Knowledge Base

What is the definition of the primary reporter in pharmacovigilance?

21 December 2023
2 min read

In the European Union, the medical professional who confirms the report medically is considered as the primary reporter, while the consumer / non professional will be considered as the notifier. According to the standards of FDA and Canada in CIOMS and the requirements of E2B R3, the primary reporter is the first person who provides individual safety information, regardless of whether the reporter is a medical professional.

The FDA is evaluating the revised NDA for TransCon PTH (Palopegteriparatide) for adult hypoparathyroidism
Latest Hotspot
3 min read
The FDA is evaluating the revised NDA for TransCon PTH (Palopegteriparatide) for adult hypoparathyroidism
21 December 2023
The FDA is reviewing the updated New Drug Application (NDA) for TransCon PTH (also known as Palopegteriparatide) meant for the treatment of hypoparathyroidism in adults.
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Understanding Proteases Inhibitors and Methods to Keep Abreast of Their Recent Developments
Understanding Proteases Inhibitors and Methods to Keep Abreast of Their Recent Developments
21 December 2023
Protease inhibitors are drugs that inhibit proteases, enzymes crucial in various biological processes.
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Vertex Reports Encouraging Outcomes in Early Trial of New Drug VX-548 for Alleviating Diabetes-Related Nerve Pain
Latest Hotspot
3 min read
Vertex Reports Encouraging Outcomes in Early Trial of New Drug VX-548 for Alleviating Diabetes-Related Nerve Pain
21 December 2023
Vertex Pharmaceuticals Incorporated declared favorable outcomes from its Phase 2 trial assessing various dosages of the targeted NaV1.8 inhibitor, VX-548, in individuals suffering from painful diabetic peripheral neuropathy.
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Does the Risk management systems  need to be updated regularly?
Knowledge Base
2 min read
Does the Risk management systems need to be updated regularly?
21 December 2023
If the applicant / marketing authorisation holder has submitted an RMP for the product, the RMP submitted later should adopt an updated format.
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