Clinical Research covers all steps and processes which are a part of a drug's lifecycle i.e. from researching the molecule, structuring the drug, to animal testing, human testing, final launch in the market and post marketing surveillance. All this more, makes Clinical Research a huge and dynamic industry.
Clinical Research is a broad spectrum course which offers to entail the candidate with knowledge and practically important information about the industry type, working modalities, methodology of trials, techniques of quality control, drug development, post marketing safety checks and all other aspects related to the clinical research industry.
In the Regulations a clinical trial is an investigation in respect of a drug that is intended to discover or verify the clinical, pharmacological or Pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug.
Participants understand the key concepts in the responsible conduct of research and are able to conduct research that conforms to the highest standards for the protection of human research subjects.
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Pharmacovigilance is a scientific discipline which mainly pertains with identifying, validating, quantifying, evaluating and minimizing the adverse effects of therapeutic drugs, devices or biologics in order to increase their safety. The clinical research regulatory agencies worldwide including US FDA, Indian DCGI and EMEA etc., are strengthening the safety laws for adoption of a systematic Pharmacovigilance framework. The adverse event data generated by clinical trials worldwide is enormous and has led to the outsourcing of the Pharmacovigilance and Pharmacoepidemilogy services of the Pharma-Biotech Research and Development. This fact is compounded by the increasing number of local clinical trials has led to a spurt in the Pharmacovigilance job market in India.
The course will help participants acquire a basic understanding of the concepts and practice of Pharmacovigilance. The course would sensitize the students and equips them with knowledge on Pharmacovigilance practices worldwide and on the Indian scenario in detail. The objectives of the course are as follows:
To enable participants to understand issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug effects (ADEs).
The manner in which ADRs are detected and monitored and the related historic and legal frameworks.
To introduce participants to fundamental statistical, compliance and regulations concepts and methods