In this set of webinars, sponsored by MedicalDeviceSummit, these industry experts will cover the practical information you need to begin implementing an eMDR system, how to decide which of the two reporting routes to select, steps for setting up and testing your system and account, typical challenges and solutions, and where to go for further information.
“Electronic Medical Device Reporting (eMDR) allows electronic data entry and processing of medical device adverse event reports,” Kacera explains. “After several delays, the electronic reporting route is likely to become mandatory in 2012, per the FDA, after which paper submissions will no longer be accepted.
“eMDR will definitely be made mandatory…..it’s just a matter of ‘when,’” she added. “And when it does, the FDA may be so overwhelmed with simultaneous requests and questions that the Agency will not be able to provide the same level of assistance that is available now.”
The series begins May 11 when Kacera and Eugene Reilly, eMDR Coordinator for the CDRH Office of Surveillance & Biometrics, will present an eMDR Implementation Overview, The Regulation, System, and Practical Considerations. The Overview webinar will review the regulation, technology, and two eMDR submission options, looking at a broad range of FDA and early adopter experiences, with lessons to be learned and suggested additional resources.
The second webinar in the series, eMDR Implementation: Low Volume Reporting - the FDA eSubmitter and WebTrader Option, presented on May 18, combines practical industry experience in creating and switching to a low volume eMDR system with a live FDA demonstration of the eSubmitter and WebTrader technologies and their use.
The third installment, presented May 25, is eMDR Implementation: High Volume Reporting - the AS2 Business-to-Business Compliant Option. This webinar provides a case study in practical implementation of the technical systems, and allocation and coordination of internal resources; examines how the high volume option differs from that for low volume reporters; and, offers examples of user experiences, glitches, and solutions.
About Pilgrim Software, Inc.
Pilgrim Software, Inc. is a world-leading provider of Enterprise Risk, Compliance and Quality Management solutions for global organizations. Named North American Enterprise Compliance & Quality Management Company of the Year – Best Practices by Frost & Sullivan, Pilgrim helps organizations manage industry and regulatory compliance, reduce manufacturing costs and improve customer satisfaction. For more information, visit Pilgrim Software’s website at www.pilgrimsoftware.com.
Nancy DeFilippis | Marketing Programs Manager (Events & Campaigns) | Pilgrim Software
office: 813-915-1663 ext 2479 | fax: 813-915-1948 | www.pilgrimsoftware.com