1-Day Seminar: Pharmacovigilance Aspects of Licensing Agreements (London, United Kingdom - April 2, 2020)

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Jan 27, 2020, 18:00 ET

DUBLIN, Jan. 27, 2020 /PRNewswire/ -- The "Pharmacovigilance Aspects of Licensing Agreements" conference has been added to ResearchAndMarkets.com's offering.

This 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 on how to satisfy good pharmacovigilance practice and quality management requirements, as well as how to promote harmonious business partnerships.

Key issues to be addressed:

Making sense of the licensing agreement jungle
How to stay compliant with global pharmacovigilance requirements n Understand what the regulators expect
Essentials of licensing agreements - safety and business considerations
Understand the legal status and role of pharmacovigilance licensing agreements
Discuss audit and compliance aspects of third-party agreements

Whilst licensing agreements involving medicines are primarily driven by commercial considerations, 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. This is further compounded by a lack of harmonisation and clarity of the regulations around the world.

Agenda

Global regulatory framework

EU, USA and what ICH says
How it impacts partnerships
What the regulators expect

From the pharmacovigilance system
From the MAH
From the MAH's partners

Best pharmacovigilance practices in licensing agreements

Types of agreement
Safety Data Exchange Agreement
Who is responsible for what?
Joint handling of pharmacovigilance issues

Legal aspects

The legal status and role of pharmacovigilance agreements
Drafting pharmacovigilance agreements

Contract basics, dos, and don'ts
Terminology, form, and content
Using templates

Contractual liability and indemnities
Amendment and termination of pharmacovigilance agreements

Audit and compliance aspects of third-party agreements

Regulatory expectations and inspections
Which agreements to examine at audit
What to look for in safety data exchange agreements at pharmacovigilance audit
Which partners to audit and how
Measuring partner/other party compliance

Workshop - practical aspects of licensing agreements

Final discussion session and questions

For more information about this conference visit https://www.researchandmarkets.com/r/rg77ys

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SOURCE Research and Markets