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What are the difference between regulatory affairs and pharmacovigilance working
6 Nov 2014

What are the difference between regulatory affairs and pharmacovigilance working?

Pharmacovigilance professionals are focused on the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients about the adverse effects of biological products and medications. Special attention is given to identifying new information about potential hazards associated with medicines and preventing harm to patients. Pharmacovigilance consists of safety operations, risk management, safety data exchange agreements and medical writing.


On the other hand, Regulatory Affairs professionals are focused on developing global regulatory strategies for new and novel products, collaborating with regulatory bodies worldwide to set standards for new technologies, supporting clinical development activities, filing regulatory submissions and ensuring regulatory compliance across the product life cycle, among other critical responsibilities.

A specialized course which trains both the subject area in a single course is PG Certification in Drug Regulatory Affairs and Pharmacovigilance. It is dual specialization training covers pharmacovigilance, drug safety with regulation and registration.




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