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.
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!
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.
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.
This e-Learning programme will familiarise you with the data requirements in CTD Module 3.
- Online /
- Online / 31.12.2020
This e-Learning programme will focus on stability testing for chemical and biological pharmaceutical products in the ICH region.
This e-learning will help you gain an understanding of the GDPR and its implicationsfor businesses that process personal datas.
High-quality e-learning for a well-founded understanding of the concept of the Concept of the German Accounting Standards