Regulatory Webinars
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Drug Price Controls: What Are The Unintended Consequences To Innovation?
7/15/2025
Review the ripple effects of drug price controls, including recent U.S. policy shifts like the IRA and President Trump’s Executive Order introducing International Reference Pricing.
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Navigating Regulatory Uncertainty: Diversity Action Plans
7/8/2025
Sponsors planning Phase 3 and pivotal clinical trials are facing fresh uncertainty as the FDA’s Diversity Action Plan guidance continues to shift.
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Mitigating Risk With Ex-US Clinical Trials
7/8/2025
Gain insight into why certain regions offer strategic advantages, from regulatory flexibility to faster enrollment, and how to effectively integrate them into your development strategy.
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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.
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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.
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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.
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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.
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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.
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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.
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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.