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Course Details

MODE

Full time

DURATION

48 Months

The basic objective of pharmacovigilance is the safe use of drugs, patient safety, and, ultimately, safeguarding public health. To achieve this goal, national regulators and international organizations should empower healthcare professionals and the public to report more ADRs.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.

As a Pharmacovigilance Manager, your responsibility is to manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.

Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees of regulation. Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies.

Regulatory Affairs is a unique mixture of science and management to achieve a commercially important goal within a drug-development organization. Regulatory Affairs takes care of Development plan, supervising-writing /reviewing and assembling and submission management.Under this program, students learn about the process of designing, developing, and formulating drugs. The constantly evolving curriculum equips the students with the latest pharmaceutical, biomedical, social and clinical science, and the practical skills to advance tomorrow's patient care.


Eligibility Criteria

12th passed (PCB/PCM) with agg. 50% for Gen./OBC, 45% for SC/ST or Eligibility Criteria as per University Norms/VET (Vishveshwarya Entrance Test)

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