Master's Course "Drug Regulatory Affairs"

Study Modules

Modul 10 (WS 2017 / SS 2018)

Clinical documentation

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

Module Supervisor

  • Dr. Ingrid Klingmann, Wezembeek-Oppem

Topics

1  Basics of clinical trials
  • Definition of clinical trial
  • Phase of drug testing
  • Drug monitoring studies
2 Good clinical practice
  • Terminology
  • Essential documents
  • Archiving
  • Audit
3 GCP inspections
   
4  Ethics in clinical research
  • Declaration of Helsinki
  • Ethics approval process
  • Informed consent
5

Investigational medicinal products documentation

   
Relevant items in clinical trials
   
7  Clinical Pharmacology
  • Phase I studies - background
  • Pharmacokinetics, ADME
  • Bioavailability
  • Population kinetics
  • Pharmacogenetics
  • Pharmacodynamics
  • PK/PD correlation
8  Biometry in clinical research
  • Statistical analysis
  • Study designs
  • Multiple tests
  • Sample size calculation
  • Data management
  • Meta-analysis
  • Subgroup analysis
  • Interim analysis
  • Epidemiology
9 Clinical trial guidelines 1
  • Women
  • Elderly
  • Children
  • Vulnerable subjects
10 Regulatory process in clinical development
  • Provisions of the AMG Submission
  • Supervision, audits, inspections
  • Special European features
11 Clinical Trial Directive 2001/20/EC
  • Chiral active substances
  • Fixed combination medical products
12 Clinical trials guideline 2
  • Vaccines
  • Immunoglobulins
  • Plasma-derived factors
  • Recombinant factors
13 ClinicClinical development of vaccines
  • Background
  • European public assessment reports
14

Clinical Development of Blood Products

  • Background
  • European public assessment reports
15

 Clinical Trials Guidelines 3

  • Drug Interactions
  • QT-interval prolongation Control group
  • Modified-release dosage forms
16 Safety in clinical trials
  • Definitions
  • Causality assessment
  • Notification duty, reports
  • Guidelines
  • Step Plan
17 Clinical trial guidelines 4
   
18

Clinical section of the application dossier

  • Directive 75/318/EEC
  • Notice to applicants
  • Common Technical Document

 

19

Clinical Trial Performance

  • Final group exercise

Study plan

Part 1:    
Friday   01 June 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   02 June 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Wissenschaftszentrum, Ahrstr. 45, 53175 Bonn
Part 2:    
Friday   22 June 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   23 June 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
     
    Deadline seminar paper: 23 July 2018

DocumentationOnly for members

Please login to your account.