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

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