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Drafting and Managing Pharmaceutical Safety Data Exchange Agreements

Some of the topics to be covered at this meeting include overview of the legal/policy landscape as it affects the terms of CTAs, clause by clause review, legal clauses, review of a Universitys CTA

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

Contact us


Course overview

The effective management of the pharmacovigilance aspects of commercial agreements is essential for all parties involved. Ensuring the inclusion of key pharmacovigilance-relevant terms in agreements and monitoring compliance with them can be challenging, but is essential for compliance with current regulatory requirements relating to medicinal products.

This interactive seminar will address the key regulatory requirements relating to pharmacovigilance and discuss how to ensure that they are taken into account in various types of commercial arrangements. The emphasis will be on identifying the key terms needed in different types of agreement with a view to ensuring regulatory compliance and on a practical approach to drafting.

Who is this programme for?

The seminar will be of interest to personnel involved in negotiating, preparing and managing commercial agreements of various types (for example, between co-marketers and with distributors, vendors and service providers) where the inclusion of pharmacovigilance terms and obligations is needed, including those working in legal, safety, commercial, and regulatory affairs departments.

Programme at a glance...

  • Types of commercial arrangement in the pharmaceutical industry
  • Contracts – the basics
  • Regulatory requirements and guidance on pharmacovigilance relevant to pharmaceutical commercial agreements
  • Key considerations in negotiating, drafting and managing agreements
  • Key pharmacovigilance terms for commercial agreements – overview
  • INTERACTIVE SESSION – Discussion and review of sample key clauses: co-marketing and distribution agreements
  • INTERACTIVE SESSION – Discussion and review of sample key clauses: co-promotion agreements, arrangements with vendors and service providers
  • Common problems, audit and inspection findings


Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7729 6677, email us at inhouse@falconbury.co.uk or contact us below:

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Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

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Previous customers include...

  • Actelion Pharmaceutical Ltd
  • Aga Gas Linde Group
  • AS Grindeks
  • Astellas Pharma Europe BV
  • Bilthoven Biologicals B.V.
  • Conforma NV
  • CSL Behring GmbH
  • DADA Consultancy
  • Dompé Farmaceutici SpA
  • Eisai Europe Limited
  • Esteve Pharmaceuticals, S.A
  • Ferrer Interancional, S.A.
  • GE Healthcare
  • Glenmark Pharmaceuticals Europe Ltd
  • Goldenzone Ltd
  • Kyowa Kirin International plc.
  • Laboratoires Pierre Fabre
  • Leo Pharma A/S
  • Les Laboratoires Servier
  • Mylan
  • Omega Pharma Innovation & Development
  • Otsuka Pharmaceutical Europe Ltd
  • Panacea Pharma Projects
  • Pharmacovigilance Matters Limited
  • ProductLife
  • Roche Products Limited
  • SGS Belgium NV
  • Veterinary Medicines Directorate
  • Wortley Byers Law

Well prepared. Good pace. Like review of worked examples and discussing some example languages.

Marisa Kirchner, Roche Products Ltd, May 17

All in all very well put together and covered a lot of details.

Yiannis Kaltabanopoulos, Pharmacovigilance Officer, Besins Healthcare, May 17

1 day course well managed. Would need a 2nd day to go in depth in all types of SDEAS.

Viviane Bertuit, Auditor, Sanofi, May 17

Broad based, clear definitions and examples, speakers extensive experience, preparation, management, auditing of SDEAS

Jennifer McDonough, Head of Safety Alliance Management, UCB Pharma Biosciences Inc., May 17

Very interesting, insightful. I feel like I learnt a lot. Speakers kept us focused. Food was great!

Madeleine Redfern, European Legal Advisor, Glenmark Pharmaceuticals Europe Ltd, May 17

Good and clear from the speaker

Abdelkarim El-Abdellati, SGS Belgium NV, Nov 16

It was an interesting course with a lot of good and clear points. It was interactive which gives an added value as trainees mainly are there to get some practical issues solved. The presenter had very good knowledge of the topic.

Nathalie Dubois, Deputy QPPV, Omega Pharma Innovation & Development, Nov 16


Andrea Domenico Pricca, Dompé Farmaceutici SpA, Nov 16

Full of very important details and other interesting topics that linked - PSMF/Vendors

Charlotte Bunyan, Pharmacovigilance Manager, Takeda UK Ltd, Nov 16

It was good that we could ask any questions and the course was interactive

Nataliya Korneeva, Manager, Les Laboratoires Servier, Nov 16

Very good and achieved aims

Alan Jennings, Director of Regulatory Affairs, Porton Biopharma Limited, Nov 16

Very well presented lectures that all the aspects of SDEA's that I wanted to know

Sally Andrews, Head of Regulatory Affairs, Torbay Pharmaceuticals, May 16

Very well detailed and put together. Interactive and well paced. Many topics were covered and questions were answered by speakers in detail.

Jas Sangha, Mundipharma Research Ltd, May 16

Thought it was appropriate for a group attending. Material was completely relevant.

Pooja Shah, Pharmacovigilance Manager, Cancer Research UK, May 16

Well presented and covered all aspects of drafting SDEA's

Sally Andrews, Head of Regulatory Affairs, Torbay Pharmaceuticals, May 16