Collaboratively hosted by the ASQ Biomedical Division/New England Discussion Group, MassMEDIC and RAPS, this daylong program is designed to give RA, QA and C-level executives a one-day crash course on the pending regulatory issues facing the industry. The agenda will include comprehensive presentations by FDA officials, industry representatives and regulatory experts.
7:30 a.m. Registration / Continental Breakfast / Networking
8:30 a.m. Session one: Public Policy Update, Presented by MassMEDIC
- Topic: The FDA After Gottleib an insider's perspective: Aaron Josephson, Senior Director ML Strategies and a former senior policy advisor at the Center's For Devices and Radiological Health discusses how the agency has changed, after the departure of former Commissioner Scott Gottlieb. What can we expect from the agency in 2020 with new leadership.
10:00 a.m. Networking and Coffee/Snack Break
10:30 a.m. Session two: ASQ Biomedical New England Discussion Group
- Topic: FDA New England District Office Update: Joseph Matrisciano, Jr., FDA Director, New England District gives an annual update on the district offices priorities and Maura Rooney, SCSO OMDRHO Div. 1, Stoneham MA
- Topic: The Pre-Submission Process (and industry anecdotes): David Rothkopf, President and Lead Principal, MEDICEPT and Scott Blood Principal Quality and Regulatory Consultant, MEDICEPT discuss the Pre-Submission Process
12:00 p.m. Networking Luncheon
1:00 p.m. Session three: RAPS Boston Chapter
- Topic: An overview of CDRH's Standards Program: Gail Rodriguez, Senior Policy Advisor with the Standards and Conformity Assessment Program at FDA’s Center for Devices and Radiological Health, discuses CDRH’s Standards Program [including Guidance on the Appropriate Use of Standards and Declarations of Conformity, and Draft Guidance on the Accreditation Scheme for Conformity Assessment’ (ASCA)
2:30 – 3:00 pm Wrap up / Q&A
3:00 p.m. Conference Adjourns