Pharmacovigilance Aspects of Licensing Agreements

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

8 Oct 2019

GBP 699
EUR 979
USD 1,090

Book now

Course overview

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

Who should attend

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
    • Usingtemplates
  • 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

Final discussion session and questions


Carol Markwell

Carol Markwell is Principal Consultant at Director Drug Safety Solutions Ltd a consultancy providing assistance and Pharmacovigilance solutions to Pharmaceutical companies large and small across Europe: process review and optimisation; specification, implementation and validation of global safety databases; pharmacovigilance training, and interim management. She has worked in Pharmacovigilance since 1988, being one of the first to gain the Postgraduate Diploma in Pharmacovigilance from the University of Hertfordshire. In industry she managed a team responsible for international case management UK/ Eire submissions and the preparation of up to 25 PSURs annually.

Christine Bendall

Christine Bendall is a lawyer and PV Consultant. She advises on all aspects of PV systems and compliance and works as a PV auditor. Christine qualified as a solicitor in 1985 and began to concentrate upon regulation in the healthcare sector in 1989. During 1990-1991, she was seconded to the Solicitors Office, UK Department of Health, where she worked as legal advisor to the Department, in particular to the Medicines Control Agency (now MHRA) and its scientific advisory Committees. Following her return to private legal practice, she specialised in European and UK regulatory law relating to the healthcare industry and related sectors, with a special focus on pharmacovigilance. She set up her own consultancy in April 2012.

Book now

8 Oct 2019
8 Oct 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

Previous customers include...

  • Actavis Group
  • Allergan UK Limited
  • ApoPharma Inc
  • Baxter Innovations GmbH
  • F. Hoffmann-La Roche Ltd
  • Ferring Pharmaceuticals A/S
  • Ferring Pharmaceuticals Ltd
  • Glaxo Smithkline Biologicals
  • GlaxoSmithKline Services Unlimited
  • Grupo Ferrer Internacional SA
  • GSK
  • Helsinn Healthcare SA
  • Ingenix Pharmaceutical Services Spain S.L.
  • Laboratorios Salvat SA
  • LEO Pharma A/S
  • Merck KGaA/Merck Serono
  • Merial SAS
  • Novartis Pharmaceuticals UK Ltd
  • Orphan Europe
  • Parexel International Ltd
  • Pliva Hrvatska d.o.o.
  • Pronova BioPharma Norge AS
  • Redline Pharmacovigilance Ltd
  • Sandoz Limited
  • Science Union SA
  • Waymade Plc
  • Wyeth Pharmaceuticals

Christine was a good speaker regarding the legal aspects.

Smitha Bhat, Safety Data Exchange and Quality Scientist , GSK

Well structured and insightful

Shirley-Ann Van Der Spuy, EU QPPV, Redline Pharmacovigilance Ltd

The course was excellent. I thoroughly enjoyed it. The speakers were clearly very knowledgeable, and were able to answer any questions. The presentations were all very clear and concise, which makes any presentation more enjoyable.

Leah Baker, Pharmacovigilance Scientist, Norgine Ltd

Excellent, to the point

Pankaj Nautiyal, ‎Senior Pharmacovigilance Auditor, Glenmark Pharmaceuticals

It was good

Sattam Alghodyyr, Pharmacovigilance Manager, SPIMACO