinspections in Turkey
14:00 - 14:35Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Understanding the regulatory guidance availablefor GMP site audits
• Addressing the long timelines involved with GMPsite audits and how long it takes to get approvalafterwards
• Exploring the documentation which must beprepared for GMP site audits and other specificrequirements
• Reviewing whether and when procedures for GMPinspections in Turkey will change
Participants
Özdemir Şengören, UCB Pharma A.S., Turkey
Best practice for filing a variation and gainingapproval in Asia-Pacific
14:00 - 14:35Emerging Markets Stream 2: Latin America & Asia-Pacific
• Outlining key requirements for filing variations inAsia-Pacific
• Clarifying classification of variations and whetherthis is harmonised across countries in Asia-Pacific
• Exploring the timelines to get approval forvariations
• Overcoming the key challenges associated withfiling variations in Asia-Pacific
Participants
Judith Rupprecht, Mundipharma Research GmbH & CoKG, Germany
Flash case study – understanding how theupdated IDMP timelines can be leveraged toimprove business operations
14:00 - 14:15Global eSubmissions
• Outlining the strategy taken with the IDMP projectfollowing the updated EMA timelines
• Exploring how the updated IDMP timelines can beleveraged to improve business operations
• Reviewing any adjustments which were made andhow these were carried out
• Highlighting the importance of steps that can betaken at this stage to ensure preparation andreadiness for a phased implementation approach
• Discussing whether any funding or staffing hasbeen scaled down and which parts of the projecthave been kept going
Participants
Patrick Middag, Bristol-Myers Squibb, Belgium
Effective labelling as a tool for patient safety
14:00 - 14:35Pharmaceutical Labelling
• Why is effective labelling important? Safeguardingpatient safety
• Training patients on how to read labels• Educating patients on how to recognise side
effects and report to their doctor• The importance of patient -doctor communication• Collaboration between patient organisations and
the EMA• Collaboration between patient organisation and
companies• What needs to be done to improve the existing
situation?
Participants
Souzi Makri, EUPATI Fellow
Flash Case Studies Q&A Session
14:15 - 14:35Global eSubmissions
Joined by speakers from the session
Exploring local manufacturing in the GCC as anopportunity for faster generics registration
14:35 - 15:10Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Current status of local manufacturing in the GCC• Understanding how this impacts generics
registration
Participants
Ibrahim Harb, Abbott, USA
Case study: Best practice for filing a variationand gaining approval in Asia-Pacific
14:35 - 15:10Emerging Markets Stream 2: Latin America & Asia-Pacific
• Reviewing best strategies for filing variations inAsia-Pacific
• Overcoming key challenges experienced
Participants
Ching Li, Biotest Pharma GmbH, Germany
SME perspective: Understanding the strategiesand key challenges associated with getting anIDMP project started
14:35 - 15:10Global eSubmissions
• Exploring strategies and recommendations forgetting an IDMP project started
• Determining how the project was set up and wherethe company governance is located
• Spreading the understanding and implications ofIDMP to internal stakeholders
• Overcoming key challenges with starting an IDMPproject
Participants
Sue Metz, PAREXEL
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 3 - 20/10/2016
Global Pharmaceutical RegulatoryAffairs Summit
18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
Examining the patient perspective: Improvingpharmaceutical labels
14:35 - 15:10Pharmaceutical Labelling
• Patient Information Leaflets: What should they looklike in an ideal world?
• Key recommendations for improving the PIL andexamining the implications for industry
• Ensuring PILs are as patient friendly as possible• Effectively conveying crucial & complex
information
Participants
Anne Lenihan, Pfizer
Networking and afternoon tea
15:10 - 15:40Main agenda
Exploring regulatory requirements forregistration of biosimilars in MENA
15:40 - 16:15Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Reviewing current regulatory requirements anddefinitions in place for biosimilars
• Examining the criteria for biosimilarity and howsimilar a product must be to be considered abiosimilar
• Case examples of successful biosimilarsregistration in MENA
• Exploring which regulatory pathways to take forproduct approval
• Understanding expectations for extrapolatingindications for biosimilars
Participants
Helmut Brunar, PassionBio – Creating Ventures,Austria
Evolving regulatory requirements for biosimilarregistrations in Asia-Pacific
15:40 - 16:15Emerging Markets Stream 2: Latin America & Asia-Pacific
• Exploring current regulatory requirements anddefinitions in place for biosimilars
• Examining the criteria for biosimilarity and howsimilar a product must be to be considered abiosimilar
• Best practice for successful biosimilarsregistration in Asia-Pacific
• Exploring which regulatory pathways to take forproduct approval
• Understanding expectations for extrapolatingindications for biosimilars
Participants
Rodeina Challand, Challand Biosimilar Consulting, UK
Case study: Practically implementing a MasterData Governance approach to overcome IDMPchallenges
15:40 - 16:15Global eSubmissions
• Assessing your current state• Establishing Internal Governance• Planning system related changes for improved
data management
Participants
Wil Foster, Eisai Limited, UK
Examining readability and usability of the PILand SmPC
15:40 - 16:15Pharmaceutical Labelling
• Evaluating current EU guidelines surrounding thePIL and SmPC
• Readability: assessing what information should bedisplayed and how it should be structured
• Examining the PIL and other mechanisms to getlabelling information to patients – getting accurateinformation to the end user in a language theyunderstand
Participants
Em Stevens, B.Braun Melsungen AG
Case study: Practical advice for successfulgenerics registration in MENA
16:15 - 16:50Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Case examples of successful generic productsregistration in MENA
• Examining successful documentation preparationfor generics
• Reviewing the timelines for obtaining approval• Stability study requirements for generics in MENA• Overcoming key regulatory pitfalls for registration
of generics
Participants
Anna Roznovska, PRO.MED.CS, Czech Republic
Latest updates and progress on controlledvocabularies for successful IDMPimplementation
16:15 - 16:50Global eSubmissions
• Understanding the importance of updatingcontrolled vocabularies for IDMP implementation
• Examining the current status of controlledvocabulary projects
• Exploring tools available to help map textual datawith IDMP’s controlled vocabularies
• Outlining key challenges faced and advice on howthese can be overcome
Participants
Andrew P Marr, Marr Consultancy Ltd., UK
An update on the EC report on readability ofthe SmPC
16:15 - 16:50Pharmaceutical Labelling
• Examining the current status of the report• Discussing implications for industry
Participants
Dominique Westphal, Paul Ehrlich Institute, Germany
Case study: Best practice for generic productregistration in Asia-Pacific
16:15 - 16:50Emerging Markets Stream 2: Latin America & Asia-Pacific
• Case examples of successful registration ofgeneric products in Asia-Pacific
• Examining the preparation of documents forgenerics
• Reviewing the timeline for getting approval forgenerics in Asia-Pacific
• Clarifying stability study requirements for generics
Participants
Pelin Boran, Pelin Boran Regulatory Affairs Solutions &Consultancy, Turkey
End of conference Stream 2 - please feel freeto move to Stream 1
16:50 - 16:50Main agenda
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 3 - 20/10/2016
Global Pharmaceutical RegulatoryAffairs Summit
18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
TURKEY AND MENA COLLABORATION ZONE
16:50 - 18:00Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
Round table 1: GCC
Round table 2: Jordan
Round table 3: Iran
Round table 4: Africa
Round table 5: Turkey
Participants
Abid Hussain, Saudi Pharmaceutical Industries – SPI,Saudi Arabia
Syndie Messager, Laboratorios Cinfa
Wesal Haqaish, Jordan FDA, Jordan
Abdul Mateen, AstraZeneca, UK
Merle Scher, Merck, South Africa
Mercè Caturla, Janssen Pharmaceutica N.V., Belgium
Özdemir Şengören, UCB Pharma A.S., Turkey
Erhan Baş, Bilim Pharmaceuticals, Turkey
Tine Vermeulen, PLANPHARMA, Belgium
IDMP EXPERIENCE EXCHANGE ROUNDTABLES
16:50 - 17:25Global eSubmissions
In this interactive session, attendees will be split intosmall groups enabling them to share experiences andsolutions to common problems in an informalenvironment.
• How has the updated EMA timelines for IDMPimplementation impacted industry?
• Which parts of IDMP projects have companies keptgoing? Has any funding or staffing been scaleddown?
• To what extent is the delay being leveraged tooptimise business operations?
• Overcoming key challenges and concerns
End of conference
18:00 - 18:00Main agenda
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 3 - 20/10/2016
Global Pharmaceutical RegulatoryAffairs Summit
18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
TIME MAIN AGENDA EMERGING MARKETS STREAM1: RUSSIA, CIS, TURKEY,MIDDLE EAST & AFRICA
EMERGING MARKETS STREAM2: LATIN AMERICA & ASIA-PACIFIC
GLOBAL ESUBMISSIONS PHARMACEUTICAL LABELLING
09:00 09:00 - Opening remarks from theChairperson
09:10 - Practical advice for productregistration and regulatory updatesfrom the Gulf Cooperation Council(GCC)
09:45 - Latest regulatory updates andpractically registering in Jordan
09:10 - Working globally and adaptingto requirements in emerging marketswith a focus on Latin America
09:45 - Ensuring specific stabilitydata requirements are met in LatinAmerica
09:10 - Understanding the updatedEMA timelines for IDMP Iteration 1and impact of a phasedimplementation approach on industry
09:45 - FDA perspective: Update onthe GSRS and its use at FDA
09:10 - WORKSHOP: Best practicesfor creating a CCDS suitable forglobal implementation
10:00 10:55 - Networking and morningcoffee
10:20 - Reviewing current Africaregulatory harmonisation initiativesand practical advice on productregistration
10:20 - Reviewing labelling andpackaging requirements andovercoming challenges in Asia-Pacific
10:20 - Presentation to be deliveredby AMPLEXOR
11:00 11:25 - Overcoming challenges forsuccessful product registration inSouth Africa
11:25 - ASIA-PACIFICCOLLABORATION ZONE
11:25 - Flash presentation: Casestudy – successfully preparing forIDMP implementation irrespective ofthe delay
11:40 - Flash presentation: Casestudy – successfully preparing forIDMP implementation irrespective ofthe delay
11:25 - WORKSHOP: PART TWO: Bestpractices for creating a CCDSsuitable for global implementation
12:00 12:35 - Networking lunch 12:00 - Outlining the regulatoryframework in North Africa andpractical advice for market entry
12:00 - Flash presentation: Casestudy – successfully preparing forIDMP implementation irrespective ofthe delay
12:15 - Flash presentation: Casestudy – understanding how theupdated IDMP timelines can beleveraged to improve businessoperations
12:00 - Company Core Data SheetIndustry case study
SCHEDULEREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMA LABELLING DAY 3 - 20/10/2016
Global Pharmaceutical Regulatory Affairs Summit18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs
TIME MAIN AGENDA EMERGING MARKETS STREAM1: RUSSIA, CIS, TURKEY,MIDDLE EAST & AFRICA
EMERGING MARKETS STREAM2: LATIN AMERICA & ASIA-PACIFIC
GLOBAL ESUBMISSIONS PHARMACEUTICAL LABELLING
13:00
14:00 14:00 - Case study: Overcoming thechallenge of GMP inspections inTurkey
14:35 - Exploring local manufacturingin the GCC as an opportunity forfaster generics registration
14:00 - Best practice for filing avariation and gaining approval inAsia-Pacific
14:35 - Case study: Best practice forfiling a variation and gaining approvalin Asia-Pacific
14:00 - Flash case study –understanding how the updated IDMPtimelines can be leveraged toimprove business operations
14:15 - Flash Case Studies Q&ASession
14:35 - SME perspective:Understanding the strategies and keychallenges associated with getting anIDMP project started
14:00 - Effective labelling as a toolfor patient safety
14:35 - Examining the patientperspective: Improvingpharmaceutical labels
15:00 15:10 - Networking and afternoon tea 15:40 - Exploring regulatoryrequirements for registration ofbiosimilars in MENA
15:40 - Evolving regulatoryrequirements for biosimilarregistrations in Asia-Pacific
15:40 - Case study: Practicallyimplementing a Master DataGovernance approach to overcomeIDMP challenges
15:40 - Examining readability andusability of the PIL and SmPC
16:00 16:50 - End of conference Stream 2 -please feel free to move to Stream 1
16:15 - Case study: Practical advicefor successful generics registration inMENA
16:50 - TURKEY AND MENACOLLABORATION ZONE
16:15 - Case study: Best practice forgeneric product registration in Asia-Pacific
16:15 - Latest updates and progresson controlled vocabularies forsuccessful IDMP implementation
16:50 - IDMP EXPERIENCEEXCHANGE ROUND TABLES
16:15 - An update on the EC report onreadability of the SmPC
17:00
18:00 18:00 - End of conference
SCHEDULEREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMA LABELLING DAY 3 - 20/10/2016
Global Pharmaceutical Regulatory Affairs Summit18 - 20 October 2016Maritim proArte Hotel
Berlin
lifesciences.knect365.com/global-pharma-regulatory-affairs