Regulations & Compliance STREAM

1. 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.

2. 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.

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. 3 FDA Approvals In 2025 That Shift The Landscape For 2026 1/20/2026

   In this presentation, Precision’s Chief Medical Officer and former FDA Director, Division of Oncology 2, Harpreet Singh, MD breaks down 3 FDA approvals from last year that are impacting 2026.

5. 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.

6. 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?

7. 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.

8. 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.

9. 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.

10. 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.