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December 2021

NCI Drug Development Workshop

December 10, 2021 @ 12:00 pm - 2:30 pm EST
National Cancer Institute

For more information and to register, Click Here! Session 10. Case Studies - December 10, 2021, 12 pm – 2:30 pm ET Case study 1: Development of small molecule product Jolanta Grembecka, Ph.D., University of Michigan Case study 2: Development of biological products Jason Yovandich, Ph.D., National Cancer Institute Q&A   NCI Drug Development Workshop How to Advance A Therapeutic Candidate from Bench to Bedside Navigation through the Investigational New Drug (IND)-enabling activities and acquisition of the full set of…

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May 2022

US-Canada Regional ICH Consultation

May 11 @ 1:00 pm - 4:00 pm EDT
US Food and Drug Administration

Click here for more information and to register!   US-Canada Regional ICH Consultation May 11th, 2022 1:00pm to 4:00pm ET ABOUT THIS MEETING FDA and Health Canada will be co-hosting a regional public meeting to provide information and solicit input prior to the next ICH biannual Assembly and Management Committee meetings scheduled for May 21 - 25, 2022. The public meeting will include discussion of harmonization guidelines recently reaching significant ICH milestones. TOPICS COVERED ICH Background ICH Guidelines Reaching Key…

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Regulatory Fitness in Rare Disease Clinical Trials (Day 1)

May 16 @ 9:00 am - 4:00 pm EDT
US Food and Drug Administration

Click Here to Learn More and Register! Regulatory Fitness in Rare Disease Clinical Trials (Day 1)   On May 16 and 17, 2022, the National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS) and the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) will host a jointly sponsored virtual workshop to explore Regulatory Fitness in Rare Disease Clinical Trials. Advances in rare diseases, particularly in the field of genetics, result in an active, highly innovative, and…

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Regulatory Fitness in Rare Disease Clinical Trials (Day 2)

May 17 @ 9:00 am - 12:00 pm EDT
US Food and Drug Administration

Click Here to Learn More and Register! Regulatory Fitness in Rare Disease Clinical Trials (Day 2)   On May 16 and 17, 2022, the National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS) and the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) will host a jointly sponsored virtual workshop to explore Regulatory Fitness in Rare Disease Clinical Trials. Advances in rare diseases, particularly in the field of genetics, result in an active, highly innovative, and…

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June 2022

Regulatory Education for Industry (REdI) Annual Conference 2022 (Day 1)

June 6 @ 8:30 am - 5:00 pm EDT
US Food and Drug Administration

Click here to learn more and register!   Regulatory Education for Industry (REdI) Annual Conference 2022 Featuring three medical product center tracks: Drugs, Devices, and Biologics PLENARY As we now enter the 3rd year of FDA’s public health response to the COVID-19 pandemic, this plenary session will reflect on some of FDA’s noteworthy milestones and landmark accomplishments. We’ll review the use of the emergency use authorization (EUA) authority that advanced the timely availability of a wide range of medical products…

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Regulatory Education for Industry (REdI) Annual Conference 2022 (Day 2)

June 7 @ 8:30 am - 5:00 pm EDT
US Food and Drug Administration

Click here to learn more and register!   Regulatory Education for Industry (REdI) Annual Conference 2022 Featuring three medical product center tracks: Drugs, Devices, and Biologics PLENARY As we now enter the 3rd year of FDA’s public health response to the COVID-19 pandemic, this plenary session will reflect on some of FDA’s noteworthy milestones and landmark accomplishments. We’ll review the use of the emergency use authorization (EUA) authority that advanced the timely availability of a wide range of medical products…

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Regulatory Education for Industry (REdI) Annual Conference 2022 (Day 3)

June 8 @ 8:30 am - 5:00 pm EDT
US Food and Drug Administration

Click here to learn more and register!   Regulatory Education for Industry (REdI) Annual Conference 2022 Featuring three medical product center tracks: Drugs, Devices, and Biologics PLENARY As we now enter the 3rd year of FDA’s public health response to the COVID-19 pandemic, this plenary session will reflect on some of FDA’s noteworthy milestones and landmark accomplishments. We’ll review the use of the emergency use authorization (EUA) authority that advanced the timely availability of a wide range of medical products…

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Regulatory Education for Industry (REdI) Annual Conference 2022 (Day 4)

June 9 @ 8:30 am - 5:00 pm EDT
US Food and Drug Administration

Click here to learn more and register!   Regulatory Education for Industry (REdI) Annual Conference 2022 Featuring three medical product center tracks: Drugs, Devices, and Biologics PLENARY As we now enter the 3rd year of FDA’s public health response to the COVID-19 pandemic, this plenary session will reflect on some of FDA’s noteworthy milestones and landmark accomplishments. We’ll review the use of the emergency use authorization (EUA) authority that advanced the timely availability of a wide range of medical products…

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Regulatory Education for Industry (REdI) Annual Conference 2022 (Day 5)

June 10 @ 8:30 am - 5:00 pm EDT
US Food and Drug Administration

Click here to learn more and register!   Regulatory Education for Industry (REdI) Annual Conference 2022 Featuring three medical product center tracks: Drugs, Devices, and Biologics PLENARY As we now enter the 3rd year of FDA’s public health response to the COVID-19 pandemic, this plenary session will reflect on some of FDA’s noteworthy milestones and landmark accomplishments. We’ll review the use of the emergency use authorization (EUA) authority that advanced the timely availability of a wide range of medical products…

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Achieving Broad Participation in Meaningful Clinical Research at the Point of Care

June 14 @ 2:00 pm - 5:15 pm EDT
Duke-Margolis Center for Health Policy

Click here to learn more and register!   Achieving Broad Participation in Meaningful Clinical Research at the Point of Care Founded in 2021, The Coalition for Advancing Clinical Trials at the Point of Care (ACT@POC™) aims to promote quality clinical research evidence in real time to better evaluate treatments and therapeutics. The Coalition looks to engage a broader, more diverse group of patients and providers and develop digital health tools that make clinical trials simpler to run and more accessible…

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