Clinical research is a rapidly progressing, essential field of medical science that deals with the evaluation of new medicines and therapies with an ethical approach. Developing these new medicines is very challenging considering the inter-individual, inter-racial and cultural diversities that we possess as human beings.

Advancement towards the idea of developing personalized treatments is giving a new dimension to the research and development efforts of the global drug development industry.

Fundamental to clinical research is the domain of regulatory affairs which forms a network of standardized laws, regulations and guidelines creating an equilibrium between facilitation of innovation and safety of subjects enrolled in clinical trials.

In the present global clinical research landscape, regulatory affairs professionals lead multinational assignments and make sure that clinical trials are performed in compliance to the applicable regulatory requirements of the sponsor’s nation as well as the international locations where the clinical trial is being conducted.

At JLI we strive to develop clinical research and regulatory affairs professionals who are equipped with the most relevant and up-to-date knowledge and skills. This Advanced Clinical Research and Regulatory Affairs training program is practically driven and centered on the tasks expected of a regulatory affairs professional in the clinical research industry. In this Regulatory Affairs training you are provided with the understanding of the global regulatory structure and acquire skills needed for regulatory strategic planning throughout the product lifecycle.

In this training course you will understand the techniques of critical evaluation for risk/benefit analysis by assessing the economic, societal, regulatory and corporate requirements. You will also attain the expertise essential for performing in an advisory role as a regulatory affairs specialist for pre and post marketing projects.

Additionally, you will learn how to interface with the regulatory agencies and other key stakeholders for accomplishing regulatory compliance.

The curriculum for the program – Post Graduate Diploma in Clinical Research & Regulatory Affairs (APGDCR-RA) is comprehensive, has been developed and evaluated by experienced pharmaceutical regulatory affairs professionals and is fully endorsed by the clinical research industry. Not only is this online training course suitable for new graduates but also for working professionals who either wish to grow further in their clinical research and/or regulatory affairs career, or those who wish to make a move to the clinical research or pharmaceutical regulatory affairs domain from any other related industry.

Courses:

• Post Graduate Diploma in Clinical Research and Regulatory Affairs