FDAnews Announces — Digital Health Tools: What YOU Need to Know: Prepare now for the FDA’s Transformative Project Webinar, Aug. 1, 2018
FALLS CHURCH, Va. (PRWEB) July 18, 2018 -- Digital Health Tools: What YOU Need to Know:
Prepare now for the FDA’s Transformative Project
**An FDAnews Webinar**
Aug. 1, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/digitalhealthtools
The line between drugs and devices is blurring as the FDA rushes into the realm of digital health tools. Following on Commissioner Scott Gottlieb’s dramatic promise to strike out in novel directions, the agency is making changes right and left.
It’s groundbreaking for every FDA-regulated health sciences manufacturer including: drugs and biologics, medical devices, combination products.
Bradley Merrill Thompson Esq. of Epstein Becker & Green P.C., Washington DC, takes attendees through the ins and the outs. Over the course of 90 intensive minutes attendees will discover:
• AI-powered clinical decision support software: How a recent FDA approval could affect manufacturers
• The “Working Model”: The agency’s master plan for implementation
• “Pre Cert 1.0”: What the first version may look like by late 2018
• Drug development and digital tools: How the FDA is expanding opportunities and enabling patient-care innovations
• Post-market surveillance: The varied roles smart tools may play
• Cooperation with industry: Moves the FDA is making and mulling
• Artificial intelligence: The FDA’s new approach
• Pre-market digital safety: A new FDA program launches
• Digital Health Incubator: Another new FDA program launch
• And much more.
With consumers themselves taking control of their health via mobile apps and other tools, the move to digital is becoming a tidal wave. Discover what’s happening now and down the road, and it’s affect.
Meet the Presenter:
Bradley Merrill Thompson Esq., Epstein Becker & Green P.C., counsels device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement and clinical-trial issues. Mr. Thompson regularly defends companies receiving Warning Letters on subjects including good manufacturing practice, compliance and off label promotion.
Who Will Benefit:
This presentation is directed at makers of drugs, biologics, medical devices and combination products. It will be particularly useful to the following executives and professionals:
• C-suite
• QA/QR/QC
• Regulatory affairs
• Compliance affairs
• Strategic planning
• Marketing/sales
• General counsel/outside counsel
• Digital health consultants
Webinar Details:
Digital Health Tools: What YOU Need to Know:
Prepare now for the FDA’s Transformative Project
**An FDAnews Webinar**
Aug. 1, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/digitalhealthtools
Tuition:
$287 per site
Easy Ways to Register:
Online: http://www.fdanews.com/digitalhealthtools
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
Michelle Butler, FDAnews, http://www.fdanews.com, +1 703-538-7660, [email protected]
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