Organizations may have to revisit their regulatory affairs structure and functionality in order to comply with new regulations as health authorities publish new policies and guidelines. They may face a number of challenges at various stages of the process. What emerging trends should be researched and how might they influence how stakeholders carry out regulatory affairs? Well, this is why most companies get their professionals undergo a Certificate Course in Drug Regulatory Affairs frequently. It helps them explore the evolving developments in Regulatory Affairs by adapting to latest technological advancements.
Top 4 developments observed in drug regulatory affairs industry
Pharma companies can reassess clinical development by implementing certain strategies. The following are some of the latest developments in this field, covered by most Certificate Course in Regulatory Affairs:
Using virtual first methods
In response to the COVID-19 emergency, many organizations are launching virtual trials, especially in areas where interventions are well-established and considered low-risk, such as novel indications of existing medicines for chronic diseases. The main advantage of virtual trials in Drug Regulatory Affairs is that they offer location flexibility by allowing the quick recruitment of specific patient segments irrespective of their residence. Industry experts also argue that virtual trials are more time-efficient since it takes only four months to recruit participants as compared to seven months in the traditional procedure.
Using contemporary technology
With computers, mobile devices, and other wearable biosensors, there is a lot of health-related data that is being collected and stored. It may be possible to improve the design and execution of clinical trials and research in the healthcare sector by utilizing this data. Moreover, now we are ready to process these data of drug regulatory affairs, apply the findings to medical development, and accelerate the approval procedure with the help of the created advanced, new analytical skills.
Telemedicine
Telemedicine, which was first conceived to aid health care systems, is the remote provision of therapeutic services to patients using electronic communications, thus foregoing a traditional in-person visit. Routine follow-up visits, management of chronic conditions, monitoring and review of medications, specialist referrals, and countless other services that can be remotely provided with secure video and audio connectivity are among the most popular applications for telemedicine. In case you want to learn the implementation of telemedicine in drug regulatory affairs, you can opt for a Drug Regulatory Affairs Certification.
Pragmatic clinical trials (PCTs)
The lag in the delivery of results for clinical trials for COVID-19 treatment led to developing a new and better method of conducting a randomized clinical trial. A study of DRA maintains that quick evidence production is possible in order to help improve the drug approvals much more especially during pandemics, through streamlining the research environment and accelerating the regulatory approval of pragmatic (practical) clinical trials (PCTs).
Conclusion
Clinical research has been the traditional process used by drug manufacturing companies, but the COVID-19 pandemic has highly disrupted this traditional way of testing of new drugs. The drug manufacturing companies will have to continue to seek for new avenues and find novel ways to cope with higher digital penetration as the pandemic is still restraining the scope of clinical research. To learn more about these developments, enroll yourself to the best Drug Regulatory Affairs Courses offered by Company Connect Consultancy.
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