Agenda – 2nd eRegulatory Submissions Summit

  • Day One
  • Day Two

Day One

 Tuesday, July 9

9:00AM – 10:00AM

Carousel Discussion Exercise

This conversational forum is ideal for sharing and exploring best practices. Each group is assigned a different operational challenge that professionals face. After 20 minutes, they begin a rotation in which they spend 10 minutes reading the recorded solutions of other groups, then add their own. The end product of this activity is a comprehensive digest of participants’ best practices.

10:00AM – 10:45AM

Enhanced Understanding of eCTD Formats When Submitting for INDs and DMFs
Michael Hellerstein, Director, Regulatory Affairs and Quality Systems, GEOVAX

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

Effectively Implementing Electronic Submissions
Deborah Satoh, Head of CMC Submissions, TAKEDA

12:45PM – 1:45PM

Luncheon

1:45PM – 2:30PM

Preparation and Implementation of OPDP 2253 eCTD Submissions
Suzanne Libby, Associate Manager, Regulatory Operations, AGIOS PHARMACEUTICALS

2:30PM – 3:15PM

Understand Industry Standards With Real-Life Experience
Marc Stern, Director, Regulatory Processes, Operations and Publishing, EAGLE PHARMACEUTICALS

3:15PM – 3:45PM

Networking Break

3:45PM – 4:30PM

Experiences, Challenges, and Solutions for an eCTD Management System
Brooke Czapkowski, Global Submissions Manager, PFIZER


Day Two

 Wednesday, July 10

8:00AM – 8:45AM

Continental Breakfast

9:00AM – 9:45AM

Maintain Efficiency and Cohesiveness Throughout the Submission Process
Lakshmi Ramkumar, Medical Writing Department Head, BOSTON BIOMEDICAL

9:45AM – 10:45AM

Carousel Discussion Exercise

This conversational forum is ideal for sharing and exploring best practices. Each group is assigned a different operational challenge that professionals face. After 20 minutes, they begin a rotation in which they spend 10 minutes reading the recorded solutions of other groups, then add their own. The end product of this activity is a comprehensive digest of participants’ best practices.

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

The Challenges of Supplying Information for Another Company’s Application
Michael Hellerstein, Director, Regulatory Affairs and Quality Systems, GEOVAX

12:00PM – 12:45PM

The Evolution of the Regulatory Operations Team
Sonja Justice, Director / Head, Global Regulatory Affairs Operations, AMICUS THERAPEUTICS

12:45PM – 1:45PM

Luncheon

1:45PM – 2:15PM

Understand and Maintain IDMP Compliance
Sameer Thapar , Parma, Director, Gobal Pharmacovigilance, ORACLE (HSC)

2:15PM – 3:00PM

Maintain Efficiency Through Team Management
Robert Stumpo, Director Global Regulatory Medical Writing, TEVA PHARMACEUTICALS