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)

Seminar Leaders

Speakers

  • Eric Ahuja, PhD, Dir, Analytical Dev & Commercialization, Merck & Co Inc
  • Tara Gooen, Chemical Engineer, FDA
  • John Groskoph, Director, New Products Group, Pfizer
  • Frank Holcombe, PhD, Chemist, FDA
  • Robert Horan, PhD, Biotechnology Specialist, FDA
  • Zena Kaufman, DVP Quality Center, Abbott Laboratories
  • Steven Kozlowski, MD, Dir.,Office Biotech Products, FDA
  • Grace McNally, Consumer Safety Officer, FDA
  • Christine Moore, Deputy Director/ONDC, FDA/CDER/ONDC
  • Moheb Nasr, PhD, Director, New Drug Quality, FDA/CDER/ONDQA
  • Roger Nosal, Executive Director, Pfizer Inc.
  • Rebeca Rodriguez, Consumer Safety Officer, DHHS/FDA/ORA/ORO/DFI
  • Stephen Simmons, Vice President, Wyeth Pharmaceuticals
  • Steven Wolfgang, Review Chemist, FDA

Event Sponsors