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Falconbury Ltd

Drafting and Negotiating Clinical Trial Agreements

4.9 ausgezeichnet 27 Meinungen
Falconbury Ltd
In London (England)
Emagister-Preis

815 € 699 
zzgl. MwSt.
*Orientierungspreis
Originalpreis in GBP:
£ 699  £ 599

Wichtige informationen

Tipologie Kurs
Ort London (England)
Beginn Mai
weitere Termine
Beschreibung

Some of the topics to be covered at this meeting include an overview of the legal/policy landscape as it affects the terms of CTAs, clause-by-clause review, legal clauses, review of a University’s CTA.

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.

Wichtige informationen

Preis für Emagister-Nutzer: Until 10th of April

Einrichtungen (1)
Wo und wann
Beginn Lage
Mai
Oktober
London
11 Thurloe Place , SW7 2RS, London, England
Karte ansehen
Beginn Mai
Oktober
Lage
London
11 Thurloe Place , SW7 2RS, London, England
Karte ansehen

Meinungen

4.9
ausgezeichnet
Kursbewertung
89%
Empfehlung der User
4.6
ausgezeichnet
Anbieterbewertung

Meinungen über diesen Kurs

K
Kristyna Pravdova
19.05.2019
Über den Kurs: The course covers all the major areas of lawyers concern. The speaker is knowledgeable and keeps the attention of everybody.
Kurs abgeschlossen: Mai 2019
Würden Sie diesen Bildungsanbieter weiterempfehlen?: Ja
S
Serkan Gunay
21.05.2019
Über den Kurs: The speaker was so energetic. The course was organized so nicely and was so informative
Kurs abgeschlossen: Mai 2019
Würden Sie diesen Bildungsanbieter weiterempfehlen?: Ja
J
James Tandy
19.05.2019
Über den Kurs: Good course and people were good.
Kurs abgeschlossen: Mai 2019
Würden Sie diesen Bildungsanbieter weiterempfehlen?: Ja
F
Francis McAuley
18.05.2019
Über den Kurs: I had the best learning experience with the course.
Kurs abgeschlossen: Mai 2019
Würden Sie diesen Bildungsanbieter weiterempfehlen?: Ja
L
Laura Lew
20.05.2019
Über den Kurs: The course was represented so well at the right level the speaker was amazing.
Kurs abgeschlossen: Mai 2019
Würden Sie diesen Bildungsanbieter weiterempfehlen?: Ja
*Erhaltene Meinungen durch Emagister & iAgora

Was lernen Sie in diesem Kurs?

Negotiation Skills
Law
Clinical Data management
Clinical Trial
Medical Trials
NHS Training
Drafting
Key Roles
Medical law
CTA
Case Study
Agreement
Clinical Trial Agreements
Drafting Contracts
Drafting Skills
Agreement Clauses
EU Regulatory Framework
UK NHS Approval
Drafting CTAs
Negotiating CTAs

Themenkreis

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

Zusätzliche Informationen

Arnold & Porter LLP is an international law firm with over 1000 lawyers across offices in the US, Belgium, China, Germany, and the UK. The EU life sciences team has unrivalled experience in advising on every aspect of the regulation of medicines, devices,cosmetics, foods and borderline products. The team includes a number of lawyers with scientific qualifications, including two physicians. It is regularly ranked as the leading firm providing regulatory advice and specialist litigation services to the life sciences sector.