Master's Course "Drug Regulatory Affairs"

Study Modules

Modul 08 (WS 2017 / SS 2018)

Chemical-pharmaceutical documentation

attendance approx. Seminar Paper Method of examination Credit
approx. 30 h approx. 30 h seminar paper and oral examination 6

Module Supervisor

  • Dr. Susanne Ding, Biberach an der Riss

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

     
  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)

Study plan

Part 1:    
Friday   13 April 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   14 April 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
Part 2:    
Friday   27 April 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   28 April 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
     
    Deadline seminar paper: 28 May 2018

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