FDA Co-sponsored Event: Regulatory Perspectives on Hot Topics, Regulatory Trends, and Observations (E07)

4-5 June
1.2 CEUs Working Agenda
Current as of 31 March 2008
Download Working Agenda PDF, 24 KB

Co-sponsored by the FDA, these highly interactive sessions provide a forum for exchange of ideas, and an opportunity for you to hear about new initiatives, and interface with dozens of regulators. Discussions will include:

An update on implementation of Quality by Design (QbD)
QbD for legacy products
QbD for biopharmaceuticals
QbD for generics
An update on process validation and impact on ICH guidance
A continuous processing/Process Analytical Technology (PAT) case study
Quality systems and industry point of view
Regulatory GMP trends, domestic and worldwide
An update on Preapproval Inspections (PAI) field center role
A case study on how a PAI inspection went bad
Risk-based approach to post approval changes

Above the standard question and answer sessions, there will be a Town Hall Forum where you can pose questions directly to regulators and receive candid assessments of your concerns.

The session also features a live report from concurrent International Conference on Harmonization (ICH) meetings taking place.

Program Committee

FDA:

Joseph Famulare, Deputy Director, FDA, USA
Richard Friedman, Director, DMPQ, FDA/CDER, USA
David Morely, Office of New Drug Quality Assessment (ONDQA), Center for Drug Evaluation and Research, FDA, USA
Moheb Nasr, PhD, Director, ONDQA, FDA/CDER/ONDQA, USA

Industry:

Paul D’Eramo, Executive Director, Johnson & Johnson, USA
Charles Hoiberg, PhD, Executive Director, Pfizer, USA
Joseph X. Phillips, Sr., International Regulatory Affairs Advisor, ISPE, USA

How You Will Benefit

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

Discuss current and important issues facing regulators and industry and bring this information back to their respective companies;
Examine the significance of ICH guidance and its impact regionally and globally;
Better understand QbD concepts and how they give direction to regulatory initiatives; and
Summarize current tracking and trending in PAI relative to inspection efforts and problematic areas in the industry.

Who Should Attend

All industry professionals with a burning regulatory concern and with an interest to understand the current changing regulatory environment

Communities of Practice (COPs)

Active Pharmaceutical Ingredients (API), Biotechnology (BIO), Commissioning and Qualification (C&Q), Containment, Critical Utilities (CU), Disposables, Good Automated Manufacturing Practice (GAMP), Heating, Ventilation, and Air Conditioning (HVAC), Investigational Products (IP), Packaging, Process Analytical Technology (PAT), Process/Product Development (PPD), Project Management (PM), and Sterile Products Processing (SPP)