Boston QSP June 2019 Event Announcement
Boston QSP is excited to announce our June event titled “Evolving Regulatory Landscape in Digital Health” in the IBDH series. We are co-locating/collaborating for this event with Digital Health Pharma Congress/World Pharma Week (WPW) to be held June 17-20, 2019 in Boston at the SeaportWorld Trade Center. This event will feature a panel discussion with three experts in medical devices and digital technology regulation. Plus, both IBDH and Boston QSP members get some special benefits (listed below) provided by the WPW!
FDA is adapting to rapid advances in digital health, and you should too!
Since the publication of the FDASIA IT Health Report in 2014 and the passing of the 21st Century Cures Act in 2016, the regulatory landscape for digital medical products has changed significantly. Still more changes are expected in response to technological advances in computing and artificial intelligence/machine learning. Our panel are leading experts with rich experience in medical devices and digital technology regulation and is here to answer your questions.
5:10-6:05 PM: 4th of July Celebration (BBQ, Beer and Wine, Cornhole, Jenga, Fun!) and Poster Viewing--Commonwealth Hall
6:15-7:15 PM: Panel Discussion on "Evolving Regulatory Landscape in Digital Health"--Harborview 2, Plaza Level (3rd Floor)
Venue: Exhibit Hall Ballroom, Seaport World Trade Center, Boston, MA
Sponsors: Digital Health Pharma Congress
RSVP here by June 17th! Limited seats.
Step 1: RSVP on the IBDH Meetup page
Step 2: Register on the WPW page for Free Hall Pass and access to all wonder events & activities in the Exhibit Hall.
Upon arrival, the IBDH event attendees will check in with both BQSP and the Digital Health Pharma Congress/WPW registration staff to gain a name tag with a special sticker.
Regulatory Affairs Advisor, Canon
Sarah Fairfield currently works with Canon’s Healthcare Research Optics Laboratory in Cambridge on joint product development ventures with MGH and Brigham and Women’s Hospital. She began her career in the medical device industry as a Process Engineer and moved into Regulatory Affairs just over 11 years ago. Her experience includes global regulatory strategy development, premarket submission work and post-market compliance activities for consumable, reusable and capital equipment. She holds a Bachelor of Science degree in Biomedical Engineering from Purdue University, holds her US Regulatory Affairs Credential (RAC), and will be pursuing an MBA with Boston University starting this fall.
Regulatory Affairs Consultant, Johnson & Johnson
Matthew King currently works for Johnson and Johnson’s DePuy Synthes franchise in Raynham as a Digital Regulatory Affairs Lead. Throughout a 25-year career, he has worked for several biotech and medical device companies, both as a consultant and an employee. Most recently, Matthew was the Senior Director for Regulatory Affairs with Insulet Corporation, where he led efforts for three 510(k) clearances and several IDE submissions that had digital and software aspects. He recently participated in a three-day workshop between the FDA, Industry, and diabetes advocacy groups on the Software Pre-certification program. He holds a BS in Biology and an MS in Regulatory Affairs, both from Northeastern University.
Manager, Regulatory CMC Medical Devices and Combination Products, Biogen
Krystin Meidell works with the Regulatory CMC Medical Devices and Combination Products group at Biogen where she supports combination product and medical device regulatory strategy. Krystin’s experience includes global regulatory and analytical roles in medical devices, companion diagnostics, drug delivery, and combination products, with a focus on software and electrical products. She holds a Bachelor of Science degree in Chemical Engineering from Carnegie Mellon University, is an active member of the Combination Products Coalition Digital Health working group, and volunteers as a regulatory advisor to Tufts University students at the Gordon Institute.
The WPW offers great benefits to both IBDH and Boston QSP members who will attend the June IBDH event. Free 4-day WPW Hall Pass: The June IBDH event attendees execute the regular free RSVP Meetup registration process on this page, and the WPW Hall Pass registration (a link offered below). This WPW Hall Pass will give the attendees 4-day (17-20th) full access to the Exhibit Hall and hosted events, including Plenary Keynote Sessions, Roundtable Breakout Discussions, >130 exhibiting companies, >130 scientific posters, network with 1,500 attendees during Receptions and Coffee Breaks, etc. The early registration (by June 7th) is highly encouraged to ensure a smooth check-in and free WPW Hall Pass issue. Please follow the RSVP steps listed above. 2. WPW Discount pass: Use the code WPWQSP50 during the Registration to get 50% off the current rate for newly paid registrations only (no other discounts permitted). The code is valid until June 17th. This gives you access to the full scientific program. To learn more about the event visit http://bit.ly/2JyE3XZ #WorldPharmaWeek Join us June 17-20 in Boston Note: This pass provides the registrants access to all of the WPW congresses/events, except for the short courses.
About Boston QSP
Boston QSP is a 501(c)(3) non-profit organization whose mission is to foster the sharing of QSP knowledge, challenges, solutions, and opportunities to advance the field as an interdisciplinary community in Boston.