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Drafting and Negotiating Clinical Trial Agreements Training Course

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

& 24 Feb 2022 , 13 May 2022 , 1 Aug 2022 , 4 Nov 2022

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Details

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

Programme

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

Presenter

Alex Denoon (More...)

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.

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5 Nov 2021
Live webinar
5 Nov 2021
Live webinar
GBP 599.00
EUR 859.00
USD 970.00
+ VAT @ 20.00%
Enrol now
to attend
Live webinar

Please note: this event is being organised by our training partner Falconbury; clicking Enrol will take you to falconbury.co.uk to complete your purchase.
24 Feb 2022
Live webinar
24 Feb 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 20 Jan 22*
Enrol now
to attend
Live webinar

Please note: this event is being organised by our training partner Falconbury; clicking Enrol will take you to falconbury.co.uk to complete your purchase.
13 May 2022
Live webinar
13 May 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 8 Apr 22*
Enrol now
to attend
Live webinar

Please note: this event is being organised by our training partner Falconbury; clicking Enrol will take you to falconbury.co.uk to complete your purchase.
1 Aug 2022
Face-to-face, (venue not yet confirmed)
1 Aug 2022
Face-to-face
(venue not yet confirmed)
GBP 699 599
EUR 979 839
USD 1,090 934
Until 27 Jun 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)

Please note: this event is being organised by our training partner Falconbury; clicking Enrol will take you to falconbury.co.uk to complete your purchase.
  • 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
4 Nov 2022
Live webinar
4 Nov 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 30 Sep 22*
Enrol now
to attend
Live webinar

Please note: this event is being organised by our training partner Falconbury; clicking Enrol will take you to falconbury.co.uk to complete your purchase.

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

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Previous customers include...

  • Allergan Ltd
  • Allergy Therapeutics
  • BioLineRx Ltd.
  • Cardiff University
  • Catalent Pharma Solutions
  • CGX Training (Trading as Clinnovate Ltd)
  • Coloplast A/S
  • Entuli Law Firm
  • Erytech Pharma
  • GODDYN BVBA
  • Icon Clinical Research Ltd
  • Insud Pharma, S.L.
  • Ipsen Pharma SAS
  • Kendle Clinical Development Services
  • Lindsays
  • Medway NHS Foundation Trust
  • Novartis Animal Health Inc
  • Orion Clinical Services Ltd
  • Pharmacosmos A/S
  • Plymouth University
  • PPD Global Limited
  • Respiratory Clinical Trials
  • Roche Products Ltd
  • Samsung Bioepis Co., Ltd.
  • Shepherd & Wedderburn LLP
  • Unilever R&D Vlaardingen
  • University College London
  • University of Turku
  • Veterinary Medicines Directorate
  • W.L. Gore & Associates GmbH

Would highly recommend this course to in-house lawyers.

Zera Ong, Commercial Associate, Evox Therapeutics, Feb 21

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, Feb 21

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 21

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 perfect – really qualified and experienced.

Anne-Caroline Béraud, In House Legal Counsel, Erytech Pharma, 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 were excellent – knowledgeable, professional, approachable, willing to explain and very friendly.

Tina Zivkovic, Lead Contract Specialist, Janssen Pharmaceutical , 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 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 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

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

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