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 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 28 Feb

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.

Programme

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

Presenters

Carol Markwell (2 Apr 2020, 9 Oct 2020)

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 (2 Apr 2020)

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

2 Apr 2020
2 Apr 2020 Cavendish 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 28 Feb*
Enrol now
Limited places
9 Oct 2020
9 Oct 2020 Rembrandt Hotel, London 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.

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

Previous customers include...

  • Actavis Group
  • Alfrapharma Srl
  • APOTEX EUROPE
  • Archimedes Pharma UK Limited
  • Arrow No.7 Limited
  • ASTRAZENECA GMBH
  • AstraZeneca R&D Charnwood
  • AWD Pharma GmbH & Co KG
  • Chiesi Farmaceutici SPA
  • CILAG AG INTERNATIONAL
  • F. Hoffman-La Roche Ltd
  • Faes Farma S.A.
  • FERRER
  • Ginsana SA
  • Glenmark Pharmaceuticals
  • GSK
  • P & G Pharmaceuticals Iberia, S.L.
  • PHARMACO50
  • Red Line Pharmacovigilance
  • Redline Pharmacovigilance Ltd
  • Rosemont Pharmaceuticals
  • SCHERING HEALTH CARE LTD
  • Shire Pharmaceutical Ltd
  • SPIMACO
  • Takeda Development Centre Europe Ltd
  • Teva Pharmaceuticals Romania
  • Valeant Pharmaceuticals Ltd
  • Vertex Pharmaceuticals, Inc
  • Vifor SA
  • Zentiva Group AS

Christine was a good speaker regarding the legal aspects.

Smitha Bhat, Safety Data Exchange and Quality Scientist , GSK

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

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