The "Pharmacovigilance Aspects of Licensing Agreements" conference has been added to ResearchAndMarkets.com's offering.
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance.
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 lack of harmonisation and clarity of the regulations around the world.
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, how to satisfy good pharmacovigilance practice
and quality management requirements, as well as how to promote harmonious business partnerships.
This programme will be of interest to all personnel involved in business development and licensing agreements, including those working in drug safety and pharmacovigilance, regulatory affairs and drug registration, medical directors, R&D directors and company lawyers.
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
- 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 session Practical aspects of licensing agreements
For more information about this conference, visit https://www.researchandmarkets.com/research/pzv4lm/pharmacovigilance?w=4.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180903005325/en/
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Related Topics: Drug Discovery
