3 past events found
Back to Search Begin New Search Save Search Auto-Notify
Product Information for Medicinal Produ...
Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment. The PL reflects the mor...
June 19, 2017
Organizer: GlobalCompliancePanel
Location: Switzerland, CA
Add Favorite
The New Clinical Trials Regulation and...
Course "The New Clinical Trials Regulation and Regulatory Affairs Aspects of Medicinal Product Development in the EU" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to...
June 15-16, 2017
Organizer: GlobalCompliancePanel
Location: Zurich, Switzerland, SZ
Add Favorite
Conference on Validation and Part 11 Co...
Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 req...
December 1, 2016
Organizer: GlobalCompliancePanel
Location: Zurich,Switzerland, CA
Add Favorite
Back to Search Begin New Search