Results FOR "Regulatory affairs & vigilance"

High-quality training in regulatory affairs and pharmacovigilance

Our regulatory courses and conferences are presented by established experts who will provide you with practical information on the fundamentals and trends in marketing authorisation, regulatory maintenance and post-marketing surveillance.

PharmaFORUM Webcast Biologics "Downstream development (late stage)"

Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.

PharmaFORUM Webcast International "RA and PV in Mexico"

Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs and pharmacovigilance at your fingertips!

PharmaFORUM Webcast Biologics "Pharmaceutical Development of Biologics Drug Products: the interface of formulation, primary packaging and application"

Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.

Regulatory Affairs/CMC and GMP Inspections in Russia and the EAEU

This seminar provides you within-depth knowledge on marketing authorisation, CMC documents and GMP-requirements in Russia, Belarus, Kazakhstan and Ukraine.

Medical Writing in Pharmacovigilance

This two-day course provides an introduction to medical writing for pharmacovigilance, as well as insights into several relevant safety documents.

Pharmacovigilance Requirements in Emerging Markets

The diversity of PV-relevant regulations defining the art of good PV practice call for a finely tuned balance to ensure that all PV systems employed by a company tie into a unified and truly global PV matrix. Our experts in this course will give you a detailed update on the current legal and regulatory background and on your duties.

eSubmission Manager in Europe

The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD.

PharmaFORUM Webcast Biologics "Bioassays"

Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.

Annual CMC Conference

This conference addresses quality-related questions from the CTD compilation to quality changes/variations.