1-Day Seminar: Drafting & Negotiating Clinical Trial Agreements

May 1, 2019 Off By BusinessWire

DUBLIN–(BUSINESS WIRE)–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.

Who Should Attend?

- Contract managers
- Clinical contract specialists
- Clinical trial managers
- R&D staff
- Regulatory specialists
- Lawyers
- Legal executives

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/r/6lx8xl