Marketing Authorisation, Registration of Medicinal Products and Medical Devices: Compact Training - Seminar / Kurs von PTS Training Service

System of Rules and Authorities - Process from Research to an approved product -Marketing Authorisation application procedures in the EU and in the US - Common Technical Document CTD

Inhalte

A journey through the world of registration for non-RA personnel with information about rules, authorities, processes, documentation and much more.A training for: 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

Lernziele

  • The route from Research to an approved product
  • System of Rules and Authorities
  • 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

SG-Seminar-Nr.: 1477348

Anbieter-Seminar-Nr.: 2039

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