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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 lifecycle, among other critical responsibilities.

 

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