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Virtual

27 feb 2024 10:00 a.m. - 27 feb 2024 2:00 p.m.

Short Course: Good Pharmacovigilance Practices (GVP) Operations Development – From Clinical Trial to Post Marketing

This is a In-Person Pre-Conference Short Course in conjunction with the Global Pharmacovigilance and Risk Management Strategies Conference

Perspectiva general

*Short Courses require an additional registration fee. You do not need to be registered for the conference to attend*

 

New Date, Time, and Format!

 

This course is an introduction to Good Pharmacovigilance Practice (GVP) operations development, from clinical trials to the post marketing environment. We will examine the laws within the US & EU and some other regions as well, and how to take those requirements and operationalize them into practice at a company. The audience will then learn from a real-world example of what it was like to start up a safety unit at a small biotech, from staffing & vendor selection, to process implementation and preparing for the post market experience.

 

Registration for Live Short Course will be accepted onsite, or until capacity has been reached. Register prior to guarantee your seat.

Receive $150 off your forum registration by registering for any combination of at least two short courses and/or primers as well as the main forum. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Objetivos de aprendizaje

At the conclusion of this session, participants should be able to:

  • Define the role of the safety department in product development
  • Evaluate the regulations surrounding a companies obligation to product safety and surveillance
  • Discuss valuable insights from real-world scenario on what is it like to startup a GVP department

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