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.
Basic and advanced know-how on the current regulatory framework of the various countries will be addressed in this course.
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!
Save the date! Your regulatory update in pharmacovigilance with european drug safety experts and a special network event.
Do you need essential European regulatory affairs knowledge? This course gives you a compact overview about all important issues. Each day may be booked separately according to your needs!
After this workshop, you will be familiar with organisational matters and best practice when writing, reviewing and ensuring the quality of your documents. Practical exercises and text review sessions will allow you to apply what you have learnt directly.
Informazione Medico Scientifica per Esperti
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
These six webcasts enable you to deal with the legal challenges in marketing authorisation and life cycle management.