Event Date/Time: Feb 06, 2006
End Date/Time: Feb 08, 2006
Pharmaceutical companies today face consumers who are better informed and more sharply focused about drug safety, and regulators who are increasingly proactive and vigilant about safety issues. FDA has strengthened its commitment to raising the safety bar on pre- and post-marketing risk management and surveillance programs. Last Spring, they issued three guidance documents focused on pre-marketing Risk Assessment, Development and Use of Risk Minimization Action Plans and Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. Determining and successfully implementing the appropriate structure of risk assessment and risk minimization strategies to advance the management of drug safety data and pharmacovigilance processes is therefore critical for pharmaceutical, medical device, biotech and generic drug companies to protect market growth and sustain consumer confidence.