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

13 Nov 2018

& 14 May 2019

GBP 699
EUR 979
USD 1,090

Book now

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.

Presenters

Ewan Townsend (13 Nov 2018, 14 May 2019)

Ewan Townsend is Counsel in Arnold & Porter’s London office and assists clients in the life sciences sector on regulatory and commercial matters. He has experience with a broad range of regulatory issues that arise throughout the medicinal product and medical device life cycle, including research and development, clinical trials, marketing authorisations, manufacturing, distribution, advertising, pricing and reimbursement. Ewan’s work also includes drafting and negotiating commercial agreements for his life sciences clients, such as licence agreements, manufacturing, distribution and supply agreements, clinical trial agreements and service agreements, and advising on the intellectual property and regulatory issues that arise in the context of those transactions.

Bonnie Clemence (13 Nov 2018)

Bonnie Clemence is an Associate in Arnold & Porter’s London office. She advises clients in the life sciences and medical devices industries on UK and EU regulatory issues that arise throughout the product life cycle, including borderline classification, clinical research, authorisation, packaging and labeling, pricing and reimbursement, advertising and promotion, and pharmacovigilance. She assists companies in developing and implementing global and regional compliance programmes, conducting internal investigations into potential regulatory and compliance breaches, and formulating plans for remedial action. Bonnie has experience in public and administrative law litigation before the UK and EU Courts, advising on actions arising from the decisions of regulatory bodies, such as the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), and assisting on challenges to public procurement tenders under the UK rules. She also advises on life sciences transactional matters, including drafting and negotiating sponsorship agreements, joint-working agreements, research and development agreements, clinical study agreements, manufacturing, distribution and supply agreements. She has been seconded to a global pharmaceutical company to provide support in relation to its commercial contracts.

Adela Williams (14 May 2019)

Adela Williams is Partner in the life sciences group at Arnold & Porter. She advises clients in relation to the regulation of medicinal products in the UK and at the EU level. She also regularly advises on clinical trial issues and represents clients in product liability litigation arising from use of medicines in the research context.

Jacqueline Mulryne (14 May 2019)

Jackie Mulryne is Counsel in the life sciences group at Arnold & Porter. She has a broad practice providing regulatory compliance and public policy advice, and has extensive experience advising commercial clients on clinical trial agreements, both within and outside the NHS, and variations across the EU.

Continuing professional development

This course qualifies for the following CPD programmes:

  • CPD certificate of attendance: 6.00 hours

Book now

13 Nov 2018
13 Nov 2018 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
14 May 2019
14 May 2019 Cavendish Hotel, London
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • BioLineRx Ltd.
  • Bohmann
  • Boston Scientific
  • Cardiff University
  • Cochlear Europe Limited
  • ETH Zurich
  • GODDYN BVBA
  • Immunocore Ltd
  • Kendle Clinical Development Services
  • Kendle International
  • Kyowa Hakko Kirin UK Limited
  • Mayday University Hospital
  • Medicines for Malaria Venture
  • Morphosys AG
  • Nestec SA
  • Orion Clinical Services Ltd
  • Queen Anne Street Medical Cent
  • Research and Markets
  • Roche Products Limited
  • Rubiecon Contracts Ltd
  • Salvius Legal
  • Saudi Arabian Airlines
  • Servier R&D Ltd
  • Shire
  • Stratagem IPM Limited
  • University of Bristol
  • University of Cambridge
  • University of Exeter
  • University of Sussex
  • Vincent Sykes & Higham LLP

Speakers and content were all great

Edith Gomez, Contracts Manager, University of Leicester

A concrete and effective overview of CTAs

Suzanne Alizart, Contracts Manager, University of Leicester

Helpful and informative.

Grant Nicholson, Director of Clinical Research, Respiratory Clinical Trials

The training was useful and informative

Shinichi Nishimura, Clinical Liaison Manager, Chugai Pharma Europe Ltd

Overall, pretty good course

Michael Tomlins, Pharma/Commercial Counsel, Roche Products Limited

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

Malgorzata Stach, Contracts Manager, MTS Contracts Consulting Ltd

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

Marie Anne Punchard, Clinical Project Manager, TiGenix

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