Presented by
Falconbury

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

5 Nov 2021 + 4 more dates

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  • Format: Live online, Classroom
  • CPD: 6 hours for your records
  • Certificate of completion

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.

Key topics covered in this intensive and interactive seminar:

  • An overview of the legal, ethical and policy considerations that underpin the conduct clinical trials as these affect how the terms of clinical trials agreements are drafted
  • Recognising and dealing with key commercial and regulatory issues (including in particular relating to Brexit and the “flexibilities” adopted during the pandemic) that arise when drafting clinical trials agreements
  • Drafting and negotiating techniques to minimise disputes and maximise efficiency


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

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The Drafting and Negotiating Clinical Trial Agreements course will cover:

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)
  • UK framework post Brexit
  • 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 (particularly in light of the 3/2019 guidance from the European Data Protection Board)
  • Product liability – what is the law (and crucially current practice) on product liability and the requirement of clinical trials insurance
  • Confidentiality and intellectual property rights:
    • the tension between principle of transparency and 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 (and the UK model CTAs updated in March 2020)
  • 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
  • Specific ideas arising from a very large contract with a CRO to whom the pharma company outsourced all of its clinical trial management requirements. Making the CRO de facto (and in a couple of cases de jure) sponsor.

Additional considerations relevant to drafting and negotiating CTAs

  • Multi-jurisdictional trials
  • The implications of Brexit

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Alex Denoon

Alex Denoon is head of the regulatory team at Bristows, primarily advising life sciences clients. He has more than 20 years’ experience advising clients in the sector. In addition to his LLB, Alex has a BSc in Human Genetics. Alex spent more than five years in-house, including as GC and Company Secretary of Biotech Australia. He works with clients to devise and implement regulatory strategies throughout the product life cycle of pharmaceuticals and medical devices, and has advised clients in relation to more challenging issues including: genomics, cell therapies, tissue and cells requirements, borderline products, combination products, 3D printing, healthcare apps and remote diagnostics, and has been involved in the development of a number of regulatory frameworks and guidelines.

In addition to a range of contentious (judicial review) and advisory matters, he has a breadth of international experience in structuring, negotiating and drafting commercial agreements. Alex is widely published and speaks regularly at conferences.

More details

Book Drafting and Negotiating Clinical Trial Agreements Live online/Classroom training

5 Nov 2021

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
05:30-13:00 New York (UTC-04)
Course code 11032

  • GBP 599
  • EUR 859
  • USD 970

Limited places remaining

In your basket 

24 Feb 2022

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 11559

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 20 Jan

In your basket 

13 May 2022

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 11650

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 08 Apr

In your basket 

1 Aug 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11425

  • GBP 599 699
  • EUR 839 979
  • USD 934 1,090

Until 27 Jun

  • 1 day classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

4 Nov 2022

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
05:00-13:00 New York (UTC-04)
Course code 11781

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 30 Sep

In your basket 

Reviews of IPI's Drafting and Negotiating Clinical Trial Agreements training course


Would highly recommend this course to in-house lawyers.

Feb 26 2021

Zera Ong
Commercial Associate, Evox Therapeutics

Feb 26 2021

The content touched upon the most relevant parts of a clinical trial agreement, the presentation was good and the speakers knowledge and expertise also gave me more insight in the practical side of clinical trial agreements.

Angela Paltan
Legal counsel, Erasmus MC

Feb 26 2021

The speakers appear to be passionate about the topic and the adjacent fields. Gave good insight in relevant cases and practice.

Martin de Vlaming
Legal Counsel, Erasmus MC

May 14 2019

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

Nov 5 2019

The speakers were perfect – really qualified and experienced.

Anne-Caroline Béraud
In House Legal Counsel, Erytech Pharma

Nov 5 2019

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

May 14 2019

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 14 2019

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

Jordan Stefanov
Senior Operations Coordinator, Novartis

Nov 13 2018

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

Tina Zivkovic
Lead Contract Specialist, Janssen Pharmaceutical

Nov 13 2018

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 13 2018

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 7 2017

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

Grant Nicholson
Director of Clinical Research, Respiratory Clinical Trials

Nov 7 2017

The speakers and content were all great.

Edith Gomez
Research Grants Manager, University of Leicester

Nov 7 2017

A concrete and effective overview of CTAs.

Suzanne Alizart
Contracts Manager, University of Leicester

May 10 2016

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

Malgorzata Stach
Contracts Manager, MTS Contracts Consulting Ltd

May 10 2016

The training was useful and informative.

Shinichi Nishimura
Clinical Liaison Manager, Chugai Pharma Europe Ltd

May 10 2016

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

Marie Anne Punchard
Clinical Project Manager, TiGenix

UK

  • Abbvie Ltd
  • Allergan
  • Allergan Ltd
  • Allergy Therapeutics
  • Anglia Ruskin University
  • Arnold & Porter (UK) LLP
  • Artios Pharma Limited
  • Bates Wells Braithwaite London LLP
  • Bayer Healthcare
  • Bayer plc
  • Bevan Brittan LLP
  • BioMarin
  • Biomet UK Ltd
  • Bionical Limited T/A Bionical Emas,
  • Bond Dickinson LLP
  • BPE Solicitors LLP
  • Bristol Myers Squibb Pharmaceuticals Limited
  • Bristows LLP
  • BTG International Ltd
  • Cancer Research UK
  • Cardiff University
  • Catalent Pharma Solutions
  • CGX Training (Trading as Clinnovate Ltd)
  • Chugai Pharma Europe Ltd
  • Chugai Pharma Europe Ltd.
  • Cmed Clinical Research Services Ltd
  • CMS Cameron McKenna LLP
  • Cochlear Europe Limited
  • EastHORN Clinical Services
  • Edinburgh Research and Innovation Limited
  • EUSA Pharma (UK) Ltd
  • Evox Therapeutics
  • Exeter Clinical Trials Unit
  • GlaxoSmith Kline
  • Immunocore Ltd
  • Imperial College Healthcare NHS Trust
  • Institute of Cancer Research
  • IQVIA
  • Isaac & Co
  • Janssen Pharmaceutical
  • Keele University
  • Kendle Clinical Development Services
  • Kendle International
  • King's College London
  • Kings College Hospital
  • Kyowa Hakko Kirin UK Limited
  • Leeds Teaching Hospitals NHS Trust
  • Lewis Silkin
  • Lindsays
  • London School of Hygiene and Tropical Medicine
  • Mayday University Hospital
  • McDonough Clinical Research Ltd
  • McGrigors LLP
  • Medical Research Council
  • Medway NHS Foundation Trust
  • MTS Contracts Consulting Ltd
  • Nhs Blood & Transplant
  • Norgine Ltd
  • Orion Clinical Services Ltd
  • Osborne Clarke
  • Oxford University Hospitals NHS Trust
  • Parexel International Ltd
  • Pharmacovigilance Matters Limited
  • Plymouth Hospitals NHS Trust
  • Plymouth University
  • PPD Global Limited
  • Quanta Dialysis Technologies Ltd
  • Queen Anne Street Medical Cent
  • Queen Mary University of London
  • Queens University Belfast
  • Quotient Clinical
  • RB
  • Renishaw plc
  • Respiratory Clinical Trials
  • Roche Products Limited
  • Roche Products Ltd
  • Roiter Zucker
  • Royal Marsden Hospital NHS Foundation Trust
  • Rubiecon Contracts Ltd
  • Servier R&D Ltd
  • Shepherd & Wedderburn LLP
  • Shire Pharmaceutical Ltd
  • Shire Pharmaceuticals
  • Simbec Orion
  • St Stephens AIDS Trust
  • Stratagem IPM Limited
  • The Royal Marsden NHS Foundation Trust
  • The University of Sussex
  • UCL
  • United Therapeutics Europe Ltd
  • University College London
  • University of Bristol
  • University of Cambridge
  • University of Edinburgh
  • University of Exeter
  • University of Leeds
  • University of Leicester
  • University of Oxford
  • University of Sheffield
  • University of Surrey
  • University of Sussex
  • University of Warwick
  • Veterinary Medicines Directorate
  • Vincent Sykes & Higham LLP
  • VWV

Switzerland

  • Debiopharm
  • ETH Zurich
  • Helsinn Healthcare SA
  • Incyte Biosciences International Sàrl
  • Medicines for Malaria Venture
  • MEDTRONIC INTERNATIONAL TRADING
  • Nestec SA
  • Nestle
  • Novartis
  • Novartis Animal Health Inc
  • Outcome Europe Sarl

Belgium

  • Ablynx NV
  • Boston Scientific
  • Celyad SA
  • EORTC
  • Galapgos NV
  • GODDYN BVBA
  • Laboratoires SMB SA
  • SGS Belgium
  • Terumo
  • Terumo Europe

Netherlands

  • ENGAGE Clinical Contracts Solutions
  • Entuli Law Firm
  • Erasmus MC
  • Erasmus Medical Center
  • Hogan Lovells International Ltd
  • Nutricia Research BV
  • Philips International B.V.
  • Salvius Legal
  • Unilever R&D Vlaardingen

Denmark

  • Arla Foods amba
  • Coloplast A/S
  • DuPont Nutrition & Health
  • Genmab A/S
  • Leo Pharma A S
  • Leo Pharma A/S
  • Novo Nordisk A/S
  • Pharmacosmos A/S

France

  • Becton Dickinson
  • Erytech Pharma
  • Innate Pharma
  • Ipsen Group
  • Ipsen Pharma SAS
  • MEDINCELL
  • Registrat-Mapi

Germany

  • Bohmann
  • koeln
  • Morphosys AG
  • W.L. Gore & Associates GmbH

Ireland

  • Icon Clinical Research Ltd
  • Saolta/NUI Galway
  • Tallaght University Hospital

Hungary

  • Gedeon Richter
  • Gedeon Richter Plc.

Israel

  • BioLineRx Ltd.
  • Kahr-Medical

Korea, Republic Of

  • Samsung Bioepis
  • Samsung Bioepis Co., Ltd.

Saudi Arabia

  • King Faisal specialist hospital and research centre
  • Saudi Arabian Airlines

Spain

  • Insud Pharma, S.L.
  • TiGenix

United States of America

  • Passage Bio
  • W L Gore & Associates Inc

Austria

  • Boehringer Ingelheim RCV GmbH & Co KG

Czech Republic

  • Cermak a Spol

Finland

  • University of Turku

Iceland

  • Iceland Medical Fund

India

  • Norwich Clinical Services

Latvia

  • DOKUMEDS

Macedonia, The Former Yugoslav Republic Of

  • ALKALOID AD Skopje

Norway

  • MSD (Norge) AS

Portugal

  • BIAL - Portela & Companhia SA

Sweden

  • Karolinska Institutet

Enrol now

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy