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Clinical Research
&Pharmacovigilance
What is Clinical Research?
Clinical Research is a systematic study for new drugs in
human
subjects to generate data for di...
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
Introduction why Pharmacovigilance
Aim of Pharmacovigilance
Pharmacovigilance: Future Challenges, Need &
issues
Outcom...
 Pharmacovigilance Programme of India launched on July 14, 2010 is
currently capturing ADR data in Indian population in a...
 All medicines have risks as well as benefits. The aim of
Pharmacovigilance 1 is to protect public health by identifying,...
 Drug Technical Advisory Board (DTAB) set up Vigilance Cells
 Forensic Pharmacy and Forensic Psychology
 Adverse Drug R...
 In this regard, IPC which acts as the national coordination
centre (NCC) for Pharmacovigilance Program of India (PvPI)
a...
Surveillance Programmes
Haemovigilance Meterio-Vigilance
Bio-Vigilance
prajithkanna@gmail.com
Clinical research and pharmacovigilance biopharmaceutics
Clinical research and pharmacovigilance biopharmaceutics
Clinical research and pharmacovigilance biopharmaceutics
Clinical research and pharmacovigilance biopharmaceutics
Clinical research and pharmacovigilance biopharmaceutics
Clinical research and pharmacovigilance biopharmaceutics
Clinical research and pharmacovigilance biopharmaceutics
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Clinical research and pharmacovigilance biopharmaceutics

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Clinical Research and Pharmacovigilance Biopharmaceutics

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Clinical research and pharmacovigilance biopharmaceutics

  1. 1. Clinical Research &Pharmacovigilance
  2. 2. What is Clinical Research? Clinical Research is a systematic study for new drugs in human 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.
  3. 3. Definition of clinical Research & Clinical Trail
  4. 4. Importance of Research in Clinical Trials
  5. 5. Different type of Clinical Trials
  6. 6. Overview of Clinical Trial
  7. 7. Surveillance Programmers In India
  8. 8. Introduction why Pharmacovigilance Aim of Pharmacovigilance Pharmacovigilance: Future Challenges, Need & issues Outcome of successful Program in Pharmacovigilance Summery & Conclusion
  9. 9.  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
  10. 10.  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
  11. 11.  Drug Technical Advisory Board (DTAB) set up Vigilance Cells  Forensic Pharmacy and Forensic Psychology  Adverse Drug Reactions (ADRs)  Clinical Trial Safety
  12. 12.  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.
  13. 13. Surveillance Programmes Haemovigilance Meterio-Vigilance Bio-Vigilance
  14. 14. prajithkanna@gmail.com

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