EUDRAC will be exhibiting at the annual DIA Annual Meeting in Basel, Switzerland from 17th – 19th April 2018. Our team would be pleased to welcome you at booth number 41 to discuss your potential regulatory affairs, pharmacovigilance and publishing needs. A member of our Management Team will be...
Read moreFebruary and March 2018 brought updates to the four EMA QRD Annex IV templates: Conditional positive template Exceptional circumstances positive template Standard positive template PSUR template Please ensure that the most recent template is used when performing Linguistic Review. See the EMA...
Read morePharmacovigilance fees From 12 February 2018, there has been a 1.4% increase in the fees payable for pharmacovigilance activities to the EMA. This increase is due to inflation in 2015 and 2016. Please see the EMA press release . Types of fee There are two types of fee covered by Regulation (EU) No...
Read moreEnd of three-month grace period (22 Feb 18) On 22 nd February 2018 the grace period for MAHs to become familiar with the major updates to EudraVigilance will end. From this date, a pilot period of one year will begin for the MAHs of the active substances included in this list to perform monitoring...
Read moreEUDRAC attended the recent EMA/DIA meeting where the philosophy and key points of the change to the RMP template were explained and discussed. Impact on marketing authorisation holders The use of RMP Rev.2 for all RMP submissions becomes mandatory for all RMP submissions as of 31 March 2018 ...
Read morePharmacovigilance contractual documents Pharmacovigilance Agreements (PVA), Safety Data Exchange Agreements (SDEA) and Safety Management Plans (SMP) are some of the terms used to describe the contractual documents which outline the responsibilities between the MAH (or Sponsor) and Pharmacovigilance...
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