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1 Day Course: Drafting and Negotiating Clinical Trial Agreements (London, United Kingdom - November 13, 2018) - ResearchAndMarkets.com

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The "Drafting
and Negotiating Clinical Trial Agreements"
conference has been
added to ResearchAndMarkets.com's offering.

Clinical trial agreements 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.

Agenda

Overview of the legal/policy landscape as it affects the terms of CTAs

  • What 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

Case Study

Negotiating and drafting CTAs

  • Overview 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

Case Study

Negotiating and drafting CTAs - Continued discussion of case study:

  • Manufacture of the investigational medicinal product
  • Warranties and indemnities
  • Liabilities and insurance requirements
  • Termination and its consequences

Additional considerations

  • Introduction 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

For more information about this conference visit https://www.researchandmarkets.com/research/3gd7pk/1_day_course?w=4

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