Studiengang „Master of Drug Regulatory Affairs"

Studienmodule

Modul 01 (WS 2015 / SS 2016)

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. Josef Hofer, Grafing

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   04. September 2015 von 8.30 – 18.30 Uhr
Samstag   05. September 2015 von 8.00 – 16.00 Uhr
Ort:   BfArM, Kurt-Georg-Kiesinger-Allee 3
Teil 2:    
Freitag   18. September 2015 von 8.30 – 18.30 Uhr
Samstag   19. September 2015 von 8.00 – 16.00 Uhr
Ort:   Uni-Hauptgebäude, Hörsaal 17 (XVII)
     
    Abgabe Studienarbeit: 19.10.2015

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