Pharmacovigilance Aspects of Licensing Agreements

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

2 Apr 2020

& 9 Oct 2020

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 Agreement
  • 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 a Consultant with more than 30 years experience in pharmacovigilance. She was 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. She then set up own pharmacovigilance consultancy providing assistance and pharmacovigilance solutions to pharmaceutical companies large and small across Europe, from a full PV service to process review and optimisation; specification, implementation and validation of global safety databases; pharmacovigilance training, and interim management and offering full PV servi

Book now

2 Apr 2020
2 Apr 2020 Cavendish Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
9 Oct 2020
9 Oct 2020 Venue not yet confirmed GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

Previous customers include...

  • Alfrapharma Srl
  • Almirall S.A.
  • Arrow No.7 Limited
  • AWD Pharma GmbH & Co KG
  • Bayer Pharma AG
  • Bayer plc
  • Boots UK Ltd
  • CSL Behring UK Ltd
  • Eli Lilly & Co Ltd
  • Faes Farma S.A.
  • Ferring Controlled Therapeutics (Scotland) Ltd
  • Ferring Pharmaceuticals Ltd
  • Ginsana SA
  • Glaxo Smithkline Biologicals
  • Harefield Pharmacovigilance Ltd
  • Institut De Recherches Internationales Servier
  • Mercury Pharmaceuticals Ltd
  • P & G Pharmaceuticals Iberia, S.L.
  • PharmaChem Consulting
  • Pliva Hrvatska d.o.o.
  • Sandoz International GmbH
  • SEQ Limited
  • Stallergenes SAS
  • The Veterinary Medicines Directorate
  • Valeant Pharmaceuticals Ltd
  • Vifor SA
  • Wyeth Pharmaceuticals
  • Xellia Pharmaceuticals AsP

The course fulfilled my expectations...In general, I would and did recommend to other colleagues working with PV agreements.

Ivana Babiakova, Regional PV Manager, Boehringer Ingelheim

Christine was a good speaker regarding the legal aspects.

Smitha Bhat, Safety Data Exchange and Quality Scientist , GSK

It was good

Sattam Alghodyyr, Pharmacovigilance Manager, SPIMACO

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