The document outlines global pharmacovigilance requirements, emphasizing the importance of patient safety and the need for consistent adverse event reporting across various countries. It details international guidelines, regional reporting obligations, common practices, and technological innovations, such as AI and real-world data, that enhance drug safety monitoring. Key challenges such as reporting gaps and data quality issues are highlighted, alongside future trends aimed at improving safety through global cooperation and advanced technologies.

1. Welcome
Global pharmacovigilance regulatory requirments
D.Nasar Reddy
B.Pharmacy
172/092024
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
1

2. Index
• Introduction
• Key International Guidelines and Frameworks
• Overview of Regional PV Requirements
• Common Global PV Requirements
• Technological Innovations in Pharmacovigilance
• Key Challenges in Global Pharmacovigilance
• Conclusion and Future Trends
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
2

3. INTRODUCTION
Definition of Pharmacovigilance
Pharmacovigilance (PV) is the science and activities related to the detection,
assessment, understanding, and prevention of adverse effects (side effects) or
any other drug-related problems. In simple terms, it is about keeping medicines
safe for the people who use them.
Importance of Pharmacovigilance
Patient Safety
Confidence in Medicines
Global Health Protection
Early Detection of Risks
Improving Drug Labels and Warnings
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
3

4. International Guidelines
ICH E2E (International Council for Harmonisation):
A set of global guidelines that helps countries align their pharmacovigilance
practices. It defines how companies should report adverse reactions (side
effects), monitor safety, and manage risks for drugs.
WHO (World Health Organization):
Provides guidelines for global reporting of adverse events and safety
information. This ensures that data from different countries can be shared
and used to improve drug safety.
MedDRA (Medical Dictionary for Regulatory Activities):
A common medical language used worldwide to report adverse events
clearly and consistently.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
4

5. OverviewofRegionalPVRequirements
United States (FDA)
•Adverse Event Reporting:
The FDA requires companies to report serious adverse
reactions within 15 days of receiving the information. Less serious
events are reported within 30 days.
•Risk Management:
If a drug has known safety risks, the FDA may require
Risk Evaluation and Mitigation Strategies (REMS), which may
include restrictions on how the drug is prescribed or monitored.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
5

6. • Japan (PMDA)
• Adverse Event Reporting:
Serious adverse events must be reported within 7-15 days depending
on the type of event. Companies also need to submit regular safety
reports.
• Japanese Adverse Drug Event Reporting System (JADER):
A system where adverse events are submitted to Japan's regulatory
body (PMDA).
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
6

7. • Canada (Health Canada)
• Adverse Event Reporting:
Serious adverse events must be reported within 15 days. Canada has a
Canadian Vigilance Program that collects and monitors safety reports.
• Periodic Safety Reports:
Like other regions, companies must submit PSURs regularly to update
Health Canada on the safety of their products.
• Australia (TGA)
• Adverse Drug Reaction Reporting:
Serious reactions must be reported promptly, and Australia has a
national system (ADR Reporting Scheme) for collecting this
information.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
7

8. Common Global PV Requirements
1. Adverse Event Reporting
What it means: Report any bad reactions to medicines (like side effects).
Why it's important: Helps identify safety problems and protect patients.
Timeline: Serious reactions must be reported within 15 days.
2. Periodic Safety Update Reports (PSURs)
What it means: Companies send regular safety reports to authorities.
Why it's important: Keeps regulators informed on the safety of drugs.
Timeline: Usually every year for the first 3 years, then every 3 years.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
8

9. 3. Risk Management Plans (RMPs)
What it means: A plan to manage and reduce known risks of a drug.
Why it's important: Helps prevent harm from drugs with known safety
concerns.
4.Signal Detection
What it means: Looking for new safety problems with a drug.
Why it's important: Helps detect risks early to protect patients.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
9

10. Technological Innovations in
Pharmacovigilance
1. Real-World Data (RWD)
What it means: Using data from everyday sources like patient records,
insurance claims, and health apps.
Why it's important: Helps find safety issues that may not show up in clinical
trials.
2. Artificial Intelligence (AI)
What it means: AI systems that analyze large amounts of safety data to find
patterns and risks.
Why it's important: Speeds up the process of detecting new safety signals and
making safety decisions.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
10

11. 4. Machine Learning for Signal Detection
What it means: Machine learning algorithms that can identify possible
safety problems based on past data.
Why it's important: Helps find new drug risks faster and more
accurately.
5. Data Mining Tools
What it means: Software that scans large databases to find hidden
safety issues.
Why it's important: Allows regulators and companies to identify trends
and signals from massive amounts of data.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
11

12. Key Challenges in Global
Pharmacovigilance
1. Reporting Gaps
2. Differences in Regulations
3. Data Quality and Consistency
4. Timely Detection of Risks
5. Managing Large Volumes of Data
6. Patient Privacy and Data Security
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
12

13. Conclusion and Future Trends in
Pharmacovigilance
Conclusion:
• Pharmacovigilance is crucial for ensuring that medicines are safe and
effective for everyone.
• Global efforts to track and manage drug safety help protect patients
from harmful side effects.
• Despite challenges like reporting gaps and data quality issues,
continuous improvement is key to better safety monitoring.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
13

14. • Future Trends:
• AI and Machine Learning: Will help detect safety problems faster
and more accurately.
• Real-World Data: More use of patient records and health data to
spot issues outside of clinical trials.
• Global Cooperation: Countries will continue to work together to
harmonize safety regulations and share information.
• Blockchain: Will increase trust and security in safety data, ensuring
better transparency.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
14

15. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
15