Overview of Pharmacovigilance

Pharmacovigilance is the scientific discipline that is concerned with the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems associated with the use of medicinal products.

The primary objective of pharmacovigilance is to ensure the safety and efficacy of medicinal products throughout their life cycle, from preclinical development to post-market surveillance. This involves the systematic collection, analysis, and reporting of adverse drug reactions (ADRs) and other drug-related problems associated with the use of medicinal products.

Key components of pharmacovigilance include:

ADR reporting: Healthcare professionals, patients, and other stakeholders are encouraged to report suspected ADRs to regulatory authorities or pharmaceutical companies. This information is used to detect and assess potential safety signals associated with the use of medicinal products.

Signal detection: The systematic monitoring and analysis of ADR reports, clinical trial data, and other sources of safety data are used to identify potential safety signals associated with the use of medicinal products.

Risk assessment: The assessment of safety signals involves a thorough evaluation of the available safety data to determine the nature and severity of the safety concern, and to identify any potential risk factors that may contribute to the safety concern.

Risk management: Once a safety concern has been identified and assessed, appropriate risk management strategies may be implemented to mitigate the risk or to ensure that the medicinal product is used in a safe and effective manner.

Communication: The dissemination of safety information to healthcare professionals, patients, and other stakeholders is an important component of pharmacovigilance. This information is used to raise awareness about potential safety concerns associated with the use of medicinal products and to promote the safe use of medicinal products.

1. Welcome OVERVIEW OF PHARMACOVIGILANCE B. VINEELA DOCTOR OF PHARMACY 060/032023 4/26/2023 www.clinosol.com | follow us on social media @clinosolresearch 1

2. Index Definition Aim and Activities of PV Evaluation of PV 4/26/2023 www.clinosol.com | follow us on social media @clinosolresearch 2

3. Definitions Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Pharmacovigilance is defined by the European Commission as the “Process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines”. 4/26/2023 www.clinosol.com | follow us on social media @ clinosolresearch 3

4. Title Here Text Here. 4/26/2023 www.clinosol.com | follow us on social media @clinosolresearch 4

5. Aim and Activities The international Pharmacovigilance systems aim to monitor the risk/benefit ratio of drugs as well as improve patients’ safety and their quality of life. Pharmacovigilance activities include : collecting and managing data on the safety of medicines looking at individual case reports to detect new “signals” pro - active  risk management to minimize any potential risk associated with the use of medicines communicating and informing stakeholders and patients . 4/26/2023 www.clinosol.com | follow us on social media @clinosolresearch 5

6. Evaluation Pharmacovigilance is commonly considered to have begun as a separate, identifiable activity in the United States with passage of the Drug Efficacy Amendments of 1962, that were legislated in response to the thalidomide catastrophe that had occurred in Europe . The task of standardizing definitions and processes was taken up by the Council for International Organization of Medical Sciences (CIOMS ). Initially established in 1949 as a nongovernmental organization for international exchange of knowledge in the medical sciences, CIOMS was reorganized in 1966 to include activities such as harmonization of infrastructural concepts, definitions, and processes for the safe use of pharmaceutical products, including medicines and vaccines, through contributions from stakeholders with subject matter expertise . CIOMS used a global working group mechanism of collaborative subject matter experts drawn from government, academia, and industry to tackle newly developing issues in this arena . Some of these issues include: adverse drug reactions periodic reporting risk–benefit safety reporting in clinical trials signal detection and risk minimization . 4/26/2023 www.clinosol.com | follow us on social media @clinosolresearch 6

7. Another important, complementary organization is the International Council for Harmonisation (ICH) (formerly the International Conference for Harmonisation ).  Organized in 1990, the ICH has provided a forum for the regulatory agencies and pharmaceutical industries of Europe, Japan, and the United States to harmonize the regulatory infrastructures of these regions. It has since expanded its international outreach and inclusion of stakeholders. The term “ pharmacovigilance ,” first proposed in the 1970s, has gradually gained traction to become one of the two common terms of art for the overall discipline, the other, older term being “drug safety .” 4/26/2023 www.clinosol.com | follow us on social media @clinosolresearch 7

8. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 4/26/2023 www.clinosol.com | follow us on social media @clinosolresearch 8