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Webinars

Explore our 2026 webinar lineup below. 

Click Here for on-demand topics

Upcoming Webinars

The R2 Revolution: Transforming CMC Summaries into Regulatory Assets

  • August 14, 2026
  • 60 Minutes

The Bayesian Shift: Implementing the 2026 FDA Guidance for Modern Clinical Trials

  • August 18, 2026
  • 60 Minutes

Accelerate Your Approval Timeline: Mastering the FDA’s Split Real-Time Application Review (STAR) Program

  • August 20, 2026
  • 60 Minutes

Real-Time Clinical Trials (RTCTs): FDA’s Next Regulatory Revolution and What Sponsors Must Do Now

  • August 20, 2026
  • 60 Minutes

AI-Enhanced Clinical Study Reporting: Efficiency, Compliance, and Risk Management

  • August 25, 2026
  • 60 Minutes

FDA Standards & Requirements for the Creation and Submission of Clinical Trial Datasets

  • August 26, 2026
  • 60 Minutes

AI in Regulatory Affairs: Practical Uses, Hallucination Risks and FDA’s Emerging Guidance on AI-Assisted Submissions

  • August 28, 2026
  • 60 Minutes

The 2026 SaMD Masterclass: Clinical Evidence Strategies and New FDA Enforcement Frontiers

  • September 2, 2026
  • 60 Minutes

10 Steps to the Perfect Clinical Trial Protocol: FDA-Compliant Protocol Development 

  • September 04, 2026
  • 60 Minutes

CAR-T Manufacturing Compliance 2026: Navigating the FDA’s New Flexible CMC Framework

  • September 9, 2026
  • 60 Minutes

Artificial Intelligence in Clinical Trial Design: FDA Expectations for Patient Stratification & Predictive Modeling

  • September 14, 2026
  • 60 Minutes

Navigating FDA’s 2026 Guidance on Demonstrating Substantial Evidence of Effectiveness: Key Insights for Successful NDA and BLA Submissions

  • September 16, 2026
  • 60 Minutes

How to Write Perfect FDA-Compliant SOPs: Stepwise Instructions

  • September 18, 2026
  • 60 Minutes

FDA is Changing GMP Audit Practices: Are You Ready?

  • September 18, 2026
  • 60 Minutes

FDA Compliant Vendor Validation Programs

  • September 21, 2026
  • 60 Minutes

How and When to Use a US Agent When Dealing with the FDA

  • September 22, 2026
  • 60 Minutes

FDA Approved Adaptive Clinical Trials: Smart Trial Design for Drug, Biologics and Devices

  • September 24, 2026
  • 60 Minutes

FDA Regulation of Dietary Supplement Imports into the US

  • September 28, 2026
  • 60 Minutes

Five Steps to Manage the Temporary Shutdown and Restart of a GMP Facility

  • September 29, 2026
  • 60 Minutes

FDA Rules for the Content, Tone and Format of an Investigator’s Brochure

  • September 30, 2026
  • 60 Minutes

Drug Master Files – Helping with FDA DMFs

  • October 5, 2026
  • 60 Minutes

FDA Permitted Off-Label Promotion of Regulated Products

  • October 7, 2026
  • 60 Minutes

How to “Win” FDA’s Support for Your Clinical Development Program

  • October 8, 2026
  • 60 Minutes

​Safety Reporting in Clinical Trials: Are you Compliant with the Current FDA Rules?

  • October 9, 2026
  • 60 Minutes

Good Tissue Practices and GMP for HCT/P and Stem cell Therapies

  • October 14, 2026
  • 60 Minutes

New Rules for Using Social Media in Marketing FDA Regulated Products

  • October 15, 2026
  • 60 Minutes

Synthetic Data in Clinical Trials: FDA’s Current Stance on In Silico Evidence.

  • October 16, 2026
  • 60 Minutes

​Avoid Data Integrity Issues: How to Audit a CRO and Other Vendors

  • October 21, 2026
  • 60 Minutes

Trial Master File (TMF): FDA Expectations from Sponsors and Sites​

  • October 22, 2026
  • 60 Minutes

New 510k for Modified 510k-Cleared or 510k-Exempt Devices: Best Practices​

  • October 26, 2026
  • 60 Minutes

​​Expedited Approval Pathways in the US: Best Ways to Get the Most Incentives​

  • October 28, 2026
  • 60 Minutes

FDA Rules for Investigating Out-of-Specification (OOS) Test Results

  • October 29, 2026
  • 60 Minutes

Cleaning Validation for GMP Facilities

  • October 30, 2026
  • 60 Minutes

CMC Considerations for INDs and NDAs for 505(b)(2) Products

  • November 3, 2026
  • 60 Minutes

Development and Marketing of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) In the US

  • November 5, 2026
  • 60 Minutes

Best Practices for Clinical Trial Risk Management: Common Issues and Potential Solutions

  • November 6, 2026
  • 60 Minutes

Regulatory Strategies for Small and Medium Companies

  • November 9, 2026
  • 60 Minutes

On Demand Topics

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