MEDICAL DEVICE REGULATIONS SUMMIT 2020 - Qepler€¦ · MEDICAL DEVICE REGULATIONS SUMMIT 2020 September 22-23 | Prague, Czech Republic Bijan Elahi Award Winning International Medical

MEDICAL DEVICEREGULATIONSSUMMIT2020

September 22-23, 2020 | Prague, Czech Republic

◆ 10+ Program Hours | 8+ Networking Hours◆ Refreshments & Coffee Breaks◆ Business Lunches & Dinner ◆ Case Studies & Workshops◆ Roundtable Discussions | Q & A

Bijan ElahiAward Winning International Medical Device Risk-Mgmt Educator, Consultant and AuthorMedtronic, NL

Fayez Abou HamadMD Vigilance Expert – Pharmacist, Complaint & Vigilance ManagerTerumo Europe, BE

Dr. Daniel LathamHead – Device Development & LCM Novartis, CH

Dr. Clemens GüntherDirector Nonclinical Safety Consumer CareBayer AG, DE

Dr. Silke ConradQuality Expert Medical DevicesNovartis, CH

Philippe AuclairSenior Director. Regulatory Strategy and AdvocacyAbbott, BE

Dr. Max D. SinghGlobal Director – Orthopedic Focus TeamTÜV SÜD Product Service GmbH, DE

Mark A. Chipperfield, M.Sc., B.Eng.(Hons), AMIMechE, MTOPRACompany Director and Principal ConsultantCorvus Device , UK

Torsten KneussQuality Assurance Manager Combination ProductsBayer Pharma, DE

Mariano ChiusanoEMEA Director of Regulatory AffairsJohnson & Johnson, CH

Serge MathonetGlobal Regulatory Affairs CMC Biologics - Site LeaderSanofi R&D, FR

WHO YOU WILL MEET

INDUSTRIES◆ Pharmaceutical◆ Biotechnology◆ Chemical◆ Medical Devices◆ Plastics

INDUSTRIES◆ CMOs/CDMOs◆ CROs ◆ NOPs◆ Regulatory Agencies◆ Training providers◆ Other

POSITIONS◆ C-Level, Presidents, Chairs, Members of the Board & VPs◆ Vice presidents, Directors, & Heads◆ Leaders & Managers◆ Principals, Engineers, Analysts & Scientists◆ Instructors & Trainers & Teachers◆ Advisors, Coordinators, Auditors & Consultants◆ Other Professionals, Experts & Specialists

DIVISIONS◆ R&D ◆ Regulatory Affairs ◆ Risk Management ◆ Safety Management ◆ Sterilization ◆ Traceability ◆ Validation ◆ Vigilance ◆ Other

◆ IVDR ◆ MDR ◆ Medical Devices ◆ Packaging ◆ PFS ◆ Product Development ◆ QA ◆ QC

◆ CMC ◆ Combination Products ◆ Compliance ◆ Design Controls ◆ Device Design ◆ Device Engineering ◆ Device Manufacturing ◆ In-Vitro Diagnostic

🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]

SNAPSHOT OF ATTENDEES - Pre-Filled Syringes Summit 2018:- AbbVie - Accord Healthcare - Aptar Pharma - Aristo Pharma - Bayer - Becton Dickinson - Bespak Europe - Bioton - Bristol-Myers Squibb - Cambridge Consultants - Celanese - Corvus Device Datwyler - F. Hoffmann-La Roche - Flex - GlaxoSmithKline - Hekuma - HTL-STREFA - Intertek - Janssen - Laboratoire Aguettant - Medac - Merck Group - Novartis - Novo Nordisk - Pall Life Sciences - RAUMEDIC - Sanofi - SCHOTT Pharmaceutical Packaging - SHL Group - Solvias - Sonceboz - STADA Arzneimittel - Stevanato Group - Terumo Europe - TOPAS Advanced Polymers - West Pharmaceutical Services - Worrell - OthersAgenda: https://qepler.com/pdf/pfs.pdf

SNAPSHOT OF ATTENDEES - Drug/Device Combination Products Summit 2018:AbbVie - Ablynx - anteris medical - AOP Orphan Pharmaceuticals - Astellas Pharma - AstraZeneca - BIOCORP - Biogen - Boehringer Ingelheim microParts - Bristol-Myers Squibb - BSI Group - Corvus Device - Cytel - Design Science - Eli Lilly - Freelancer - GSK - H&B Electronic - H&T Presspart - Hanway Associates - Janssen - LEO Pharma - Maetrics - Medac - Medtronic - Nelson Labs - Nelson Labs Europe - Novartis - Orion Corporation - Orion Pharma - Pall Life Sciences - Pharmathen - Progress - PME - Regeneron Pharmaceuticals - Sanofi R&D - Sanofi-Aventis - sfm medical devices - Sharp Clinical Services - Spiegelberg - TERUMO EUROPE - tesa Labtec - Teva - UPM Raflatac - OthersAgenda: https://qepler.com/pdf/ddc.pdf

SNAPSHOT OF ATTENDEES - Pharmaceutical Lyophilization Summit 2019:- Bachem AG - Bayer - Bayer Pharmaceuticals - BIOCAD - BioTestLab, Ltd - Boehringer Ingelheim - Boehringer Ingelheim Animal Health - CONTIPRO a.s. - CSL Behring AG - CSLBehring GmbH - Datwyler Pharma Packaging International NV - De Montfort University - Ghent University - GOETHE Biotechnology GmbH - iQ-mobil solutions GmbH/Tempris - Janssen Pharmaceutica NV - Kingston University London - Laboratoire Aguettant - Lonza AG - Lyofal - Martin Christ Gefriertrocknungsanlagen GmbH - MediWound - MSD International - Novartis - oncomed manufacturing a.s. - Patheon - PIGO srl - Sanofi Pasteur - sfm medical devices GmbH - Shire - Skan AG - SP Scientific - Takeda - Takeda GmbH - Takeda Vaccines - UCL School of Pharmacy - Vaxxinova Int. - Weibo Hi-tech Group - OthersAgenda: http://qepler.com/pdf/lyo.pdf

https://qepler.com/pdf/pfs.pdf

https://qepler.com/pdf/ddc.pdf

http://qepler.com/pdf/lyo.pdf

MEDICAL DEVICE REGULATIONS

SUMMIT2020

September 22 | Prague, Czech Republic07:30 - 08:00 ✍ Registration and Welcome Coffee

08:00 - 08:10 🎤 Opening Address from the Chairman

08:50 - 09:30 🤝 Speed Networking

08:10 - 08:50

09:30 - 10:10

10:40 - 11:20

11:20 - 12:00

10:10 - 10:40 🍵 Morning coffee and networking break

12:00 - 13:00 🍽 Business lunch


13:00 - 13:30

TBA

Serge Mathonet | Global Regulatory Affairs CMC Biologics - Site Leader | Sanofi R&D, FR

Case Study 3 - RESERVED FOR

GlaxoSmithKline

TBA

Dr. Daniel Latham | Head – Device Development & LCM | Novartis, CH

Slot Reserved for a Gold or Silver Sponsor

Implementation of the MDR and effect on Combination Products

Mark A. Chipperfield, M.Sc., B.Eng.(Hons), AMIMechE, MTOPRA | Company Director and Principal Consultant | Corvus Device , UK


SUMMIT2020

September 22 | Prague, Czech Republic

14:30 - 15:00 🍵 Afternoon coffee and networking break

18:10 - 18:20 🎤 Chairman’s closing remarks and end of day one

19:00 - 21:00 🥂 Business dinner

13:30 - 14:10

14:10 - 14:30

15:00 - 15:40

15:40 - 16:40

17:20 -18:10 💡 Roundtable Discussion


Slot Reserved for a Booth or Bronze Sponsor

Workshop - Risk Management

Bijan Elahi | Award Winning International Medical Device Risk-Mgmt Educator, Consultant and author | Medtronic, NL

EU MDR Vigilance System – EU Vigilance Decision Tree and Optimal Set Up

Fayez Abou Hamad | MD Vigilance Expert – Pharmacist, Complaint & Vigilance Manager | Terumo Europe, BE

16:40 -17:20

Updating the QMS to MDR

◆ MDR – Main changes◆ QMS gap analysis on existing combination product/medical device processes and action plan◆ Step wise implementation

Dr. Silke Conrad | Quality Expert Medical Devices | Novartis, CH

TBA

Torsten Kneuss | Quality Assurance Manager Combination Products | Bayer Pharma, DE

Relation between manufacturers and Notified Bodies

◆ Implementation of the regulation is just starting◆ The current environment is fluid ◆ Both manufacturers and Notified bodies are learning◆ Review of the challenges seen◆ How to overcome them

Philippe Auclair | Senior Director. Regulatory Strategy and Advocacy | Abbott, BE


SUMMIT2020

September 23 | Prague, Czech Republic08:00 - 08:30 ✍ Registration and Welcome Coffee

08:30 - 08:40 🎤 Opening Address from the Chairman

08:40 - 09:20

10:30 - 10:50

09:20 - 10:00


10:00 - 10:30 🍵 Morning coffee and networking break

10:50 - 11:50

Slot Reserved for a Speaking Sponsor

11:50 - 12:50 🍽 Business lunch

12:50 - 13:30 Case Study - RESERVED FOR

Zimmer Biomet

EUDAMED, The European Medical Device Database. Current Status and Future Developments

EUDAMED, the European Medical Device Database of Medical Devices is one of the most significant changes introduced by the new European Medical Device Regulations on Medical Devices (MDR) and In Vitro Diagnostics Medical Devices (IVDR). As the core of the new regulatory system of MDR and IVDR, a lot of resources and efforts have already been spent by the EU Commission and different stakeholders to design, build, validate and further develop the database. This presentation will analyze the current status of EUDAMED and future improvements of one of the most challenging European Initiatives ever introduced in the medical device sector.

Mariano Chiusano | EMEA Director of Regulatory Affairs | Johnson & Johnson, CH

Workshop - EU MDR Post Market Surveillance – Requirements and Lessons Learned

Fayez Abou Hamad | MD Vigilance Expert – Pharmacist, Complaint & Vigilance Manager | Terumo Europe, BE


SUMMIT2020

September 23 | Prague, Czech Republic

14:30 - 15:00 🍵 Afternoon coffee and networking break

16:40 -16:50 🎤 Chairman’s closing remarks and end of day two

15:40 - 16:20

15:00 - 15:40

13:30 - 14:30 Workshop: General Safety and Performance Requirements (GSPR) according to the EU MDR

Dr. Max D. Singh | Global Director – Orthopedic Focus Team | TÜV SÜD Product Service GmbH, DE

Biocompatibility testing to meet the requirements of the EU Medical Device Regulation

◆ Understanding the principles of nonclinical safety evaluation of medical devices ◆ Clarifying the requirements for biocompatibility testing according to ISO-10993◆ Selecting an appropriate test strategy◆ How to practically apply biocompatibility testing◆ Examples and potential pitfalls

Dr. Clemens Günther | Director Nonclinical Safety Consumer Care | Bayer AG, DE

Case Study

16:20 - 16:40 💡 Q & A


BIOGRAPHIES



SUMMIT2020

September 22-23 | Prague, Czech Republic

Bijan ElahiAward Winning International Medical Device Risk-Mgmt Educator, Consultant and AuthorMedtronic, NL

Bijan Elahi has worked in risk management for medical devices for over 25 years at the largest medical device companies in the world, as well as small startups. He is currently employed at Medtronic as a Technical Fellow where he serves as the corporate expert on safety risk management of medical devices. In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide. Bijan is also a lecturer at Delft University of Technology, and Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. Bijan is a frequently invited speaker at professional conferences, and is also a contributor to ISO 14971, the international standard on the application risk management to medical devices. He is the author of the book Safety Risk Management for Medical Devices.

Fayez Abou HamadMD Vigilance Expert – Pharmacist, Complaint & Vigilance ManagerTerumo Europe, BE

Fayez is a pharmacist with more than 15 years experience in the quality assurance within the pharmaceutical and medical device industry. Since 2008, Fayez joined Terumo Europe where he held roles of increasing responsibility in maintaining quality, risk management and clinical evidence systems. In his current position, he is responsible for global complaint handling and vigilance systems. Fayez is also a certified lead auditor for medical device quality system regulations.

Dr. Daniel LathamHead – Device Development & LCM Novartis, CH

Daniel Latham is Head of Device Development Operations in Global Drug Development, Novartis, where he leads an organization responsible for developing delivery systems for combination products for new biologic entities, biosimilars and small molecules.During the past 10 years at Novartis he has overseen significant device and primary packaging developments and launches and has significantly supported the growth of device development and combination products within the organization.Prior to Novartis he working in a variety of roles in consumer healthcare focusing on the development of OTC medicines, transdermal patches and medical devices.He has a PhD in controlled drug delivery from Queen Mary’s, University of London and Bachelor and Master’s degrees in Engineering from the University of Sheffield.

Dr. Clemens GüntherDirector Nonclinical Safety Consumer CareBayer AG, DE

Dr. Clemens Günther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany. From 1990 to 2006 he started his professional career at Schering AG, Berlin-Germany.From 2007 to 2013, Dr. Clemens Günther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology. In this position, he was responsible for Nonclinical Safety for the marketed product portfolio of Bayer Dermatology as well as the global preclinical development strategy including human DMPK for development and life cycle management projects.Since integration of Intendis into Bayer in 2013, he became Director Nonclinical Safety Consumer Care within the Division of Bayer Pharmaceuticals.Meanwhile Dr. Clemens Günther has gained 29 years experience in nonclinical safety. He has been involved in nonclinical development and regulatory toxicology of small molecules, biologics, medical devices and drug device combination products.

Dr. Silke ConradQuality Expert Medical DevicesNovartis, CH

Silke Conrad is currently Quality Expert for Medical Device Development at Novartis Pharma AG. In her current role, she mainly supports medical devices and combination products from a QA perspective, negotiates and approves QA agreements and establishes and maintains QA processes for medical device development. Silke joined Novartis in 2011 as Regulatory CMC Associate Director for Biologics from the medical devices company Ypsomed AG/Switzerland, where she was leading the regulatory affairs department.Prior to Ypsomed AG, Silke worked for Sanofi-Aventis in Frankfurt/Germany and Holmes Chapel/UK holding different positions in Regulatory Affairs and Quality Assurance with main focus on biotech/biological products and combination products.Silke is a food chemist/environmental toxicologist from education and holds a doctorate degree in molecular biology/cancer research from the Technical University of Kaiserslautern/Germany.

Torsten KneussQuality Assurance Manager Combination ProductsBayer Pharma, DE

Torsten Kneuss studied Business Administration and Engineering. Since 1999 he has been working with pharmaceutical packaging materials, medical devices and combination products, including several years within the field of quality control, development, operations, and pharmacovigilance. Since November 2017 he is, as a Quality Manager Combination Products, responsible for devices and combination products within Bayer AG.

Mariano ChiusanoEMEA Director of Regulatory AffairsJohnson & Johnson, CH

Mariano Chiusano is a Chemical Engineer with more than 20 years of experience in the medical device sector covering different roles in Quality and Regulatory Affairs within Johnson & Johnson for different medical devices classes in Endo-surgery, Cardiology, Orthopedics. He has been spending the last 7 years in Diabetology expanding his experience to In vitro Medical Devices and Digital products covering the role of Legal Manufacturer for the systems for the measurement of blood glucose and insulin delivery.

BIOGRAPHIES



SUMMIT2020

September 22-23 | Prague, Czech Republic

Mark A. Chipperfield, M.Sc., B.Eng.(Hons), AMIMechE, MTOPRACompany Director and Principal ConsultantCorvus Device , UK

Mark serves as an independent consultant to the Pharma and Medical Device industries via his company Corvus Device Ltd.He has over twenty years of experience in Medical Device, Drug Delivery Device and Combination Products across Development, Operations, Regulatory/Quality Compliance and product maintenance – from a range of roles with GSK, sanofi-aventis, Novartis and F. Hoffmann-La Roche.Through his career to date he has been heavily involved in development of medical devices for combination products in several forms: syringes, pen injectors, auto-injectors, patch injectors, solution/suspension inhalers, multi-dose disposable and reusable dry powder inhalers, convenience kits, dispensers and special purpose applicators.He has performed numerous due diligence and technical evaluations of novel delivery technologies; developed products through the full design control phases to market; and maintained marketed products.Mark is a veteran of several successful IND/CTA/NDA/BLA/MAA submissions and approvals that have included drug delivery devices.He has experienced many of the challenges associated with delivery device development and device product maintenance within large pharmaceutical companies and implemented Medical Device development guidance, quality systems and business processes.Qualified with a Master’s Degree in Engineering Management from Loughborough University and a Bachelor’s Degree in Mechanical Engineering from London South Bank, he has maintained Continuous Professional Development with supplemental and progressive training in areas such as Technical, Manufacturing, Risk Management, Quality & Compliance, Technical Authorship, Project Management and Leadership.He is an active presenter in the field and has co-authored a case study chapter for PDA’s 2013 publication ‘Combination Products: Implementation of cGMP requirements’, and worked with RAPS to co-author the introduction for their 2016 publication; ‘Global Medical Device Strategy’.

Serge MathonetGlobal Regulatory Affairs CMC Biologics - Site LeaderSanofi R&D, FR

Serge is a global regulatory affairs group leader with more than 14 years of regulatory affairs experience in Chemistry, Manufacturing and Controls (CMC) focusing on biologics and biologics/device combination product development, licensing and launch/life cycle management activities. Prior to joining Global Regulatory Affairs, Serge has held various positions in Sanofi Industrial Quality Operations in API Regulatory Compliance activities either at corporate or industrial site level.Serge is a core member of EBE Biomanufacturing group leading the combination product topic groups advocating in coordination with 7 Industry groups - Medtech and Pharma.

Philippe AuclairSenior Director. Regulatory Strategy and AdvocacyAbbott, BE

Philippe represents European Industry in various European Commission expert groups and is the proud recipient of a US FDA CDRH Director’s Special Citation for his engagement with GHTF. Since 2015, he serves as an advisor to the Asian Harmonization Working Party Technical Committee.He chairs the Post Market Surveillance and the Notified Body Working Groups of association Medtech Europe.Philippe received a “Global Leadership Award” from the Regulatory Affairs Professional Society (RAPS) in 2010, has been elected “RAPS Fellow” in 2012 and is co -chair of the RAPS European Advisory Committee.

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Medical Device Regulations Summit 2020

PACKAGE NAME Register by 17.04..2020 Register by 19.06.2020 Register by 14.08.2020 Standard price

Individual ticket (2 Days) €1395 (save €500) €1595 (save €300) €1695 (save €200) €1895

Individual ticket (1 Day) €795 (save €200) €845 (save €150) €895 (save €100) €995

Group ticket ( 2-3 delegates) €1095 (save €600) €1295 (save €400) €1395 (save €300) €1695

Group ticket ( 4+ delegates ) €895 (save €700) €995 (save €600) €1095 (save €500) €1595

Non-profit organizations €695 (save €300) €795 (save €200) €895 (save €100) €995

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Documentation €499 Promotional materials distribution €699 Speaker €2495 Pop up stand €3495 Bronze €4095

Booth €5495 Silver €6995 Gold €7995

MARKETING CAMPAIGN✓Website ✓Email Marketing ✓Digital Advertising ✓Social Marketing ✓Press ✓Direct SalesPARTICIPATION FEEFees are inclusive of the 2-day summit, materials, online post-event documentation/presentation package, lunches, snacks, refreshments and business dinner. TRAVEL AND ACCOMMODATIONHotel accommodation and travel expenses are not included in the fee. Special rates for the event venue will be sent upon availability. VENUEEvent venue will be announced online and sent to the delegates within a reasonable period before the summit start date.POST-EVENT DOCUMENTATIONPresentations and other materials will be sent to the attendees within 72 hours after the event. Presentation content is subject to speaker's approval for distribution.DISCOUNTSEarly booking discounts are not valid in conjunction with any other offer.

SPONSORSHIP PACKAGES

BENEFITSSPEAKER

€2495POP UP STAND€3495

BRONZE€4095

BOOTH€5495

SILVER€6995

GOLD€7995

Number of passes included 1 1 2 2 3 4

Registration fee for additional company representatives €1295 €1295 €1195 €1195 €1095 €1095

Coupon (1 free pass for the other Qepler events) ● ●Pop up stand in the break area (3m wide x 3m height; includes 1 table, chairs, 1 electrical socket) ● ●Exhibition booth with LCD monitor for video presentations in the break area (3m wide x 3m deep; includes 1 table, chairs, 1 electrical socket)

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Opening keynote presentation 15 min

Recognition in chairman’s opening address ● ● ● ● ● ●Seat on a panel discussion ● ● ● ●Opening & closing speech ●Chairman of Day 1 ●Chairman of Day 2 ●Logo and URL on summit website, agenda and pre/post-summit communication activities ● ● ● ● ● ●Recognition on Qepler social media channels (LinkedIn/Facebook/Twitter/Instagram) ● ● ● ● ● ●Colour advert in placed in agenda 1/4 Page 1/4 Page 1/2 Page 1 Page

Company flyer/brochure included in conference folder (to be provided by sponsor) ● ● ● ●Online distribution of your company’s promotional materials to all attendees ● ● ● ●Lanyards for summit badges, notepads, pens and other promotional materials (max. 5) given to all participants and speakers (to be provided by sponsor)

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If you are unable to attend, you may purchase these packages:

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DOCUMENTATIONPost-event presentations and other materials. Presentation content is subject to speaker's approval for distribution.

€499

PROMOTIONAL MATERIALS DISTRIBUTION(Distribution of your company’s promotional materials to all attendees)

€699

◀ WAYS TO REGISTER

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PACKAGES

EVENTS CALENDAR2019 - 2021

PHARMACEUTICAL LYOPHILIZATION SUMMIT.......................................................................................................................................February 13-14, 2019Prague, Czech RepublicDiscuss best practices in tech & regulatory updates, process, formulation, testing, monitoring and new products development.http://qepler.com/pdf/lyo.pdf

HIGHLY POTENT APIs SUMMIT...................................................................................................................................................................February 20-21, 2019Berlin, GermanyAssess and reduce manufacturing and handling challenges for highly potent active pharmaceutical ingredients.https://qepler.com/pdf/hpapi.pdf

GENOTOXIC IMPURITIES IN PHARMACEUTICALS SUMMIT..........................................................................................................................April 11-12, 2019Berlin, GermanyGTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.https://qepler.com/pdf/genetoxic.pdf

INHALED DRUG DELIVERY SUMMIT...................................................................................................................................................................May 23-24, 2019Berlin, GermanyAssess and harness novel approaches to the development of inhaled drug products for enhanced patient care.https://qepler.com/pdf/inhalation.pdf

2ND ANNUAL PRE-FILLED SYRINGES SUMMIT....................................................................................................................................................June 4-5, 2019Barcelona, SpainEnhance expertise sharing in developing pre-filled syringes and provide attendees with ample networking opportunities.https://qepler.com/pdf/pfs.pdf

EXTRACTABLES & LEACHABLES SUMMIT..................................................................................................................................................October 15-16, 2019Berlin, GermanyGet the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.https://qepler.com/pdf/enl.pdfREGISTRATION IS OPEN NOW!

2ND ANNUAL DRUG/DEVICE COMBINATION PRODUCTS SUMMIT.......................................................................................................December 4-5, 2019Prague, Czech RepublicGet up to date with the regulatory and quality compliance strategies for combination product development.https://qepler.com/pdf/2ddc.pdfREGISTRATION IS OPEN NOW!

PHARMA - MEDICAL DEVICES - CHEMISTRY

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Denis PolikarpovExecutive Director

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EVENTS CALENDAR2020

2ND ANNUAL PHARMACEUTICAL LYOPHILIZATION SUMMIT.............................................................................................................February 12-13, 2020Berlin, GermanyOverviewing regulatory updates and advanced technologies, developing lyophilization process that ensure quality at all stages.http://qepler.com/pdf/2lyo.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

2ND ANNUAL HIGHLY POTENT APIs SUMMIT.........................................................................................................................................February 19-21, 2020Prague, Czech RepublicEnhancing HPAPIs manufacturing and handling via new technologies, engineering improvement and successful contamination control strategies.https://qepler.com/pdf/2hpapi.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

PHARMACEUTICAL ASEPTIC PROCESSING SUMMIT......................................................................................................................................May 19-20, 2020Prague, Czech RepublicEnsuring safe highly potent aseptic production based on new regulations and technologies implementation.https://qepler.com/pdf/ap.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

3RD ANNUAL PRE-FILLED SYRINGES SUMMIT.................................................................................................................................................May 28-29, 2020Prague, Czech RepublicImproving process development at all stages and enhancing patient safety through new drug delivery systems.https://qepler.com/pdf/3pfs.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

2ND ANNUAL INHALED DRUG DELIVERY SUMMIT............................................................................................................................September 17-18, 2020Prague, Czech RepublicEnhancing respiratory drug delivery and improving patient care through new approaches of product development and advanced technologies.https://qepler.com/pdf/2idd.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

MEDICAL DEVICE REGULATIONS SUMMIT...........................................................................................................................................September 22-23, 2020Prague, Czech RepublicExploring EU MDR and IVDR updates and preparing company for new requirements implementation.https://qepler.com/pdf/mdr.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

2ND ANNUAL EXTRACTABLES & LEACHABLES SUMMIT........................................................................................................................October 22-23, 2020Prague, Czech RepublicThe latest developments that accelerate E&L: regulatory requirements, new methodologies, study design, safety assessment.https://qepler.com/pdf/2enl.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

CLEANROOM TECHNOLOGY SUMMIT....................................................................................................................................................November 12-13, 2020Prague, Czech RepublicGet the latest updates in cleanroom technologies, new regulations, compliance strategies, engineering and design, EM and contamination control.https://qepler.com/pdf/ct.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

2ND ANNUAL GENOTOXIC IMPURITIES IN PHARMACEUTICALS SUMMIT......................................................................................November 19-20, 2020Prague, Czech RepublicGTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.https://qepler.com/pdf/2gti.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

3RD ANNUAL DRUG/DEVICE COMBINATION PRODUCTS SUMMIT.......................................................................................................December 3-4, 2020Vienna, AustriaCombination products development based on regulatory requirements, safety assurance, quality compliance and risk management excellence.https://qepler.com/pdf/3ddc.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!








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Whatsapp, Viber: +420 608 030 490


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EVENTS CALENDAR2021

3RD ANNUAL PHARMACEUTICAL LYOPHILIZATION SUMMIT..............................................................................................................February 10-11, 2021Vienna, Austria

http://qepler.com/pdf/3lyo.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

3RD ANNUAL HIGHLY POTENT APIs SUMMIT..........................................................................................................................................February 17-19, 2021Vienna, Austria

https://qepler.com/pdf/3hpapi.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

ENVIRONMENTAL MONITORING SUMMIT....................................................................................................................................................March 11-12, 2021Berlin, Germany

http://qepler.com/pdf/em.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

WEARABLE INJECTORS SUMMIT.....................................................................................................................................................................March 25-26, 2021Berlin, Germany

https://qepler.com/pdf/wi.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

2ND ANNUAL PHARMACEUTICAL ASEPTIC PROCESSING SUMMIT.............................................................................................................May 20-21, 2021Berlin, Germany

https://qepler.com/pdf/2ap.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

4TH ANNUAL PRE-FILLED SYRINGES SUMMIT.................................................................................................................................................May 27-28, 2021Vienna, Austria

https://qepler.com/pdf/4pfs.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

3ND ANNUAL INHALED DRUG DELIVERY SUMMIT............................................................................................................................September 16-17, 2021Vienna, Austria

https://qepler.com/pdf/3idd.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

2ND ANNUAL MEDICAL DEVICE REGULATIONS SUMMIT.................................................................................................................September 22-23, 2021Berlin, Germany

https://qepler.com/pdf/2mdr.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

CONTAMINATION CONTROL SUMMIT...................................................................................................................................................September 29-30, 2021Prague, Czech Republic

https://qepler.com/pdf/cc.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

CMC EXCELLENCE SUMMIT..........................................................................................................................................................................October 14-15, 2021Berlin, Germany

https://qepler.com/pdf/2cmc.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

3RD ANNUAL EXTRACTABLES & LEACHABLES SUMMIT.........................................................................................................................October 21-22, 2021Vienna, Austria

https://qepler.com/pdf/3enl.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

PHARMACEUTICAL QUALITY RISK MANAGEMENT SUMMIT................................................................................................................ October 28-29, 2021Berlin, Germany

https://qepler.com/pdf/2qrm.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

3RD ANNUAL GENOTOXIC IMPURITIES IN PHARMACEUTICALS SUMMIT.........................................................................................November 9-10, 2021Vienna, Austria

https://qepler.com/pdf/3gti.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

INTRADERMAL & TRANSDERMAL DRUG DELIVERY SUMMIT...................................................................................November 16-17, 2021Berlin, Germany

https://qepler.com/pdf/2tdd.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

2ND ANNUAL CLEANROOM TECHNOLOGY SUMMIT..........................................................................................................................November 18-19, 2021Berlin, Germany

https://qepler.com/pdf/2ct.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!

4TH ANNUAL DRUG/DEVICE COMBINATION PRODUCTS SUMMIT.......................................................................................................December 2-3, 2021Barcelona, Spain

https://qepler.com/pdf/4ddc.pdfTHE CALL FOR SPEAKERS IS OPEN NOW!








Whatsapp, Viber: +420 608 030 490




Whatsapp, Viber: +420 608 030 490


summit name to:

DRU

G D

ELIV

ERY

- FO

RMU

LATI

ON

- R&

D -

DEV

ICES

- CO

MBI

NAT

ION

PRO

DU

CTS

- PFS

- LY

OPH

ILIZ

ATIO

N -

E &

L -

IMPU

RITI

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HPA

PI -

INH

ALA

TIO

N -

ASE

PTIC

PRO

CESS

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- M

DR

- CM

C - Q

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PFS

- DD

C - E

M



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MEDICAL DEVICE REGULATIONS SUMMIT 2020 - Qepler€¦ · MEDICAL DEVICE REGULATIONS SUMMIT 2020 September 22-23 | Prague, Czech Republic Bijan Elahi Award Winning International Medical

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