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Drafting and Negotiating Clinical Trial Agreements

Falconbury Ltd
Course summary
1 day
599 - 699 GBP excl. VAT
English
Professional Training
Next available date: 26/02/2021 - Online courses
Course Dates
Online courses
599 GBP
26/02/2021

Online courses
599 GBP
10/06/2021

Online courses
599 GBP
05/11/2021

London
699 GBP
04/11/2021

Drafting and Negotiating Clinical Trial Agreements

Why You Should Attend

The life science sector is heavily regulated and CTAs are some of the most important agreements for companies operating in this sector. Having appropriate CTAs in place is therefore essential for managing relationships between the different stakeholders, and apportioning risk and responsibilities between them. If appropriate contractual arrangements are not in place, a clinical trial may not receive approval or issues may arise with the integrity or validity of the data collected. Further, disputes between the parties can arise if responsibilities are not clearly defined in the agreement.

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted. Participants will receive an overview of the legal framework regulating clinical trials in the European Union (and UK), before taking a closer, comprehensive look at specific issues that must be considered when drafting a CTA. Using a case study, participants will also look at some example clauses and will have the opportunity to practise negotiation skills in the safe environment of the course room under the guidance of our expert faculty.

By the end of the programme, you will be more confident in spotting and addressing the key issues that arise when negotiating and drafting CTAs, understand how best to mitigate against the risks and deal with them effectively when they do arise.

Key topics covered in this intensive and interactive seminar:

  • An overview of the legal, ethical and policy considerations that underpin the conduct clinical trials as these affect how the terms of clinical trials agreements are drafted
  • Recognising and dealing with key commercial and regulatory issues (including in particular relating to Brexit and the “flexibilities” adopted during the pandemic) that arise when drafting clinical trials agreements
  • Drafting and negotiating techniques to minimise disputes and maximise efficiency

Attending this seminar will enable you to:

  • Understand the legal framework concerning clinical trials in the EU and the UK
  • Recognise and address the issues that arise when drafting and negotiating CTAs
  • Gain a better understanding of the commercial and regulatory issues that affect CTAs
  • Consider the issues through the differing perspectives of sponsors and health care organisations

Who Should Attend?

This course will be particularly beneficial to:

  • Contract managers
  • Clinical contract specialists
  • Clinical trial managers
  • R&D staff
  • Regulatory specialists
  • Lawyers and in-house legal teams
  • Legal executives

Provider: Falconbury Ltd

Falconbury Ltd

Falconbury - Professional Training for the business of learning

Falconbury specialise in business and management training, legal training and executive education for individuals and teams across all types of organisations, large and small, public and private, domestic and international. Falconbury are confident that you will find a training solution...


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Contact information for Falconbury Ltd

Falconbury Ltd

10-12 Rivington Street
EC2A 3DU London

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www.falconbury.co.uk


Reviews by course attendees

Average rating 4.4

Based on 20 reviews.

Amber
(5)
Good content, presentation and speakers. felt that Ewan Townsend was a brilliant speaker and was able to impart his considerable knowledge in a way that was easy to follow and digest. I felt that Adela Williams was very knowledgeable but assumed a lot more prior knowledge on her subject matters.
Amber
(5)
Good content, presentation and speakers. felt that Ewan Townsend was a brilliant speaker and was able to impart his considerable knowledge in a way that was easy to follow and digest. I felt that Adela Williams was very knowledgeable but assumed a lot more prior knowledge on her subject matters.
A Heathcote
(5)
Good content, presentation and speakers. felt that Ewan Townsend was a brilliant speaker and was able to impart his considerable knowledge in a way that was easy to follow and digest. I felt that Adela Williams was very knowledgeable but assumed a lot more prior knowledge on her subject matters.
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Reviews
Course rating
(4.4)
Based on 20 reviews.
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