International Guidelines, FDA Meeting Preparation Strategies Among New Discussion Topics (Chicago) – For the second year in a row, regulatory affairs CMC professionals will have the opportunity to discuss the most top-of-mind challenges and latest guidelines...
Curious about how medical devices are classified by regulatory agencies? MedCity News has the most up-to-date information on global regulatory requirements through the FDA, European Health Commission, Health Canada, and more. According to the article, “The...
The Pharmaceutical Price Regulation Scheme is only into the second year of implementation and already companies are facing rising payments to the Department of Health and may not be reconsidering their options. According to PharmaPhorum.com, “for 2016 through...
Dr. Stefan Burde IVD Product Expert BSI GROUP Dr. Burde is an IVD Product Expert in the In Vitro Diagnostics Notified Body at BSI Healthcare. He joined BSI in 2014 as part of BSI’s expansion of the IVD team to address the growing need for Quality and Technical...
Andrea Miller Quality Assurance Director EPIC RESEARCH AND DIAGNOSTICS Ms. Miller has over 20 years of quality assurance experience in medical device manufacturing including positions at international device manufacturers such CR Bard, Inc. and DJO Global Inc....
