The onset of the COVID-19 pandemic has brought unforeseen changes to global drug development and its regulatory processes. As the effects of the pandemic continue to linger around the world, the need to understand the virus and develop treatments at a rapid pace has provided new learning opportunities for the pharmaceutical industry. Companies have glimpsed ways they can improve upon traditional methods to offer a competitive service, while complying with industry regulations. The need for global platforms, decentralized trials, efficient technology, and adaptable regulations are among some of the top concerns being addressed by the industry since the arrival of the COVID-19 pandemic.
Now more than ever, students can benefit from an understanding of regulatory systems, legislation, and practices relating to the development and quality of pharmaceutical goods. Let’s take a closer look at the effects of COVID-19 on regulatory affairs.
The Impact of COVID-19 on Regulatory Affairs
Across the world, governments and industries have been forced to take measures to mitigate the spread of COVID-19. The pandemic has placed unprecedented strain on health care systems, threatening the intricate network of international drug development. Clinical trials, clinical research, regulatory affairs, and manufacturing were all disrupted by social distancing measures, travel restrictions, and an increased demand for resources. Global health systems and the pharmaceutical industry have been tasked with maintaining ongoing clinical research while working to accelerate the production of treatments for COVID-19.
The pressing need to find solutions under these conditions has forced the industry to re-evaluate the flexibility of regulatory affairs that could facilitate future drug development. The pandemic has raised a question over whether the innovative measures applied under COVID-19 can be applied to other life-threatening illnesses to improve the efficiency of drug development.
Graduates of regulatory affairs courses gain an understanding of the challenges and opportunities faced by the industry through studying:
- Global regulatory strategies
- The applications of regulatory submissions
- Post approval activities and compliance
- Biotechnological products
Changing Standards for Compliance
Pharmaceutical companies now have a responsibility to balance speed with regulatory compliance. Regulatory standards must continue to rely on scientific data that offer an assessment of the relevant benefits and risks in drug development. However, strict regulatory affairs pose an obstacle to quick and efficient assessments necessitated by the COVID-19 pandemic. The pharmaceutical industry has been forced to consider different regulatory changes, including:
- Maximizing clinical trial capacity by pulling from trial networks
- Harmonized regulatory processes
- Clinical evaluations using shared working models
- Mobile technology to allow for remote and decentralized clinical trials
- Technology to improve regulatory review and adapt clinical trial designs
Students in a regulatory affairs program will explore the impact of the latest regulatory changes to affect the pharmaceutical industries, with a focus on some of the major strategic issues facing drug submissions.
What to Expect After Regulatory Affairs Courses
What lies in store for regulatory affairs? Professionals in the field are already working on a wave of new technologies that offer promising guides for the future of healthcare. The COVID-19 pandemic has exposed inefficiencies within current regulatory procedures, while illustrating the value of accepting a digital transformation within the pharmaceutical industry. Speed and efficiency are newfound priorities when it comes to regulatory affairs. By embracing new digital processes, pharmaceutical companies can improve the collection of necessary data that will maximize patient safety procedures while adhering to regulatory standards. Professionals considering a career in regulatory affairs should expand their knowledge of these technological advancements to stay ahead of industry trends in the post-pandemic era.
Are you ready to earn your regulatory affairs certification?
Contact the Academy of Applied Pharmaceutical Sciences today!