Regulations & Compliance STREAM

1. 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.

2. 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.

3. Tackling The EU CTR Compliance Challenge 10/4/2018

   Maintaining disclosure compliance is tricky enough with ClinicalTrials.gov, but when it comes to EU CTR compliance, the complexity rises to a whole new level. As a sponsor, do you find your organization “guilty” of these common errors?

4. 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.

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. 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.

7. 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.

8. Managing A Continually Evolving Disclosure Landscape 2/20/2024

   Compliance is more important than ever. Keep up with how regions are enforcing disclosure requirements by learning how to adjust compliance strategies accordingly.

9. TrialScope Intelligence 7/16/2024

   This easy-to-use platform reduces the risk of clinical trial disclosure noncompliance by tracking global disclosure regulations for you. Browse comprehensive regulatory authority and trial registry requirements.

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.