Regulatory Webinars

1. Operationalizing Adaptive Design For FDA's One-Trial Era 10/20/2026

   The FDA now accepts one pivotal trial as the default path to approval. Learn how adaptive designs can help you build a single study strong enough to stand on its own.

2. Cast A Clinical Trial Disclosure 'Net,' Not A 'Line' 10/13/2026

   In clinical trial disclosure, each country’s obligations are typically treated as separate, isolated tasks. This approach may appear efficient on the surface but can introduce major compliance risks.

3. Scaling Pharmacovigilance: Clinical Development To Commercialization 10/1/2026

   Commercial growth brings new PV challenges. Gain practical insights on operating models, technology, governance, and leadership for long-term success.

4. The Future Of Clinical Trials: AI, Real-Time Data, And FDA Innovation 9/30/2026

   How does building trial protocols into health records lets key safety and efficacy signals reach sponsors and regulators in days, cutting manual data entry and speeding decisions.

5. Cell & Gene Unscripted: Regulatory Affairs 9/17/2026

   One platform, multiple payloads: how delivery systems can lower costs and boost access. Parexel experts break down the regulatory data that matters on Cell & Gene Unscripted.

6. Cell & Gene Unscripted: Pre-Clinical 9/17/2026

   Regulatory modernization is progressing, but harmonization gaps remain. Parexel's Chris Learn & Liz Spehalski dive into pre-IND strategy and precision therapies on Cell & Gene Unscripted.

7. The Evidence Gap In Hematology: From Trial Endpoints To Patient Outcomes 9/16/2026

   Hematology trials face shrinking patient pools and fierce competition. Discover how real-world data and evidence can sharpen feasibility, site selection, and regulatory strategy.

8. A New Chapter for Orexin Therapies: What's Changing in Drug Development 9/16/2026

   Join Beatrice Setnik, PhD and Denise Milova, PhD, for a conversation on orexin rescheduling and the evolving regulatory landscape.

9. Protocol Builder And Informed Consent Builder Version 2.0 9/16/2026

   Built by research compliance experts, this platform streamlines the protocol-writing process through customizable templates, workflow tools, and collaboration support for research teams.

10. Protocol Design Choices That Trigger IRB And Regulatory Requirements 8/20/2026

    Learn how protocol choices like AI, adaptive designs, and decentralized methods impact IRB review, participant protections, consent, and key regulatory requirements in clinical research.