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Pharmacovigilance

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Course offered by Hemanth Nyathani

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Pharmacovigilance courses typically cover a wide range of topics to ensure a comprehensive understanding of drug safety and regulatory requirements.

1. **Introduction to Pharmacovigilance**: Overview of the field, its importance, and historical context.

2. **Regulatory Requirements**: Understanding global and local regulations, including ICH guidelines.

3. **Adverse Drug Reactions (ADRs)**: Identifying, assessing, and managing ADRs.

4. **Signal Detection**: Techniques for detecting safety signals from data.

5. **Risk Management**: Strategies for minimizing drug-related risks.

6. **Clinical Trials Safety**: Ensuring safety during clinical trials.

7. **Post-Marketing Surveillance**: Monitoring drug safety after it has been released to the market.

8. **MedDRA Coding**: Using the Medical Dictionary for Regulatory Activities for coding adverse events.

9. **Ethics in Pharmacovigilance**: Ethical considerations and best practices.

10. **Reporting and Documentation**: Proper documentation and reporting of adverse events.

11. **Software Training**: Using pharmacovigilance software for data management and analysis.

12. **Aggregate Reporting**: Compiling and analyzing data for periodic safety reports. 

13. Safety systems Configuration including product, study, user configurations

Case form creation 

About the Trainer

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Hemanth Nyathani

Master of Pharmacy (M.Pharm) from Kakatiya University in 2010

14 Years of Experience

I have 14 years of experience in pharmacovigilance domain working fro a top MNC.
End to End case processing, System configuration, Study, Product configuration,
system Validation.

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