CRED Understanding Clinical Development 2024

09/10/2024

Definition and Aims of Pharmacovigilance

• Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem • The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

- WHO

The Organisation for Professionals in Regulatory Affairs

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PV through the lifecycle of a drug

Drug Discovery

Identification of candidate

Non-clinical testing

Safety and efficacy tests

Non

clinical

Phase 1

Clinical Regulatory Post

Phase 2/3

Submission of marketing authorisation request

Availability and pricing

Approval after evaluation by authorities

Phase 4/ real world use

Marketing

The Organisation for Professionals in Regulatory Affairs

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