Clinical Research & Regulatory Affairs Courses: As a professional in clinical research and regulatory affairs, you work in a drug discovery company or a public health care units, bearing tasks for documenting and endorsing the worth, effectiveness and safety of new drugs in approval submissions for regulatory. You estimate and document the fulfillment of clinical studies to regulatory requirements. You issue applicable conditions for the preparation, execution and evaluation of clinical studies to the division concerned. You use the results of such studies in the clinical study report, the approval report, the medical manuscripts and the patient information booklet. You recognize latent risks for the endorsement of a drug early on and can meddle if necessary.
TheClinical Research & Regulatory Affairs Courses tutor you the factor, methods and events of clinical research, and of new drug approval in the American and European markets. The program highlights on the interfaces and interdependencies between clinical research and regulatory approval processes of new drugs.
James Lind Institute’s Clinical Research & Regulatory Affairs Courses Program offers you with in-depth training on present regulations and their realistic application to the development and marketing of biotechnology, medical device , pharmaceutical and healthcare related products.