Roles & Responsibilities in Pharmacovigilance

Roles & responsibilities in PV

1. Clinical Research & Pharmacovigilance Roles & Responsibilities In Pharmacovigilance Presented By Guided By Samiksha Hamane Pranali Chandurkar (M. Pharm) (Assistant Professor) Dr. Rajendra Gode Institute of Pharmacy, Amravati. 1 17-04-2024

2. Content - Introduction Definition & importance Aim & objectives Roles of pharmacovigilance Responsibilities of pharmacovigilance 2 17-04-2024

3. Introduction to Pharmacovigilance Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. It is a critical process that ensures the safe and effective use of medications. Definition and Importance 1.Definition Pharmacovigilance is the pharmacological science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. 2.Importance Pharmacovigilance helps to identify and manage risks associated with the use of medicines, ultimately improving patient safety and enhancing public health. 3 17-04-2024

4. Aim and Objectives Aim The primary aim of pharmacovigilance is to enhance patient care and safety in relation to the use of medicines, and to support public health programs. Objectives Identify and quantify the risks associated with the use of medicines Detect, assess, understand and communicate the information on the benefits, risks, and effective use of medicines Promote the safe and effective use of medicines 4 17-04-2024

5. Roles of Pharmacovigilance Monitoring Continuously monitoring the safety of medicines to identify any potential adverse events or risks. Drug safety monitoring is the process of identifying expected and unexpected adverse reactions resulting from the use of medicines in the post-marketing phase. It is a risk mitigation exercise in which the ADRs caused by therapeutic drugs, biologicals or devices can explored, prevented or minimized. Before releasing into the market, a medicine is tested using a limited population ranging from 500 to 5000. Once the medicine comes into the market it becomes legally available for consumption by the general population. The population may be children, pregnant women, patients suffering from other diseases and the elderly. T he drug is taken in different therapeutic situations and physiological conditions. It is therefore, very much necessary to observe and record the effectiveness and safety of the medicine under real-life conditions. A close and effective monitoring is required to assess the risks associated with the use of medicines. 5 17-04-2024

6. 2. Data Collection Collecting data on suspected adverse drug reactions is crucial for identifying safety concerns and minimizing risks to patient health This information helps regulatory agencies, healthcare providers, and pharmaceutical companies make informed decisions about drug safety and efficacy 6 17-04-2024

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8. Implementing Risk Monitoring and Reporting Processes Continuous Surveillance Proactively monitor for new or evolving safety signals through various data sources. Timely Reporting Ensure adherence to regulatory timelines for reporting adverse events and safety issues. Risk Communication Collaborate with healthcare providers, patients, and authorities to share critical safety information. 8 17-04-2024 3. Risk Management Developing and implementing strategies to manage and mitigate the risks associated with the use of medicines

9. 4. Communication Effectively communicating safety information to healthcare providers, regulatory authorities, and the public. C ommunications play a crucial role in pharmacovigilance to ensure the safe and effective use of medicines and protect public health. Effective communication channels are essential for transmitting safety information to patients and healthcare professionals, promoting transparency, and fostering understanding and accountability. The exchange of information & knowledge between different stakeholder involved in the monitoring, assessment & prevention of adverse effects or other drug-related problem. 9 17-04-2024

10. Responsibilities of Pharmacovigilance 10 17-04-2024

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