Results FOR "Pharma / Medical devices"

Global Regulatory Affairs Manager

This online training addresses the needs of regulatory affairs managers dealing with marketing authorisations outside the EU or planning to do so in the future.

Development Expert Biologics

Informazione Medico Scientifica per Esperti

Informazione Medico Scientifica per Esperti

IDMP 2020 - the first iteration!

This workshop helps you collect, clean and structure all necessary data for IDMP and informs you on ePI (structured electronic product information) - a digitalisation project potentially utilizing IDMP and SPOR

eCTD preparation and submission

This online training programme consisting of three recorded webcasts will train you how to develop documents, compile them and submit an eCTD step by step.

e-Learning: Introduction to EU Marketing Authorisation

This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe (MRP, DCP, CP) . It will also introduce you to post-authorisation duties (renewal, variation...).

e-Learning: Marketing Authorisation Outside the ICH Region

This e-learning will familiarise you with the regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements. Dossier requirements in Australia, Hong Kong, India, South Korea, Taiwan, Saudi Arabia, GCC, Jordan, Turkey, Thailand, China, South Africa, Russia, Kazakhstan, Eqypt, Brazil, Mexico & Argentina will be addressed

e-Learning: Common Technical Document & eCTD

Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required.

e-Learning: Stability Testing in the ICH Region

This e-Learning programme will focus on stability testing for chemical and biological pharmaceutical products in the ICH region.

e-Learning: CTD Module 3

This e-Learning programme will familiarise you with the data requirements in CTD Module 3.