martes, 14 de febrero de 2017

FDA training, events, and information for industry (registration closing soon for BSL-4 data quality course!)

New FDA Logo Blue
Best Practices for Communication Between FDA and IND Sponsors During Drug Development

New online course

The FDA Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) has launched a new online training course: Best Practices for Communication Between FDA and IND Sponsors During Drug Development.*
The one-hour course describes best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public.
*Note: course begins playing automatically, with audio narration.
Related Information

Data quality course: register by Feb. 24

FDA and the University of Texas Medical Branch, Galveston National Laboratory collaborate to provide an annual training course in how to meet Good Laboratory Practice (GLP) requirements in high and maximum biocontainment security level (BSL-3 and -4) laboratory facilities.
This year's course will be held April 24-28, 2017 at the National Institutes of Health in Bethesda, MD. Continuing education credits may be available for healthcare professionals (physicians, nurses, pharmacists and veterinarians). Register by noon February 24, 2017.
Instructor and student at FDA UTMB data quality course

Guidance and information for industry
  • New! March 8-9, 2017: Examining Opportunities for the Future of Medical and Public Health Preparedness: A Workshop (Washington, DC), hosted by the National Academies of Sciences, Engineering and Medicine, Health and Medicine Division
  • March 9, 2017: Vaccines and Related Biological Products Advisory Committee (Rockville, MD and webcast) - the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017-2018 influenza season
  • April 6, 2017: Public workshop - Emerging Tick-Borne Diseases and Blood Safety(Bethesda, MD) - to discuss tick-borne pathogens that continue to emerge as threats to blood safety, the effectiveness of current and potential mitigation strategies, and the general approach to decision making on blood safety interventions - register by March 23, 2017
  • New! April 25-28, 2017: Preparedness Summit  (Atlanta, GA) (fee) - FDA's Gregory Measer, JD, will present Beyond the Last Mile: Monitoring and Assessing Medical Countermeasure Use in Response to Public Health Emergencies
In case you missed it
  • CDC has developed a new tool for public health officials to communicate with the public in a radiation emergency. The Radiation Hazard Scalehelps people better understand their risk for health effects from the emergency, and can encourage people to follow recommended protective actions if needed and reduce their risk. (February 7, 2017)
Radiation Hazard Scale

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