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Your Interactive Seminar Leaders:
David Powell, Contract Manager, National Institute for Social Care and Health Research (view my 60 second interview)
Anne Crofts, Partner, Beachcroft LLP
Diana Galpin, Senior Legal Adviser, Research and Innovation Services, University of Southampton
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Fundamentals of Clinical Research Contracts
- Examining what is included in the clinical research model contract
- Sharing practical insight: simplifying terminology and levels of coverage explained
- Understanding different elements of contract risk
- Allocation of rights and responsibilities, and governance check: do you always need a contract?
- Unmasking essential confidentiality, indemnity and intellectual property issues
- Practical hints and tips on setting out and embedding finances
- Practical considerations for University involvement: understanding when they should be a party or not
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Making Modifications to the Standard Model Contracts for Clinical Research
- Introduction to the suite of model contracts: what they cover and when to use them
- Sharing examples of common areas of negotiation and modifications, and avoiding classic pitfalls
- Gaining legal insight into acceptable changes: ensuring you are covered
- Inclusion of foreign law provisions when working with international companies
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Contracting outside of the Clinical Research Model Agreement Remit
- Understanding the range of clinical studies and their different contracting needs
- Reviewing the benefits and risks of formal contracts vs appropriate documentation
- What key areas should trusts focus in on for non-standard agreements?
- A quick guide to Human Tissue Agreements: when might the protocol be enough?
- Best practice sub-contracting outside the NHS and between NHS organisations
- Understanding the requirements of IMP Manufacturing
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Organisation Level Agreements: Developing an Overarching Agreement between University of Southampton and University Hospital Southampton NHS Foundation Trust
- Sharing the journey of how an overarching agreement was developed
- Delivering process efficiency key benefits of overarching agreements and some pitfalls
- Ingredients to an effective agreement: outline of what needs to be included and how to structure it with a more detailed discussion around some of the key elements and principles
- The challenge of keeping it up to date
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Practical sessions
Legal Clinic: Sharing Common Areas of Dispute and Practical Examples of Clinical Research Contracts
- Examples and case studies of common hurdles and trip points for NHS Trusts
- Avoiding disputes: essential insight to safeguard your interests
- Practical guidance and experienced reassurance: quick legal insight into areas of concern
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Event Timing: Registration 9.30am - Start 10.00am - Close 4.30pm
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Contact : 01732 897788 |
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