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Pharmacovigilance Aspects of Licensing Agreements Training Course: face to face & live webinar

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

9 Oct 2020

& 15 Apr 2021 , 8 Oct 2021

Book now

Course overview

Whilst licensing agreements involving medicines are primarily driven by commercial factors, 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, which is further compounded by a lack of harmonisation and clarity of the regulations around the world.

This intensive one-day 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 and how to satisfy good pharmacovigilance practice and quality management requirements, as well as how to promote harmonious business partnerships.

A practical workshop session will help consolidate the information provided under the guidance of our expert trainers.

Benefits of attending

  • Make sense of the licensing agreement jungle
  • Ensure you stay compliant with global pharmacovigilance requirements
  • Understand what the regulators expect
  • Master the essentials of licensing agreements – safety and business considerations
  • Consider the legal status and role of pharmacovigilance licensing agreements
  • Discuss audit and compliance aspects of third-party agreements

Who should attend

The 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 agreement


Carol Markwell (More...)

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.

Joanne Flitcroft (More...)

Joanne is a qualified solicitor with over 22 years’ experience. She trained in the City of London and later specialised in pharmacovigilance as part of a FTSE 100 pharmaceutical company’s global legal team. Joanne founded Opallios in 2016, a legal consultancy providing advice to companies operating in the life sciences sector. Her clients include pharmaceutical companies, CROs and health communications companies.Joanne is a Non-Executive Director on the Board of the British Society of Gastroenterology, a Governor on the Board of Edge Hill University and a school governor. She has travelled across West Africa in a Ford Fiesta and besides travel, enjoys spending her spare time pursuing her interest in the classics.

Book now

  attend Face to face attend Live webinar
9 Oct 2020, Rembrandt Hotel, London
9 Oct 2020 Rembrandt Hotel, London GBP 599.00
EUR 839.00
USD 934.00
Until 28 Aug*
Enrol now
to attend
Face to face
GBP 499.00
EUR 719.00
USD 814.00
Until 28 Aug*
Enrol now
to attend
Live webinar
15 Apr 2021, Venue not yet confirmed
15 Apr 2021 Venue not yet confirmed GBP 599.00
EUR 839.00
USD 934.00
Until 4 Mar 21*
Enrol now
to attend
Face to face
GBP 499.00
EUR 719.00
USD 814.00
Until 4 Mar 21*
Enrol now
to attend
Live webinar
8 Oct 2021, Venue not yet confirmed
8 Oct 2021 Venue not yet confirmed GBP 599.00
EUR 839.00
USD 934.00
Until 27 Aug 21*
Enrol now
to attend
Face to face
GBP 499.00
EUR 719.00
USD 814.00
Until 27 Aug 21*
Enrol now
to attend
Live webinar

Learn more about our different training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Previous customers include...

  • ALEXION Europe SAS
  • Almus Pharmaceuticals Ltd
  • Archimedes Pharma UK Limited
  • Arrow No.7 Limited
  • Aurobindo Pharma Ltd
  • Celgene Europe Ltd
  • Chemidex Pharma
  • Eli Lilly & Co Ltd
  • Ferring Pharmaceuticals Ltd
  • Gentium S.r.l
  • GlaxoSmithKline
  • H. Lundbeck A/S
  • Helsinn Healthcare SA
  • Janssen Pharmaceutica NV
  • Merial SAS
  • MorphoSys AG
  • Novartis Pharmaceuticals UK Ltd
  • Orphan Europe
  • Parexel International Ltd
  • Procter & Gamble Technical Centres Ltd
  • Recordati Rare Diseases Sarl
  • Research and Markets
  • Rosemont Pharmaceuticals
  • Sanofi-Aventis R&D
  • SEQ Limited
  • Stallergenes SAS
  • Teva Pharmaceuticals Industries Ltd

The course was very interesting and useful for our daily work in the future.

Ioana Vochin, Pharmacovigilance Agreement Associate, Teva Pharmaceuticals Romania, Oct 19

The speakers are experienced and knowledgeable on the current regulations and did very well in their respective presentations.

Kennedy Cliff-Eribo, Assistant Pharmacovigilance MAnager, Glenmark Pharmaceuticals Europe R&D Ltd, Oct 19

The course covered all aspects of managing PVAs. The presentation was clear and concise and speakers had a high degree of knowledge of the subject.

Alicia Rodriguez, Pharmacovigilance Technician , PharmaMar, Oct 19

Overall, it was a good course. The speakers and presentations were to the point, and the speakers had good knowledge and experience.

Ingvild Liborg, General Manager, Chemidex Pharma, Oct 19

Christine was a good speaker regarding the legal aspects.

Smitha Bhat, Safety Data Exchange and Quality Scientist , GSK, Oct 18

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 , Oct 18

Excellent, to the point

Pankaj Nautiyal, ‎Senior Pharmacovigilance Auditor, Glenmark Pharmaceuticals , Feb 18

It was good

Sattam Alghodyyr, Pharmacovigilance Manager, SPIMACO, Feb 18

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, Feb 18

Well structured and insightful

Shirley-Ann Van Der Spuy, EU QPPV, Redline Pharmacovigilance Ltd, Feb 18