Quick Summary
- Commencement - February 03
- 11 Live Sessions
- Access to Lectures
- Complementary Career Guidance Session
- Placement Assitance
- 3 Quizzes + 2 Case Assessments
- 16 Hours
- Course Completion Certificate
Dr. Haroon Meeran Pharm.D.
Program Director
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:
- Gain a comprehensive understanding of pharmacovigilance principles and the importance of drug safety in healthcare.
- Recognize and classify adverse drug reactions, using global reporting systems to ensure effective documentation.
- Understand regulatory compliance and guidelines essential for pharmacovigilance, including FDA, EMA, and WHO standards.
- Develop skills in data collection, analysis, and signal detection for identifying and managing drug risks.
- Learn to communicate drug safety information effectively, including crisis management for recalls or alerts.
- Apply pharmacovigilance practices to special populations, such as pediatrics and geriatrics.
- Explore career paths in pharmacovigilance, gaining practical skills and knowledge for industry success.
CURRICULUM
Our consultants, including researchers, clinicians, and industry experts in Pharmacovigilance with extensive experience on the field.
Theory | Online
Module 1: Introduction to Pharmacovigilance
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.
Schedule:
February 03 | 06.00 pm
Module 2: Classification and Scales in Pharmacovigilance
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.
Schedule:
February 05 | 06.00 pm
Module 3: MedDRA: Medical Dictionary for Regulatory Activities
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.
Schedule:
February 07 | 06.00 pm
Module 4: Surveillance Techniques in Pharmacovigilance
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.
Schedule:
February 10 | 06.00 pm
Module 5: Signal Detection and Assessment
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.
Schedule:
February 12 | 06.00 pm
Module 6: Regulatory Pharmacovigilance
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..
Schedule:
February 14 | 06.00 pm
Module 7: Quality Assurance and Compliance
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.
Schedule:
February 17 | 06.00 pm
Module 8: Pharmacovigilance in the Pharmaceutical Industry
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.
Schedule:
February 19 | 06.00 pm
Module 9: Pharmacovigilance Databases: An Overview
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.
Schedule:
February 21 | 06.00 pm
Module 10: Panel Discussion
What’s Inside?
Discussion about case assessments, career opportunities, and anything you’re looking for direct guidance.
Schedule:
February 24 | 06.00 pm
Why to Enroll?
Features and Benefits
- Expert-Led Modules
- Flexible Online Learning
- Exclsuive benefits of institutions
- Certification of Completion
- Access to Lectures
- Career Guidance Sessions
- Networking Opportunities
- Interactive Quizzes
- Case Assessments
FEE
Choose the Best Fit Plan.
Single
COURSE
₹ 1299
11 Live Sessions
Access to recordings
3 Quizzes + 2 Case Assessments
Certificate of Program Completion
Career Guidance Session
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Group
COURSE PLUS (Minimum 05 Students)
₹ 999
12 Live Sessions
Access to recordings
3 Quizzes + 2 Case Assessments
Certificate of Program Completion (Hard Copy on demand)
Career Guidance
Placement Assistance +
CUSTOMIZED
Programs for Institutions
Let's Talk.
Customized Learning Model
Access to recordings
Quizzes + Case Assessments
Certificate of Program Completion (Hard Copy on demand)
& More