eRegulatory nd Submissions - pmaconference.com · Master GDUFA metric goals to apply to the ANDA Ensure there is proper information for justification of impurity limits, per the ANDA
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FEATURED SPEAKERS: SPECIAL FOCUS
IDMP Update on the new planning strategies for ISO IDMP
Standards Preparing for IDMP Compliance — What you need to know,
What is IDMP? How to plan for IDMP
Global Submissions Review different requirements across regions (U.S., EU,
Canada) and explore some of the key challenges Understand how EU and U.S. dossiers can be reused for
emerging market submissions Study international submissions, streamline and process,
understand the validation, why is it not clear
Regulatory Information Management Learn some of the changes in regulations and the impact in
the RIM business Gather submission management, regulatory, project
management, agency interactions, time-to-market strategies Keeping up with Regs, Technology, Data Management, Public
Perception
eCTD Streamline the implementation of eCTD and document
management Discuss Module 1and the life cycle of documentation How industry data is handled and how eCTDs are processed
“As a young professional, it is very informative and somewhat comforting to know that some of the problems I face as a company are actually industrywide.”
—Senior Regulatory Manager, KASHIV PHARMA
“Well put together and offered a lot of useful information.”—Submission Manager, BMS
eRegulatory SubmissionseRegulatory Submissions
Navigate the Regulatory Submission Landscape by Examining Regulatory Trends and Challenges for IDMP, RIM, Global and Regulatory Electronic Submissions SUMMIT
July 12-13, 2018The Sonesta Hotel | Philadelphia, PA2nd2nd
SPONSORS
CONFERENCE CHAIR Olga Alfieri,
Director, Global Submission Management, EISAI
Marc Stern, Director, Regulatory Processes, Operations, and Publishing, EAGLE PHARMACEUTICALS, INC.
Michael Hellerstein, Director, Regulatory Affairs and Quality Systems, GEOVAX
Deborah Satoh, Head of CMC Regulatory Submission, SHIRE
Alexis Harper, Global Head of Submission Portfolio Management, UCB
Daniel Capion, Director, Global Regulatory Operations, FERRING PHARMACEUTICALS
Thomas Noto, Senior Director, Regulatory Operations, LEXICON PHARMACEUTICALS, INC
VENUE INFORMATIONSonesta Philadelphia Downtown Rittenhouse Square 1800 Market St. | Philadelphia, PA 19103
To make reservations, please call 1.800.SONESTA and request the negotiated rate for ExL’s July Meetings. You may also make reservations online using the following weblink: http://bit.ly/2n4J6CI. The group rate is available until June 20, 2018. Please book your room early, as rooms available at this rate are limited.
*ExL Events is not a affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us at info@exlevents.com. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL’s reserved guest room block using the details provided.
WHO SHOULD ATTENDThis conference is specifically designed for pharma, biotech, and med device professionals responsible for:
Regulatory Affairs
Regulatory Writing/Medical Writing/Publishing/Information/Submissions
Document and eRecords Management
IDMP
Business Operations/Processing
Labeling
Clinical Trials Management/Data
Clinical Data
Publishing
Global Regulatory Operations
Outsourcing/Clinical Outsourcing/Vendor Management
Product Development
Quality Assurance/Quality Control
This event is also of interest to: CROs
Regulatory Specialists
Regulatory Publishing/Regulatory Submission Software Designers
Dear Colleague,
When the eCTD submissions became mandatory by the FDA in 2015, life science organizations became confronted with many evolving regulatory changes, trends and challenges that came with these regulations. Regulatory submissions had to include all documentation submitted for review, and it became essential to ensure the quality of each document for the regulatory submission process. The Electronic Common Technical Document (eCTD) is an interface and international specification for the pharmaceutical industry that has improved the regulatory review processes and implementation of submissions.
The 2nd eRegulatory Submissions Summit will take place on July 12-13 in Philadelphia, PA, and you will hear experiences from regulatory affair leaders who have adapted, operated and transformed into these regulations successfully. Don’t miss out on two days of reviewing format requirements, staying up to date with the industry, and current trends and challenges on eCTD, RIM, IDMP, and global submissions.
Don’t miss out on these featured sessions: Strategic Planning for Submitting Master Files and Commercial Investigational New Drug Applications in eCTD Format Regulatory Perspective: Explore How to All Be on the Same Page, Including Vendors RIM/Records Management: Building Key RIM Partnerships and Changes in Records Policy EMA Announced the New Location, November 20, 2017, Netherlands — Explore the Impact of the Industry in Light of This
Announcement ANDA, CMC Criterion: Discuss Some of the Enhancements of CMC Filling Requirements in ANDA
8:00 Registration and Continental Breakfast
9:00 Chairperson’s Opening Remarks
Olga Alfieri, Director, Global Submission Management, EISAI
Managing eCTD Requirements and Tackling Current Trends and Challenges
9:15 Strategic Planning for Submitting Master Files and Commercial Investigational New Drug Applications in eCTD Format Discuss some of the new eCTD requirements for IND and for DMF
Outline how companies are complying with the May 5, 2018 deadline and how they were fully prepared
Understand how to reduce errors and the delaying process to approval
Study IND eCTDs production and delivery strategies
David Ross, Director, Global Regulatory Affairs, ASTRAZENECA
10:00 The Juggling Act of Implementing Electronic Submissions at a Small Company Assess deciding between in-house implementation and outsourcing in a small company, where many functions are already outsourced but budgets are lean and the do-it-yourself mentality is strong
Highlight juggling eCTD implementation with numerous non-regulatory responsibilities
Outline challenges, best practices, and my experience in achieving management buy-in
Hear experiences in interpreting the sometimes opaque guidance from FDA
Michael Hellerstein, Director, Regulatory Affairs and Quality Systems, GEOVAX
10:45 Networking Break
11:15 Regulatory Sourcing in an Emerging Pharmaceutical Company Discuss strategic souring and review some sourcing examples
Explore how to all be on the same page including vendors Walk through some of the pros and cons, beneficial strategies, and pitfalls
Heather Sinsel, Manager, Regulatory Operations and Submissions, INOVIO PHARMACEUTICALS
12:00 Document Production, Document Management, Regulatory Submission Management and Regulatory Information Management Reveal some of the challenges when transitioning from paper to electronic fillings
Clarify some of the new procedures for documentation and file management
Implement some of the key factors into eCTD publishing
Daniel Capion, Director, Global Regulatory Operations, FERRING PHARMACEUTICALS
12:45 Luncheon
1:45 Module 1: Future Expectations and Practical Implications for the Industry Verify the guidance for compiling an eCTD dossier Understand specifications for compiling and validating your eCTD regulatory activity
Address how the industry data handled and how eCTDs are being processed
Examine the new U.S. Module 1 V2/3 Refine some of the regulatory experiences and errors
Olga Alfieri, Director, Global Submission Management, EISAI
2:30 Implementing and Managing eCTD: Experiences, Solutions and Challenges Explore standardized and improved regulatory affairs processes; implemented SOPs and an electronic regulatory communications management systems
Include some of the experiences occurred in implementing a new eCTD system
Develop and implement regulatory strategies and understand how to manage, and monitor regulatory processes
Review some of the challenges with outsourced manufacturing projects
Study reports and tools for the preparation of eCTD and republishing eCTD
Alexis Harper, Global Head of Submission Portfolio Management, UCB
3:15 Networking Break
Touch on Identification of Medicinal Products and Master Regulatory Information Management
3:45 Submission Document and Publishing Systems Oversee some of the challenges experienced during the transition to a new RIM system
Identify how to message senior MGE on eSubmissions infrastructure tasks and outcomes
Manage keeping up with regs, technology, data management and public perception
Marc Stern, Director, Regulatory Processes, Operations, and Publishing, EAGLE PHARMACEUTICALS, INC.
4:30 RIM/Records Management: Building Key RIM Partnerships and Changes in Records Policy Review late document arrival, a problem that has arisen Explore data standards, more requirements are coming from FDA on pharm-tox and clinical on this — a need to work back into their organization for electronic submission people
Discuss Drug Master Files, new FDA deadline of May, 2018 and clarify the various difficulties facing this industry segment, potential litigation with FDA, long-term need to comply
Assess the cost of electronic publishing systems
S. Albert Edwards, President, S. ALBERT EDWARDS, PHARM.D., LTD
5:15 Day One Concludes
Thursday, July 12, 2018 | Day OneC
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8:00 Continental Breakfast
8:45 Chairperson’s Recap of Day One
Olga Alfieri, Director, Global Submission Management, EISAI
9:00 IDMP: Preparing for IDMP Compliance — What You Need to Know About IDMP? Evaluate ISO IDMP SPOR data domains and OMS/RMS implementation
Review FDA’s future with IDMP and eCTD mandates on U.S. applications
Understand how to approach IDMP master data management
Discuss the series of IDMP standards and understand the benefits to patients and the healthcare community
Daniel Capion, Director, Global Regulatory Operations, FERRING PHARMACEUTICALS
Global Submission Strategy and Planning
9:45 ANDA, CMC Criterion: Discuss Some of the Enhancements of CMC Filling Requirements in ANDA Master GDUFA metric goals to apply to the ANDA Ensure there is proper information for justification of impurity limits, per the ANDA Impurities Guidances
Review proper CMC submission and industry-specific challenges
Deborah Satoh, Head of CMC Regulatory Submission, SHIRE
10:30 Networking Break
11:00 AdPromo Submissions in eCTD Format Disscuss the process of submitting AdPromo in eCTD Hear challenges to changing from a legacy process Understand and gain AdPromo stakeholders perspective and why it is important
Thomas Noto, Senior Director, Regulatory Operations, LEXICON PHARMACEUTICALS, INC
11:45 Navigate With FDA’s New Requirements for eCTD Submissions and Managing Global Changes From eCTD Global Submissions Establish some of the emerging marketing submission for EU and U.S. Dossiers
Review some of the requirements and preparation of new countries adopting to eCTD
Discuss recent trends and best practices for successful eCTD submission
Address key challenges of electronic filling
ModeratorHeather Sinsel, Manager, Regulatory Operations and Submissions, INOVIO PHARMACEUTICALS
12:15 Luncheon
1:15 EMA Announced the New Location, November 20, 2017, Netherlands — Explore the Impact of the Industry in Light of This Announcement Outline some of the changes that accompany this announcement
Evaluate some of the global dossier submission strategies that are occurring
Review how to submit and maintain an eCTD dossier throughout the life of a drug product
Specify regional differences
Olga Alfieri, Director, Global Submission Management, EISAI
2:15 Global Submission Latest Updates and Expectations of eCTD Navigate regulatory documents and discuss why they are getting rejected
Develop and implement process documents Discuss emerging markets, global access and marketing when the compound is submitted
Establish dossier requirements and country requirements Touch on changing evolving health authority regulations and how more countries are switching to eCTD but are experiencing confusion and conflicts
Discuss eCTD in other countries (South Africa and Canada)
Luke Everhart, Senior Specialist, Regulatory Operations and Submissions, INOVIO PHARMACEUTICALS
3:00 Conference Concludes
Friday, July 13, 2018 | Day Two
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“ As a young professional, it is very informative and somewhat comforting to know that some of the problems I face as a company are actually industry wide.”
—Senior Regulatory Manager, KASHIV PHARMA
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Registration
Registration Fees for Attending ExL’s 2nd eRegulatory Submissions SummitEARLY BIRD PRICING — Register by Friday, June 1, 2018
Conference $1,895
STANDARD PRICING — Register After Friday, June 1, 2018
Conference $2,095
ONSITE PRICING Conference $2,195
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eRegulatory SubmissionseRegulatory Submissions
July 12-13, 2018The Sonesta Hotel | Philadelphia, PA
Navigate the Regulatory Submission Landscape by Examining Regulatory Trends and Challenges for IDMP,
RIM, Global and Regulatory Electronic Submissions SUMMIT
FEATURED SPEAKERS:
CONFERENCE CHAIR Olga Alfieri, Director, Global
Submission Management, EISAI
Marc Stern, Director, Regulatory Processes, Operations, and Publishing, EAGLE PHARMACEUTICALS, INC.
Michael Hellerstein, Director, Regulatory Affairs and Quality Systems, GEOVAX
Deborah Satoh, Head of CMC Regulatory Submission, SHIRE
Alexis Harper, Global Head of Submission Portfolio Management, UCB
Daniel Capion, Director, Global Regulatory Operations, FERRING PHARMACEUTICALS
Thomas Noto, Senior Director, Regulatory Operations, LEXICON PHARMACEUTICALS, INC
SPECIAL FOCUSIDMP Global
SubmissionsRegulatory Information Management
eCTD
Update on the new planning strategies for ISO IDMP Standards
Preparing for IDMP Compliance — What you need to know, What is IDMP?
How to plan for IDMP
Review different requirements across regions (U.S., EU, Canada) and explore some of the key challenges
Understand how EU and U.S. dossiers can be reused for emerging market submissions
Study international submissions, streamline and process, understand the validation, why is it not clear
Learn some of the changes in regulations and the impact in the RIM business
Gather submission management, regulatory, project management, agency interactions, time-to-market strategies
Keeping up with Regs, Technology, Data Management, Public Perception
Streamline the implementation of eCTD and document management
Discuss Module 1and the life cycle of documentation
How industry data is handled and how eCTDs are being processed
2nd2nd
Please make checks payable to: “PMA"
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