PHARMACOVIGILANCE
ASPECTS OF LICENSING
AGREEMENTS

Conference Date: 24 Feb 2010
Conference Ref: A2-4310
Fee: £545 + VAT
Venue: The Rembrandt Hotel, London

BENEFITS OF ATTENDING

Whilst licensing agreements involving medicines are primarily driven by commercial considerations, the successful handling of the pharmacovigilance and safety data exchange sections of the contract is a critical, but frequently overlooked, consideration.  Negotiating the safety arrangements of the agreement 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 meeting 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.

ISSUES TO BE ADDRESSED DURING THIS SEMINAR:

• Making Sense of the Licensing Agreement Jungle
• How to stay Compliant with Global Pharmacovigilance Requirements
• Essentials of Licensing Agreements – Safety & Business Considerations
• Global Regulatory Framework
• Practical Approaches and Challenges
• Regulatory Expectations and Inspections of Licensing Agreements
• Drafting, Adapting & Using SDEA templates

Chaired by:
Dr Elliot Brown Elliot Brown Consulting Ltd

Speakers:
Christine Bendall Arnold & Porter
Iris Triebel Solvay, Germany
Theresa Cooper Elliott Brown Consulting, UK

To book your place, please click here