Stephanie Philbin

Ms. Philbin frequently lectures on food and drug law. Most recently, in March 2021, she presented on “Preparing for the Worst: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls” at the American Conference Institute’s FDA Boot Camp. Her other speaking engagements include:

• “Analyzing Recent Changes to FDA Approval Processes and Future Implications on Product Liability Cases” at the American Conference Institute’s 25th Annual Conference on Drug and Medical Device Litigation (December 2020) (Co-presenter)
• “Preparing for the Worst: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls” at the American Conference Institute’s FDA Boot Camp (September 2020)
• “Deep Learning Advances in MedTech: Unlocking Investment Opportunities” for the Columbia Business School Alumni Club of New York (December 2019)
• “Law and Digital Health: Legal and Compliance Strategies and Implications” at scwish:pharma’s “New Rules, New Roles” (November 2019)
• “Post-Marketing Issues for Medical Device Companies” for the Food and Drug Law Institute’s Introduction to Drug and Device Law and Regulation for Patient Organizations (November 2019)
• “Introduction to Medical Devices, Combination Products, Companion Diagnostics, and Medical Apps: A Review of FDA Guidelines and Regulations” at the American Conference Institute’s FDA Boot Camp (September 2019)
• “Dealing with Adverse Events/Product Problems” for the Food and Drug Law Institute/Center for Devices and Radiological Health In-House Training Course: Introduction to Medical Device Law and Regulation (June 2020, June 2019, October 2015, April 2015 and November 2014)
• “Post Marketing Issues” at the Food and Drug Law Institute’s Introduction to U.S. Medical Device Law and Regulation (April 2019, July 2018 and May 2014)
• “Overview of Reportable Malfunctions” at Q1 Productions’ 5th Annual Medical Device Postmarket Surveillance (January 2019)
• “The Regulation of Digital Health and Health IT” at the Canadian Consulate General’s Canadian Technology Accelerator (October 2018)
• “FDA Regulation of Digital Health and Health IT” in Wolters Kluwer’s Health Law Thought Leadership webinar (May 2018)
• “Premarket Notification 510(k)s and De Novo Applications” at the Food and Drug Law Institute’s Introduction to U.S. Medical Device Law and Regulation (April 2018)
• “Postmarket Surveillance and Remediation” at the MedTech Intelligence Medical Device Cybersecurity Workshop (October 2017)
• “Regulations and Definitions” at MedTech Intelligence’s Medical Device Recalls (November 2016)
• “Medical Device Reporting” at the American Conference Institute’s FDA Boot Camp: Devices Edition (July 2016)
• “Presenting Risk Information in Promotional Materials and Updated Good Reprint Practices” at AdvaMed’s Advertising and Promotion of Medical Devices Program (November 2014 and November 2013)
• “Fundamentals of FDA Regulatory Device Law” and “Comprehending the 510(k) Clearance Process” at the American Conference Institute’s FDA Boot Camp Devices Edition (October 2012)
• “The Food and Drug Administration Safety and Innovation Act: The 2012 Device Amendments and Their Potential Effect” in a Bloomberg BNA webinar (October 2012)
• “Off-Label Issues: Scientific Exchange and Unsolicited Requests” at the AdvaMed 2012 MedTech Conference (October 2012)
• “Medical Devices: Classification and the Essentials of the Device Premarket Review Process” at the American Conference Institute’s FDA Boot Camp (March 2012 and March 2010)
• “Enforcement and Compliance” for the Food and Drug Law Institute’s Introduction to Medical Device Law and Regulation (March 2012 and March 2010)
• “Premarket Approval Application” at the American Conference Institute's FDA Boot Camp Devices Edition (October 2011)
• “Changes to FDA’s 510(k) Program” in a BNA webinar (May 2011)
• “Legal Considerations: Industry Use of Social Media” at MassMEDIC's program on Use of Social Media During Regulatory Uncertainty (May 2011)
• “The FDA, the Internet & Social Media: Regulatory Issues and Evolving Policy” before the Medical Development Group (September 2010)
• “Post Marketing Issues" and "Quality System Regulation (QSR)” for the Food and Drug Law Institute’s Introduction to Medical Device Law and Regulation (January 2010)
• “Presenting Risk Information in Promotional Materials” at AdvaMed’s Medical Technology Learning Institute’s program on Advertising & Promotion of Medical Devices in an Age of DTC and Social Media Marketing (November 2009)
• “Post-Market Requirements and Concerns for Medical Devices” at the American Conference Institute’s FDA Boot Camp (July 2007)
• “Device Postmarket Reporting in the Drug Safety Age” for AdvaMed (November 2006)
• “Preparing for and Responding to an FDA Inspection” for AdvaMed (May 2005)
• “Medical Device Technologies and the FDA: GMPs for Combination Products” at the Virginia Biotechnology Summit (2004) 

Ms. Philbin has co-authored numerous articles including "Emerging from the Laboratory: Regulatory Considerations" (The Journal of Biolaw & Business, 2004, co-authored with Mark A. Heller and Melisa Moonan), and "Part 11: The FDA’s New View" (Bio-IT World, April 15, 2003, co-authored with Mark A. Heller). She also contributed to "Legal Responsibility for RA Professionals: Mistakes Can Be Costly" by Mark A. Heller (Regulatory Affairs Focus, April 1998).