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!
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.
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...).
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
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.
These six webcasts enable you to deal with the legal challenges in marketing authorisation and life cycle management.
This e-Learning programme will familiarise you with the data requirements in CTD Module 3.
This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.
First Accredited Diploma in Pharmacovigilance for the Middle East
Do you need to be well versed in European pharmacovigilance for your daily work? Then we would like to invite you to join this webcast series. You can choose between three different packages according to your level of expertise and requirements.