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Overview and statistics on marketing authorization procedures and drug regulations in the EU / US |
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| Basic classification of medicines with definitions |
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| Explanation of common regulatory terms |
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The registration dossier
- Purpose
- Structure
- Preparation
- Electronic submission
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Product Variations in the EU / US
- Statistics
- Classification
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The competent authorities in the EU and US
- Organization
- Responsibilities and duties
- International cooperation between authorities
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Meetings with authorities
- Categories of meetings
- Preparation of meetings
- Scientific advice
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Drug Regulatory Affairs in the pharmaceutical industry
- Goals
- Qualification and responsibilities of personel
- Organizational aspects
- Interactions with other departments within the company
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Good Regulatory Practices
- Definition
- GRP at the authorities
- GRP in the pharmaceutical industry
- Best Practice Guides
- Quality assurance in the pharmaceutical industry
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| Sources of regulatory information |
Dr. Mohamed Baccouche,
Radolfzell
