Past CPI News and Events

 Critical Path News

• CPI Funding Opportunity for Modernizing Medical Product Manufacturing - 20 July 2011 Deadline
• FDA and Critical Path Institute Co-sponsor Pediatric Safety Surveillance Workshop, September 2010 
  
• Critical Path Institute's Predictive Safety Testing Consortium Announces First-Ever Qualification Decision by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), June 2010
• Critical Path Institute's Coalition Against Major Diseases (CAMD) Introduces the First Combined Pharmaceutical Trial Data on Neuro-degenerative Diseases, June 2010
• Critical Path Institute's Predictive Safety Testing Consortium Announces Special Issue of Nature Biotechnology Dedicated to Newly Qualified Kidney Safety Biomarkers, May 2010
• Global Partners to Join Forces to Speed Development of New TB Drug Combinations, March 2010
• FDA Awards Contract to Harvard Pilgrim to Develop Sentinel System Pilot, Jan. 8, 2010
• Initiation of 4-year Dual Antiplatelet Therapy Study, a Critical Path Collaboration to Improve Patient Safety,
  under management of Harvard Clinical Research Institute. Study is comparing two different durations of treatment with aspirin plus antiplatelet drugs
  (12 months vs. 30 months on the antiplatelet medication while continuing on aspirin), September 2009.
• Grant Opportunity - Clinical Trials Transformation Initiative (U19), June 19, 2009²
  • Federal Register Notice³

Press Releases

• FDA awards nearly $3 million for TB research
• FDA and International Serious Adverse Events Consortium Complete Third Data Release
  (Focusing on genetic basis of drug-induced liver injury and serious skin reaction), Feb. 19, 2010
• FDA and International Consortium Report New Data on Drug-Induced Liver Injury, May 31, 2009
• FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events, February 10, 2009

 Meetings and Presentations

• Brookings Roundtable on Active Medical Product Surveillance
  Learning from the Observational Medical Outcomes Partnership (OMOP)
  Thursday, July 1, 2010, 12:00 p.m. - 1:00 p.m. EST Live Webinar
• FDA/NHLBI/NSF Workshop on Computer Methods for Cardiovascular Devices: the Integration of Nonclinical and Computer Models, June 10-11, 2010
  Hilton, Rockville, MD 20852
• Tuberculosis Public Workshop, June 7-8, 2010 
  Free workshop sponsored by FDA/CDC/NIAID
  National Labor College, Silver Spring, MD
•  FDA/URI College of Pharmacy conference on 'PAT', Pharma Conference/URI College of Pharmacy
   Hyatt Regency, Bethesda, MD, May 11-12, 2010
• AASLD/FDA/PhRMA Drug-Induced Liver Injury: Getting the Medicine and Science Together, March 24-25, 2010, Silver Spring, MD. Meeting information and registration
• Science Writers Symposium, Nov. 4-5, 2009, FDA White Oak Campus, Silver Spring, MD 20993
• Expert Meeting Presentations on Standardized Data Collection for Cardiovascular Trials, September 11, 2009¹
• The Critical Path Rounds lecture series 2009
• FDA/eHealth Foundation Meeting: Sentinel System, December 16, 2008
• Science Writers Symposium, November 10, 2008
• Critical Path on the Move, DIA meeting, September 15 and 16, 2008
• FDA Commissioner testifying on Critical Path at the University of Utah --, June 1, 2007

Workshops, Courses, and Training

• March 15, 2011
  Public Workshop -FDA's Center for Devices and
  Radiological Health's Innovation Initiative
• Feb. 28, 2011 DIA Webinar - FDA's Draft Guidance for Industry on
  Electronic Source Documentation in Clinical Investigations
• Nov. 2010 FDA Clinical Investigator Training Course

• Medical Devices Technology Innovation Partnership (MD-TIP) Workshop
     Oct. 26, 2010 FDA White Oak Campus Building 31 
     Silver Spring, Maryland

• Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations
  Sept. 23, from 7:30 a.m. to 5:00 p.m.
  Hilton Washington DC/North Gaithersburg, 620 Perry Pkwy, Gaithersburg, MD, 20877
   
• Public Workshop on Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices
  Sept. 30, from 8 a.m. to 5:30 p.m.
  Moscone Center, Room 102, 747 Howard Street, San Francisco, CA, 94103
• Two-day workshop Imaging and PET Radiopharmaceuticals, April 13-14, 2010
• First Annual Patient-Reported Outcomes (Pro) Consortium Workshop
  Bethesda Marriot, Bethesda MD 20814, March 23, 2010
• 2nd Annual Sentinel Initiative Public Workshop: January 11, 2010, 8:30 a.m. – 4:45 p.m.
  Washington Marriott at Metro Center, 775 12th St, NW, Washington DC Registration is free of charge on a first-come-first-served basis at: http://tinyurl.com/yce6c3z.
• 1st Annual FDA Clinical Investigator Training Course, November 16 and 17, 2009 8 a.m. - 5 p.m., November 18, 2009, 8 a.m. - 3:30 p.m., National Labor College, Silver Spring, Maryland
• FDA/ NHLBI/NSF Computer Methods for Cardiovascular Devices Workshop, June 1-2, 2009
• Developing a Strategy for a Neurotoxicity Testing Battery, ASTM Workshop, Co-Chaired by FDA, May 19, 2009
• SPL Release Four Training Sessions 2009
• 1st Annual Sentinel Initiative Public Workshop: Structure, Function, and Scope, December  16, 2008.
• The Federal Register notice⁸, meeting agenda⁹ and transcript¹⁰ of this meeting are available in the links provided.
•  Critical Path Workshop on Clinical Trials for Local Treatment of Breast Cancer by Thermal Ablation, September 15, 2008
  • Transcript (PDF, 709KB)
  • FR Notice 
• Artificial pancreas public workshop, July 21-22, 2008
• Public Hearing on Antimicrobial Resistance, April 28, 2008
• Public Workshop on Draft Guidance, Developing Coronary Drug Eluting Stents, April 29, 2008
• Workshop on In Vitro Analyses of Cell/Scaffold Products, Dec. 6-7, 2007
• Workshop on Improving the Quality of Cancer Clinical Trials, Oct. 4-5, 2007
• BIMO Workshop, May 10-11, 2007
• Public Hearing: Should prescribing information be distributed electronically?-- April 27, 2007
• Part 15 hearing - Electronic Submission of Regulatory Information, Dec. 18, 2006
• Part 15 hearing - Conduct of Emergency Clinical Research, Oct. 11, 2006
• Sex Differences and Critical Path Initiative, FR Notice, Nov. 13, 2006