We are pleased to announce that our own, Gretchen Bowker, will be moderating the Association of Food and Drug Officials (ADFO) meeting today June 22nd. The AFDO is holding their event this week from June 20th to June 24th in Indianapolis at the Sheraton Indianapolis...
Sarah Witwer will be teaching for the third time in Orthopedic Regulatory and Clinical Affairs Program this fall at Grace College. She has three decades of practice in the life science industry and is a Pearl Pathways Regulatory Compliance Advisor. Sarah is well...
The Indiana Medical Device Manufacturers Council (IMDMC) is holding an event on the background of FDA regulation for those new to the medical device field. There will be multiple presentations, including one from Pearl Pathways’ Gretchen Bowker COO & RAC on,...
After the recent issuing of three final guidance’s by the US FDA, there have been many speculations. Some supporter favor these final documents, while others fear the documents led to the risk of “taking a copycat product.” There are two main groups that reached out...
Recently, the European Medicines Agency (EMA) sent out a survey to its stakeholders asking for their opinion regarding a new clinical trials database design. The rationale for EMA asking its stakeholders for their opinions is due to new regulations that were created...
