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Study Data Standards Update for FDA CBER

Virtual Event Virtual Event

FDA's Center for Biologics Evaluation and Research (CBER)  will host a free virtual format workshop on 5 October 2022 entitled Study Data Standards Update for CBER: Your Guide to a Successful Submission. CBER will discuss CBER’s support and requirement starting March 15, 2023 for the Standard for the Exchange of Nonclinical Data (SEND) , which

VRBPAC Meeting – Vaccine Strain Selection 2023 Southern Hemisphere Flu Season

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The FDA Vaccines and Related Biological Products Advisory Committee will convene on 6 October 2022 in open session to discuss the Strain Selection for the Influenza Virus Vaccines for the 2023 Southern Hemisphere Influenza Season. Materials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page. Interested

FDA NanoDay Symposium 2022

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The FDA NanoDay Symposium 2022 will be held on 11 October 2022. The event will address drug development of products that contain nanomaterials in their formulation and how the newly finalized guidance to industry for products that contain nanomaterials can be implemented in filings to the FDA. Highlighted topic areas include: Primary Chemistry Manufacturing and

Epidemics That Didn’t Happen

Virtual Event Virtual Event

Join Resolve to Save Lives for a dynamic conversation to mark the release of the second edition of “Epidemics that Didn’t Happen.” This virtual event and new report will illustrate how global and local investments in preparedness, combined with swift, strategic responses by public health authorities, can transform the trajectory of outbreaks, saving lives and preventing suffering.

Quality Considerations for MAM for Therapeutic Proteins

Virtual Event Virtual Event

The multi-attribute method (MAM) is a liquid chromatography-mass spectrometry (LC-MS) based peptide mapping approach used for the identification and quantitation of product quality attributes (PQAs) in therapeutic proteins. The U.S. FDA Center for Drug Evaluation and Research (CDER), Emerging Technology Program (ETP) has assessed the use of MAM in quality control environments and laboratory resources

65th Annual Biosafety and Biosecurity Conference

Wisconsin Center 400 W. Wisconsin Ave., Milwaukee, WI, United States

The ABSA's 65th Annual Biosafety and Biosecurity Conference will be held 14-19 October 2022 in a hybrid virtual and in-person format in Milwaukee, Wisconsin. The event offers intensive professional development courses over three full days of state-of-the-art keynotes, papers, and panels highlighting best practices and hands-on skills crucial for today’s biosafety and biosecurity professionals. Approximately

GSRS22 – 12th Global Summit on Regulatory Science

Orchard Hotel Singapore 442 Orchard Road, Singapore, Singapore

GSRS22: The 12th Global Summit on Regulatory Science will be held from 19-21 October 2022 in Singapore. Convening under a theme of "Advances in Nanotechnology for Food and Medical Products: Innovations, Safety and Standards". the Summit will highlight topics including: Nanomaterials for Gene Delivery Nanotechnology in Agri-Products Emerging Nanomaterial Contaminants in Food Generic Medical Products

CBRN Threats and Challenges – Fall Quarterly Update

The NDIA will host a CBRN Threats and Challenges Fall Quarterly Update Forum on 19 October 2022. This quarterly meeting is set to provide a SECRET-level classified update from government representatives in the Chemical and Biological Defense Program (CBDP). This update will inform industry and government attendees about the CB Threat concerns that the DASD

Board of Scientific Counselors, National Center for Health Statistics

Virtual Event Virtual Event

The CDC has announced the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS) will convene 24 October 2022 in a live broadcast public meeting. The Board is charged with providing advice and making recommendations to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, NCHS, regarding the