Clinical research and pharmacovigilance biopharmaceutics
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Transcript of 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