Regulatory Webinars

  1. How To Take Advantage Of Early Access Programs For The EU 6/12/2024

    Learn how to leverage Early Access Programs (EAPs) in the EU to expedite market entry for innovative life science products. Gain insights into running successful EAPs, including crucial steps for France.

  2. Exploring The Principles Integral To Rare Disease Drug Development 6/12/2024

    This on-demand webinar offers valuable insights into successful rare disease drug development, including study design, regulatory engagement, and market access strategy.

  3. US And EU Regulatory Expectations For Combination Products 6/11/2024

    Explore the regulatory nuances in the US and EU for combination products in this on-demand webinar. Key topics include differing regulatory requirements, the influence of new guidelines, and more.

  4. Balancing Data, Technology, And Strategy In Clinical Research 6/11/2024

    Here, viewers will learn about best practices for developing an effective data collection strategy and selecting technology solutions that align with research needs.

  5. A Clearer Harmony And Attractiveness For EU Clinical Trials Regulation 5/6/2024

    Explore the latest insights on navigating the transition to the EU Clinical Trials Regulation (EU CTR) and ensuring alignment across stakeholders for seamless adaptation in this Pharmaphorum podcast.

  6. The Synergistic Role Of Drug Safety In Clinical Trial Operations 4/25/2024

    Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.

  7. 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).

  8. 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.

  9. 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.

  10. 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.