Are international regulations such as FDA and EMA covered in the Pharmacovigilance course in India?
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1 Answer
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Yes, most Pharmacovigilance courses in India cover international regulations, including those set by the FDA (U.S.), EMA (Europe), and WHO. These regulations are crucial for drug safety compliance on a global scale.
Since many pharmaceutical companies in India cater to international markets, understanding these guidelines is essential. Students learn about global adverse drug reaction (ADR) reporting standards and pharmacovigilance regulatory frameworks.
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