Regulatory Webinars

1. Planning Your IND: When And Why To Engage The FDA 7/2/2025

   This presentation explores how and when to initiate IND activities, highlighting that sponsors can strategically open an IND to access FDA guidance and enable U.S. clinical trials.

2. FDA Shifts Reshape Drug Development 6/13/2025

   Listen to regulatory leaders share CRO insights on how FDA changes are reshaping global clinical trials, sponsor strategies, and investment trends in a new podcast series debut.

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. Mastering GMO & Companion CDx Trials: The EU Regulatory Playbook 6/12/2025

   This presentation offers strategic and operational guidance for navigating the regulatory challenges of conducting gene-modified organism (GMO) trials in Europe.

5. Mastering The Complexities Of Gene Therapy Document Writing 5/20/2025

   Gain the insight and strategic flexibility needed to confidently navigate the unique scientific, regulatory, and documentation challenges of gene therapy development.

6. Balancing Science With Intellectual Property 5/16/2025

   Joshua Kresh, Emily Michiko Morris, and Mark Schultz from IPPI: The Intellectual Property (IP) Policy Institute discuss the dos and don’ts of IP and trade secrecy protections for biotech.

7. 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.

8. Assessing Diversity In Early-Phase Clinical Trials In A Rapidly Changing Regulatory Environment 5/5/2025

   Learn more about structuring early-phase trials to address population variation and the contributing factors to safe drug administration, both of which are essential to a drug development plan.

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. Blueprint For Efficient Clinical Trial Disclosure 4/21/2025

    Explore a comprehensive framework that helps organizations continuously assess and improve their clinical trial disclosure processes.