Method of examination: Course work and written or oral examination
Credit points: 6

Module Head: Dr. Susanne Keitel

No		Topics
1		Formal requirements: Notice to Applicants vs. Common Technical Document (Quality) Quality-relevant information for the SPC and Patient Information Leaflet/Physicians’ Circular Special characteristics of the analytical expert report and the quality overall summary
2		Production of starting materials Requirements for new and know substances Pharmacopoeial monographs EDMF vs. certificate of suitability Impurities and degradation products Batch conformity
3		Validation of analytic methods Development of internal company test methods Product-specific validation of pharmacopoeial methods Cross-validation Method transfer
4		Composition, development and production Product development in general and responsibilities of pharmaceutical development (preformulation, formulation development, investigations into the suitability of the container material) Production formula / production methods / production regulations Process validation Requirements for special dosage forms
5		Primary packaging – requirements for development and routine testing
6		Biopharmacology
7		Specifications of starting substances and finished pharmaceutical products Establishment of specifications Reference substances Changes to specifications during development and after marketing authorization Batch testing Certificates of analysis
8		Stability/shelf life (Part II F.) Stability testing of the active substance Stability testing of the finished product Release vs shelf-life specification Test plan and evaluation Abridged stability testing (extrapolation, bracketing, matrixing)
9		Special requirments for biotechnology-derived substances and pharmaceuticals Production of active substances · Specification determination /impurities In-process controls Documents on Common Technical Document (CTD) Appendix 2 Stability testing Comparability
10		Common deficiencies of regulatory dossiers
11		Preparation of a model dossier (group work)