logging in or signing up ac3-03dm aSGuest10171 Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 29 Category: Education License: All Rights Reserved Like it (0) Dislike it (0) Added: January 12, 2009 This Presentation is Public Favorites: 0 Presentation Description No description available. Comments Posting comment... Premium member Presentation Transcript Pediatrics Update : Pediatrics Update Dianne Murphy, M.D. Director, Office of Pediatric Therapeutics Office of the Commissioner Director, OCTAP Center for Drug Evaluation March 3, 2003 Pediatrics Update : Pediatrics Update Organization of Pediatrics - D. Murphy New Office of Pediatric Therapeutics - D. Murphy Overview of Postmarketing Safety Surveillance in FDA – M. Chen Adverse Events Reporting - S. Iyasu Division of Pediatric Drug Development - S. Murphy Statistics - T. Crescenzi Historical Perspective : Historical Perspective Office of Pediatric Drug Development and Program Initiatives (OPDDPI) Office of Counter-Terrorism & Pediatric Drug Development (OCTAP) Division of Pediatric Drug Division of Counter-Terrorism Development (DCT) (DPDD) Slide 4: Pediatrics Structure OCTAP Office of the FDA Commissioner International Activities & Strategic Initiatives CDER Division of Pediatric Drug Development Office of Pediatric Therapeutics Office of Pediatric Therapeutics : Office of Pediatric Therapeutics How established? Best Pharmaceuticals for Children Act (1/4/02) Section 6 Duties? “Coordination and facilitation of all activities of FDA that may have any effect on a pediatric population OR the practice of pediatrics OR may in any way involve pediatric issues” Office of Pediatric Therapeutics : Office of Pediatric Therapeutics Staff: One or more individuals with expertise concerning ethical issues position currently being advertised in NEJM One or more experts in Pediatrics Solomon Iyasu, M.D., M.P.H. adverse event reporting Office of Pediatric Therapeutics : Office of Pediatric Therapeutics Two important functions that impact you Subpart D Adverse Event Reporting Office of Pediatric Therapeutics : Office of Pediatric Therapeutics Subpart D FDA regulated products Expert panel to be convened because of referral from an IRB Office of Pediatric Therapeutics : Office of Pediatric Therapeutics Adverse Event Reporting Drugs with Pediatric Market Exclusivity Any adverse event reports must be referred to the Office of Pediatric Therapeutics for a one-year period from the date a drug receives pediatric exclusivity. Review of reports by Pediatric Advisory Subcommittee Office of Pediatric Therapeutics : Office of Pediatric Therapeutics Adverse Event Reporting Partnership between Office of Drug Safety (ODS) and Office of Pediatric Therapeutics (OPT) ODS - How they collect adverse events OPT - Solomon Iyasu, M.D., M.P.H. How we will report adverse events to you Office of Pediatric Therapeutics : Office of Pediatric Therapeutics How to avoid overlap and duplication with Division of Pediatric Drug Development? Solution = Efficiencies Efficiencies : Efficiencies Office of Pediatric Therapeutics : Office of Pediatric Therapeutics How to Contact Us? Email: opt@fda.gov Phone: 301-827-9218 Fax: 301-827-4001 You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
ac3-03dm aSGuest10171 Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 29 Category: Education License: All Rights Reserved Like it (0) Dislike it (0) Added: January 12, 2009 This Presentation is Public Favorites: 0 Presentation Description No description available. Comments Posting comment... Premium member Presentation Transcript Pediatrics Update : Pediatrics Update Dianne Murphy, M.D. Director, Office of Pediatric Therapeutics Office of the Commissioner Director, OCTAP Center for Drug Evaluation March 3, 2003 Pediatrics Update : Pediatrics Update Organization of Pediatrics - D. Murphy New Office of Pediatric Therapeutics - D. Murphy Overview of Postmarketing Safety Surveillance in FDA – M. Chen Adverse Events Reporting - S. Iyasu Division of Pediatric Drug Development - S. Murphy Statistics - T. Crescenzi Historical Perspective : Historical Perspective Office of Pediatric Drug Development and Program Initiatives (OPDDPI) Office of Counter-Terrorism & Pediatric Drug Development (OCTAP) Division of Pediatric Drug Division of Counter-Terrorism Development (DCT) (DPDD) Slide 4: Pediatrics Structure OCTAP Office of the FDA Commissioner International Activities & Strategic Initiatives CDER Division of Pediatric Drug Development Office of Pediatric Therapeutics Office of Pediatric Therapeutics : Office of Pediatric Therapeutics How established? Best Pharmaceuticals for Children Act (1/4/02) Section 6 Duties? “Coordination and facilitation of all activities of FDA that may have any effect on a pediatric population OR the practice of pediatrics OR may in any way involve pediatric issues” Office of Pediatric Therapeutics : Office of Pediatric Therapeutics Staff: One or more individuals with expertise concerning ethical issues position currently being advertised in NEJM One or more experts in Pediatrics Solomon Iyasu, M.D., M.P.H. adverse event reporting Office of Pediatric Therapeutics : Office of Pediatric Therapeutics Two important functions that impact you Subpart D Adverse Event Reporting Office of Pediatric Therapeutics : Office of Pediatric Therapeutics Subpart D FDA regulated products Expert panel to be convened because of referral from an IRB Office of Pediatric Therapeutics : Office of Pediatric Therapeutics Adverse Event Reporting Drugs with Pediatric Market Exclusivity Any adverse event reports must be referred to the Office of Pediatric Therapeutics for a one-year period from the date a drug receives pediatric exclusivity. Review of reports by Pediatric Advisory Subcommittee Office of Pediatric Therapeutics : Office of Pediatric Therapeutics Adverse Event Reporting Partnership between Office of Drug Safety (ODS) and Office of Pediatric Therapeutics (OPT) ODS - How they collect adverse events OPT - Solomon Iyasu, M.D., M.P.H. How we will report adverse events to you Office of Pediatric Therapeutics : Office of Pediatric Therapeutics How to avoid overlap and duplication with Division of Pediatric Drug Development? Solution = Efficiencies Efficiencies : Efficiencies Office of Pediatric Therapeutics : Office of Pediatric Therapeutics How to Contact Us? Email: opt@fda.gov Phone: 301-827-9218 Fax: 301-827-4001