Why is the requirement for regulatory affairs?
Have you ever thought who guards the public health by safeguarding the quality, safety and efficiency of drugs we ingest? We all are aware that a new molecule prices some millions of bucks. At the same time, the lack of proper regulation of these drugs can cost several lives. Another thought to consider is that it takes not less than 15 years to cultivate and release a new pharmaceutical product. It includes research and development, diverse phases of clinical trials, regulatory submissions, manufacturing and publicizing, distribution and post-market scrutiny.
In the interim, the regulatory setting undergoes dynamic fluctuations. So, it is essential to be well familiar with the ever-changing laws in those countries where the products are supposed to be dispersed and marketed. Furthermore, the dawn and operation of multinational companies and their trading of drugs to diverse countries stirred the need to be conscious of regulations laid down by respective governments to enable safe and effectual marketing of the drugs.
The Role of Regulatory Professionals
Regulatory affairs is a field which deals with piloting severe regulatory checks of produces such as pharmaceutical and veterinary formulations, medicinal devices, dietary products, pesticides, agrochemicals, food, and cosmetics prior to getting marketed. Regulatory activities for companies are controlled by regulatory professionals who examine old, current as well as new protocols in a region in regard to a company’s products, devices and processes, advice on the scientific and legal fronts of the constrictions and requirements and arbitrate subsequent negotiations to achieve marketing authorizations for the products.
A regulatory professional act as a link amid manufacturing companies and supervisory authorities. Right from the commencement of the production of the product to publicizing the planned and technical decisions is often taken by senior-level regulatory specialists. This profession just does not include memorizing regulations but needs scrutiny of the drug market and expectancy of effect of altering regulations on the market.
How to build a career in regulatory affairs?
A graduate or post-graduate degree in the realm of chemistry, pharma, business, life sciences, or even some distinct disciplines serves to achieve entry into the regulatory industry. Though, regulatory specialists have a cross-functional drill to offer an all-round awareness on the industry. Various universities and top institutes offer online training programs in the arena of regulatory affairs. These programs train individuals in numerous aspects of regulatory affairs in India and other nations.
Certified courses in Regulatory Affairs at IPM
Institute of Pharmaceutical Management (IPM) in Mumbai endows progressive post-graduate diploma in the realm of regulatory affairs to discover positions such as Regulatory affairs associate, Regulatory affairs executive, Regulatory affairs manager, to name a few. These courses are self-paced and been intended by the industry specialists to fulfill the end-to-end requirements of tirelessly developing pharmaceutical companies and various other federal agencies.
IPM offer personalized classroom activities by way of a Tutoring Centre, Excellent Tutoring and other opportunities.