Module 5 Presentations

05/07/2024

EU Legislative Framework – Directive 2011/20

Legislation

Clinical trials

Ethics

Eudralex– The Rules Governing Medicinal Products in EU Volume 1, 2, 3, 4, 9,10

Declaration of Helsinki ICMR Ethical guidelines for biomedical research

Directive 2003/94/EC on GMP for clinical trials

Directive 2001/20/EC on clinical trials

ICH

Regulation 726/2004/EC on centralised procedures

Directive 2005/28/EC on GCP

Ethics committes

GxP

Directive 2001/83/EC on human medicinal products

National legislation

GDPR

International, national, professional codex/guidelines

47

47

EU Legislative Framework – Regulation 536/2014

Legislation

Clinical trials

Ethics

Eudralex– The Rules Governing Medicinal Products in EU Volume 1, 2, 3, 4, 9,10

Delegated Regulation 2017/1569 on GMP for investigational medicinal products for human use Implementing Regulation 2017/556 on detailed arrangements for the good clinical practice

Declaration of Helsinki ICMR Ethical guidelines for biomedical research

Regulation No 536/2014 on clinical trials on medicinal

products for human use

Regulation 726/2004/EC on centralised procedures

ICH

inspection procedures

Ethics committes

GxP

Implementing Regulation 2022/20 setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials

Directive 2001/83/EC on human medicinal products

National legislation

GDPR

EU Pharmaceutical Legislation Reform

International, national, professional codex/guidelines

48

48

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