Masterstudiengang „Drug Regulatory Affairs"

Studienmodule

Modul 01 (WS 2017 / SS 2018)

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
   
The registration dossier
  • Purpose
  • Structure
  • Preparation
  • Electronic submission
Product Variations in the EU / US
  • Statistics
  • Classification
The competent authorities in the EU and US
  • Organization
  • Responsibilities and duties
  • International cooperation between authorities
Meetings with authorities
  • Categories of meetings
  • Preparation of meetings
  • Scientific advice
Drug Regulatory Affairs in the pharmaceutical industry
  • Goals
  • Qualification and responsibilities of personel
  • Organizational aspects
  • Interactions with other departments within the company
Good Regulatory Practices
  • Definition
  • GRP at the authorities
  • GRP in the pharmaceutical industry
  • Best Practice Guides
  • Quality assurance in the pharmaceutical industry
Sources of regulatory information

Studienplan

Teil 1:    
Freitag   15. September 2017 von 8.30 – 18.30 Uhr
Samstag   16. September 2017 von 8.00 – 16.00 Uhr
Ort:   Uni-Club
Teil 2:    
Freitag   22. September 2017 von 8.30 – 18.30 Uhr
Samstag   23. September 2017 von 8.00 – 16.00 Uhr
Ort:   Uni-Club
     
    Abgabe Studienarbeit: 23.10.2017

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