Master's Course "Drug Regulatory Affairs"

Study Modules

Modul 04 (WS 2017 / SS 2018)

General aspects of Module 1 (CTD) and authorisation of specific medicines

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

Module Supervisor

  • Dr. Niels Krebsfänger, Leverkusen

Topics

Regulatory Intelligence

Abridged / Generic Applications with emphasis on administrative processes and content of the dossier in module 1 

  • Essentially similar and informed consent applications
  • Bibliographical applications
  • Content of the dossier (modules 1, 2 and specific aspects for modules 3 and 4)
  • Line-extensions
  • Scientific Advice at the BfArM
  • The marketing authorization application form

Product Information Management

  • Clinical Trial reports according to Annex one of Directive 2001/83, Clinical Summary and Overview, relevant aspects in the assessment of clinical part of the dossier
  • Assessment process, e.g. efficacy (Wirksamkeitsprüfung)
  • Company Core Data Sheet
  • Summary of Product Characteristics (SmPC)
  • Package leaflet and consultation with target patient groups
  • Labelling (Kennzeichnung)
  • Labelling principles in national phases of EU procedures

Advanced Therapies

  • Relevant Directives, Regulations, Guidelines
  • Definition and classification: advanced therapy medicinal products, tissue products, combined products
  • Authorization procedures
  • Incentives

Vaccines

  • Definitions and specific aspects
  • Combinations
  • Influenza vaccines
  • Authorization procedure (brief introduction)

Blood products

  • Specific regulatory aspects for Blood components
  • Official Batch Release
  • Specific requirements for marketing authorization of blood products (example coagulation factors)
  • Plasma Master File

Specific aspects in marketing applications procedures for herbal and homeopathic medicinal products (Arzneimittel der besonderen Therapierichtungen)

  • Definitions
  • Requirements (AMG, AMPrüfRL, pharmacopoeas)
  • Possible MAA/registration procedures and required data on S, Q, E
  • Herbal medicinal products, HMPWP, Botanical nomenclature, Extracts (labeling)
  • Homeopathic medicinal products: the homeopathic principle, manufacturing according to PhEur
  • Registration procedure
  • Anthroposophical products (brief introduction)

Veterinary products 

  • Definitions, Veterinary Legislation in Germany, EU and globally
  • EMEA, CVMP, HMA and CMD(v), VICH, Animal Health Industry Associations
  • Specific aspects of the SmPC
  • Parts of a Dossier - Part I, II, IIIA Safety, IIIB Residues, IV
  • Withdrawal Periods
  • Ecotoxicity

Study plan

Part 1:    
Friday   19 January 2018 from 8.30 a.m. - 6.30 p.m.
Saturday   20 January 2018 from 8.00 a.m. - 4.00 p.m.
Location:    Haus der evang. Kirche, Adenauerallee 37, Bonn
Part 2:    
Friday   26 January 2018 from 8.30 a.m. - 6.30 p.m.
Saturday   27 January 2018 from 8.00 a.m. - 4.00 p.m.
Location:
  Uni-Club
     
    Deadline seminar paper: 26 February 2018

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