GMP & Regulatory Affairs - Clinical Trials and Drug Development - Nursing Assignment Help

Assignment Task:

Task:

(a) Give a detailed overview of the trials and declarations which led to the ethical principles and guidance for physicians and other participants in a clinical trial. (15 Marks)
(b) Describe in your own words the roles and responsibilities of the sponsor and investigator during a clinical trial. (10 Marks)
(c) What are the main benefits of the pharmacovigilance process? (5 Marks)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community, Having regard to Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approx-imation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (1), and in particular Article 1(3), Article 13(1) and Article 15(5) thereof,
Whereas:

(1) Directive 2001/20/EC requires the adoption of principles of good clinical practice and detailed guidelines in line with those principles, minimum requirements for author- isation of the manufacture or importation of investiga-tional medicinal products, and detailed guidelines on the documentation relating to clinical trials to verify their compliance with Directive 2001/20/EC.

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