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DTSTART;TZID=America/New_York:20210924T094500
DTEND;TZID=America/New_York:20210924T160000
DTSTAMP:20210812T195235Z
CREATED:20210812T195020Z
LAST-MODIFIED:20210812T195235Z
UID:49495-1632476700-1632499200@globalbiodefense.com
SUMMARY:Review of Third-Party Research Risk: Is There a Role for IRBs?
DESCRIPTION:“Review of Third-Party Research Risk: Is There a Role for IRBs?\,” an HHS Office for Human Research Protections (OHRP) Exploratory workshop\, will be livecast on 24 September 2021. \nThe research community has generally focused on the protection of human research subjects as defined by the\nCommon Rule. However\, sometimes the conduct of research can have an impact on people who are third parties\nand who do not meet the definition of human subjects. This meeting will explore who some of the impacted parties are and what types of risks they might face in various types of research. It will further explore the idea of expanding regulatory protections to cover third parties in some circumstances. Panelists will discuss whether and what support for this idea already exists in the field of research ethics and whether institutional review boards (IRBs) have a role to play in oversight of such protections should they be warranted. \nHighlighted sessions include: \n\nPanelists will consider whether researchers and the research community have a responsibility to protect third parties and if so\, in what capacity.\nResearch Studies That Do Not Directly Involve Human Subjects\nThird-Party Risk in Clinical Research Trials\nEnsuring Privacy\, Building Trust: Collecting\, Processing\, and Sharing Third-Party Information in Social\nand Behavioral Health Research\nEthical Considerations for Third-Party Risk in Research\nLimiting Non-Consenting Third Parties to Reasonable Research Risks\nPublic Risk Perception and the Creation of Clear Communications\nReviewing Third-Party Risks: A Proposed Framework for IRBs (and Researchers)\nAre IRBs the Right Oversight Bodies for Protecting Third Parties?\n\nVideos of each session will be available on the HHS OHRP website after the event. All Exploratory Workshop sessions meet the Certified IRB Professional (CIP) recertification guidelines exit disclaimer icon and are eligible for a maximum of 5 hours of credits.
URL:https://globalbiodefense.com/event/review-of-third-party-research-risk-is-there-a-role-for-irbs/
LOCATION:https://videocast.nih.gov/watch=41987
CATEGORIES:Conference,Continuing Education
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2021/08/ohrp-review-third-party-research-risk-role-irb-clinical-trial-bioethics.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221011
DTEND;VALUE=DATE:20221012
DTSTAMP:20220921T200930Z
CREATED:20220921T200613Z
LAST-MODIFIED:20220921T200930Z
UID:56431-1665446400-1665532799@globalbiodefense.com
SUMMARY:FDA NanoDay Symposium 2022
DESCRIPTION: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. \nHighlighted topic areas include: \n\nPrimary Chemistry Manufacturing and Controls (CMC) and nonclinical hurdles for developing products that contain nanomaterials\nDevelopment and Characterization of Generic Drug Products Containing Nanomaterials\nConsiderations for the Quality\, Safety and Efficacy of Prophylactic Lipid Nanoparticle mRNA Vaccines\nCase studies on the development of the COVID mRNA lipid nanoparticle vaccine products\nFuture of Continuous Manufacturing of Drug Products Containing Nanomaterials\nEfforts to establish standards and standard methods for monitoring products that contain nanomaterials\nA contextualized discussion of the development of the COVID mRNA lipid nanoparticle vaccine products\nA nonclinical perspective of developmental challenges of products that contain nanomaterials\nSafety Evaluation of Food Contact Substances Containing Nanomaterials\n\nThe intended audience includes: Regulatory science and regulatory affairs professionals working on drug products\, including biologicals\, that contain nanomaterials and submit IND/NDA/BLA/ANDA applications for FDA review; researchers working on applications of nanotechnology for pharmaceutical products\, analytical methodology for control of pharmaceuticals that contain nanomaterials\, and nonclinical studies to support human clinical trials; and foreign regulators who review comparable pharmaceutical products that contain nanomaterials. \nPlease visit the FDA’s NanoDay Symposium 2022 website for more information. \nFDA RESOURCES\n\nGUIDANCE DOCUMENT: Drug Products\, Including Biological Products\, that Contain Nanomaterials – Guidance for Industry; APRIL 2022\nGUIDANCE DOCUMENT: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology – Guidance for Industry; JUNE 2014\nGUIDANCE DOCUMENT: Liposome Drug Products: Chemistry\, Manufacturing\, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; APRIL 2018\nGUIDANCE DOCUMENT: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs\, Including Well-Characterized\, Therapeutic\, Biotechnology-derived Products – Guidance for Industry; NOVEMBER 1995
URL:https://globalbiodefense.com/event/fda-nanoday-symposium-2022/
LOCATION:
CATEGORIES:Continuing Education,Government Hosted
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221026
DTEND;VALUE=DATE:20221027
DTSTAMP:20220921T211348Z
CREATED:20220921T211237Z
LAST-MODIFIED:20220921T211348Z
UID:56442-1666742400-1666828799@globalbiodefense.com
SUMMARY:In-Depth Look at Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs
DESCRIPTION:The FDA will host a meeting on 26 October 2022 to provide additional clarity to the final guidance with respect to Agency expectations for submissions containing Bioavailability information for drug products\, and will discuss: \n\nSelect case studies on various bioavailability (BA) related subtopics (e.g. pharmacodynamic (PD) endpoints\, endogenous compound Narrow Therapeutic Index (NTI)\, biowaivers).\nBioavailability Studies Submitted in NDAs and INDs – General Considerations\nBioavailability Determination: Special Topics\nRelative Bioavailability Evaluation: Potential for Using Pharmacodynamic and Non-Traditional Pharmacokinetic Endpoints\nRecommended In Vitro Studies\n\nThe intended audience for this event is: Regulatory Scientists assessing bioavailability studies as part of IND/NDA/BLA submissions; Research Coordinators overseeing in vivo studies in the context of IND/NDA/BLA submissions; Drug Development/New Drug industry scientists involved with bioavailability studies for support of a new/existing IND/NDA/BLA dossier; and foreign regulators. \nPlease visit the FDA’s In-Depth Look at BA Final Guidance Meeting website to register. \nFDA RESOURCES\nFinal Guidance for Industry: Bioavailability Studies Submitted in NDAs or INDs — General Considerations
URL:https://globalbiodefense.com/event/in-depth-look-at-final-fda-guidance-bioavailability-studies-submitted-in-ndas-or-inds/
LOCATION:
CATEGORIES:Continuing Education,Government Hosted
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