Regulatory Page 2
Technology Trends & News
13 Dec 2023 - 7 min read
What Does the Newest Edition of GAMP®5 Bring to the Table?
RegulatoryIn the realm of digital health and life sciences, the transition from the first edition of GAMP®5 to the second…
14 Nov 2023 - 8 min read
GAMP®5
RegulatoryThe world of regulation has always been a minefield of both complex rules and a multitude of very specific terms…
26 Oct 2023 - 6 min read
AI and ML’s Impact on Pharmaceutical Manufacturing
RegulatoryFDA published two discussion papers to encourage dialogue on artificial intelligence and machine learning in drug development and Manufacturing. In…
03 Sep 2023 - 13 min read
Digital Health Regulation: A Comparative Study of the EU and the USA
Healthcare technologyRegulatoryIn the last decade, healthcare technology has advanced to a significant level. Many fields, such as cardiology, home care, dentistry,…
02 Sep 2023 - 20 min read
The Future of Clinical Research: The Regulatory Perspective
Healthcare technologyRegulatoryThe clinical research enterprise is at a crossroads. As we peer into the future of clinical research, the regulatory perspective…
23 Jul 2023 - 15 min read
AI in Healthcare: Navigating Regulatory Pathways in Europe and the USA
RegulatoryOver the past couple of years, we have seen the greater involvement of AI (Artificial Intelligence) in every possible aspect…
04 Jul 2023 - 7 min read
FDA Draft Guidance on GCPs: Steps to Innovate Clinical Trials
RegulatoryThe FDA is bringing to the table draft recommendations on innovative trial designs and health technologies to be incorporated into…
