Master's Course "Drug Regulatory Affairs"

Study Modules

Modul 09 (WS 2017 / SS 2018)

Pharmacological-toxicological documentation

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

Module Supervisor

  • Dr. Gerd Bode, Göttingen

Topics

1  

Regulatory background

  • Council regulations/AMG
  • Preclinical guidelines/ICH process
  • GLP
  • Animal welfare
  • The preclinical scientific advise procedure
  • Counterfeit Medicine
2  

Pharmacological-toxicological documentation

  • Common Technical Document (CTD-S)
  • Nonclincal overview / Summaries
  • Bibliographic documentation
 

General principles of toxicity studies

  • In vitro
  • In vivo
4  

Pharmacology

  • Objectives
  • Pharmacodynamic effects relating to the proposed indications
  • Safety pharmacology
  • Assessment of the Potential for QT-interval prolongation
  • Drug interaction
4a  

Pharmacokinetics/Toxicokinetics/Metabolism

  • Objectives
  • Pharmacokinetics after a single dose
  • Pharmacokinetics after repeated administration
  • Distribution in normal and pregnant animals e.g. autoradiography, Biotransformation
  • Repeated Dose Tissue Distribution Studies
  • The Assessment of Systemic Exposure in Toxicity Studies/Toxicokinetics
  • Pharmacokinetics and Metabolic Studies in the Safety Evaluation of New Medicinal Products
  • In Vivo Drug Metabolism/Drug Interaction Studies
4b  

Juvenile Toxicity Testing 

     
5a  

Single dose/Repeated dose toxicity

  • Objectives
  • Species selection
  • Route of administration
  • Duration, dose frequency
  • Number of animals and groups
  • Data evaluation and presentation
  • The Assessment of Systemic Exposure in Toxicity Studies/Toxicokinetics

5b

5c

 

Local tolerance / Phototoxicity

Inhalation toxicity

     
6  

Reproductive toxicology

  • Objectives
  • Fertility and early embryonic development
  • Embryo-fetal development
  • Prenatal and postnatal development, including maternal function
7  

Genotoxicity

  • Objectives and reasoning for genetic toxicity testing of pharmaceuticals
  • Genotoxic mechanisms, impact of metabolism, threshold mechanisms, relevance for carcinogenicity
  • Regulatory test systems
  • Assessment of test results
  • Regulatory experience with submissions
8  

Impurities 

  • Impurities in Drug Substance/Product
  • Genotoxic Impurities
9  

Carcinogenicity

  • Need for Carcinogenicity Studies of Pharmaceuticals
  • Testing for Carcinogenicity of Pharmaceuticals
  • Dose Selection for Carcinogenicity Studies of Pharmaceuticals
10  

Specialities (2)

  • Preclinical testing strategies
  • Timing of preclinical studies
  • Biotechnology derived products
11  

Specialities (3)

  • ERA
  • Anticancer drug development
  • Contamination of controls
12  

The preclinical section of the SPC

  • Objectives
  • Content and structural format
  • Pregnancy: From testing to labelling
  • Cross species considerations
  • Prediction of potential adverse effects in humans

Study plan

Part 1:    
Friday   11 May 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   12 May 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
Part 2:    
Friday   25 May 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   26 May 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
     
    Deadline seminar paper: 25 June 2018

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