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Drafting and Negotiating Clinical Trial Agreements

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

3 Nov 2020

& 10 Jun 2021 , 5 Nov 2021

GBP 699
EUR 979
USD 1,090

Book now

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?

This course will be particularly beneficial to:

  • 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.

Presenters

Katie Chandler

Katie Chandler is a Partner in Taylor Wessing’s London Disputes and Investigations Group. She acts for clients in high-value, complex commercial litigation relating to corporate governance and shareholder disputes, technology implementation project disputes and product liability claims. Katie acts for clients in a variety of sectors including technology, life sciences, food and drink and consumer and retail, with a particular focus on advancing technologies such as the Internet of Things and automated and connected vehicles. Katie is admitted as a solicitor in Ireland, as well as in England and Wales.

She also advises on product safety law and regulatory compliance including acting on product recalls for clients across a variety of industries such as pharmaceuticals and healthcare, automotive, technology and consumer goods. She regularly advises clients on food safety matters including allergens management and liaises with regulators including BEIS, Trading Standards, FSA and HSE. Katie also represents clients in Coroner’s Inquests.

Tasmina Goraya

Dr Tasmina Goraya is a Partner in the Patents team of Taylor Wessing and a member of the firm’s Life Sciences Group. She specialises in three areas with a particular focus on life sciences: regulatory compliance; patent and commercial disputes with a particular focus on arbitrations; and transactional IP (including IP and regulatory support on M&As and investments). Her regulatory work covers a wide spectrum of regulatory and compliance issues in the pharmaceutical, medical device and healthcare sectors.

Tasmina has a degree in Toxicology & Pharmacology from London University and a PhD in Pharmacology from Cambridge University and was previously a post-doctoral research associate in academia prior to moving into law. She qualified as a solicitor (England & Wales) in 2011 and has a Diploma in Intellectual Property Law and Practice from Oxford University.

Sally Annereau

Sally Annereau is a Senior Data Protection Adviser at Taylor Wessing, London. She has over 28 years’ experience of providing advice on data protection and wider regulatory issues governing the way in which businesses use information. Sally’s experience includes advising on privacy sensitive technologies, conducting privacy impact assessments, coordinating data protection and compliance issues, reviewing clinical trial and research study agreements, and reviewing and drafting privacy policies and separate data protection grounds within informed consent notices

Sally previously worked at the UK Information Commissioner’s Office for six years, which enforces both data protection and freedom of information law<Her time there included roles within both strategic policy development and managing a regulatory team investigating complaints made by individuals in respect of the exercise of their rights.

Continuing professional development

This course qualifies for the following CPD programmes:

  • CPD certificate of attendance: 6.00 hours

Book now

3 Nov 2020
3 Nov 2020 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
10 Jun 2021
10 Jun 2021 Venue not yet confirmed GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
5 Nov 2021
5 Nov 2021 Venue not yet confirmed GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

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  • Bayer Healthcare
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  • BTG International Ltd
  • CGX Training (Trading as Clinnovate Ltd)
  • Chugai Pharma Europe Ltd.
  • DuPont Nutrition Biosciences ApS
  • EastHORN Clinical Services
  • Hogan Lovells International Ltd
  • Imperial College Healthcare NHS Trust
  • Janssen Pharmaceutical
  • Karolinska Institutet
  • Kyowa Hakko Kirin UK Limited
  • Lewis Silkin LLP
  • London School of Hygiene and Tropical Medicine
  • McGrigors LLP
  • Medicines for Malaria Venture
  • Norgine Ltd
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  • Novartis Animal Health Inc
  • Pharmacovigilance Matters Limited
  • Renishaw plc
  • Samsung Bioepis Co., Ltd.
  • Servier R&D Ltd
  • Shepherd & Wedderburn LLP
  • Star Medical
  • University of Cambridge
  • University of Exeter
  • University of Leeds
  • University of Leicester
  • Veterinary Medicines Directorate

The speakers were perfect – really qualified and experienced.

Anne-Caroline Béraud, In House Legal Counsel, Erytech Pharma, Nov 19

The training is very useful and gives a good and concrete overview of CTAs. Both speakers were willing to explain and answer all questions we had during the training and were very professional and approachable. The course contains the relevant topics and has a good balance between the theoretical part and the practical part.

Tinneke De Boeck, Junior Legal Counsel, Galapgos NV, Nov 19

The speakers were all eloquent, knowledgable and to the point.

Jordan Stefanov, Senior Operations Coordinator, Novartis, May 19

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, May 19

Good content, presentation and speakers. Ewan Townsend was a brilliant speaker and was able to impart his considerable knowledge in a way that was easy to follow and digest.

Amber Heathcote, Manager, Business Operations, BioMarin, May 19

Both speakers presented well and dealt with most questions in detail. I particularly liked the chance to discuss and exchange experiences with other attendees and speakers. The course was well structured and presented.

Duncan McFarlane, Solicitor / Academic Contracts Officer (Research), University of Exeter , Nov 18

The course was very good and well worth doing with an atmosphere and environment for open discussion and learning. The speakers were good and knowledgeable and the course content was excellent.

Phill Hunter, Legal and Finance Manager, CGX Training (Trading as Clinnovate Ltd), Nov 18

Both speakers were excellent – knowledgeable, professional, approachable, willing to explain and very friendly.

Tina Zivkovic, Lead Contract Specialist, Janssen Pharmaceutical , Nov 18

The speakers and content were all great.

Edith Gomez, Research Grants Manager, University of Leicester, Nov 17

A concrete and effective overview of CTAs.

Suzanne Alizart, Contracts Manager, University of Leicester, Nov 17

A helpful and informative course – the depth of knowledge was impressive.

Grant Nicholson, Director of Clinical Research, Respiratory Clinical Trials, Nov 17

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

Malgorzata Stach, Contracts Manager, MTS Contracts Consulting Ltd, May 16

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

Marie Anne Punchard, Clinical Project Manager, TiGenix, May 16

The training was useful and informative.

Shinichi Nishimura, Clinical Liaison Manager, Chugai Pharma Europe Ltd, May 16