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 International "eCTD worldwide"

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!

Variations in Europe

Variation Regulation, Classification guideline, eSubmission - all processes explained in this course.

Medical Devices Regulatory News for 4 Continents

For all who carry responsibility in market access for medical devices in Non-EU countires with hands-on expertise, including practical examples and projects.

PharmaFORUM Webcast International "Interpreting and implementing new global PV requirements"

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!

Project Management in Pharmacovigilance

In this new course you will learn about what is important in planning, implementing and monitoring PV projects.

Marketing Authorisation in Latin America

A course to discuss real cases/challenges for marketing authorisation in Mexico, Argentina, Colombia, Peru, Chile and Brazil with local experts from Brazil and Spain.

Regulatory Leaders FORUM 2018

A course for all who carry responsibility in regulatory affairs with hands-on expertise, including practical examples and projects in the field of eSubmission (CESSP, IDMP..) and in the field of regulatory strategy.

PharmaFORUM Webcast Biologics "Interaction with Agencies"

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.

CMC Documents: Scientific Writing for Regulatory Submission

How to write the Module 3 for Regulatory Submission.