Who should attend?
Individuals with limited experience in the clinical safety/pharmacovigilance area. Those from the pharmaceutical industry, academia, regulatory authorities. Medical writers, marketing personnel, and those who need an overview of clinical safety and may interact with members of those departments.
• Understand the history, the principles and regulatory framework for clinical safety/pharmacovigilance
• Know the basic definitions of terms used in day-to-day work
• Recognize EU, US and international safety surveillance regulatory requirements
• Know the criteria and elements of expedited and periodic reporting of drug safety from Phase I studies to postmarketing
• Have an awareness of risk management and pharmacoepidemiology
Gaby L. Danan, MD, PhD • Pharmacovigilance Expert France
William W. Gregory, PhD • Senior Director, Worldwide Safety and Regulatory Pfizer Inc, United States
Bina S. Patel • Director Case Management Group GlaxoSmithKline R&D Ltd., United Kingdom
Harri Tapani Helajarvi • Former Qualified Person for Pharmacovigilance Finland