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?
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.
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.
At the FDA/Xavier PharmaLink conference in March 2017, FDA National Expert Investigator Robert Tollefsen presented a case study on a pharma company with compliance problems, and led a group discussion with the audience on what the appropriate actions would be for the company to undertake, given the circumstances.
At the 2017 FDA/Xavier University PharmaLink conference Robert Tollefsen, an FDA National Expert Investigator – Drugs/Computers, Pharmaceutical Inspectorate/Level III Certified in Drugs, Medical Products and Tobacco Program Operations Branch, and Dell Moller, FDA Cincinnati District Supervisory Investigator, presented FDA’s top ten drug GMP inspection citations for FY 2016. This article includes a brief comment/analysis on the findings and additional information regarding inspection trends and other inspection findings.
Dr. Marla Phillips, Xavier Health Director, spoke at the 15th Annual Cold Chain GDP & Temperature Management Logistics Global Forum.
The Xavier AI Summit was a featured topic on Cincinnati Edition, a live interview program on Cincinnati Public Radio station WVXU, 91.7 FM.
Xavier Health Director, Dr. Marla Phillips, presented at the 121st Association of Food and Drug Officials (AFDO) conference, June 19, 2017, in Houston.