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23-Jan-2019

1-Day Seminar: Pharmacovigilance Aspects of Licensing Agreements (London, United Kingdom - April 2, 2019) - ResearchAndMarkets.com

The "Pharmacovigilance Aspects of Licensing Agreements" conference has been added to ResearchAndMarkets.com's offering.

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.

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.

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

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/vzxmcf/1day_seminar?w=4

View source version on businesswire.com: https://www.businesswire.com/news/home/20190123005350/en/

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Last Updated: 23-Jan-2019