Professional Training
4.5 (10 Reviews)

Pharmacovigilance Aspects of Licensing Agreements

Length
1 day
Price
649 GBP 549 GBP
Next course start
10 July, 2024 (+2 start dates)
Course delivery
Self-Paced Online
Length
1 day
Price
649 GBP 549 GBP
Next course start
10 July, 2024 (+2 start dates)
Course delivery
Self-Paced Online
Leave your details so the provider can get in touch

Pharmacovigilance Aspects of Licensing Agreements

Whilst licensing agreements involving medicines are primarily driven by commercial factors, the successful handling of pharmacovigilance obligations is a critical, but frequently overlooked, consideration. Negotiating the safety arrangements to ensure regulatory compliance by both partners can be a complex process, which is further compounded by a lack of harmonisation and clarity of the regulations around the world.

This intensive one-day seminar will review the existing global requirements relating to pharmacovigilance in contractual agreements. The emphasis will be on practical advice as to how to remain compliant with the legal obligations and how to satisfy good pharmacovigilance practice and quality management requirements, as well as how to promote harmonious business partnerships.

A practical workshop session will help consolidate the information provided under the guidance of our expert trainers.

Benefits of attending

  • Make sense of the licensing agreement jungle
  • Ensure you stay compliant with global pharmacovigilance requirements
  • Understand what the regulators expect
  • Master the essentials of licensing agreements – safety and business considerations
  • Consider the legal status and role of pharmacovigilance licensing agreements
  • Discuss audit and compliance aspects of third-party agreements

Upcoming start dates

Choose between 2 start dates

10 July, 2024

  • Self-Paced Online
  • Online
  • English

27 November, 2024

  • Self-Paced Online
  • Online
  • English

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Reviews by course attendees

Average rating 4.5

Based on 10 reviews.
Write a review!
4/5
Kennedy C
08 Oct 2019

The speakers are experienced and knowledgeable on the current regulations and did very well in their respective presentations.

4/5
Alicia R
08 Oct 2019

The course covered all aspects of managing PVAs. The presentation was clear and concise and speakers had a high degree of knowledge of the subject.

5/5
Ioana V
08 Oct 2019

The course was very interesting and useful for our daily work in the future.

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