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

4 Jun 2020

& 3 Nov 2020

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

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.

Presenter

Tasmina Goraya

Tasmina Goraya is a partner in Taylor Wessing’s Patent team and is a core member of the firm’s UK and International Life Sciences Group. She works with clients in the life sciences sector advising on contentious and non-contentious areas, including a broad range of regulatory and compliance issues relating to pharmaceuticals, medical devices, food supplements, human cells and tissue. Tasmina regularly advises on patent, regulatory and contract disputes, with a particular focus on arbitrations as well as the regulatory aspects of corporate transactions. Tasmina further assists clients with specialist agreements, such as clinical trials agreements.

Continuing professional development

This course qualifies for the following CPD programmes:

  • CPD certificate of attendance: 6.00 hours

Book now

4 Jun 2020
4 Jun 2020 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.
3 Nov 2020
3 Nov 2020 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

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Previous customers include...

  • Actelion Pharmaceuticals Ltd
  • Allergan Ltd
  • Bates Wells Braithwaite London LLP
  • Bristows LLP
  • Cardiff University
  • Catalent Pharma Solutions
  • Cermak a Spol
  • CGX Training (Trading as Clinnovate Ltd)
  • ENGAGE Clinical Contracts Solutions
  • Helsinn Healthcare SA
  • Icon Clinical Research Ltd
  • Imperial College Healthcare NHS Trust
  • Ipsen Group
  • Ipsen Pharma SAS
  • Kahr-Medical
  • Mayday University Hospital
  • Norgine Ltd
  • Novo Nordisk A/S
  • Nutricia Research BV
  • Plymouth Hospitals NHS Trust
  • Quotient Clinical
  • RB
  • Rubiecon Contracts Ltd
  • SGS Belgium
  • Shepherd & Wedderburn LLP
  • Star Medical
  • Stratagem IPM Limited
  • University College London
  • University of Leeds
  • 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

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

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

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

Tina Zivkovic, Lead Contract Specialist, Janssen Pharmaceutical

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

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)

Helpful and informative.

Grant Nicholson, Director of Clinical Research, Respiratory Clinical Trials

A concrete and effective overview of CTAs

Suzanne Alizart, Contracts Manager, University of Leicester

Speakers and content were all great

Edith Gomez, Research Grants Manager, University of Leicester

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

Marie Anne Punchard, Clinical Project Manager, TiGenix

The training was useful and informative

Shinichi Nishimura, Clinical Liaison Manager, Chugai Pharma Europe Ltd

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

Malgorzata Stach, Contracts Manager, MTS Contracts Consulting 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