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Pharmacovigilance

CERTIFICATE COURSE

Quick Summary

Course Description

This Pharmacovigilance Certificate Course is an immersive, comprehensive program designed to prepare participants for a pivotal role in the healthcare and pharmaceutical industries, emphasizing patient safety and drug efficacy. This course provides an in-depth exploration of pharmacovigilance fundamentals, advanced methodologies, and regulatory frameworks essential for monitoring and managing the risks associated with pharmaceutical products. Participants will journey through every stage of the pharmacovigilance lifecycle, from adverse event detection and assessment to regulatory compliance and safety signal management.

Key Learning Objectives

By the end of this course, participants will be able to:

CURRICULUM

Our consultants, including researchers, clinicians, and industry experts in Pharmacovigilance with extensive experience on the field.

Theory | Online

What’s Inside?
Covers the basics of pharmacovigilance (PV), its history, and its significance in healthcare. Introduces key terms, objectives, and the role of PV in ensuring medication safety.

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Will be updated soon.

What’s Inside?
Examines the classification of adverse drug reactions and causality assessment scales, such as Naranjo and WHO-UMC, to assess causality, severity, and preventability of drug-related events.

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Will be updated soon. pm

What’s Inside?
Provides an overview of MedDRA terminology, structure, and applications in PV, including standardized coding of medical information, classification levels, and its importance in regulatory reporting.

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Will be updated soon.

What’s Inside?
Explores active and passive surveillance techniques, spontaneous reporting, cohort event monitoring, and post-marketing surveillance to monitor drug safety in real-world settings.

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Will be updated soon.

What’s Inside?
Covers methods for detecting safety signals from PV data, including disproportionality analysis and data mining, and explains the signal evaluation process and decision-making criteria.

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Will be updated soon.

What’s Inside?
Discusses global and regional PV regulations, including ICH, FDA, EMA, and CDSCO guidelines, covering reporting requirements, regulatory compliance, and the PV lifecycle from drug development to post-market..

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Will be updated soon.

What’s Inside?

Introduces quality assurance measures in PV, such as auditing, SOPs, and GVP (Good Pharmacovigilance Practices), emphasizing maintaining PV data quality, consistency, and compliance with regulatory standards.

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Will be updated soon.

What’s Inside?
Focuses on how PV is integrated within pharmaceutical companies, covering in-house PV processes, industry roles, risk management plans, and challenges in ensuring drug safety from development through marketing.

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Will be updated soon.

What’s Inside?
Introduces major PV databases, such as WHO VigiBase, etc  focusing on their roles in adverse event reporting, data entry standards, and analysis tools.

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Will be updated soon.

What’s Inside?
Discussion about case assessments, career opportunities, and anything you’re looking for direct guidance.

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Will be updated soon.

Why to Enroll?

Features and Benefits

FEE

Choose the Best Fit Plan.

Single

COURSE

₹ 999

10 Live Sessions

Access to recordings

3 Quizzes + 2 Case Assessments

Certificate of Program Completion

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Group

COURSE PLUS (Minimum 10 Students)

₹ 799

12 Live Sessions

Access to recordings​

3 Quizzes + 2 Case Assessments

Certificate of Program Completion (Hard Copy on demand)

Career Guidance With Panel Discussion

Placement Assistance

CUSTOMIZED

LOOKING FOR SOMETHING ELSE IN PV?

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Customized Learning Model

Access to recordings​

Quizzes + Case Assessments

Certificate of Program Completion (Hard Copy on demand)

& More