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 Oct 2018

& 2 Apr 2019

GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 10 Aug

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 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.

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
    • 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


Sophie Candlin (2 Oct 2018)

As a Patient Safety Specialist at AstraZeneca, Sophie was involved in case processing, literature searching, clinical study support and regional adverse event awareness training . She also provided 3 months on-site training and mentoring to the new data entry team in Budapest when the function was outsourced in 2009.
Sophie moved to Hospira in 2010 where her responsibilities included periodic reporting, risk management plans, quality and compliance, and product labelling. During this time, she travelled to the Philippines to set up and train a new data entry team. Sophie became team leader, directly managing the EMEA Product Safety team.
In 2014, Sophie joined the consultancy Drug Safety Solutions Ltd, where she now works with clients to meet all of their Pharmacovigilance needs, including writing and managing PSMF’s and SOP’s, risk management plan and acting as QPPV.

Book now

2 Oct 2018
2 Oct 2018 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
GBP 599.00
EUR 839.00
USD 934.00
Until 10 Aug
Enrol now
2 Apr 2019
2 Apr 2019 Venue not yet confirmed GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

Previous customers include...

  • ApoPharma Inc
  • Archimedes Pharma UK Limited
  • AstraZeneca UK Ltd
  • Britannia Pharmaceuticals Ltd
  • Cephalon Ltd
  • F. Hoffman-La Roche AG
  • Ferring Pharmaceuticals Ltd
  • GlaxoSmithKline
  • GlaxoSmithKline Services Unlimited
  • GlaxoSmithKline Vaccines
  • GSK
  • Napp Pharmaceutical Group Ltd
  • Norgine Ltd
  • Novartis Pharmaceuticals
  • Novartis Pharmaceuticals UK Ltd
  • P & G Pharmaceuticals Iberia, S.L.
  • Pharmatek Consultancy Services
  • Pharmathen Industrial SA
  • Ranbaxy Laboratories Ltd
  • Rosemont Pharmaceuticals Limited
  • Rosemont Pharmaceuticals Ltd
  • Sanofi-Aventis R&D
  • Schwarz BioSciences GmbH
  • Science Union SA
  • Stiefel Labs (UK) Limited
  • Valeant Pharmaceuticals Ltd
  • Vertex Pharmaceuticals, Inc
  • Waymade Plc
  • Wyeth Pharmaceuticals

Well structured and insightful

Shirley-Ann Van Der Spuy, 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