Masterstudiengang „Drug Regulatory Affairs"
Studienmodule
Modul 01 (WS 2018 / SS 2019)
Definition und Aufgabenbeschreibung von Drug Regulatory Affairs, Good Regulatory Practices
Präsenzzeit |
Studienarbeiten |
Prüfungsform |
Leistungspunkte |
ca. 30 Stunden |
ca. 30 Stunden |
Studienarbeit |
5 |
Modulleiter/in
- Dr. Jan Heun, Unterschleißheim
Themen
Overview and statistics on marketing authorization procedures and drug regulations in the EU / US Basic classification of medicines with definitions 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 |
Studienplan
Teil 1: |
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Freitag |
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07. September 2018 von 8.30 – 18.30 Uhr |
Samstag |
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08. September 2018 von 8.00 – 16.00 Uhr |
Ort: |
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Uni-Club |
Teil 2: |
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Freitag |
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21. September 2018 von 8.30 – 18.30 Uhr |
Samstag |
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22. September 2018 von 8.00 – 16.00 Uhr |
Ort: |
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Uni-Club |
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Abgabe Studienarbeit: 22.10.2018 |
UnterlagenNur für Mitglieder