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WEBINARS

  • Webinar

    2020 SEND Progress Update: From Guides to Rules and How they Impact your SEND requirement

    Mar 23, 2020

    As we enter the second quarter of 2020, a major SEND milestone has been reached with the requirement of SEND v3.1 for both IND and BLA/NDA study submissions. See how this impacts your submission and the increased scope of the standard within this update. Additionally learn about some recent updates, including the Technical Conformance Guide (TCG) and the Conformance Rules published by CDISC. Released by the FDA, the TCG is non-binding guidance, updated and released bi-annually, which describes the proper use of simplified TS.XPT files within the eCTD to help avoid a possible technical rejection. Released in March, the Conformance Rules for SENDIG v3.0 isolate and reformat rules from the SENDIG v3.0 into a table format. See how both of these items can influence your current and future SEND submissions. Along with the TCG, the FDA has released webinars covering their review experience with SEND datasets submitted. How can we apply the lessons learned in these webinars to improve and harmonize submissions

  • Webinar

    Webinar - Amphetamine to Zolpidem: Navigating the ABCs of Early Phase CNS Drug and Cannabinoid Development

    Mar 19, 2020

    CNS drug development continues to evolve with changing regulations, particularly in light of prescription drug abuse and risk/benefit optimization.  The uncertainty with regulations around emerging therapeutics, including cannabinoids, adds to the confusion. Navigating a successful regulatory and commercial pathway for CNS drugs can pose challenges and delays when requirements are not met. In addition to NDA-enabling phase I studies, specialty studies may be required to further evaluate your risk/benefit profile and support a drug scheduling recommendation. This webinar will present a comprehensive overview of early phase CNS drug development and will help you navigate the regulatory requirements for successful submission.  

  • Webinar

    Webinar - Bioanalytical Project Management — a Critical Function Adapted to the Study Type(s) of Your Drug Development Program

    Mar 19, 2020

    The objective of quantitative bioanalysis is to provide precise and accurate sample analysis results within the acceptable tolerance (variability), in line with the study scope, so that sponsors can make appropriate go/no-go decisions. For proactive and efficient study progression, stakeholders must fully understand the operational, logistical, technical, and scientific considerations for the bioanalytical phase of various study types within a drug development program. Webinar participants will receive insight on this framework and the relevant critical control points.

  • Webinar

    Webinar - Strategic Considerations for a Successful CNS Clinical Development Pathway

    Mar 18, 2020

    Central Nervous System (CNS) drug evaluation requires the assessment of specific safety endpoints, such as the drug’s potential to cause impairing effects on driving, the likelihood that it may be abused or misused, or the risk of causing withdrawal symptoms if abruptly discontinued. Evaluation of CNS effects in Phase I studies can be very helpful in determining if dedicated driving simulator, abuse potential, and dependence studies are needed. Furthermore, including drug effect evaluations and measures of cognition in early studies enables better pharmacological characterization since larger dose ranges are studied. Methods for determining the need for additional studies will enable developers to accurately project their clinical development timeline and have more informed discussions with regulatory agencies

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