Master's Course "Drug Regulatory Affairs"

Study Modules

Modul 01 (WS 2017 / SS 2018)

Definition and description of the functions of Drug Regulatory Affairs, Good Regulatory Practices

attendance approx. Seminar Paper Method of examination Credit
approx. 30 h approx. 30 h seminar paper 5

Module Supervisor

  • Dr. Jan Heun, Unterschleißheim

Topics

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

Study plan

Part 1:    
Friday   15 September 2017 from 8.30 a.m - 6.30 p.m
Saturday   16 September 2017 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
Part 2:    
Friday   22 September 2017 from 8.30 a.m. – 6.30 p.m.
Saturday   23 September 2017 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
     
    Deadline seminar paper: 23 October 2017

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