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  1. Medical Countermeasures Initiative (MCMi)

About MCMi Professional Development

Through professional development, FDA meets the regulatory challenges posed by new science and technology developments.

About MCMi Professional Development

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A participant in a data quality course conducts a training exercise wearing BSL-4 personal protective equipment.
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A participant in an MCMi-sponsored data quality course conducts a training exercise wearing BSL-4 personal protective equipment.

Through professional development, FDA meets the regulatory challenges posed by new science and technology developments. In addition to supporting a broad regulatory science program—including professional development components—FDA fosters collaborative activities with scientific institutions, academia, and industry.

Lectures, training courses and symposia

The FDA Medical Countermeasures Initiative (MCMi) supports lectures that cover a range of topics including guidance development, the policies, procedures, and framework for assessing applications for review, and other timely medical countermeasure (MCM)-related topics. Lectures include:

Foundations for Preclinical Review

Monthly lecture series to engage subject matter experts from FDA Centers and offices on issues related to obtaining valid, reliable animal models for human disease. Goals include examining common study pitfalls and supporting consistent guidance development.

MCMi Lecture Series

Periodic presentations to broaden understanding of the policies, procedures, and U.S. governmental framework for FDA reviewers assessing applications for medical products to counter chemical, biological, radiological, and nuclear (CBRN) threats and emerging infectious diseases.

Training course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (Bethesda, MD)

To help address the challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and the University of Texas Medical Branch, Galveston National Laboratory (UTMB) collaborate to provide a week-long annual training course on how to meet GLP requirements in BSL-4 facilities.

New! Training Course (Pilot): Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens

This new annual course, hosted by FDA and UTMB, focuses on the preparation and execution of research clinical trials to facilitate the approval of MCMs for high-consequence pathogens. This course will be offered in Nebraska in 2020.

MCMi Regulatory Science Symposium 

MCMi has sponsored regulatory science symposia [ARCHIVED] to exchange ideas on MCM development and explore the latest research. Webcast recordings are available. Also see FDA Science Forum

Advancing skills of FDA staff with continuing education

The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) contains key legal authorities to sustain and strengthen our Nation's preparedness for public health emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, as well as emerging infectious disease threats. PAHPRA provisions focusing on FDA's interactions with government and industry working to develop MCMs help ensure that FDA personnel involved in review of applications for MCMs have sufficient background information, training, and expertise.

FDA recruits and fosters top talent by providing innovative skill development programs to prepare staff to successfully address the regulatory challenges presented by new areas of science and medicine. MCMi offers continuing education credits to physicians, nurses, pharmacists, and veterinarians who attend selected professional development activities.

FDA hosts numerous public meetings and workshops each year. For MCM-related events, visit our News and Events page.

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