Medicinal product

Results: 622



#Item
531Scientific method / EudraCT / Clinical trial / Institutional review board / First Amendment to the United States Constitution / Good Clinical Practice / Clinical research / Research / Science

Substantial Amendment Notification Form (Cf. Section 3.7.b of the Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notificatio

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 08:59:14
532Business / Pharmaceutical sciences / Technology / Clinical research / Pharmaceuticals policy / Quality assurance / Good manufacturing practice / Quality management system / Validation / Pharmaceutical industry / Quality management / Quality

Ref. Ares[removed][removed]EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Medicinal Product – quality, safety and efficacy

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Source URL: ec.europa.eu

Language: English - Date: 2014-03-31 10:03:22
533Directive 2001/83/EC / Medicinal product / Medicine / European Union / Good Clinical Practice Directive / European Directive on Traditional Herbal Medicinal Products / Clinical research / Pharmaceuticals policy / Health

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products – quality, safety and efficacy Brussels, [removed]

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:46:52
534Medicine / Health / Clinical research / Pharmaceuticals policy / Biology / Pharmacology / Medicinal product / Nutrient systems

Microsoft Word - Annex 4 - updated legal references[removed]doc

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:08:46
535Economics / Simulation / Futures contract / Exchange rate / Price / Gross domestic product / Pricing / Marketing / Business

External reference pricing of medicinal products: simulationbased considerations for crosscountry coordination Final Report Written by Prof. Mondher Toumi, MD, PhD, MSc

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Source URL: ec.europa.eu

Language: English - Date: 2014-03-07 11:01:07
536Marketing authorization / Certificate of pharmaceutical product / Pharmaceutical industry / Pharmaceuticals policy / Good manufacturing practice

The European Agency for the Evaluation of Medicinal Products Inspections MRA

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Source URL: ec.europa.eu

Language: English - Date: 2012-10-18 12:54:01
537Good distribution practice / Health / Medicinal product / Research / Science / Pharmaceuticals policy / Pharmaceutical industry / Marketing authorization

COMMENTS TO THE DRAFT COMMISSION GUIDELINE ON GOOD DISTRIBUTION PRACTICE OF MEDICINAL PRODUCTS FOR HUMANE USE

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:37:29
538Research / Pharmaceutical sciences / Pharmaceutical industry / Health policy / European Union / Good manufacturing practice / Medicinal product / Qualified Person / Biologic / Pharmaceuticals policy / Clinical research / Pharmacology

Ref. Ares[removed][removed]EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:37:36
539Public consultation / Public policy / Statutory law / Medicinal product / Comitology / Breydel building / Law / Knowledge / European Commission / Government / Consulting

Revision of the Variations Regulations: launch of first public consultation Page 1 of 1 From: EGA - Beata Stepniewska [[removed]] Sent: mardi 25 septembre[removed]:33

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:06:57
540Pharmaceutical sciences / Research / Quality / Validation / Validity / Biologic / Vaccine / Medicinal product / Biology / Pharmacology / Pharmaceutical industry / Clinical research

NL (I)VMP-assessor’s comments on the Draft Commission Regulation, version 24 October 2007 for variations and Public Consultation Paper "Better Regulation of pharmaceuticals: ..". (Assessor’s comment in blue) The Comm

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:07:05
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