Regulatory Webinars

  1. Success Planning For An Original NDA/BLA Submission 4/15/2024

    Experts in regulatory strategy, operations, and program leadership provide strategies for initiation triggers, team coordination, submission processes, and Electronic Submission Gateway (ESG).

  2. Seeking Clarity With DCT Guidance 4/10/2024

    Merissa Govender, Global Innovation Leader at Sanofi, Lindsay Kehoe, Senior Project Manager at Clinical Trials Transformation Initiative (CTTI), and Aneta Woroniecka-Osio, DCT Strategy Development Lead at Bayer join folks at Clinical Leader Live for the session Last Year’s DCT Is Today’s Clinical Trial. In this snippet, Kehoe covers topics such as the ICH E6(R3) guidance and its annex for DCTs, the use of RWD, and connecting with regulators.

  3. Some Common DCT Concerns Addressed 4/10/2024

    In this segment of  Clinical Leader Live- Last Year’s DCT Is Today’s Clinical Trial, our panel of experts discusses the delegation of duties log and safety reporting with DCTs.

  4. Advancing Development Of New Oncology Therapies 4/4/2024

    Learn how the FDA's Project FrontRunner expedites cancer drug approval for early advanced metastatic cancer, emphasizing efficacy and safety in earlier clinical settings.

  5. psiXchange: Intelligent, Automated Safety Reporting 3/25/2024

    Say goodbye to manual burdens and embrace efficiency by fully automating your safety reporting. This will significantly cut down on effort and costs, all while enhancing compliance standards.

  6. Improving Safety Reporting Speed And Accuracy With Automation And Embedded Intelligence 3/15/2024

    Watch this exploration of real-world case studies of companies utilizing intelligent process automation and embedded, regularly updated safety reporting regulatory intelligence of psiXchange software.

  7. Managing A Continually Evolving Disclosure Landscape 2/20/2024

    Compliance is more important than ever. Keep up with how regions are enforcing disclosure requirements by learning how to adjust compliance strategies accordingly.

  8. Exploring The Interactions Between Validation, Technology Transfer 1/24/2024

    Listen as Gerardo Gomez delves into the intricate relationship between validation and technology transfer, taking into account the perspectives and standards set by regulators.

  9. Navigating The Unique Attributes Of Psychedelic Drug Development 1/22/2024

    Join our panel of experts for an in-depth review of the FDA's guidance on psychedelic drug development, exploring necessary methodological adaptations for safety, pharmacology, and efficacy.

  10. ICH E6(R3): Practical Steps For Implementation 12/14/2023

    Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.