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Self Paced

Pharmacovigilance for Drug Safety & Efficacy

Ensuring Safer Medicines, Enhancing Patient Care

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MODE
Online/ e-LMS

TYPE
Self Paced

LEVEL
Moderate

DURATION
1 Month

About

The “Pharmacovigilance for Drug Safety & Efficacy” program offers a comprehensive overview of the systems and methodologies used to detect, assess, understand, and prevent adverse effects or other drug-related problems. Over one month, participants will delve into the regulatory landscape that governs drug safety, exploring both national and international guidelines. The course covers the lifecycle of pharmacovigilance from pre-clinical development to post-market surveillance, emphasizing critical analysis and decision-making based on real-world data.

Aim

This program aims to equip participants with the essential skills and knowledge to monitor and evaluate the safety and efficacy of pharmaceuticals. Through a detailed exploration of pharmacovigilance principles and practices, students will learn to identify, assess, and mitigate risks associated with drug use, ensuring public health and compliance with global regulatory standards.

Program Objectives

Understand the principles and scope of pharmacovigilance.
Learn to identify and report adverse drug reactions effectively.
Analyze risk-benefit ratios in the context of drug safety.
Navigate the regulatory requirements for drug safety reporting.
Apply data analysis tools and techniques in pharmacovigilance.

Program Structure

Module 1:
Session 1: Introduction to Pharmacovigilance

● Overview of pharmacovigilance and its significance in the pharmaceutical industry
● Importance of pharmacovigilance in ensuring drug safety and patient welfare
● Regulatory frameworks and guidelines governing pharmacovigilance

Session 2: Adverse Drug Reactions (ADRs)

● Definition and classification of adverse drug reactions
● Identification, assessment, and reporting of ADRs
● Tools and techniques for ADR detection and signal management

Session 3: Pharmacovigilance Databases and Systems

● Introduction to pharmacovigilance databases and their role in data collection and analysis
● Case studies: Analyzing real-world data from pharmacovigilance databases

Session 4: Pharmacovigilance in Clinical Trials

● Role of pharmacovigilance in clinical trial safety monitoring
● Adverse event reporting in clinical trials
● Ethical considerations and patient safety in clinical research

Module 2:

Session 5: Risk Management in Pharmacovigilance

● Overview of risk management strategies in pharmacovigilance
● Risk minimization measures and their implementation
● Pharmacovigilance planning and risk management plans

Session 6: Signal Detection and Management

● Principles of signal detection and signal management
● Tools and methodologies for signal detection and assessment
● Case studies: Analyzing and managing safety signals

Session 7: Pharmacovigilance Audits and Inspections

● Overview of pharmacovigilance audits and inspections
● Preparation and compliance for pharmacovigilance audits
● Ensuring quality and regulatory compliance in pharmacovigilance

Module 3:

Session 8: Pharmacovigilance in Special Populations

● Pharmacovigilance considerations in special populations (pediatrics, geriatrics, pregnant women, etc.)
● Monitoring and reporting adverse events in vulnerable populations
● Case studies: Addressing pharmacovigilance challenges in special populations

Session 9: Pharmacovigilance Communication and Reporting

● Effective communication of drug safety information to healthcare professionals and the public
● Regulatory reporting requirements and timelines
● Practical exercises: Preparing pharmacovigilance reports and communication materials

Session 10: Emerging Trends and Future Directions in Pharmacovigilance

● Latest advancements and technologies in pharmacovigilance
● Digital pharmacovigilance and the role of artificial intelligence
● Discussion on future challenges and opportunities in pharmacovigilance

Participant’s Eligibility

Undergraduate degree in Pharmacy, Nursing, Medicine, or related health sciences.
Professionals in pharmaceutical, biotechnology, or clinical research organizations.
Individuals passionate about improving drug safety and patient care.

Program Outcomes

Mastery of drug safety monitoring techniques
Enhanced ability to comply with international drug safety laws
Skills in managing drug-related risks
Expertise in adverse effect analysis and reporting
Preparedness for leadership roles in pharmacovigilance

Fee Structure

Standard Fee: INR ~~4,998~~ USD ~~110~~

Discounted Fee: INR 2499 USD 55

We are excited to announce that we now accept payments in over 20 global currencies, in addition to USD. Check out our list to see if your preferred currency is supported. Enjoy the convenience and flexibility of paying in your local currency!

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Certificate

Program Assessment

Certification to this program will be based on the evaluation of following assignment (s)/ examinations:

Exam	Weightage
Mid Term Assignments	50 %
Project Report Submission (Includes Mandatory Paper Publication)	50 %

To study the printed/online course material, submit and clear, the mid term assignments, project work/research study (in completion of project work/research study, a final report must be submitted) and the online examination, you are allotted a 1-month period. You will be awarded a certificate, only after successful completion/ and clearance of all the aforesaid assignment(s) and examinations.