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| Updates on Human Abuse Potential Studies: Challenges and Regulatory Guidelines, Upcoming Webinar Hosted by Xtalks | ||
| By: PR Newswire Association LLC. - 08 Feb 2024 | Back to overview list |
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In this free webinar, gain insights into key topics on the clinical evaluation of abuse and dependence potential discussed at the September 2023 CCALC meeting. Attendees will learn about recent recommendations on the design and analysis of human abuse potential studies. Attendees will also receive an update on best practices for the collection and documentation of abuse-related adverse events. The featured speakers will discuss the guidelines on what the FDA requires/expects with respect to measuring physical dependence and withdrawal in human subjects. TORONTO, Feb. 8, 2024 /PRNewswire-PRWeb/ -- Participate in this crucial webinar delving into the latest insights from the Cross-Company Abuse Liability Council (CCALC) and The Food and Drug Administration (FDA) in drug development and clinical evaluation of human drug abuse and dependence potential. This webinar aims to discuss current knowledge and recent updates on the clinical evaluation of the abuse and dependence potential of drugs. In September 2023, the CCALC – a group of representatives from across the industry – held its first face-to-face meeting with members of the Controlled Substances Staff of The FDA since 2018. At this meeting, key opinion leaders discussed nonclinical and clinical assessments, current issues in the design and analysis of these studies and pertinent topics that have emerged based on recent trends in drug development (e.g., hallucinogens). The clinical portion of the meeting discussed a broad range of topics; however, the current webinar will focus on updating attendees on: Join this webinar to gain valuable knowledge from the recent CCALC meeting, FDA guidelines, and discussions on advancements in drug development. 1) Discussions relating to the design and statistical analysis of human abuse potential (HAP) studies 2) Challenges related to recording and documenting abuse-related adverse events 3) Regulatory requirements for assessing physical dependence and withdrawal within a clinical program Join this webinar to gain valuable knowledge from the recent CCALC meeting, FDA guidelines, and discussions on advancements in drug development. Join Dr. Lynn Webster, MD, Executive Vice President, Scientific Affairs, Dr. Vince Clinical Research; Dr. Naama Levy-Cooperman, PhD, Director, Altreos Research Partners; and Dr. Kerri Schoedel, PhD, Director, Altreos Research Partners, for the live webinar on Wednesday, February 28, 2024, at 1pm EST (10am PST). For more information, or to register for this event, visit Updates on Human Abuse Potential Studies: Challenges and Regulatory Guidelines. ABOUT XTALKS Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars and digital content to the global life science, food, healthcare and medical device communities. Every year, thousands of industry practitioners (from pharmaceutical, biotechnology, food, healthcare and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps professionals stay current with industry developments, regulations and jobs. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers. To learn more about Xtalks visit https://xtalks.com Media Contact Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, vkovacevic@xtalks.com, https://www.xtalks.com
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