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Regulatory Affairs and Pharmacovigilence

Regulatory Affairs refers to the field of managing and navigating the complex regulations and guidelines set forth by government agencies for the development, approval, and marketing of pharmaceuticals, medical devices, and other healthcare products. Professionals in this field ensure compliance with safety, quality, and efficacy standards, while also facilitating communication between the company and regulatory authorities.

Pharmacovigilence, on the other hand, involves the systematic monitoring, detection, assessment, and prevention of adverse effects or any other drug-related problems associated with the use of medications. This crucial field focuses on the collection, analysis, and reporting of data to ensure the continued safety and efficacy of drugs in the market. Pharmacovigilence professionals play a vital role in identifying potential risks and improving patient safety by promoting the appropriate use of medicines.