|
01
|
Definition and Scope of Drug Regulatory Affairs and Good Regulatory Practice
Teaching time ca. 30 hours, Study paper ca. 30 hours
|
5
|
|
|
02
|
Pharmaceutical Law
Pharmaceutical law in Germany, the EU and other countries and related laws
Teaching time ca. 30 hours, Study paper ca. 30 hours
|
6
|
|
|
03
|
International Registration Procedures
Principles and procedures for the authorisation of medicinal products, diagnostics and medical devices in the EU, the USA, Japan and worldwide
Teaching time ca. 45 hours, Study paper ca. 30 hours
|
7
|
|
|
04
|
General Aspects of Module 1 (CTD), Registration of Special Medicinal Products
Formal requirements for authorisation and contents of Module 1 CTD, product information texts (summary of product characteristics, package leaflet), special requirements for special therapeutic indications, veterinary medicinal products, blood products, vaccines and advanced therapy medicinal products (ATMPs)
Teaching time ca. 30 hours, Study paper ca. 30 hours
|
5
|
|
|
05
|
Maintenance of Marketing Authorisations / Pharmacovigilance
Monitoring during use, advertising, product changes, amendment and renewal of authorisation
Teaching time ca. 30 hours, Study paper ca. 30 hours
|
6
|
|
|
06
|
Information Management, e-CTD
From literature research to the processing of documents and data to information evaluation and electronic submission
Teaching time ca. 20 hours, Study paper ca. 20 hours
|
3
|
|
|
07
|
Quality Management / Medical Devices
Good practice rules, international standards, quality assurance systems and control, medical device law
Teaching time ca. 30 hours, Study paper ca. 30 hours
|
5
|
|
|
08
|
Chemical Pharmaceutical Documentation
Documentation from synthesis to analysis, pharmacopoeia monograph, dosage form and production
Teaching time ca. 30 hours, Study paper ca. 30 hours
|
6
|
|
|
09
|
Pharmacology and Toxicology Documentation
Documentation of pharmacology, toxicology, genotoxicity and ecotoxicology
Teaching time ca. 30 hours, Study paper ca. 30 hours
|
6
|
|
|
10
|
Clinical Documentation
Documentation of drug trials on humans, clinical trial samples, observational studies and experience reports
Teaching time ca. 30 hours, Study paper ca. 30 hours
|
6
|
|
|
11
|
Benefit, Efficiency, Reimbursement
SGB V, IQWiG, G-BA, GKV-SV, market access, RA & HTA, European developments
Teaching time ca. 20 hours, Study paper ca. 20 hours
|
3
|
|
|
12
|
Regulatory Management / Decision Making
Authorisation strategy, regulatory aspects and marketing
Teaching time ca. 15 hours, Study paper ca. 15 hours
|
2
|
|
