Drafting and Negotiating Clinical Trial Agreements

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

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Course overview

Clinical trial agreements are one of the most important agreements in the pharma industry as no research can start without the right agreement in place between sponsor and host organisation. They provide a contract which manages the relationship and responsibilities of both parties, and provide for the allocation of risk, obligations, the protection of academia, terms of collaboration, IP rights and much more.

This intensive one-day programme, delivered by experts in the field, will provide you with a full understanding of the importance of CTAs. It will describe how the regulatory environment affects them and explain the typical clauses which make up a CTA and what the key differences are between European and the US. By the end of this seminar you will be confident in spotting and addressing issues which arise when negotiating and drafting clinical trial agreements.

Who should attend?

  • Contract managers
  • Clinical contract specialists
  • Clinical trial managers
  • R&D staff
  • Regulatory specialists
  • Lawyers
  • Legal executives

Programme at a glance...

Overview of the legal/policy landscape as it affects the terms of CTAs

  • What is a clinical trial?
  • EU regulatory framework: What are the key regulatory considerations relevant to conducting a clinical trial?
  • Introduction to the parties to the CTA and key roles and responsibilities
  • Policy issues in public hospitals, e.g. UK NHS approval
  • Other ethical/legal issues
  • Standard contracts, e.g. NHS standard CTA
  • Implications of Brexit

CASE STUDY

Negotiating and drafting CTAs
  • Overview of issues that frequently come up in the negotiation/drafting of CTAs
  • Introduction to case study
  • Discussion of case study
    • Definitions
    • Intellectual property and publication provisions
    • Use of data generated during the trial
    • Data protection, medical records, freedom of information, etc

CASE STUDY

Negotiating and drafting CTAs • Continued discussion of case study:
** Manufacture of the investigational medicinal product
** Warranties and indemnities
** Liabilities and insurance requirements
** Termination and its consequences

Additional considerations

  • Introduction to differences between US, UK and Continental European legal systems and how they may affect contract drafting
  • Unlicensed product vs off-label use
  • First-in-man studies
  • Investigator initiated studies
  • Compliance and anti-corruption issues

PRACTICAL EXERCISE – Negotiation

Presenters firm

Arnold & Porter logo

Arnold & Porter LLP is an international law firm with over 1000 lawyers across offices in the US, Belgium, China, Germany, and the UK. The EU life sciences team has unrivalled experience in advising on every aspect of the regulation of medicines, devices,cosmetics, foods and borderline products. The team includes a number of lawyers with scientific qualifications, including two physicians. It is regularly ranked as the leading firm providing regulatory advice and specialist litigation services to the life sciences sector.

Continuing professional development

This course qualifies for the following CPD programmes:

  • CPD certificate of attendance: 6.00 hours

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

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Previous customers include...

  • Allergy Therapeutics
  • Arla Foods amba
  • Bevan Brittan LLP
  • Bohmann
  • BTG International Ltd
  • Chugai Pharma Europe Ltd.
  • DuPont Nutrition Biosciences ApS
  • EastHORN Clinical Services
  • ENGAGE Clinical Contracts Solutions
  • Erasmus Medical Center
  • Immunocore Ltd
  • Imperial College Healthcare NHS Trust
  • Karolinska Institutet
  • Keele University
  • McGrigors LLP
  • MEDTRONIC INTERNATIONAL TRADING
  • MSD (Norge) AS
  • Nestec SA
  • Norgine Ltd
  • Novartis Animal Health Inc
  • Orion Clinical Services Ltd
  • Outcome Europe Sarl
  • Roiter Zucker
  • Salvius Legal
  • Terumo Europe
  • Unilever R&D Vlaardingen
  • University of Leicester
  • University of Oxford
  • University of Surrey
  • University of Turku

“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 Heathcote, Manager, Business Operations, BioMarin

“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.”

Désirée de Lange, Legal Counsel, Erasmus Medical Center

“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. ”

Jordan Stefanov, Senior Operations Coordinator, Novartis

“Both speakers were excellent - knowledgeable, professional, approachable, willing to explain and help and very friendly”

Tina Zivkovic, Lead Contract Specialist, Janssen Pharmaceutical

“Overall, the course was very good and well worth doing. The speakers were good and knowledgeable.
The venue, format and layout of the course was also very good, with an atmosphere and environment for open discussion and learning. The course content was excellent.”

Phill Hunter, Legal and Finance Manager, CGX Training (Trading as Clinnovate Ltd)

“Course was well structured and presented. For me, as a university employee it was a little too much directed to international / EU clinical trials and not some of the more basic contract research type trials. ”

Duncan McFarlane, Solicitor / Academic Contracts Officer (Research), University of Exeter

“Helpful and informative. ”

Grant Nicholson, Director of Clinical Research, Respiratory Clinical Trials

“Speakers and content were all great”

Edith Gomez, Research Grants Manager, University of Leicester

“A concrete and effective overview of CTAs”

Suzanne Alizart, Contracts Manager, University of Leicester

“Overall, the course was well prepared, presented by the experienced speakers”

Malgorzata Stach, Contracts Manager, MTS Contracts Consulting Ltd

“The training was useful and informative”

Shinichi Nishimura, Clinical Liaison Manager, Chugai Pharma Europe Ltd

“Speakers were good and made the course interesting but the content in my opinion should be more detailed”

Alessia Piccirilli, Manager Legal Affairs Research and Development, Helsinn Healthcare SA

“Overall, pretty good course”

Michael Tomlins, Pharma/Commercial Counsel, Roche Products Limited

“Well presented course with a good program and atmosphere for open discussion”

Marie Anne Punchard, Clinical Project Manager, TiGenix