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Course Description

This course is designed to provide solid practical foundations for those working in drug safety. Participants will have a good working knowledge of the principles of drug safety, its regulations and proactive strategies for risk management.

Who is the target audience?

Pharmaceutical industry personnel from areas including pharmacovigilance, clinical research, medical affairs, medical writing, regulatory affairs and medical information

What am I going to get from this course?

  • Manage ICSRs and analyze possible signals
  • Perform signaling analysis and risk assessment & management functions
  • Apply local PV requirements during clinical trials and manage the safety reporting processes
  • Recognize post-marketing PV expectations and compliance on a local and global level
  • Prepare and conduct PV audits