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

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

Adela Williams

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

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.

Ewan Townsend

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.

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

You may also be interested in

Reviews

Previous customers include...

  • Abbvie Ltd
  • Arnold & Porter (UK) LLP
  • Bates Wells Braithwaite London LLP
  • Becton Dickinson
  • Bevan Brittan LLP
  • BioLineRx Ltd.
  • Bond Dickinson LLP
  • Boston Scientific
  • Bristows LLP
  • Catalent Pharma Solutions
  • CMS Cameron McKenna LLP
  • EastHORN Clinical Services
  • Edinburgh Research and Innovation Limited
  • Imperial College Healthcare NHS Trust
  • Kings College Hospital
  • Landspitali University Hospital
  • Lindsays
  • Medicines for Malaria Venture
  • Medway NHS Foundation Trust
  • Novartis Animal Health Inc
  • Queen Anne Street Medical Cent
  • Quotient Clinical
  • Renishaw plc
  • Research and Markets
  • Respiratory Clinical Trials
  • Rubiecon Contracts Ltd
  • UCL
  • United Therapeutics Europe Ltd
  • University of Sheffield
  • University of Turku

Helpful and informative.

GrantNicholson, Director of Clinical Research, Respiratory Clinical Trials

A concrete and effective overview of CTAs

SuzanneAlizart, Contracts Manager, University of Leicester

Speakers and content were all great

EdithGomez, Contracts Manager, University of Leicester

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

AlessiaPiccirilli, Manager Legal Affairs Research and Development, Helsinn Healthcare SA

Overall, pretty good course

MichaelTomlins, Pharma/Commercial Counsel, Roche Products Limited

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

MalgorzataStach, Contracts Manager, MTS Contracts Consulting Ltd

The training was useful and informative

ShinichiNishimura, Clinical Liaison Manager, Chugai Pharma Europe Ltd

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

Marie AnnePunchard, Clinical Project Manager, TiGenix