Gerald A. Faich, FISPE, Presidential Address - International Society ...

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Events of 2004-5 5 are driving recognition of, and demand for, epidemiology • Vioxx • FDA guidelines finalized March 2005 • EMEA/ICH/CIOMS guidances • US Congressional and IOM inquiries • Tysabri, Bextra
Statement on Regulatory Systems to Improve Pharmaceutical Safety Three OF Eight Eight ISPE SUGGESTED ACTIONS, Feb 2005 • MORE STUDIES- Rapid conduct of pharmacoepidemiologic studies should be done whenever an important safety concern arises for a marketed product • MORE REGULATORY AUTHORITY- In some countries there should be increased regulatory authority to require the conduct of postmarketing studies in a timely manner. • LIMITED PROMOTION- Cautious promotion of products during the initial marketing phase should be done
Page 1 and 2: State of the Society Presidential A
Page 3 and 4: Our mission and program goals • M
Page 5 and 6: ISPE MEMBERSHIP BY COUNTRY Japan 2.
Page 7 and 8: ISPE Financial details fy 2004 REVE
Page 9 and 10: Forum-Meetings • Bordeaux meeting
Page 11 and 12: Nashville • Over 700 registrants
Page 13: ISPE PUBLICATIONS PDS - Medline lis
Page 17 and 18: Leadership • Executive Committee-
Page 19 and 20: ISPE Committees-1 Bylaws & Policy D
Page 21: Academic Council Stephen Evans Indu
Page 25 and 26: 2005 Elections • You elected to t
Page 27 and 28: Special Interest Groups • Effecti

Gerald A. Faich, FISPE, Presidential Address - International Society ...

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