Certificate in Pharmacovigilance Syllabus 2025: Subjects, Specializations, and Semester-wise Syllabus

  • course years 1 Years
  • type of course Certificate
  • course stream Pharmacy
  • course type Full Time
Written By universitykart team | Last Updated date Oct, 09, 2024

Certificate in Pharmacovigilance Course Syllabus: Explore drug safety protocols, regulations, and more in our comprehensive curriculum.

Syllabus for Certificate in Pharmacovigilance Course

The Certificate in Pharmacovigilance course syllabus encompasses a comprehensive study of the critical aspects of drug safety and surveillance. The program typically begins with an introduction to pharmacovigilance principles and regulatory frameworks, providing students with a solid foundation. It then delves into the methodologies and techniques for collecting, assessing, and managing adverse drug reactions (ADRs), including signal detection and risk assessment. Furthermore, the curriculum covers the role of pharmaceutical companies, regulatory authorities, and healthcare professionals in pharmacovigilance, emphasizing the importance of compliance with global safety standards. The course also explores the use of databases and tools for data analysis and pharmacovigilance reporting. Ethical considerations, communication strategies, and crisis management in the context of pharmacovigilance are other key topics addressed. Throughout the program, students engage in case studies, practical exercises, and discussions to gain hands-on experience and a deeper understanding of real-world pharmacovigilance challenges. By the end of this course, participants will be well-equipped with the knowledge and skills necessary to ensure the safe and effective use of pharmaceutical products in the healthcare industry while adhering to regulatory guidelines.

Syllabus of Certificate in Pharmacovigilance

S.NoSubjects
1Introduction to Pharmacology, Clinical Trials, and Pharmacovigilance
2Adverse Drug Reactions and Safety Reports
3Methodologies in Pharmacovigilance
4Seriousness & Expectedness & Causality Assessment Criteria
5Aggregate Safety Reports
6 Pharmacovigilance Regulations in Various Countries
7Pharmacovigilance Programme in India (PVPI)
8Signal Detection and Data Mining
9Pharmacovigilance of Herbal Drugs & Medical Devices
10Pharmacovigilance Compliance and Inspections
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