Regulatory Affairs and it's scope in current industry
DRA, DMF,DOSSIER, CTD, eCTD, Regulatory Authorities, Medical devices, ICH guidelines, Regulatory Affairs, Regulatory Submission, U.S. Food and Drug Administraion (FDA), Regulatory Requirements, Quality System, Good Manufacturing Practice (GMP), Standard Operating Procedure (SOP), Corrective and Preventive Action (CAPA), Design Control, Biotechnology, Validation, Regulatory Documentation, Clinical Trial, CE Marking.
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REGULATORY AFFAIRS AND ITS SCOPE IN CURRENT INDUSTRY
The Regulatory affairs domain is incorporated in almost every field of production and manufacturing be it food, medicines, medical equipment, technical devices, agrochemical, veterinary, etc. Every year, a large number of new products are developed by various pharmaceutical companies, all of which are then subjected to rigorous testing and verification procedures before the launch. Regulatory affairs in the pharmaceutical industry play an important role as the Pharmaceutical sector is rising very rapidly and there is a want of regulatory affairs professionals to provide the current needs of industries for the global competition. Regulatory affairs professional also play an important role in Pharmacovigilance of drugs
A regulatory affair (RA) is a profession which acts as the interface between the pharmaceutical industry and drug regulatory authorities across the world. It is mainly involved in the registration of drug products in the respective countries prior to their marketing. The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical companies. Regulatory Affairs is actively involved in every stage of development of new medicine and the post-marketing activities with authorized medicinal products.
Scope of Regulatory affairs in Industries:
Regulatory affairs professionals are employed in industry, government regulatory authorities and academics. The wide range of regulatory professionals includes in these areas:
- Pharmaceuticals
- Medical devices
- Biologics and biotechnology
- Nutritional Products
- Cosmetics
- Veterinary Products
Drug Regulatory Affairs and Its Job Opportunities:
Drug Regulatory Affairs is a diverse field with a lot of room for advancement. Drug Regulatory Affairs is the domain in charge of testing and maintaining the safety of products in order to improve community health. Many important responsibilities fall to regulatory affairs professionals, such as monitoring research, data analysis, testing products for adverse effects, reviewing products in accordance with lawsuits filed in various countries, etc. As the need for a more efficient healthcare system increases day by day it results to a rising demand for trained professionals in the field.
Demand of Regulatory Affairs in India:
As the industries are evolving there is more need for a workforce in the regulatory affairs niche making it a promising and well-demanded career options. An investment in healthcare today can shape our country’s future. The Government is constantly making efforts by investing more funds in this sector. A career in Drug Regulatory affairs can take you to unseen paths of success.
Current Trends in Drug Regulatory Affairs:
AI And Machine Learning: Since the introduction of technology, we have seen the automation of things in every aspect of life. Many innovative technical equipment, such as health monitoring devices, AI-assisted surgeries, online doctor consultations, data-based medical treatments, and so on, have been implemented. With an increase in Innovation and AI in healthcare, the scope to surveil the effects and usability of these devices has become a need so it does not turn out to be a disaster. All these factors contribute to increasing the demand and importance of Drug Regulatory Affairs in the near future.
Virtual Trials: With the technological advancements being done in the healthcare niche there’s soon gonna come a time when even the clinical trials will be conducted online. It will be as simple as asking a friend for assistance with a project. As these new models of research are developed, regulatory affairs is playing a vital part to set the guidelines and monitor the patient rights being granted through the trials.
Mobile Apps: Since the takeover of social media, the awareness about health care has increased and people have started to be more considerate of their well-being. Healthcare when merged with technology provides a miraculous solution. One of which is the healthcare mobile apps that can be leveraged to achieve our healthcare solution goals along with efficiency and quality. The mobile apps developed for this purpose must be tried and tested effectively to identify the loopholes and key points which bring the regulatory affairs into the picture.
Future Trends: The next big thing that’s going to be change the healthcare domain is Augmented Reality. Imagine conducting surgeries without any patient, sounds stupid right? But this unrealistic thought here has the potential of becoming the future trend. There will be a time in the future when all complex surgeries will be performed using AR, without causing any harm and errors at the time of complex surgeries.
Conclusion:
As we have gone through all the new upgrades that are ready to dive into the healthcare pool we can say that Drug Regulatory Affairs is going to be mandatory on the checklist for milennials. All the new methodologies, devices, treatments, human health applications, etc will need to be handled and experimented by an authorized body. Without regulatory affairs, all these developments cannot access the global market, which is quite obvious because it’s a well-being of all the humans we are talking about. The Regulatory Affairs Committee will assist in determining the benefits and drawbacks of a product, testing it, and launching it only if it can bring value and comfort to our daily lives. If you wish to work in regulatory affairs, this is a fantastic moment to do so because the field is still evolving and many developments require monitoring and oversight. Regulatory Affairs department is continually evolving and growing and is the one which is least impacted during the acquisition and merger, and also during the recession. Regulatory Affairs departments are growing within companies. Due to the changing resources necessary to fulfill the regulatory requirements, some companies also choose to outsource or out task regulatory affairs to external service providers. The proper implementation of regulatory guidelines and laws will improve the economic growth of the company and also improves the safety of the people.