Pharmacovigilance siva PPT

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Pharmacovigilance clinical perspective not pharmaceutical company perspective :

Pharmacovigilance clinical perspective not pharmaceutical company perspective Prepared & Presented by Dr. Siva Reddy Challa , Professor & HOD, Dept. of Pharmacology KVSR Siddhartha College of Pharmaceutical Sciences, Siddhartha Nagar, Vijayawada-520010 Andhra Pradesh, INDIA Email: sivareddypharma@gmail.com

10 important FAQs in PV :

10 important FAQs in PV

PowerPoint Presentation:

10 important FAQs in PV

PowerPoint Presentation:

10 important FAQs in PV

The aims of pharmacovigilance:

The aims of pharmacovigilance 1. The identification and quantification of previously unrecognized adverse drug reactions (ADR). 2. The identification of sub-groups of patients at particular risk of ADRs (the risk relating to dose, age, gender and underlying disease). 3. The continued monitoring of the safety of a product, throughout the duration of its use, to ensure that its risks and benefits remain acceptable. This includes safety monitoring following significant newly approved indications. 4. The comparative adverse drug reaction profile of products within the same therapeutic class. 5. The detection of inappropriate prescription and administration. 6. The further elucidation of a product’s pharmacological/toxicological properties and the mechanism by which it produces adverse drug reactions. 7. The detection of significant drug–drug interactions between new products and co therapy with agents already established on the market, which may only be detected during widespread use.

Responsibilities of national PV centers :

Responsibilities of national PV centers Promoting the reporting of adverse reactions; Collecting case reports of adverse reactions; Clinically evaluating case reports; Collating, analyzing and evaluating patterns of adverse reactions; Distinguishing signals of adverse reactions from “noise”; Recommending or taking regulatory action in response to findings supported by good evidence; Initiating studies to investigate significant suspect reactions;

Historical Aspects :

Historical Aspects

National Scenario :

National Scenario

Chronological developments in Pharmacovigilance sector:

Chronological developments in Pharmacovigilance sector

As Per old National Pharmacovigilance Program :

As Per old National Pharmacovigilance Program

As Per New Pharmacovigilance Program of India (PvPI) :

As Per New Pharmacovigilance Program of India (PvPI)

About Adverse Drug Reactions (ADR) & Reporting :

About Adverse Drug Reactions (ADR) & Reporting

Classification of ADRs:

Classification of ADRs

ADR Vs ADE:

ADR Vs ADE

Steps in Pharmacovigilance :

Steps in Pharmacovigilance

WHO classification of causality assessment :

WHO classification of causality assessment

Thank You :

Thank You

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