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Compact: Marketing Authorisation of Medicinal Products

Basistraining, June 7, 2018 in Baden-Baden
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 findet zu einem späteren Zeitpunkt statt.
amJune 7, 2018 in Baden-Baden
TeilnehmergebührTeilnehmergebühr760,- Euro

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

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Hier finden Sie weiterführende Informationen
Marketing Authorisation is important✓ You want to know why and how to get approvals? This seminar is your chance!
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Diese Angebote zum Themengebiet: Zulassung sollten für Sie interessant sein:

am 05.09.2018
Finden Sie hier das komplette Angebot


am: June 7, 2018,
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 am Sophienpark
Sophienstr. 14, 76530 Baden-Baden| mehr
Im Rahmen des reservierten Zimmerkontingents über PTS beträgt der Einzelzimmerpreis: 130,- Euro inklusive Frühstück. Die Übernachtungskosten stellt das Hotel dem Teilnehmer am Abreisetag in Rechnung. Die Begleichung der Rechnung erfolgt nicht durch PTS.


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