November 2, 2022
EMA user access
If you ever wonder which the different user access categories are when setting up users in EVWEB and the EMA User Access Portal then this… Read more »
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Blog
October 31, 2022
MHRA updates for pharmacovigilance in the UK
The MHRA published updated PV guidance on its website on 28-OCT-2022. The changes involve updates regarding further details on submission requirements for the MHRA, in… Read more »
Read MoreJuly 15, 2022
EMA Calls for Companies to Register a Single Point of Contact
European Medicines Agency (EMA) requires the Marketing Authorisation Holders (MAHs) to register an Industry Single Point of Contact (i-SPOC). This is to inform the EMA… Read more »
Read MoreJune 26, 2022
AESI or Adverse Events of Special Interest
Adverse Events of Special Interest is an important concept in management of safety risks for medicinal products and vaccines. The is no single definition of… Read more »
Read MoreJanuary 21, 2022
MHRA inspection metrics for 2020-2021
MHRA has again issued inspection metrics which has a lot interesting information. Note that the number of for cause inspections is high The UK’s national… Read more »
Read MoreDecember 14, 2021
CTIS – Clinical Trial Information System at EMA launch January 2022
Users are reminded that certain preparatory steps must be taken before it is possible to use CTIS. Sponsor organisations opting for the organisation-centric approach that… Read more »
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