+49 2932 51477 info@pts.eu
+49 2932 51477 info@pts.eu

Compact: Marketing Authorisation and changes of Medicinal Products

Basistraining, June 27, 2019 in Wiesbaden

How to get approval of your medicinal product

Application procedures
Common Technical Document CTD
Variations and Change Control
A journey through the world of registration for non-RA personnel or newcomers in RA
Process from research to an approved product


Dieses Seminar/Training ist bereits abgelaufen.
amJune 27, 2019 in Wiesbaden
ThemengebietThemengebiet: Zulassung
PTS-KennzifferPTS-Kennziffer: 3287
TeilnehmergebührTeilnehmergebühr: 760,- Euro
BildungspunkteBildungspunkte: 125
SpracheSprache: EN

Registration and success of the company
The insight into different departments and the overview on the regulatory requirements is often difficult due to the required high specialization in the companies. The knowledge about the overall process, however, is important for the individual as well as for the success of the whole company. Interdisciplinary understanding and an optimized communication are core aspects for the achievement of common goals. Nearly all departments are involved in the preparation of documents or are delivering data for the registration dossier. Therefore personnel from all areas should have a basic knowledge about the regulatory requirements. When dealing with changes after the first approval of a product personnel from a number of departments outside Regulatory Affairs are important to keep the regulatory compliance.

API manufacturers, Excipient manufacturers and Service Providers can benefit from a basic knowledge in regulatory requirements. It guaranties an optimal service for the pharmaceutical industry.


The route from Research to an approved product
System of Rules and Authorities
Requirements on Medicinal Products and APIs

Registration procedures
Regulatory requirements
Marketing Authorisation applications and CE Certification
MRP, CP, DCP in Europe

Common Technical Document
Format and content
ASMF and CEP for APIs
Difference in the regions
Phytopharmaceuticals and homeopathic products
Other dossiers

Variations and Change Control
Variation procedures

Regulatory compliance
Registration and GMP
Registration in the day to day work


Overview on the main aspects for the registration of pharmaceutical products Knowledge to fulfill the regulatory requirements efficiently Participants will be a competent contact person for the Regulatory Affairs department and other areas

Who should attend

Newcomers in the RA department to get a first compact overview Personnel not working in the RA department, e.g. production, QC, QA or warehousing to get an insight in requirements of Regulatory Affairs


Training in English language Exchange of experience with the other participants and the trainer

Industry sector

Pharmaceutical companies API and excipient manufacturers Suppliers of raw materials and equipment Contract manufacturers and laboratories Service providers


Bonusmaterial: Bücher und Produkte gratis
Teilnehmer dieser Veranstaltung erhalten exklusiv und gratis diese Bücher und Produkte

Hyperpharm: Abkürzungen, Akronyme in Deutsch und Englisch

Hyperpharm: vollständig überarbeitete 6. Auflage 2019 im DIN A 5 Format mit 100 Seiten und über 1400 Abkürzungen und Akronyme für Pharma und Medizinprodukte in Deutsch und Englisch

Viele Experten (…)
Hier finden Sie weiterführende Informationen
Marketing Authorisations and changes are important✓ You want to know why and how to get approvals? This seminar is your chance!

Diese Angebote zum Themengebiet: Zulassung sollten für Sie interessant sein:

Finden Sie hier das komplette Angebot


am: June 27, 2019,
Beginn: 09:00 Uhr, Ende: ca. 17:00 Uhr


760,- € zzgl. 19% Mwst., schließt ein Mittagessen sowie Dokumentation und Getränke während der Veranstaltung mit ein.


Hotel Oranien
Platter Str. 2, 65193 Wiesbaden|mehr



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