Studienmodul 01 - Wintersemester 2018 - Sommersemester 2019 - Studiengang „Master of Drug Regulatory Affairs" - DGRA e.V. - Deutsche Gesellschaft für Regulatory Affairs

Studienmodule

Präsenzzeit	Studienarbeiten	Prüfungsform	Leistungspunkte
ca. 30 Stunden	ca. 30 Stunden	Studienarbeit	5

Overview and statistics on marketing authorization procedures and drug regulations in the EU / US Basic classification of medicines with definitions Explanation of common regulatory terms

The registration dossier Purpose Structure Preparation Electronic submission
Product Variations in the EU / US Statistics Classification
The competent authorities in the EU and US Organization Responsibilities and duties International cooperation between authorities
Meetings with authorities Categories of meetings Preparation of meetings Scientific advice
Drug Regulatory Affairs in the pharmaceutical industry Goals Qualification and responsibilities of personel Organizational aspects Interactions with other departments within the company
Good Regulatory Practices Definition GRP at the authorities GRP in the pharmaceutical industry Best Practice Guides Quality assurance in the pharmaceutical industry
Sources of regulatory information