Drug Safety and Risk Management Advisory Committee (DSaRM)

 

Slides

 


DAY 2                                     THURSDAY MAY 19, 2005

 

 

Overview of Drug Safety Challenges                              Gerald DalPan, M.D., M.H.S.,

[HTML)     [PPT]                                                         Director, DSRCS, ODA ODS

 

Pregnancy Exposure Registries                                      Kathleen Uhl, M.D.

[HTML)     [PPT]                                                         Pregnancy & Lactation Team, Office of New Drug

 

Postmarketing Studies from                                            Julie Beitz, M.D.

OND Perspective                                                          Deputy Director,

[HTML)     [PPT]                                                         Office of Drug Evaluation III

 

Post marketing Studies from the                                     Gretchen S. Dieck, Ph.D., Vice President

Industry Perspective                                                      Management Strategy, Worldwide Development,

[HTML)     [PPT]                                                         Pfizer, Inc.

 

Population-Based Epidemiologic Safety                           David Graham, M.D., M.P.H.

Studies – Overview Challenges                                      Medical Officer, ODS

[HTML)     [PPT]

 

Open Public Hearing Speakers

[HTML)     [PPT]

 

                  Hugo Stevenson, M.D.

                  President, Quintiles Strategic Research Services

                  [HTML)     [PPT]

 

                  Jeffrey A. Green, Pharm.D.

                  President & Chief Executive Officer

                  DATATRAK International, Inc.

                  [HTML)     [PPT]

 

Questions to the Committee

[HTML)     [PPT]