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U.S. Department of Health and Human Services

Emergency Preparedness and Response

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MCMi Professional Development Activities

 

MCMi Strategic Planning Lecture

FDA's Strategic Plan: 2012 to 2016      

Goal Number 1: Develop and maintain a highly qualified workforce with the technical training, scientific skills, and subject-matter expertise necessary to support the availability of the medical products that will be needed to counter a chemical, biological, radioactive, or nuclear (CBRN) agent or an emerging infectious disease threat.
 
 
 
 
 
To support this goal, FDA is working hard to recruit, develop, and retain top talent. FDA offers its staff dynamic and innovative professional development activities; fosters collaborative activities with scientific institutions, academia, and regulated industry; and recognizes scientific achievements. The goal is to ensure that FDA scientists can meet the regulatory challenges posed by new areas of science and technology. In addition to the many workshops and public meetings sponsored by the MCMi, key professional development activities include the following.
 
  • Foundations for Pre-Clinical Review lecture series: A monthly lecture series on pre-clinical scientific and technical issues. Goals include examining common study pitfalls and supporting consistent guidance development. Presentations are invited from both internal and external experts in the field. Although occasionally open to the public, most lectures are for FDA staff.
  • MCM Lecture Series: These lectures broaden the understanding of the policies, procedures, and US governmental framework for FDA reviewers who are assessing applications for medical products to counter CBRN threats.  Lectures are presented by highly respected leaders in their fields.
  • Conference Support: During the year, MCMi staff attend key MCM-related external conferences (e.g., the ASM Biodefense and Emerging Diseases Research meeting, the Biodefense Vaccines and Therapeutics and Biosecurity workshop).
  • Threat briefings: By outside experts in their fields; briefings bring the latest scientific and technical information on biosecurity issues to FDA staff.
  • MCMi Hot Topics: Are timely, scientific briefings on MCM-related topics of interest to FDA staff involved in the review of medical product applications. Subject matter experts from from Federal agencies, academia, and regulated industry are invited to speak on issues that are not product specific.
  • Georgetown University Certificate Program on Biohazardous Threat Agents and Emerging Infectious Diseases: This 12-credit, on-line, graduate level certificate program is available to FDA staff involved in MCMi activities who want to learn more about the science behind and impact of biothreat agents and emerging diseases. Upon successful course completion, participants receive a Certificate in Biohazardous Threat Agents and Emerging Diseases.
  • MCMi regulatory science research, including collaborative research, was presented June 5 & 6, 2012, at the MCMi Regulatory Science Symposium.
  • GLP Training: FDA and the University of Texas Medical Branch, Galveston National Laboratory (UTMB - GNL) are planning a collaboration to provide training in how to meet Good Laboratory Practice (GLP) requirements in high and maximum biocontainment security level (BSL)-4 laboratory facilities. The new training program will be open to all interested parties.  
  • Continuing Education: Whenever feasible, FDA offers continuing education credits to physicians, nurses, pharmacists, and veterinarians who attend these professional development activities. 

 

FDA also offers professional development activities for scientists and researchers from the private sector and academia who can explore the workings of FDA and bring novel scientific and technical ideas to fruition through collaborations with FDA staff. The Office of Scientific Professional Development in FDA’s Office of the Chief Scientist supports a number of these activities and provides additional useful links to informational and development efforts around the Agency, targeting a variety of audiences. 

 

 

 

 

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