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

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