Pharmacovigilance Aspects of Licensing Agreements 2021

Topics

• Best pharmacovigilance practices in licensing agreements
  • Safety Data Exchange
  • Types of agreement
  • Joint handling of pharmacovigilance issues Sophie Candlin
  • Who is responsible for what
• Global regulatory framework
  • How it impacts partnerships
  • EU, USA and what ICH says
  • From the pharmacovigilance system - from the MAH
  • What the regulators expect
  • Carol Markwell
  • From the MAH`s partners
• Audit and compliance aspects of third party agreements
  • Which agreements to examine at audit
  • Regulatory expectations and inspections
  • Which partners to audit and how
  • What to look for in safety data exchange agreements at pharmacovigilance audit
  • Measuring partner/other party compliance Carol Markwell
• Legal aspects
  • Drafting pharmacovigilance agreements
  • The legal status and role of pharmacovigilance agreements
  • Amendment and termination of pharmacovigilance agreements Christine Bendall
  • Contractual liability and indemnities

Who should Attend

Attendees with responsibilities in:

• Regulatory affairs and drug registration
• Drug safety and pharmacovigilance
• R&D directors
• Medical directors
• Company lawyers