SAFE-BioPharma Association executives will chair two sessions during the annual meeting of the Drug Information Association (DIA), June 21 – 25 in San Diego.
Implementing Global Electronic Submissions: The company and the regulators give their points of view will explore GSK’s eSubmissions initiative with both the FDA and EMEA. The session will be led by Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association. The FDA’s perspective on the advance to fully electronic submissions will be presented by Gary M. Gensinger, Deputy Director, Office of Business Process Support, FDA. EMEA’s perspective will be presented by Timothy Buxton, Head of Sector, Project Management, Communications and Networking Unit, European Medicines Agency. The industry perspective will be presented by Theresa Brunone, assistant director, Global Regulatory Operations, GlaxoSmithKline. The session is part of the DIA Electronic Regulatory Submissions/Document Management track and is scheduled for 8:00AM – 9:30AM PDT, Tuesday, June 23, Room 9.
Standards in your future: How SAFE-BioPharma, IHE and CDISC are collaborating to improve safety reporting will explain how these standards are collaborating to achieve faster safety trend analysis, data mining and data migration from electronic health records to archived and digitally signed electronic case report forms and to individual case safety reports. An overview will be presented by Rich Furr, Head Global Regulatory Affairs and Chief Compliance Officer, SAFE-BioPharma Association. Digital signatures in the retrieve form for data-capture workflow will be presented by Landen Bain, healthcare liaison, CDISC. Interoperability in safety reporting will be discussed by Lori Reed-Fourquet, consultant, e-HealthSign. The session is part of the DIA eClinical track and is scheduled for 8:00AM – 9:30AM PDT, Tuesday, June 23, Room 15A.
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