Regulations & Compliance STREAM

1. 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.

2. The Big Picture: Impact Of EU Disclosure On Small & Mid-Size Sponsors 5/6/2019

   With the new EU clinical trial registry portal expected to launch next year, it’s imperative that sponsors – particularly small and mid-size organizations – understand the complexities of EU disclosure. Thomas Wicks, an expert in clinical trial disclosure, and Karen Rutkowski, an expert in medical writing, share actionable insights on compliance.

3. Navigating Special Regulatory Pathways For Advanced Therapy Development Success 6/12/2025

   Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.

4. 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.

5. Achieving Regulatory Compliance With A Unified Immunogenicity Strategy 5/10/2025

   This presentation equips viewers with the knowledge and tools needed to navigate the intricacies of designing immunogenicity assays that comply with both European IVDR and US FDA regulations.

6. Moving In Unison: Proprietary Scheduling Platform 6/18/2024

   Join us for an exclusive discussion that uncovers the science behind our efficient management of key sponsor deliverables and critical milestones, driving our projects to success.

7. 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.

8. Preparing For 2022 1/19/2022

   2022 will be an important year for drug development. There are many questions around changes that came into play during the pandemic. A panel of experts look back over the year and into the future to help you prepare for the coming year.

9. 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).

10. Overcoming The Challenges Of Manufacturing And Clinical Trials 8/20/2024

    <p>Learn how CROs and CDMOs work in tandem to successfully address operational and regulatory challenges for pharmaceutical and biotech companies, and how this can determine study success or failure.</p>