Intensive One Day Programme: Drafting and Negotiating Clinical Trial Agreements 2018 (London, United Kingdom - November 13th, 2018) - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--Sep 20, 2018--The “Drafting and Negotiating Clinical Trial Agreements 2018” conference has been added to ResearchAndMarkets.com’s offering.
Clinical Trial Agreements (CTA) are one of the most important agreements in the pharma industry as no research can start without the right agreement in place between sponsor and host organisation. They provide a contract which manages the relationship and responsibilities of both parties, and provide for the allocation of risk, obligations, the protection of academia, terms of collaboration, IP rights and much more.
This intensive one-day programme, delivered by experts in the field, will provide you with a full understanding of the importance of CTAs. It will describe how the regulatory environment affects them and explain the typical clauses which make up a CTA and what the key differences are between European and the US. By the end of this seminar you will be confident in spotting and addressing issues which arise when negotiating and drafting clinical trial agreements.
Overview of the legal/policy landscape as it affects the terms of CTAsWhat is a clinical trial? EU regulatory framework: What are the key regulatory considerations relevant to conducting a clinical trial? Introduction to the parties to the CTA and key roles and responsibilities Policy issues in public hospitals, e.g. UK NHS approval Other ethical/legal issues Standard contracts, e.g. NHS standard CTA Implications of Brexit
Negotiating and drafting CTAsOverview of issues that frequently come up in the negotiation/drafting of CTAs Introduction to case study Discussion of case study Definitions Intellectual property and publication provisions Use of data generated during the trial Data protection, medical records, freedom of information, etc Manufacture of the investigational medicinal product Warranties and indemnities Liabilities and insurance requirements Termination and its consequences
Additional considerationsIntroduction to differences between US, UK and Continental European legal systems and how they may affect contract drafting Unlicensed product vs off-label use First-in-man studies Investigator initiated studies Compliance and anti-corruption issues
Practical Exercise - Negotiation
Who Should Attend:Contract Managers Clinical Contract Specialists Clinical Trial Managers R&D Staff Regulatory Specialists Lawyers Legal Executives For more information about this conference visit https://www.researchandmarkets.com/research/m6g2jh/intensive_one_day?w=4
View source version on businesswire.com:https://www.businesswire.com/news/home/20180920005356/en/
Laura Wood, Senior Manager
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Related Topics:Clinical Trials
KEYWORD: UNITED KINGDOM EUROPE
INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS
SOURCE: Research and Markets
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PUB: 09/20/2018 06:49 AM/DISC: 09/20/2018 06:49 AM