Regulations & Compliance STREAM

  1. Strategies For Research Institutions In An Evolving Era Of Oncology 11/11/2024

    As biomarker-directed therapies drive advancements in the oncology space, experts are reviewing cutting-edge trends and strategies that help institutions address ethical and regulatory challenges.

  2. 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.

  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. How Standardized Terminology Can Accelerate Global Regulatory Performance 6/24/2022

    Watch this panel of regulatory experts taking part in an interactive roundtable examining the benefits of establishing standard terminology and its potential to help significantly improve regulatory quality, data accuracy, and efficiency.

  5. 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.

  6. The Unique Attributes of Psychedelic Drug Development 1/22/2024

    Navigate key considerations for psychedelic clinical development, from FDA recommendations and abuse potential evaluation to blinding and early-phase trial design.

  7. 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.

  8. What Should You Ask The FDA About AI 1/27/2025

    Understanding what some of the common questions the FDA gets about AI may help you as you plan to interact with the agency.

  9. Addressing Opportunities And Challenges In Digital Health Data 10/22/2024

    Experts from diverse industry sectors unpack key points from the FDA’s final guidance on Digital Health Technologies (DHT) for remote data collection in clinical investigations.

  10. AI Meets Informed Consent: Opportunity, Risk, And What IRBs Need To See 5/14/2026

    Expert perspectives on IRB oversight, health literacy, and research ethics offer practical guidance to strengthen consent, protect participants, and align compliance with real-world research.