[Harmonisation of regulatory requirements for clinical trials on medicinal products for human use in the Directive 2001/20/EC and complementary guidance. Implementation of the 12th Law Amending the German Drug Law].

Geisler, I; Hofmann, H-P; Nickel, L

[Harmonisation of regulatory requirements for clinical trials on medicinal products for human use in the Directive 2001/20/EC and complementary guidance. Implementation of the 12th Law Amending the German Drug Law]. / Angleichung der regulatorischen Anforderungen für die klinische Prüfung von Arzneimitteln am Menschen in der EU Die Richtlinie 2001/20/EG und die diese ergänzenden Verordnungen und Empfehlungen: die 12. Novelle zum AMG.

Geisler, I; Hofmann, H-P; Nickel, L.

Affiliation

Geisler I; Bundesministerium für Gesundheit und Soziale Sicherung, Bonn.

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz ; 48(2): 141-6, 2005 Feb.

Article in De | MEDLINE | ID: mdl-15726454

Subject(s)

Clinical Trials as Topic/legislation & jurisprudence; European Union; International Cooperation; Legislation, Drug/standards; Adult; Adverse Drug Reaction Reporting Systems/legislation & jurisprudence; Child; Europe; Germany; Guideline Adherence/legislation & jurisprudence; Humans; Informed Consent/legislation & jurisprudence; Minors/legislation & jurisprudence; Quality Assurance, Health Care/legislation & jurisprudence

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Database: MEDLINE Main subject: Clinical Trials as Topic / European Union / International Cooperation / Legislation, Drug Type of study: Guideline / Prognostic_studies Country/Region as subject: Europa Language: De Journal: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz Year: 2005 Type: Article

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