Regulations & Compliance STREAM

  1. Navigating Early Phase CNS-Active Drug Development 2/14/2023

    Early development of CNS-active drugs requires in-depth clinical expertise. Altasciences’ Dr. Beatrice Setnik, Chief Scientific Officer, examines the strategies to ensure early comprehensive data collection to fulfill regulatory requirements and aid in evaluating the risk/benefit profile.

  2. Should Sponsors Provide Source Document Templates? 12/9/2025

    Here, we debate sponsor-provided source document templates, weighing regulatory guidance, compliance risks, and operational impacts for smarter clinical trial documentation decisions.

  3. Driving Product Launch Success In Europe 10/21/2024

    Explore key steps for preparing your medicinal product for the European market, including insights on challenges, timelines, and a success story.

  4. What Is 'Fit For Use' In AI Models? 1/27/2025

    The data that you use to train AI models has to be “fit for use” according to the FDA. Tala Fakhouri explains what metrics the FDA uses to make this determination.

  5. 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.

  6. The New Era Of Project Optimus: Implications For Oncology 9/10/2025

    In this presentation, expert speakers bring the impact of Project Optimus to life through real-world case studies and practical examples.

  7. 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.

  8. Navigating Special Regulatory Pathways For Advanced Therapy Development Success 6/12/2025

    Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.

  9. 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.

  10. Exploring The FDA's Draft Guidance On Psychedelic Drug Research 7/26/2023

    Discover the crucial insights and methodological adaptations needed to effectively assess the safety, pharmacology, and efficacy of innovative psychedelic compounds designed for specific medical applications.