Regulation of Pharmaceuticals: A Global Perspective

June 6-8, 2012

June 6

8:30 A.M. TO 4:00 P.M.

Moderator: Anna Alexander, Deputy District Director, FDA, New York District

Continental Breakfast

Conference opening and welcome

Charles Becoat, Deputy Regional Food and Drug Director
Northeast Region, FDA

Keynote: Regulating Pharmaceuticals in a Global Marketplace

Murray Lumpkin, M.D., Commissioner's Senior Advisor and Representative for Global Issues, Office of the Commissioner, FDA

FDA Policies, Procedures, and Requirements for New Drugs

Giuseppe Randazzo, MS, Regulatory Scientist
Office of New Drugs, Center for Drug Evaluation and Research (CDER), FDA

Office of Generic Drugs Policies and Requirements

Paul Schwartz, Ph.D., Associate Director for Product Quality Coordination
Office of Generic Drugs, CDER, FDA

Monograph Modernization

Karen A. Russo, Ph.D., Vice President, Small Molecules
United States Pharmacopeial Convention

Q & A Panel

FDA Drug Manufacturing Requirements

Kevin Gonzalez, Investigator/Pre-Approval Manager
New York District, FDA

FDA Drug Inspections: The Drug Investigator's Point of View

Paul Mouris, Pharm.D., LCDR, Public Health Service (USPHS), Investigator
New York District, FDA

Michele Obert, Investigative Analyst
Kansas City District, FDA

The Regulatory and Scientific Impact of Finding an Objectionable Microorganism in a Non-Sterile Pharmaceutical: A Case Study

Dennis Guilfoyle, Ph.D., Pharmaceutical Microbiologist
Northeast Regional Laboratory, FDA

Q & A Panel

June 7

8:30 A.M. TO 4:00 P.M.

Moderator: Dr. Dennis Guilfoyle, Pharmaceutical Microbiologist, Northeast Regional Lab

Continental Breakfast

Global Supply Chain Issues

John M. Taylor, Counselor to the Commissioner
Office of the Commissioner, FDA

Economically Motivated Adulteration

Robert B. Clark, Vice President, Worldwide Regulatory Strategy US
Pfizer Inc.

Q8, Q9, Q10 and QbD

Jon Clark, MS, Associate Director for Program Policy
Office of Pharmaceutical Science, CDER, FDA

Q & A Panel

Real-Time Release Testing

Brett Duersch, Ph.D., Principal Analytical Chemist
Global Science Technology and Commercialization, Merck and Co

Pfizer's Perspective on the EMA-FDA pilot program for parallel assessment of QbD applications

Mike Saleh, Director, Global Chemistry, Manufacturing and Controls
Pfizer Inc

FDA’s PAT Initiative: Past, Present and Future

Richard L. Friedman, MS, Associate Director, Risk Science, Intelligence and Prioritization
Office of Manufacturing and Product Quality, Off. of Compliance, CDER, FDA

Q & A Panel

June 8

8:30 A.M. TO 1:00 P.M.

Moderator: Dr. Ivica Arsov, Professor of Biology, York College, City University of New York

Continental Breakfast

FDA Driving Biomedical Innovation

Vicki Seyfert-Margolis, Ph.D., Senior Advisor for Science Innovation and Policy, Office of the Chief Scientist, FDA

Rapid Analytical Methods for On-Site Pharmaceutical Surveillance

Connie Ruzicka, PhD, Chemist
Division of Pharmaceutical Analysis, CDER, FDA

Current GMP Compliance Issues Relating to Contamination Prevention and Microbiology

Richard L. Friedman, MS, Associate Director, Risk Science, Intelligence and Prioritization, Office of Manufacturing and Product Quality, CDER, FDA

Compliance with Regulatory Requirements for APIs – a CMO Perspective

Michael Verlander, DPhil (Oxon), President
PolyPeptide Laboratories San Diego

Regulatory Resurgence in India from a Pharmaceutical Perspective

Vijay Kshirsagar, M.Sc., D.B.M., A.I.C., Executive Vice President, Corporate Quality Assurance & Regulatory Affairs, Unichem Laboratories Limited
(Mumbai, India)

Q & A Panel