Academic clinical research in the new regulatory environment

Clinical Medicine, Journal of the Royal College of Physicians of London

Volumn 5, Issue 1, 2005, Pages 39-41

  Gennery, Brian ^a  

^a Faculty of Pharmaceutical Medicine   (United Kingdom)

Author keywords

Clinical trials approval; European clinical trials directive

Indexed keywords

CLINICAL RESEARCH; DRUG INDUSTRY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPEAN UNION; GOOD CLINICAL PRACTICE; GOOD MANUFACTURING PRACTICE; GOVERNMENT; LAW; PUBLIC HEALTH; RESEARCH ETHICS; RESPONSIBILITY; REVIEW;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH;

EID: 14644397278     PISSN: 14702118     EISSN: None     Source Type: Journal    
DOI: 10.7861/clinmedicine.5-1-39     Document Type: Review

References (4)

1. Council Directive 65/65/EC. Official J Eur Union, 26 January 1965.
2. Directive 2001/20/EC of the European Parliament and of the Council. Official J Eur Union, 1 May 2001.
3. Draft Commission Directive on Good Clinical Practice (2004).
4. Medicines and Healthcare products Regulatory Agency. Description of the Medicines For Human Use (Clinical Trials) Regulations 2004. London: MHRA, 2004.