September 14, 2021
Lab reference values
Trouble finding usable normal ranges for lab tests in clinical trials ? – this may be a solution for you. Often reference values are missing… Read more »
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Blog
September 5, 2021
The MHRA has issued guidance on the QPPV for UK authorised products
For all UK MAs, including those that cover the whole of the UK or are specific to Northern Ireland or to Great Britain, the marketing… Read more »
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September 5, 2021
Signal Management
Signal Management A drug undergoes a variety of clinical trials before it is introduced in the market for public use. However, the clinical trials conducted… Read more »
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September 5, 2021
Pharmacovigilance System Master File
PHARMACOVIGILANCE SYSTEM MASTER FILE (PSMF) The Pharmacovigilance System Master File (PSMF) is a detailed description of all aspects related to how a pharmaceutical company is… Read more »
Read MoreSeptember 5, 2021
Updated requirements for pharmacovigilance contact person at national level in EU (LCPPV)
It is difficult to get clear information about the requirements for local contact persons for pharmacovigilance in the EU as these are determined by the… Read more »
Read MoreSeptember 5, 2021
Register as EU QPPV or Responsible Person (RP) for EudraVigilance
If a change of qualified person for pharmacovigilance/responsible person for EudraVigilance (QPPV/RP), named person or legal representative within the organisation occurs, you need to notify… Read more »
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