Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Biomarkers and Precision Medicine (BPM) and Gene and Cell Therapy Products (GCTPs) Communities on June 1, 2023, 12 pm – 1 pm EST on the following topic: The European Union (EU) In Vitro Diagnostic Regulation (IVDR): Assessing the Impact on Clinical Trials What are the differences between CLIA and IVDR from a regulatory perspective? What are the requirements under the IVDR for assays and labs that support subject screening for clinical trials in the EU? What are the options for sponsors planning new clinical trials in the EU? Discussion Leaders: Mark Ma (Rally Bio), Anna Lauren (EBF), and Manuela Braun (Bayer) Organized by: Yan Ni (Passage Bio), Yanmei Lu (Sangamo Therapeutics), Karen Quadrini (Passage Bio) , and Carmen Fernández-Metzler (PharmaCadence) We start at 12:00 EST sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts. (Please remain on mute unless asking questions) When : Thursday, June 1, 2023, 12 pm – 1 pm EST Where : Please join from your computer, tablet or smartphone. https://global.gotomeeting.com/join/305789893 You can also dial in using your phone. United States: +1 (872) 240-3412 Access Code: 305-789-893 Join from a video-conferencing room or system. Dial in or type: 67.217.95.2 or inroomlink.goto.com Meeting ID: 305 789 893 Or dial directly: [email protected] or 67.217.95.2##305789893 New to GoToMeeting? Get the app now and be ready when your first meeting starts: https://global.gotomeeting.com/install/305789893 Thank you, The OSD Organizing Teams
AAPS' Introduction to Biomarkers eCourse will walk you through the fundamentals of biomarkers assays and their applications in clinical trials. The eCourse focuses primarily on the discussion of technologies, key issues in assay development and some regulatory considerations to ensure continuity of experience and best practices, sharing institutional knowledge and making literature more accessible. In this virtual session, our biomarker experts will be on hand to answer all of your questions. If you completed the eCourse or still have questions, this is your chance to ask us anything! Learning Objectives: Gain a high-level overview for the role of biomarkers in clinical development; Identify regulatory framework for biomarkers in drug development; Learn the unique aspects and considerations that apply to biomarker assays. #AMA #AskTheExperts
Dear PPDM Community Members, PPDM Community will host a seminar on 'Transporter Based Drug‐Drug Interactions: Combining the Power of Endogenous Biomarkers and PBPK Modeling'. Speaker: Manthena Varma, Ph.D., Pfizer The date and Schedule are as follows: June 13, from 12:30 PM–02:00 pm EDT. Here is a link for registration: https://www.pathlms.com/aaps/webinars/35062 Thank you, Abhisheak Sharma Chair, AAPS-Pharmacokinetics Pharmacodynamics and Drug Metabolism Community https://pharmacy.ufl.edu/profile/sharma-abhisheak
The AAPS Summer Scientific Forum makes AAPS the premier scientific convener of the pharmaceutical industry: breadth, depth, and quality science. Attend this meeting for depth in the latest bioanalysis or pharmaceutical analysis science and seize the opportunity to cross-connect with other scientists in shared high-level sessions focused on key regulatory issues facing these scientific areas. The event’s symposia will be complemented by the Rapid Fire presentations and partner engagements AAPS conference attendees prefer. Networking events will bring together industry scientists, academicians, and regulators from across these disciplines.
Scientific and career development sessions, poster presentations, networking, and more! Join AAPS for PharmSci 360 Oct. 22-25 in Orlando, FL, and see the latest science.
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