Regulatory affairs professionals play an essential role within the lifecycle of drugs, biologics, and medical devices, helping to demonstrate to regulators (such as the FDA) that these products are safe and effective. From conception and development to approval and launch, each stage of the commercialization process requires individuals with specific expertise, in areas ranging from clinical data collection to capturing and reporting adverse events.
With today’s ever-changing laws and regulations, there’s a growing demand for well-rounded professionals who understand the overall regulatory landscape and can help companies effectively bring products to market.
Developing that understanding requires staying up-to-date on emerging trends within the industry. Stephen Amato, associate teaching professor and lead faculty member for Northeastern’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program, advises that to stay competitive in regulatory affairs, professionals need an in-depth understanding of how regulations are evolving and how they’re impacting the field. To that end, he recently shared three emerging trends to watch in 2020.
Read the full article in Northeastern University website