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This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post marketing studies, and in the healthcare setting following product launch.

Who should attend?

Beginner Level

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.

Learning objectives

At the conclusion of this course, the participants should be able to

• 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

Program Committee

  • Gaby L. Danan, MD, PhD
    Gaby L. Danan, MD, PhD Pharmacovigilance Expert France
  • William W. Gregory, PhD
    William W. Gregory, PhD Senior Director, Worldwide Safety and Regulatory Pfizer Inc, United States
  • Bina S. Patel
    Bina S. Patel Director Case Management Group GlaxoSmithKline R&D Ltd., United Kingdom
  • Harri Tapani Helajarvi
    Harri Tapani Helajarvi Former Qualified Person for Pharmacovigilance Finland
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PHONE: +41 61 225 51 51

FAX: +41 61 225 51 52