FDAnews Announces — "Are You Done with UDI? Or Is This Just the Beginning?" Webinar, Sponsored by Dassault Systemes, Oct. 13, 2016

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Manufacturers should be ready to comply with UDI by now, but that’s only the beginning. Hear directly from FDA’s Senior Advisor for UDI and Industry Experts the profound effect UDI implementation will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient.

Are You Done with UDI? Or Is This Just the Beginning?
FDA and Industry Experts Discuss Leveraging UDI to Accelerate Product Quality and Safety
Sponsored by Dassault Systemes
**FDAnews Free Webinar**
Oct. 13, 2016 — 1:30 p.m. – 2:30 p.m. ET
http://info.fdanews.com/are-you-done-with-udi

Manufacturers should be ready to comply with UDI by now, but that’s only the beginning.

Hear directly from FDA’s Senior Advisor for UDI and Industry Experts the profound effect UDI implementation will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient.

Join Terrie Reed, Senior Advisor for UDI Adoption at the FDA, Daniel R. Matlis of Axendia, and Jean Colombel of Dassault Systemes on Oct. 13 as they discuss UDI and how its value resides in the ability to optimize meaningful data collection and analysis.

After attending this 60-minute webinar, attendees will understand:

  • FDA’s intent to significantly improve device evaluation and decision-making through the adoption of unique device identification (UDI) across the device ecosystem.
  • The possibilities of UDI — opportunities to go beyond compliance and leverage UDI for the future
  • The implications for patients, providers and manufacturers in leveraging UDI information in global regulatory strategies
  • The value of managing the device identifier (DI) & production identifier (PI) throughout the product lifecycle
  • Effects of UDI implementation in terms of post-market quality management and future innovation efforts including precision medicine initiatives
  • Why a platform approach drives harmonization within global operations and helps companies proactively manage quality and regulatory strategies

Once UDI is fully implemented as part of a company’s global business operation, the opportunities for improving quality, streamlining regulatory reporting, and ultimately driving innovations forward are finally possible.

Meet the Presenters:
Terrie Reed, Senior Advisor for UDI Adoption, FDA:
Terrie has spent her career advocating for the operational integration of data standards and informatics principles into healthcare and government systems in order to improve the efficiency of regulatory submissions and public health reporting. Her latest role as Senior Advisor for UDI Adoption is the culmination of years of systems analysis, information science, and regulatory science experience aimed at significantly improving device evaluation and decision-making through the adoption of unique device identification (UDI) across the device ecosystem.

Daniel R. Matlis, Founder and President, Axendia:
Dan has over 25 years of experience in the Industry spanning the entire value chain. He has been involved in projects covering R&D, Commercial Operations, Regulatory Compliance, Business Development and Information Technology. Dan is an active member in the FDA’s Case for Quality Initiative and has presented Axendia’s research findings to industry executives and the FDA.

Jean Colombel, Vice President, Life Sciences Industry, Dassault Systèmes:
His organization is responsible for creating and developing Dassault Systèmes strategy and associated solutions for pharmaceutical, medical device and healthcare industry segments. Since joining the company in 2009, Jean has grown the Life Sciences business significantly and further enhanced the product portfolio by working closely with leading corporations, global regulatory agencies and various hospital organizations, while partnering and acquiring multiple business operations.

Who Will Benefit

  • Regulatory Affairs
  • Quality Assurance
  • Engineering, R&D
  • Project Managers, Program Managers
  • Safety
  • Risk Management

Webinar Details:
Are You Done with UDI? Or Is This Just the Beginning?
FDA and Industry Experts Discuss Leveraging UDI to Accelerate Product Quality and Safety
Sponsored by Dassault Systemes
**FDAnews Free Webinar**
Oct. 13, 2016 — 1:30 p.m. – 2:30 p.m. ET
http://info.fdanews.com/are-you-done-with-udi    

Easy Ways to Register:
Online: http://info.fdanews.com/are-you-done-with-udi    
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.

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Michelle Butler
FDANEWS
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