Thu, Sep 13, 2018 10:00 AM – 11:00 AM CEST
Simplifying the Management of Complex SPOR Data
Even though ISO IDMP implementation seems light years away, the EMA?s SPOR data is already being utilised. How are you managing your SPOR data? Manually? Have you built your own in-house solution? What if there was an off-the-shelf product that does it semi-automatically for you?
In this webinar, we will demonstrate a tool SPORIFY, which does exactly that. It is a single solution to match, synchronise and integrate SPOR data. Once loaded, the matching module will automatically begin matching your local data with the EMA SPOR data. This may sound complex however it is made easy inside SPORIFY via a user friendly non-technical interface where regulatory experts can easily align local data to SPOR as required.
Gary Wilson, Delivery Manager at CorrIT
Remco Munnik, Regulatory Information Director at Asphalion
Tue, Sep 18, 2018 12:00 AM – 1:00 PM CEST
Eudravigilance Data Analysis System
After the switch to simplified reporting on 22 November 2017, EVDAS has become available by EMA in the Eudravigilance Website. However, there is still more information that can be downloaded from the Eudravigilance Website.
The aim of this Pharmacovigilance webinar is to provide the necessary tools and procedures to implement and integrate the EVDAS information into the Pharmacovigilance system of MAH. In addition, it will be provided understanding of all the outputs that EVDAS Website produce in its search of potential signals. The webinar also will go through the following items:
Speaker: Núria Cabello, PhD | Senior Drug Safety Officer at Asphalion
Brexit updates for human use medicinal products approved via MRP/DCP
As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.