The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
EMA Begins EudraVigilance Training Courses
Two sets training courses are available.
The first set of three-day training courses is targeted at marketing-authorisation holders, clinical trial sponsors and all other prospective users of EudraVigilance.
Attendees who pass the final test of the course will be able to register with EudraVigilance and start the electronic submission of individual case safety reports ("ICSRs") and ICSR acknowledgements, to meet their pharmacovigilance reporting obligations.
The first session was held from 4th to 6th of April 2016 in Madrid. Information on the dates of the next training sessions and the details of the courses is available on the EMA website.
EMA is also holding a set of EudraVigilance Data Analysis System ("EVDAS") training courses for national competent authorities in EEA member states.
Information on the training dates and the details of the courses is available on the EMA website.
EMA recommends that at least one user from each national competent authority, marketing-authorization holder, or sponsor of clinical trials in the EEA should complete the training to ensure the information collected in EudraVigilance is of the highest quality and integrity.
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 January 2017
On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders...03 January 2017