Compact: Marketing Authorisation and changes of Medicinal Products - Training / Workshop von PTS Training Service

A journey through the world of registration for non-RA personnel or newcomers in RA Application procedures Common Technical Document CTD Variations and Change Control Timelines for approvals and variations Regulatory background Training course held in Eng

Inhalte

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. 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. 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.

Lernziele

  • The route from Research to an approved product
  • Registration procedures
  • Common Technical Document
  • Variations and Change Control
  • Regulatory compliance
ReferentenDr. Josef Landwehr, PTS Training Service

Zielgruppen

Personnel not working in the RA department but who have to deal with regulatory aspects in the day to day work, Newcomers in the RA department to get a first compact overview, Personnel from contract manufacturing organizations, API and Excipients, Manufacturers or Service providers who are in contact with the pharmaceutical industry

Termine und Orte

Datum Uhrzeit Dauer Preis
Unna, DE
01.07.2021 10:00 - 17:00 Uhr 6 h Jetzt buchen ›

SG-Seminar-Nr.: 5590154

Anbieter-Seminar-Nr.: 4100

Termine

  • 01.07.2021

    Unna, DE

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Datum Uhrzeit Dauer Preis
Unna, DE
01.07.2021 10:00 - 17:00 Uhr 6 h Jetzt buchen ›