Rainer Voelksen, Vice-President for International Regulatory Affairs at Edwards Lifesciences, joins Pharma IQ to discuss why standards should have internationally compatible software requirements. He also touches upon the European QM approach, the GHTF project and the International Medical Device Regulator Forum in the interview. Full Article »

“ Barcodes aren’t glamorous or sexy, but they are powerful,” said Dawn Fowler, Sr. Manager, Labeling & Documentation at Endologix. In this exclusive Pharma IQ interview Dawn Fowler speaks about the importance of real world assessment in executing UDI programs and imparts scalable ways to implement unique identifiers for medical devices. Fowler also shares her top 3 tips for implementing UDI Information on a medical device, and insights into the common pitfalls manufacturers make when they are just setting out. Full Podcast »

Since more and more clinical research and drug manufacturing are being done in multiple countries and in multiple languages, quality language services can help bring a drug to market faster, and can help streamline the clinical trial process. Translation may be required at many stages, including clinical research, regulatory submission and review, production and marketing. Full Column »

Pharma IQ in conjunction with the Agile Technologies in Healthcare Summit prepared this Agile Info Pack, the definitive resource for professionals in the agile area. The guide summarizes the key issues related to new agile development in healthcare, changes in clinical evaluations for medical devices and tips on the agile techniques for a project and address the regulatory challenges of developing a medical device. Full Whitepaper »