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Drafting and Negotiating Clinical Trial Agreements

Management Forum
Course summary
1 day
699 GBP excl. VAT
English
Open / Scheduled
Next available date: 04/06/2020 - London
Course Dates
London
04/06/2020   (English)
699 GBP
03/11/2020   (English)
699 GBP

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.

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?

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

Programme At A Glance...

Overview of the regulation of clinical trials – the legal framework governing clinical trials in the EU and the UK

  • What a clinical trial is and the types of clinical trial
  • EU regulatory framework:
    • The current Clinical Trials Directive (Directive 2001/20/EC)
    • The new Clinical Trial Regulation (Regulation 536/2014/EU)
  • Who the stakeholders are and their roles and obligations
  • Ethics approval and policy issues (eg NHS approval)
  • What could happen if a clinical trial is not conducted in accordance with the law

Specific considerations relevant to the conduct of clinical trials

  • Informed consent – what is it and why is it needed?
  • Data protection – overview of the requirements, use of patient data during and after a clinical trial (including implications for use of personal data outside the protocol of a clinical trial), transferring personal data outside the EU
  • Product liability – risks and insurance requirements for clinical trials
  • Confidentiality and intellectual property rights:
    • Transparency vs protecting confidential information
    • Protecting intellectual property rights

CASE STUDY: Drafting and negotiating CTAs – Part 1

The anatomy of a CTA and some typical clauses and issues that might arise. We look at these issues from the perspective of each party and the negotiation tactics that could be used to reach an agreed position.
  • Structure of a CTA
  • Common sticking points in negotiation:
    • Ownership and use of intellectual property
    • Use of data generated during the trial
    • Liabilities and insurance requirements for both parties
    • Warranties and indemnities
  • Manufacture and supply
  • Disclosure of payments to healthcare professionals and healthcare organisations
  • Freedom of information requests
  • Termination and consequences of termination

PRACTICAL EXERCISE: Negotiation

This interactive session allows participants to practise negotiating specific clauses concerning liabilities and indemnities using skills and techniques to minimise disputes and maximise efficiency. Example clauses will be provided and considered within the group. Participants will be divided into small groups representing the opposite party to practise their negotiation skills.

CASE STUDY: Drafting and negotiating CTAs – Part 2
  • Discussion of points arising from the negotiation exercise
  • Standard contracts
  • Practical tips
Additional considerations relevant to drafting and negotiating CTAs
  • Multi-jurisdictional trials
  • The implications of Brexit

Presenters Firm

Taylor Wessing is a full-service international law firm, working with clients in the world’s most dynamic industries. We take a single minded approach to advising our clients, helping them succeed by thinking innovatively about their business issues.

Provider: Management Forum

Management Forum

Management Forum - Professional training courses for the Life Sciences and Intellectual Property Sectors

Management Forum is an internationally renowned training provider organising professional conferences, seminars and in-house courses for professionals and companies in the Life Sciences and Intellectual Property sectors. With their growing programme portfolio, training specialists at Management Forum aim to provide...


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Reviews by course attendees

Average rating 4.3

Based on 6 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.
Désirée
(4)
I feel the course was nicely balanced between theory and practice and it dealt with relevant topics. The size of the group of participants allowed for a useful and interactive discussion. The speakers were knowledgeable and their presentations were clear and informative.
Jordan
(4)
The course is well structured, but perhaps too heavy. A lot of material and topics to go through in one day. The afternoon session suffered a bit, it got a bit hasty. Other than that, the speakers did a great job. They were all eloquent, knowledgable and to the point.
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