Regulations & Compliance STREAM

  1. 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.

  2. TMF SUMMER SHORTS: House Of The Inspector 8/29/2024

    Discover key steps you can take to not just survive an inspection, but take the TMF Throne.

  3. Is EU CTR Driving Tighter Clinical & Regulatory Integration? 3/31/2022

    The new Clinical Trials Regulation (EU) 536/2014 has raised critical questions about business process and data interactions between Clinical and Regulatory in biopharmaceutical companies. Did you know that as of 6 March 2022, there were more than 200 draft applications in CTIS?

  4. Evaluating Abuse Potential Of CNS-Active Drugs For EU And US Submissions 1/30/2023

    Delve into the key considerations for delivering an integrated preclinical and clinical abuse potential drug development evaluation that meets EMA and FDA regulatory requirements.

  5. The New Era Of Project Optimus: Implications For Oncology Development Strategy 9/10/2025

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

  6. Plain Language Summaries Becoming A Mandate Worldwide 6/13/2024

    A growing number of countries are requiring clinical trial protocol and results disclosures to be written in plain language, influencing how these documents are authored.

  7. Think Canada: The Team Behind Your Clinical Trials 9/29/2023

    Altasciences has a bioanalytical and clinical facility in Canada. In this video, we unveil the advantages of conducting trials in Canada while introducing some of the faces that work behind the scenes on your studies.

  8. 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.

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 Exploring The FDA's Draft Guidance On Psychedelic Drug Research 7/26/2023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

  10. 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.