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
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