Establishing pan-European clinical trials: Regulatory compliance and other practical considerations

Journal of Biolaw and Business

Volumn 7, Issue 4, 2004, Pages 58-63

  Grienenberger, Aurélie ^a  

^a VOISIN CONSULTING LIFE SCIENCES   (France)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; COMMERCIAL PHENOMENA; DRUG RESEARCH; DRUG SURVEILLANCE PROGRAM; EUROPE; FUNDING; GOOD CLINICAL PRACTICE; GOOD MANUFACTURING PRACTICE; LEGAL ASPECT; PRACTICE GUIDELINE; REVIEW; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL TRIAL; ETHICS; EUROPEAN UNION; HUMAN; LEGAL APPROACH; PROFESSIONAL STANDARD; REGISTER; STANDARD;

NEW DRUG;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CLINICAL TRIALS; DRUGS, INVESTIGATIONAL; ETHICS COMMITTEES, RESEARCH; EUROPE; EUROPEAN UNION; GUIDELINES; HUMANS; REGISTRIES;

EID: 13844311355     PISSN: 10955127     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (15)

1. Directive 2001/20/EC: Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation 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.
2. GCP: Detailed Guidelines on the principles of good clinical practice in the conduct in the EU of clinical trials on medicinal products for human use
3. Application to EC: Detailed guidance on the application format and documentation to be submitted in an application for an ethics committee opinion on a clinical trial on a medicinal product for human use
4. Contents of Manufacturing/ Importation Authorization: Detailed guidelines on the community basic format and the contents of the application for a manufacturing and/or import authorization of an investigational medicinal product for human use to implement the directive on clinical trials on medicinal products for human use.
5. Manufacturing and Importation of IMP: Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
6. Application to CA: Detailed guidance for the request for authorization of a clinical trial on a medicinal product for human use to the competent authorities in the European Union, notification of substantial amendments and declaration of the end of a clinical trial.
7. Trial Master File: Detailed guidelines on the trial master file and archiving to implement the directive on clinical trials on medicinal products for human use.
8. Eudravigilance CT: Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance -Clinical Trial Module)
9. EUDRACT Database: Detailed guidance on the European clinical trials database (EUDRACT Database)
10. SUSARs Report: Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use
11. Inspector Qualifications: Detailed guidelines on the qualifications of inspectors who should verify compliance in clinical trials with the provisions of good clinical practice for an investigational medicinal product to implement the directive on clinical trials on medicinal products for human use
12. GCP Compliance and Inspection: Detailed guidelines on inspection procedures for the verification of GCP compliance to implement the directive on clinical trials on medicinal products for human use
13. http://pharmacos.eudra.org/F2/pharmacos/dir200120ec.htm
14. http://pharmacos.eudra.org/F2/eudralex/vol-1/home.htm
15. http://eudract.emea.eu.int/document.html