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

    Merissa Govender, holding the position of Global Innovation Leader at Sanofi, Lindsay Kehoe, who serves as Senior Project Manager at the Clinical Trials Transformation Initiative (CTTI), and Aneta Woroniecka-Osio, the DCT Strategy Development Lead at Bayer, converge for a thought-provoking session on Clinical Leader Live titled Last Year’s DCT Is Today’s Clinical Trial. As noted in the full discussion, oversight of remote sites or home health workers is a concern with DCTs. In this segment, Govender talks about 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

    Discover how to completely automate your safety reporting and significantly reduce your effort and costs while improving compliance.

  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. Avance Clinical Expands Pharmaceutical Safety Services With Oracle Argus 3/11/2024

    Find out what happened after this contract research organization turned to Oracle Argus for compliant clinical trial management.

  8. 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.

  9. 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.

  10. Practical Applications Of ICH E6(R3): What Do We Need To DO? 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.