Regulatory Affairs

Office of the Vice President and Innovation

January 28-30, 2020: ASM Biothreats (Arlington, VA) – Hosted by the American Society for Microbiology, to offer professionals in biodefense, biosecurity, and biological threats the opportunity to exchange knowledge and ideas, and explore the latest developments and emerging technologies. (fee)

January 28-29, 2020: HHS Tick-Borne Disease Working Group public meeting (Washington, DC and webcast) – The Working Group will 1) hear presentations from the eight subcommittees on their findings and potential actions for the TBDWG to consider; 2) hear updates from the Public Comment and Inventory Subcommittees; and 3) further discuss plans for developing the 2020 report to the HHS Secretary and Congress on federal tick-borne activities and research. Register in advance.

February 3, 2020: Advancing EUA IVD Products Toward Full Marketing Status workshop (Silver Spring, MD) – Hosted by the Medical Device Innovation Consortium (MDIC), this workshop will explore key considerations for using real world data (RWD) to generate real world evidence (RWE) to help support in vitro diagnostic (IVD) products available under FDA’s Emergency Use Authorization (EUA) to advance to full marketing status.

February 25-26, 2020: Public Workshop – Evolving Role of Artificial Intelligence in Radiological Imaging (Bethesda, MD and webcast) – Through this workshop, FDA is seeking to engage with stakeholders to explore benefits and risks of evolving applications of artificial intelligence (AI) in radiology. Register by 4:00 p.m. ET February 12, 2020.

February 25-26, 2020: Developing Medical Countermeasures To Treat the Acute and Chronic Effects of Ocular Chemical Toxicity (Rockville, MD) – Development of MCMs that mitigate acute and chronic corneal manifestations in response to ocular toxicants relies on the development of well-characterized experimental models with defined pathophysiology that allow for effective bridging to humans. Such models are also essential to demonstrate therapeutic efficacy. This meeting, sponsored by the NIH Chemical Countermeasures Research Program (CCRP), will bring together subject matter experts from the civilian and military research communities to discuss the current state of the field, including potential therapeutic approaches and available models. Register by January 31, 2020.

March 3, 2020: Public workshop – Facilitating End-to-End Development of Individualized Therapeutics (Silver Spring, MD and webcast) – To foster development of individualized therapeutic products for the treatment of one individual or a very small number of patients, based on engineering a product aimed at the specific molecular mechanism underlying a patient’s (or small group of patients’) illness. To attend in person, register by February 18, 2020.

April 20-24, 2020: Achieving Data Quality and Integrity in Maximum Containment Laboratories (Bethesda, Maryland) – This National Institutes of Health (NIH) course offers a unique opportunity for the regulatory and scientific communities to discuss complex issues in an interactive environment and identify and share best practices for ensuring data quality and integrity in high-containment (i.e., BSL-4) facilities. It is designed for researchers who conduct studies intended to support approval under the Animal Rule, which may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible. Registration opens January 6, 2020, and closes February 28, 2020.

July 27-31, 2020: National Ebola Training and Education Center (NETEC)’s Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska) Attendees will learn to apply best practices for clinical trials during an outbreak involving high-consequence pathogens, and recognize and prevent potential risks to data quality and integrity. Professionals who have experience with high-consequence pathogen clinical trials are encouraged to apply to attend. Registration opens April 6, 2020, and closes when the course is full

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