Agenda – 2nd eRegulatory Submissions Summit

  • Day One
  • Day Two

Day One

 Thursday, July 12

9:00AM – 9:15AM

Chairperson’s Opening Remarks
Olga Alfieri, Director, Global Submission Management, EISAI

 Managing eCTD Requirements and Tackling Current Trends and Challenges

10:00AM – 10:45AM

The Juggling Act of Implementing Electronic Submissions at a Small Company
Michael Hellerstein, Director, Regulatory Affairs and Quality Systems, GEOVAX

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

Regulatory Sourcing in an Emerging Pharmaceutical Company
Heather Sinsel, Manager, Regulatory Operations and Submissions, INOVIO PHARMACEUTICALS

12:00PM – 12:45PM

Document Production, Document Management, Regulatory Submission Management and Regulatory Information Management
Daniel Capion, Director, Global Regulatory Operations, FERRING PHARMACEUTICALS

12:45PM – 1:45PM

Luncheon

1:45PM – 2:30PM

Module 1: Future Expectations and Practical Implications for the Industry
Olga Alfieri, Director, Global Submission Management, EISAI

2:30PM – 3:15PM

Implementing and Managing eCTD: Experiences, Solutions and Challenges
Alexis Harper, Global Head of Submission Portfolio Management, UCB

3:15PM – 3:45PM

Networking Break

 Touch on Identification of Medicinal Products and Master Regulatory Information Management

3:45PM – 4:30PM

Submission Document and Publishing Systems
Marc Stern, Director, Regulatory Processes, Operations, and Publishing, EAGLE PHARMACEUTICALS, INC.

4:30PM – 5:15PM

ANDA, CMC Criterion: Discuss Some of the Enhancements of CMC Filing Requirements in ANDA
Deborah Satoh, Head of CMC Regulatory Submission, SHIRE


Day Two

 Friday, July 13

8:00AM – 8:45AM

Continental Breakfast

8:45AM – 9:00AM

Chairperson’s Recap of Day One
Olga Alfieri, Director, Global Submission Management, EISAI

9:00AM – 9:45AM

RIM/Records Management: Building Key RIM Partnerships and Changes in Records Policy
S. Albert Edwards, President, S. ALBERT EDWARDS, PHARM.D., LTD

 Global Submission Strategy and Planning

9:45AM – 10:30AM

IDMP: Preparing for IDMP Compliance — What You Need to Know About IDMP
Sameer Thapar, Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, RUTGERS UNIVERSITY

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

AdPromo Submissions in eCTD Format
Thomas Noto, Senior Director, Regulatory Operations, LEXICON PHARMACEUTICALS

11:45AM – 12:15PM

Navigate With FDA’s New Requirements for eCTD Submissions and Managing Global Changes From eCTD Global Submissions
Moderator
Heather Sinsel, Manager, Regulatory Operations and Submissions, INOVIO PHARMACEUTICALS

12:15PM – 1:15PM

Luncheon

2:15PM – 3:00PM

Global Submission Latest Updates and Expectations of eCTD
Luke Everhart, Senior Specialist, Regulatory Operations and Submissions, INOVIO PHARMACEUTICALS