Presented by
Falconbury

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

Find out more

  • Format: Bespoke training
  • CPD: 6 hours for your records (depending on your requirements)
  • Certificate of completion

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

Christine Bendall

More details

Elly Metcalf

More details

We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

See below or contact us to discuss your requirements.

Reviews of IPI's Drafting and Managing Pharmaceutical Safety Data Exchange Agreements training course


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

May 19 2017

Madeleine Redfern
European Legal Advisor, Glenmark Pharmaceuticals Europe Ltd

May 19 2017

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 19 2017

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

Marisa Kirchner
Roche Products Ltd

May 19 2017

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

Viviane Bertuit
Auditor, Sanofi

May 19 2017

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

Yiannis Kaltabanopoulos
Pharmacovigilance Officer, Besins Healthcare

Nov 22 2016

Excellent

Andrea Domenico Pricca
Dompé Farmaceutici SpA

May 19 2016

Well presented and covered all aspects of drafting SDEA's

Sally Andrews
Head of Regulatory Affairs, Torbay Pharmaceuticals

May 19 2016

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 19 2016

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

Sally Andrews
Head of Regulatory Affairs, Torbay Pharmaceuticals

Nov 22 2016

Very good and achieved aims

Alan Jennings
Director of Regulatory Affairs, Porton Biopharma Limited

Nov 22 2016

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

Nataliya Korneeva
Manager, Les Laboratoires Servier

Nov 22 2016

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

Charlotte Bunyan
Pharmacovigilance Manager, Takeda UK Ltd

Nov 22 2016

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 22 2016

Good and clear from the speaker

Abdelkarim El-Abdellati
SGS Belgium NV

May 19 2016

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

May 19 2016

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

Pooja Shah
Pharmacovigilance Manager, Cancer Research UK

May 19 2016

Good clear communication

Nathalie Lilienthal
SDEA Manager, Sanofi-Aventis Recherche & Developpement

UK

  • Roche Products Ltd
  • A Nelson & Co Ltd
  • Aurobindo Pharma Ltd
  • Bayer Healthcare
  • Bayer plc
  • Bayer PLC.
  • Besins Healthcare
  • Cancer Research UK
  • Eisai Europe Limited
  • Glenmark Pharmaceuticals Europe Ltd
  • Glenmark Pharmaceuticals Europe R&F Ltd
  • Goldenzone Ltd
  • Mundipharma Research Ltd
  • Mylan
  • Mylan UK
  • Niche Generics Limited
  • Otsuka Pharmaceutical Europe Ltd
  • Panacea Pharma Projects
  • Pharmacovigilance Matters Limited
  • Porton Biopharma Limited
  • ProductLife
  • ProStrakan
  • Shire Pharma
  • Takeda UK Ltd
  • Torbay Pharmaceuticals
  • Veterinary Medicines Directorate
  • Wortley Byers Law

France

  • Laboratoires Pierre Fabre
  • Sanofi
  • Sanofi-Aventis Recherche & Developpement
  • Universal Medica

Belgium

  • Conforma NV
  • Omega Pharma Innovation & Development
  • SGS Belgium NV

Denmark

  • Ferring Pharmaceutical A/S
  • Ferring Pharmaceuticals
  • Leo Pharma A/S

Netherlands

  • Astellas Pharma Europe BV
  • Bilthoven Biologicals B.V.
  • DADA Consultancy

Switzerland

  • Actelion Pharmaceutical Ltd
  • GSK
  • Helsinn Healthcare SA

Ireland

  • Aspen Pharma Trading Ltd
  • Niche Generics Ltd

Spain

  • Esteve Pharmaceuticals, S.A
  • Ferrer Interancional, S.A.

Germany

  • CSL Behring GmbH

Italy

  • Dompé Farmaceutici SpA

Latvia

  • AS Grindeks

Romania

  • SC ACTAVIS SRL

Russia

  • Les Laboratoires Servier

Sweden

  • Aga Gas Linde Group

United States of America

  • UCB Pharma Biosciences Inc.

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy