Regulations & Compliance STREAM

1. Reporting To ClinicalTrials.gov: Reflections And Challenges 11/7/2019

   Who can reflect better on this topic than Dr. Deborah Zarin, former director of ClinicalTrials.gov? Dr. Zarin, now with the MRCT Center, shared her experiences and advice at the recent EXTRA: TrialScope Transparency Experience.

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. 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.

4. 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.

5. Taking A Risk-Based Approach To An Inspection-Ready Audit Trail 2/10/2021

   Regulatory agencies agree that a risk-based approach is the best way to ensure quality in clinical trials. But knowing how to implement such a process can be daunting. In this session, we will explore how to implement RBM to ensure your TMF Audit Trail is ready for inspection.

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. 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.

8. Unlock The Secrets Of Managing CTR In A Complex Development Landscape 8/29/2024

   Lost in the CTR maze? Watch this webinar to get your burning questions answered by industry experts. Ask about vendor coordination, CTIS integration, and EU strategies.

9. Quality Checks Vs. Quality Review 8/22/2023

   Watch this presentation where speakers share how teams can improve inspection readiness and reduce potential regulatory risks that could negatively impact operational activities.

10. See How You Can Start Your Early Phase Program 6-9 Weeks Earlier In Canada 3/23/2023

    Vice President of Business Development Lisa Sanford explains whether you need an IND before starting your first-in-human trial in Canada.