Certificate in Clinical Research and Regulatory Affairs

Clinical Research is a branch of medical science that helps in adjudicating the safety and effectiveness of medications, medical devices, operative procedures, diagnostic products and many more that can help in diagnosing, preventing, managing and curing any pathological or medical conditions. Historical evidences have shown that, if neglected, these animal or human trials can lead to untoward problems ranging from scientific situations or humanitarian catastrophes. These events have led to a series of understandings and acceptance of some critical aspects on which the trials have to be conducted. These aspects are called the Regulations and Guidelines. Some Important Regulations and Guidelines as per the countries, which are very much in use are. For trials conducted in India: Schedule Y, ICMR Guidelines. Some International Regulations: FDA, EMEA directives, ICH-GCP Guidelines, etc. Currently, most of the Pharmaceutical Companies as well as Contract Research Organizations (CROs) have a dedicated unit of Regulatory experts which comprise the regulatory department. The need for such a set up is as follows:

Over the past few years there has been significant changes and development in the Indian medical landscape. There has been a growing demand for regulatory and auditing services in clinical trials and researches. All regulated markets give emphasis on the quality of clinical trial, whether it is prior to the trial, during the trial or after the trial.

For several companies, the failure of any audit might not only be very expensive, but also concerning as in an industry that is the largest globally, the word of mouth becomes very crucial.

Regulatory affairs in itself is a vast area which may include Authoring NDAs, Study design, Regulatory project for submissions/Registration etc.

IICR is providing its students a comprehensive course curriculum which will result in attaining a good amount of expertise in various areas of Regulatory Guidelines along with Clinical Research.