clinical research and pharmacovigilance biopharmaceutics

Clinical Research &Pharmacovigilance

What is Clinical Research?Clinical Research is a systematic study for new

drugs in humansubjects to generate data for discovering or

verifying the Clinical, Pharmacological (including pharmacodynamics and pharmacokinetic) or

adverse effects with the objective of determining safety and efficacy of the new drug.

A clinical trial is one type of clinical research that follows a pre-defined plan or protocol. By taking part in clinical trials,

participants can not only play a more active role in their own health care, but they can

also access new treatments and help others by contributing to medical research.

Definition of clinical Research & Clinical Trail

Importance of Research in Clinical Trials

Different type of Clinical Trials

Overview of Clinical Trial

Surveillance Programmers In India

PHARMACOVIGILANCE : CURRENT SCENARIO & FUTURE CHALLENGES IN

INDIA

CONTENTS

Introduction why Pharmacovigilance

Aim of Pharmacovigilance

Pharmacovigilance: Future Challenges, Need & issues

Outcome of successful Program in Pharmacovigilance

Summery & Conclusion

Introduction why Pharmacovigilance

Pharmacovigilance Programme of India launched on July 14, 2010 is currently capturing ADR data in Indian population in a systematic way in coordination with the IPC. The main objective of the Programme is to monitor ADRs in Indian population.

Safety Monitoring of Medicinal Products Pharmacovigilance (PV or PhV), also known as Drug Safety

Aim of Pharmacovigilance

All medicines have risks as well as benefits. The aim of Pharmacovigilance 1 is to protect public health by identifying, evaluating, managing and minimizing safety Issues to ensure that the overall benefits of medicines outweigh the risks.

Patient safety is a fundamental principle

Apply computerized statistical tool s to facilitate the evaluation of safety information through, for example, the identification of unexpected adverse events that are being reported on a disproportionate basis (safety signals)

The science of Pharmacovigilance is continuously evolving and is actively involved in working with industry, regulators, healthcare professionals and patients to enhance methodologies in this area

Aim of Pharmacovigilance

Drug Technical Advisory Board (DTAB) set up Vigilance Cells

Forensic Pharmacy and Forensic Psychology

Adverse Drug Reactions (ADRs)

Clinical Trial Safety

Outcome of successful Program in Pharmacovigilance

In this regard, IPC which acts as the national coordination centre (NCC) for Pharmacovigilance Program of India (PvPI) already had a series of strategic meetings with the Centre over the last few months.

Since 2011, around 1,10,000 adverse drug reactions have been reported from across the country. However, this was after the government made it mandatory for hospitals to have a pharmacovigilance cell. Still, officials say, there are only few hospitals across the country operating with a proper cell.

Currently, there are only 150 hospitals across the country which have pharmacovigilance cell, the official cell. However, the health ministry and the drug regulator are making efforts to ramp up such cells.

Surveillance Programmes

Haemovigilance Meterio-Vigilance

Bio-Vigilance

Summery & Conclusion

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