Drafting and negotiating clinical trial agreements

Drafting and Negotiating Clinical Trial Agreements

CPD One-Day Seminar on Tuesday 24 October 2017

About this course

This practical, one-day course provides a detailed discussion of the legal, regulatory, drafting and practice issues that arise when drafting and negotiating clinical trial agreements (CTAs) and other contractual documents that are encountered when clinical trials are run, e.g. agreements between a sponsor and a clinical research organisation (CRO). Topics that are discussed include:

• What makes CTAs different from other professional services agreements.
• The European regulatory framework for trials and how this affects the terms of agreements.
• Other laws and regulations affecting CTAs, including data protection, freedom of information, “sunshine” laws, and many other topics.
• Standard agreements – governmental, company, etc: when are they used, when are they not; and how are they revised.
• Drafting and negotiation issues.
• Practical aspects of working with colleagues to get the agreement right.
• Other agreements and documents used in clinical trials.

The main focus of this course is on helping the drafter and negotiator to navigate the contractual issues.

CTAs raise many issues; within the time available (6 hours teaching) we look at the main issues that, in our experience, tend to arise.

We will mention UK and EU regulatory issues, as they are important when drafting CTAs, and discuss how and why these affect the terms; but this course is not intended to teach the complex legal framework for the various types of regulated study. Our experience is that clients employ or consult with a regulatory expert when setting up clinical trials, and we work with them to ensure that the appropriate regulatory terms for the individual trial are reflected in the terms of the agreement.

Who should attend

The course is designed for contracts managers, lawyers and project managers who have had some exposure to CTAs but are not experts and do not have years of experience of negotiating them. We find that attenders are mostly based in universities, hospitals and life-science companies, including CROs.

Preparation for the course?

Although not essential, attenders may find it helpful to read one of the NHS standard clinical trial agreements, such as the mCTA and the accompanying guidance notes, which can be found at http://www.ukcrc.org/regulation-governance/model-agreements/mcta/ .

Learning Outcomes

At the end of the course, attenders should have an overview of the legal and regulatory environment as it affects the terms of clinical trial agreements (CTAs) and related contract documentation, the main terms of CTAs, the main negotiating issues that arise, the importance of precise drafting, some industry-standard contracts that are used in clinical trials, and the different perspectives of universities, hospitals, sponsors and CROs.

Course Schedule

09:00 Registration

09:30 Introduction to today’s course; issues that typically arise; regulatory framework (UK and EU) and how this affects CTAs.

11:00 Coffee

11:15 Drafting issues

12:00  Group drafting/negotiation exercises; answers

13:00 Lunch

14:00 Other types of agreement related to trials, including MTAs and human tissue agreements

15:15 Tea

15:30 Further discussion of detailed drafting issues

16:30 Workshop on terms: group discussion of some sample terms (to extent time permits)

17:00 Course ends

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The Presenters' Credentials

The workshop has been designed, and will be run, by Mark Anderson.

Mark has nearly 30 years’ experience of drafting, negotiating and advising on agreements for life-science companies and universities, including CTAs. He is the general editor of Drafting Agreements in the Biotechnology and Pharmaceutical Industries (OUP loose-leaf since 2008). He has many years’ experience of giving courses on CTAs. For several years, he has been recommended as a national expert on life science transactions by Chambers Directory, and on patent licensing by IAM Patent 1000. His 5-day course on IP transactions, run through UCL with approximately 30 volunteer speakers, has won both a Law Society Excellence Award (Highly Commended) and a Provost’s Teaching Award.

Queries

If you have any queries about this course please email Lisa Penfold in the UCL Faculty of Laws at lisa.penfold@ucl.ac.uk