Certificate course in Pharmacovigilance

“An incident is just the tip of the iceberg, a sign of a much larger problem below the surface-Don Brown”

Our certificate course in Pharmacovigilance provides solid fundamental and deeper understanding of pharmacovigilance and helps the trainees to understand the goal of pharmacovigilance- to ensure safe use of medicines, minimizing the risks related to the medicinal product and maximizing the benefits. Safety assessment of a drug or device starts while the product is in the development phase and continues till the product is in the market. An in-depth understanding of the regulatory and scientific requirements is essential for anyone who wants to enter into the field of pharmacovigilance and make a career.

Learning Objectives
After taking this course, you should be able to understand -
  • The basics of Pharmacovigilance (PV) and career opportunities in the domain.
  • PV structure and process of collection and reporting of adverse events.
  • Case processing, database overview-Argus ,Special situations, causality assessment and signal management process.
  • Introduction to various safety aggregate reports like PBRER/PADERS/PSUR/RMP/REMS.
  • Eligibility criteria:
    Undergraduates, graduates and post-graduates of life sciences stream, pharmacy, biotechnology, dental, physiotherapy and paramedical courses and MBBS/MD.
    Training mode:
    The course is available as online and classroom options both with our training centers at Gurgaon and Pune, India. The classroom sessions are held twice a week and for the online courses we have one Skype session every week to discuss the queries and doubts and monitor the progress of the course.
    Duration:
    The ideal duration is for 2months but one can expedite the course after submitting the assignments and the complete access will be available for 6 months.
    Expected CourseHours/week:
    Weekly 6 hours
    Assessment:
    Ongoing assessment after completion of content each week.
    Expected Outcomes:
  • Learn the career options available in Pharmacovigilance and what skills are expected.
  • Become aware of the regulatory requirements of PV for all major geographical regions.
  • Learn the types of activities involved in the safety assessment of drugs/devices.
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