Pharma’s Big Data, Real World Evidence and The Digital Revolution

Dear Reader,

Edward A. Steele

Welcome to the May 2019 edition of EAS-e-News, the free newsletter dedicated to FDA regulated industries. It has been a busy month at EAS, with the release of new complimentary On-Demand webinars, announcements of new training seminars, publication of numerous articles on a wide-variety of subjects as well as a fantastic attendance at the EAS booth during the recent Supplyside East. For those of you who had an opportunity to meet with Tara Couch, our senior director for dietary supplements and Heather Fairman, one of our expert independent consultants I am sure you came away with a lot of great information on EAS and how we can begin to assist your company with any number of FDA requirements. For those who were unable to attend, I invite you to take a look at our quick reference information sheets to learn more about EAS. We are always glad to speak with you about your GMP questions or concerns.

If you will be in Geneva for Vitafoods Europe, May 7-9 we invite you to come by the EAS booth, B149, to meet Tara Couch and Charles Breen, our Independent Advisor for FSMA. In addition to exhibiting at Vitafoods, EAS is a proud training partner for the show, offering a one-day comprehensive look at GMPs for the dietary supplement industry. Registration for this seminar, taking place May 6, the day before the official start of Vitafoods, is being handled through Vitafoods directly. In addition, Charles Breen will be speaking as part of the technical sessions on hygienic commitments for food safety.

FDA has OMB approval to initiate a short voluntary survey of the cosmetics industry, which will assess a variety of GMP aspects. This survey is important to help FDA gain a better understanding of the current state of industry GMPs, and the results provided to FDA will have no identifying information, nor will responses be used by the agency to initiate enforcement actions. A Federal Register notice regarding the survey can be found here and we encourage cosmetics firms to participate in this effort.

In other FDA news, a new effort to bolster the collaboration between FDA and the Customs and U.S. Border Patrol (CBP) is underway to better protect against illegal and harmful products from gaining entry into the U.S. through the mail system, or other ports of entry. More information on this effort can be found in the What’s New at FDA section of this edition.

As mentioned earlier, we are pleased that numerous compliance seminars are both approaching and new on the horizon. Our next GMP One-day Refresher training will take place in Denton, TX on May 7, and then Andover, MA on August 13, just outside of Boston. This one-day session is designed as an opportunity to outsource your department’s GMP refresher training. At just $300 per registration it is a great and cost-effective opportunity for your entire team to learn from our experts. More information can be found on the EAS website.

Additionally, we have two complimentary webinars coming up in May. On May 7 join Norma Skolnik for a look at how FDA eyes certain cosmetics claims and on May 14 join Jeff Roberts for a look at compliance with 21 CFR Part 11. Also, on June 13 we invite you to join EAS Senior Director for Pharmaceuticals and Devices, Bryan Coleman for a look at GMPs for OTCs.

Our issue of the month is written by John Brennan and looks at pharma big data, real world evidence and the Digital Revolution and our Ask the Expert on FDA’s plans to revamp the 510(k) process is answered by George Yanulis. Finally, I am pleased to welcome a new independent consultant, Dennis Gaalswyck and a new office manager, Kate Gibson. Learn more in our Who’s Who section of this edition.

As always, thank you for your interest in EAS and we invite you to share this newsletter with your colleagues.

Sincerely,

Edward A. Steele Signature

Ed Steele
Chairman and CEO

Posted in 2019, 2019 May, EASeNews, From the Desk of the Chairman.