1. 1 Structured labeling for home use devices – assessment of the SPL format Myron Finseth Principal Technical Writer Medtronic Cardiac Rhythm and Disease Management (CRDM)…
1.Christopher OhlyThe New India Guidelines on Similar Biologics The New India GuidelinesOn Similar Biologics Regulatory and Market Authorization Requirements By, Christopher…
1. L E K . C O ML.E.K. Consulting / Executive Insights EXECUTIVE INSIGHTS INSIGHTS @ WORKTM VOLUME XVI, ISSUE 10 The Biologics Inflection Point: Managing The Risk From Biosimilar…
1. WR Tolbert & Associates Consultants to the Biopharmaceutical Industry 11483 Cypress Woods Drive San Diego, CA 92131-3535 858-693-8163 [email protected] / www.wrtolbert.com…
1. Investigating future prospects of electronic labeling Marcus Evans Medical Device Global Labeling Strategies July 24 and 25, 2013 Myron Finseth Principal Technical Writer…
Slide 1 Slide 2 State ◦ State medical boards license physicians Federal ◦ CDC- collects and publishes outcomes data Performs annual audits of ~10% of programs…