A career in Regulatory Affairs is both a challenging and highly rewarding career. It opens up lot of opportunities as it covers a variety of disciplines. Individuals who are directly involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, Pharmacovigilance and others are considered regulatory professionals.
The Pharma industry is growing at a rapid pace and there is a rising concern over the safety and efficacy of pharmaceutical and medical device products. To maintain safety and efficacy in Pharma & medical device products, regulatory agencies like US FDA,UK MHRA, EDQM, DCGI etc all over the world are imposing no of regulation. This has resulted in creation of distinct department with highly qualified professionals who will help companies meet these requirements with ease.
In today’s competitive environment the reduction of the time taken to reach the market is critical to a product’s and hence the company’s success. The proper conduct of its Regulatory Affairs activities is therefore of considerable economic importance for the pharma company.
Inadequate reporting of data may prevent a timely positive evaluation of a marketing application. A new drug may have cost many millions of pounds, Euros or dollars to develop and even a three-month delay in bringing it to the market has considerable financial considerations. Even worse, failures to fully report all the available data, or the release of product bearing incorrect labeling, may easily result in the need for a product recall. Either occurrence may lead to the loss of several millions of units of sales, not to mention the resulting reduction in confidence of the investors, health professionals and patients.
A good Regulatory Affairs professional will have a ‘right first time’ approach and will play a very important part in coordinating scientific Endeavour with regulatory demands throughout the life of the product, helping to maximize the cost-effective use of the company’s resources.
As a Regulatory Affairs Professional progresses in his/her career, aspects of project management and strategic planning become more important. Individuals need to develop the ability to anticipate problems, analyze complex situations, and offer the optimal strategy in order to achieve marketing approvals worldwide in a timely manner.
The course will provide the student with the fundamentals required in both regulatory affairs and quality operations. The course has been framed with the following aims:
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