The highly-anticipated Good Supply Practices for the 21st Century, a global tool for industry and regulators, has just been released.
At the FDA/Xavier PharmaLink conference at Xavier University in Cincinnati, Ohio, in March 2018, Dell Moller and Nicholas Paulin presented FDA’s top ten drug GMP inspection citations for FY 2017 and participated in a panel discussion that provided insight into the observations.
A team of FDA officials and industry professionals working through Xavier Health has taken a major step towards forging the use of artificial intelligence (AI), by providing a Good Machine Learning Practices (GmLP) document for the evaluation and use of continuously learning systems (CLS).
FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.
In a fascinating podcast, Jon Speer, Founder and VP QA/RA, Greenlight Guru, interviews Marla Phillips, Director, Xavier Health, on AI explainability and why it matters in healthcare. As AI begins to transform how the pharma and medical device industries operate, overcome the media-generated hype and fear of AI to discover its benefits when using it responsibly.
Dr. Marla Phillips, Director, Xavier Health, took part in a panel discussion on Capitol Hill, July 17, 2018. The event was titled “AI Explainability: What that Means and Why It Matters in Healthcare.”
What happens when a company submitting a marketing application for a drug is located in a country with an unstable and hostile environment, but an inspection of the manufacturing facility needs to take place to approve the application?
Xavier AI Initiative Core Team members Marla Phillips, Director, Xavier Health, Xavier University, and Mac McKeen, Fellow, Regulatory Science, Boston Scientific, will be speaking at the 122nd AFDO Annual Educational Conference.
At the Xavier Health web conference in February 2018, Half Day with FDA — The Future: Alignment and Reliance, CDRH Office of Compliance Regulatory Affairs Deputy Director Capt. Sean Boyd presented a proposed reorganization plan that will collapse the Center’s seven offices into four.
Dr. Marla Phillips, Director, Xavier Health, and Cenk Undey, Amgen, presented at the IFPAC Annual Meeting, held in Bethesda, Maryland, February 11-14, 2018.