Education Session

205 - Regulatory Hot Topics - Town Hall Forum

Get Agenda 9 November 13.30-17.00
ISPE CEUs: 0.25

Tracks: RegulatoryQuality

Sponsored by the ISPE Regulatory Affairs Committee

This Town Hall Forum will provide participants the opportunity to hear brief panel presentations on relevant CMC and Quality topics by a panel of global regulators. Participants will have the opportunity to ask questions of the panel. Questions can be submitted to ISPE before the conference, but question cards will be available in the session. This is a rare opportunity to hear discussion not only on hot topics, but discussion among regulators representing different regions, regulations, and approaches. There will be an update on the ICH working group current efforts. Submit questions to Ginger Phillips at gphillips@ispe.org. Please put Regulatory Town Hall Forum Question in the subject line of your email.

How you will Benefit

At the end of this session, participants will be able to:

  • Understand global regulatory topics and perspectives
  • Explain current ICH initiatives
  • Describe regional regulatory activities related to CMC review and GMP inspections

Who Should Attend

Manufacturing industry representatives and regulatory professionals

ISPE Communities of Practice (COPs)

All

View the ISPE Community of Practice (COP) Guide

Session Leader

  • Robert Baum, PhD, Executive Director, Pfizer Inc USA

Session Presenters

  • Richard Friedman, Invited, Dir, Mfg & Product Quality, FDA/CDER USA
  • Shuntarou Fujioka, Ministry of Health, Labour and Welfare (MHLW) Japan
  • Tara Gooen, LT, PHS, Invited, Compliance Officer, FDA/CDER/DMPQ USA
  • Elaine Morefield, PhD, Division Director - DPA II, FDA/CDER/ONDQA USA
  • Jacques Morenas, Assistant Director, AFSSAPS France

Annual Meeting Sponsors