Market Overview

Pharmacovigilance Aspects of Licensing Agreements Programme (London, United Kingdom - October 2nd, 2018) -


The "Pharmacovigilance
Aspects of Licensing Agreements"
conference has been added to's

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.


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

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