Regulations & Compliance STREAM

  1. The Advantages Of Conducting Early Phase Trials In North America 10/24/2023

    In this webinar, Altasciences discuss the similarities and differences of conducting early phase research in North America versus other geographic regions.

  2. Moving In Unison: Proprietary Scheduling Platform 6/18/2024

    Join us for an exclusive discussion that uncovers the science behind our efficient management of key sponsor deliverables and critical milestones, driving our projects to success.

  3. Beyond First Impressions: CTIS Lessons Learned In First 3 Months 5/19/2022

    Now that the EU’s Clinical Trials Information System (CTIS) is up and running, disclosure and transparency experts from Sarepta, Boehringer Ingelheim, Bayer and Merck KgaA discuss the ins and outs of registering clinical trials and submitting study information to the portal.

  4. 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.

  5. 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.

  6. Illuminating IHC: Right-Sizing Your Validation And Regulatory Strategy 5/2/2025

    In this presentation, expert speakers provide an in-depth exploration of the essential validation and regulatory strategies for Immunohistochemistry (IHC).

  7. The Big Picture: Impact Of EU Disclosure On Small & Mid-Size Sponsors 5/6/2019

    With the new EU clinical trial registry portal expected to launch next year, it’s imperative that sponsors – particularly small and mid-size organizations – understand the complexities of EU disclosure. Thomas Wicks, an expert in clinical trial disclosure, and Karen Rutkowski, an expert in medical writing, share actionable insights on compliance.

  8. Accelerate Time To Target Endpoint In Cardiometabolic Studies Using Patient-Centered Technology Solutions 6/14/2022

    In this webinar, industry experts share their perspectives on how to address drug development challenges within cardiometabolic clinical studies and provide input on the impact of new regulatory guidance such as the DEPICT Act.

  9. 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.

  10. Preparing For 2022 1/19/2022

    2022 will be an important year for drug development. There are many questions around changes that came into play during the pandemic. A panel of experts look back over the year and into the future to help you prepare for the coming year.