Clinical research and pharmacovigilance biopharmaceutics
What is Clinical Research?
Clinical Research is a systematic study for new drugs in
subjects 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
Introduction why Pharmacovigilance
Aim of Pharmacovigilance
Pharmacovigilance: Future Challenges, Need &
Outcome of successful Program in
Summery & Conclusion
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
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
Drug Technical Advisory Board (DTAB) set up Vigilance Cells
Forensic Pharmacy and Forensic Psychology
Adverse Drug Reactions (ADRs)
Clinical Trial Safety
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.