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 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 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.

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
  • 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

Presenter

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.

Book now

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

Previous customers include...

  • Actavis A/S
  • Actavis Group
  • Actavis Romania
  • APOTEX EUROPE
  • Archimedes Pharma UK Limited
  • AstraZeneca R&D Charnwood
  • Aurobindo Pharma Ltd
  • Baxter Innovations GmbH
  • Boots UK Ltd
  • CHEPLAPHARM Arzneimittel GmbH
  • CILAG AG INTERNATIONAL
  • F. Hoffmann-La Roche Ltd
  • FOREST LABORATORIES INC
  • Gedeon Richter Lrd
  • Glaxo Smithkline Biologicals
  • Glenmark Pharmaceuticals
  • GSK
  • Janssen Pharmaceutica NV
  • Merial SAS
  • Mitsubishi Pharma Europe Ltd
  • Orion Corporation Orion Pharma
  • PHARMACO50
  • Procter & Gamble
  • Pronova BioPharma Norge AS
  • Roche Products Ltd
  • Rosemont Pharmaceuticals Ltd
  • Sanofi Pasteur
  • SEQ Limited
  • Summers Quality Assurance Ltd
  • Takeda Development Centre Europe Ltd

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

Excellent, to the point

Pankaj Nautiyal, ‎Senior Pharmacovigilance Auditor, Glenmark Pharmaceuticals

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