The diversity of PV-relevant regulations defining the art of good PV practice call for a finely tuned balance to ensure that all PV systems employed by a company tie into a unified and truly global PV matrix. Our experts in this course will give you a detailed update on the current legal and regulatory background and on your duties.
This two-day course provides an introduction to medical writing for pharmacovigilance, as well as insights into several relevant safety documents.
This seminar provides information on early access programmes, HTA requirements, CUP and off-label use in Europe
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 online training programme consisting of three recorded webcasts will train you how to develop documents, compile them and submit an eCTD step by step.
These recorded six webcasts enable you to deal with the legal challenges in marketing authorisation and life cycle management.
Do you need to be well versed in European pharmacovigilance for your daily work? Then we recommend this e-Learning. You can choose between three different packages according to your level of expertise and requirements.
This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.