What does the new European pharmacovigilance legislation mean for pharma?

In Regulation and Compliance by aliceLeave a Comment

Pharma is still on the cusp of the EU pharmacovigilance legislation changes that are part of the drive to improve patient safety in Europe. I wanted to discuss the next milestones in the EMAs European legislation changes and what pharma should be looking at. The EMA amendments to the way drug safety is monitored and reported in Europe are well underway with pharma facing the challenge of meeting the updating significant proportions of their safety procedures.

I have read an interesting article on the changes and what they mean to pharma. Some of the key changes that pharma and biotech firms are facing in the new environment include:

· Expansion on the adverse event reporting abilities of patients

· The formation of PRAC (Pharmaceutical Risk Assessment Committee)

· Increasing transparency between public and EMA

· Amendments to the way signal detection is processes

· Update to the pharmacovigilance inspections process

· The way safety data is handled including the expanded use of electronic records, eudravigilance and EVMPD (EudraVigilance Medicinal Product Dictionary) guidance

I would welcome any feedback on the other challenges that you are expecting/experiencing in relation to these amendments.

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