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        Study plan (MDRA-26) Study modules (MDRA-26) Study modules (MDRA-25) Internship Master's thesis Lecturer Literature
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In your studies 'Drug Regulator Affairs'

©Frank Luerweg / Universität Bonn

Study modules 

MDRA-26 (academic year 2024/2025)

Module 8 Chemical Pharmaceutical Documentation

Documentation from synthesis to analysis, pharmacopoeia monograph, dosage form and production

  • Overview
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
  • 8
  • 9
  • 10
  • 11
  • 12
Teaching time Study time Type of examination Credit points
ca. 30 hours ca. 30 hours Study paper and written examination 6
Module leader
Dr. Fatima Bicane

Module contents

1 Formal requirements:

  • Structure of the quality dossier (Module 3)
  • Structure and special features of the Quality Overall summary (Module 2)
  • Active Substance Master File (ASMF) / Common Technical Document (CTD) Form

2 Production of starting materials

  • Requirements for new and known substances
  • Active Substance Master File Verfahren
  • Certificate of Suitability for Ph.Eur. Monographie (CEP)
  • Content requirements for the active substance section of the authorisation dossier
  • Active substances for use in clinical trials

3 Validation of analytical methods

  • Regulatory requirements
  • Validation of analytical procedures, verification of pharmacopoeia procedures - examples
  • Practical implementation: validation parameters, validation planning, scope depending on the development phase, documentation in the dossier
  • Method transfer
  • Quality by Design in the development and validation of analytical methods

4 Composition, development and production

  • Pharmaceutical development - requirements in the CTD for commercial products and Investigational Medicinal Product Dossier (IMPD), regulatory requirements
  • Preparation development in general and tasks of pharmaceutical development (preformulation, formulation development, investigations into the suitability of the container material)
  • Prozess validation
  • New ICH concepts in pharmaceutical development and in the manufacturing process

5 Primary packaging - requirements for development and routine testing

  • Regulatory requirements
  • Containter closure system development
  • Quality assurance/quality control of packaging components

6 Biopharmaceutics

  • In-vitro release (dissolution)
  • Bioavailability and bioequivalence
  • Avoidance of in vivo bioequivalence studies

7 Specifications of starting materials and finished medicinal products

  • Determination of specifications - overview of relevant guidelines
  • Approaches to practical implementation: Definition of specifications for impurities in active substances and finished medicinal products, known substances, excipients
  • Changing specifications during development and after authorisation
  • Documentation examples for specifications, batch testing and certificate of analysis
  • Real time release testing

8 Reference substances

  • Regulatory requirements
  • Practical implementation: reference substances in pharmaceutical analysis, use of reference substances, characterisation of primary standards, reference substances for related substances
  • Documentation in the authorisation dossier

9 Stability/shelf life

  • Stability testing of active substances and finished medicinal products
  • Derivation of storage conditions
  • Abbreviated stability testing (extrapolation, bracketing, matrixing)
  • Documentation requirements (CTD, IMPD)
  • Stability testing for variations
  • Frequent deficiencies in the authorisation dossier

10 Special requirements for biotechnologically manufactured active substances and medicinal products

  • Special regulatory features of biotechnologically manufactured medicinal products
  • Manufacture of active substances
  • Control strategy
  • Specification determination/impurities
  • In-process controls
  • Documents for CTD Appendix 2
  • Stability testing
  • Comparability and biosimilars

11 The European Pharmacopoeia

  • Convention on the elaboration
  • Versions of the pharmacopoeia
  • Relevance in the EU
  • General chapters
  • General monographs
  • Special topics

12 Common deficiencies in the marketing authorisation dossier

  • Deficiencies in the active substance section
  • Top ten EDQM deficiencies
  • Deficiencies in the product section

Study plan

Part 1
Friday 02.05.2025 von 08:30 - 18:30 Uhr Online
Saturday 03.05.2025 von 08:00 - 16:00 Uhr Online
Part 2
Friday 16.05.2025 von 08:30 - 18:30 Uhr Universitätsclub Bonn e.V..
Saturday 17.05.2025 von 08:00 - 16:00 Uhr Universitätsclub Bonn e.V..
Submission of study paper Monday, 16.06.2025  

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