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About the Speakers
Jeffrey K. Shapiro
Jeff Shapiro is a director at the law firm of Hyman, Phelps & McNamara, P.C. Mr. Shapiro specializes in medical device law, advising and representing companies before FDA for more than 20 years. He has experience in FDA regulation of medical devices, including product clearances and approvals, MDR and Part 806 reporting requirements, labeling and advertising, recalls, and responding to Form 483s and warning letters. Mr. Shapiro also counsels clients on FDA requirements governing IVDs and HCT/Ps. Mr. Shapiro is an expert in FDA's regulation of combination products, including preparation of RFDs. As an advisor to start-ups, mid-sized, and large medical device manufacturers, Mr. Shapiro recognizes the operational and financial considerations involved in managing compliance and creating regulatory strategies.
Mr. Blank is cofounder of Barton & Blank LLC, a regulatory consulting firm specializing in providing organizational and strategic regulatory support for medical device and combination product firms. Mr. Blank is a seasoned regulatory affairs profession who has been in the medical products industry for more than 25 years. Immediately prior to forming Barton & Blank, he was with Boston Scientific Corporation where he led a regulatory affairs team responsible for obtaining regulatory approvals for the company’s cardiovascular devices (including drug-eluting stents and ICDs). In addition to his time at Boston Scientific, Mr. Blank has worked with Cardiopulmonary, Surgical, Ophthalmic, Vascular Access and Critical Care medical devices.
Social Media is increasingly being adopted as a tool for promoting medical devices. However, use of these various platforms (e.g., Facebook, Twitter, Pinterest, etc.) has become an area of particular interest by regulators as evidenced by recent FDA Guidance and Warning Letters. Come hear the latest regulatory thinking and best practice recommendations for implementing medical device promotion on social media platforms.
This webinar will guide you through the current legal and regulatory framework for social media promotion of medical devices as well as highlight best practice recommendations for implementation within your organization.
In this webinar you will:
- Receive important updates on current FDA requirements and expectations for medical device promotion in general, and on social media specifically;
- Understand the expectations and limitations of FDA’s Social Media Guidance;
- Learn from recent FDA enforcement activities in the area of medical device promotion; and
- Hear best practice recommendations for implementing social media practices within your organization.
Please contact Lisa Harrington at firstname.lastname@example.org with any registration questions.