Pharmacovigilance is an emerging field in the pharma-biotech industry, that focuses on detection, assessment, understanding, and prevention of adverse effects of drugs or any other drug-related problems. This course offers you an insight into pharmacovigilance across the globe. It also helps you understand the regulatory requirements, recent market trends, and the best approaches to ensure drug safety.
Upon the completion of this course, participants would be able to:
● Describe the origins of Pharmacovigilance.
● Understand the concept of pharmacovigilance and its role in drug warning, recalling, and labelling.
● Understand rational and safe use of medicine.
● Understand and describe different types of adverse drug reactions.
● Describe operational activities within drug safety departments.
● Describe the drug safety requirements.
● Understand the role of ICH, FDA, EMEA, MHRA, CDSCO in pharmacovigilance.
● Understand the importance of ICSR, Regulatory reporting, Medical Dictionaries in pharmacovigilance.
Who Should Attend
Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centers.