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Introduction

Pharmacovigilance plays a crucial role in ensuring the safety and efficacy of drugs in the healthcare system. It involves the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. As the pharmaceutical industry continues to grow and evolve, the need for effective pharmacovigilance practices becomes increasingly important to safeguard the health of patients.

This thesis aims to explore the role of pharmacovigilance in drug safety, focusing on the various processes and mechanisms involved in monitoring and managing the risks associated with pharmaceutical products. By examining the current practices and challenges in pharmacovigilance, this study will contribute to the existing body of knowledge on drug safety and provide insights into potential areas for improvement.

Chapter 1: Role of Pharmacovigilance in Drug Safety
1.1 Introduction
1.2 Background of Study
1.3 Problem Statement
1.4 Objective of Study
1.5 Limitation of Study
1.6 Scope of Study
1.7 Significance of Study
1.8 Structure of the Thesis
1.9 Definition of Terms

Chapter 2: Literature Review
2.1 Historical development of pharmacovigilance
2.2 Concepts and principles of pharmacovigilance
2.3 Pharmacovigilance systems and regulations
2.4 Pharmacovigilance data collection and analysis
2.5 Role of healthcare professionals in pharmacovigilance
2.6 Patient reporting in pharmacovigilance
2.7 Pharmacovigilance in clinical trials
2.8 Pharmacovigilance in post-marketing surveillance
2.9 Pharmacovigilance in drug regulatory agencies
2.10 Challenges and future perspectives in pharmacovigilance

Chapter 3: Research Methodology
3.1 Research design
3.2 Data collection methods
3.3 Data analysis
3.4 Sampling techniques
3.5 Ethical considerations
3.6 Research limitations
3.7 Validity and reliability of research findings
3.8 Research implications

Chapter 4: Discussion of Findings
4.1 Overview of pharmacovigilance practices
4.2 Impact of pharmacovigilance on drug safety
4.3 Role of stakeholders in pharmacovigilance
4.4 Challenges and constraints in pharmacovigilance implementation
4.5 Recommendations for improving pharmacovigilance practices

Chapter 5: Conclusion and Summary
5.1 Summary of key findings
5.2 Implications for practice and policy
5.3 Recommendations for future research
5.4 Conclusion

Overall, this thesis will provide valuable insights into the role of pharmacovigilance in drug safety and contribute to the ongoing efforts to enhance patient safety in the healthcare system.

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