RESEARCH & DEVELOPMENT
DIGITAL SOLUTIONS IN DRUG DEVELOPMENT Regulations to enable safe, effective, and high-quality solutions
From mobile medical apps and fitness trackers, to software that supports clinical decisions doctors make every day, digital technology has been driving a revolution in healthcare. As we are learning to live the virtual new normal in COVID-19 era, adoption of digital solutions has witnessed further acceleration. To keep pace with this promising innovation, the regulators must modernize its approach to regulation. Question to ask ourselves is “How to ensure high-quality, safe and effective digital health products”. This article highlights changing Regulatory landscape (European/FDA Guidelines) for enabling Safe, effective, high-Quality & trustworthy AI/Digital solutions in Pharma. Shrishaila Patil, Vice President, Statistical Programing, Navitas Data Sciences, a part of Navitas Life Sciences (a TAKE Solutions Enterprise)
28
P H A RM A F O C U S A S I A
ISSUE 40 - 2020
F
rom mobile medical apps and fitness trackers, to software that supports the clinical decisions that doctors make every day, digital technology has been driving a revolution in healthcare. As we learn to live in the new normal, forced by the COVID-19 pandemic, adoption of digital solutions has witnessed further acceleration. To keep pace with this promising innovation, regulators must modernise their approach to regulation. The question is “How can we ensure high-quality, safe, and effective digital health products”. This article focuses on the changing Regulatory landscape (European and FDA Guidelines) for enabling safe, effective, high-quality and trustworthy Artificial Intelligence (AI) and Digital solutions in Pharma.
With COVID-19 acting as a catalyst, just what is changing?
In the past few years, many innovations and novel approaches across Clinical Trial processes have been witnessed.
