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

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 should attend

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

Continuing professional development

This course qualifies for the following CPD programmes:

  • CPD certificate of attendance: 5.50 hours

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

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Previous customers include...

  • A Nelson & Co Ltd
  • Accord
  • Aga Gas Linde Group
  • AS Grindeks
  • Aurobindo Pharma Ltd
  • Bayer
  • Bayer PLC
  • Bilthoven Biologicals B.V.
  • 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
  • Mundipharma Research Ltd
  • Mylan
  • Niche Generics Limited
  • Otsuka Pharmaceutical Europe Ltd
  • Porton Biopharma Limited
  • ProductLife
  • SGS Belgium NV
  • Shire Pharma
  • Universal Medica
  • Veterinary Medicines Directorate
  • Wortley Byers Law

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.

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

Marisa Kirchner, Roche Products Ltd

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

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

Viviane Bertuit, Auditor, Sanofi

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

Yiannis Kaltabanopoulos, Pharmacovigilance Officer, Besins Healthcare

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

Nataliya Korneeva, Manager, Les Laboratoires Servier

Very good and achieved aims

Alan Jennings, Director of Regulatory Affairs, Porton Biopharma Limited

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

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

Charlotte Bunyan, Pharmacovigilance Manager, Takeda UK Ltd

Good and clear from the speaker

Abdelkarim El-Abdellati, SGS Belgium NV


Andrea Domenico Pricca, Dompé Farmaceutici SpA

Good clear communication

Nathalie Lilienthal, SDEA Manager, Sanofi-Aventis Recherche & Developpement

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

Sally Andrews, Head of Regulatory Affairs, Torbay Pharmaceuticals

Well presented and covered all aspects of drafting SDEA's

Sally Andrews, Head of Regulatory Affairs, Torbay Pharmaceuticals

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

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

Pooja Shah, Pharmacovigilance Manager, Cancer Research UK

I was very pleased that one of the speakers was a lawyer. It was good to hear about the topic from a lawyer's perspective.

Anna Rozmyslowicz, PV System Manager, Aurobindo Pharma Ltd