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Webinars

Explore our 2025 webinar lineup below. 

Click Here for on-demand topics

Upcoming Webinars

eCTD 4.0 Migration: Managing the Technical Hurdles of the New Electronic Submission Standard for Global Filings

  • June 10, 2026
  • 60 Minutes

Good Documentation Practices for FDA-Regulated Industry

  • June 12, 2026
  • 60 Minutes

FDA IND Submission for a Product

  • June 12, 2026
  • 60 Minutes

Your IND Will Fail Unless You Avoid These 7 CMC Mistakes

  • June 15, 2026
  • 60 Minutes

5 Steps to Finding the Best Sites for Your Clinical Trial

  • June 17, 2026
  • 60 Minutes

Strategies for Minimizing Preclinical Testing: Meeting FDA Requirements without Breaking the Bank

  • June 22, 2026
  • 60 Minutes

FDA Compliant Warehouse and Distribution Practices

  • June 24, 2026
  • 60 Minutes

How AI Has Transformed My FDA Regulatory Work

  • June 25, 2026
  • 60 Minutes

FDA Regulation of Molecular Diagnostics

  • June 24, 2026
  • 60 Minutes

FDA Policies and Expectations For Developing Companion Diagnostics

  • June 26, 2026
  • 60 Minutes

Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials

  • June 29, 2026
  • 60 Minutes

How to Start a New Clinic as a Trial Site

  • June 30, 2026
  • 60 Minutes

Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs​

  • July 02, 2026
  • 60 Minutes

Best Practices to Create FDA Audit Ready Quality Systems

  • July 06, 2026
  • 60 Minutes

FDA Compliant Use of Smartphone, Smartwatch, and Apps in Clinical Trials

  • July 07, 2026
  • 60 Minutes

Challenges in Clinical Trial Start-up

  • July 08, 2026
  • 60 Minutes

General Principles of Process Validation for Drugs and Biologics

  • July 09, 2026
  • 60 Minutes

The Rare Disease CMC Bottleneck: Fast-Track Your Path to Approval

  • July 14, 2026
  • 60 Minutes

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

  • July 14, 2026
  • 60 Minutes

Beyond the Submission — Mastering the FDA’s New RTF Checklists

  • July 16, 2026
  • 60 Minutes

The Clinical Rescue Protocol : Strategic Turnaround for Distressed Trials

  • July 15, 2026
  • 60 Minutes

Social media as a recruitment tool for clinical trials: The Best, the Worst, and the Balanced

  • July 16, 2026
  • 60 Minutes

How to Make Sure Your Foreign Vendor is FDA Compliant and Stays That Way

  • July 20, 2026
  • 60 Minutes

Bridging the Remote-to-EDC Gap: Integrating DHTs Without Violating GCP

  • July 20, 2026
  • 60 Minutes

Adaptive Trial Design Under the New FDA Framework: Integrating ICH E20, Bayesian Methods, and Trial Innovation

  • July 22, 2026
  • 60 Minutes

Navigating the FDA’s New QMSR Framework: Strategies for Auditing and Compliance

  • July 22, 2026
  • 60 Minutes

Is Your Therapeutic Asset Actually Failing, or Is Your Data Corrupted?

  • July 24, 2026
  • 60 Minutes

How to Train Yourself to be a Good Technical Writer

  • July 27, 2026
  • 60 Minutes

FDA Requirements for Creating New Mobile Endpoints for Clinical Trials 

  • July 28, 2026
  • 60 Minutes

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

  • July 29, 2026
  • 60 Minutes

Opioid Pain Management, FDA Regulations and Requirements for Good Clinical Practice

  • July 30, 2026
  • 60 Minutes

BIMO Inspection Readiness: Preparing for Bioresearch Monitoring Audits

  • August 5, 2026
  • 60 Minutes

AI-Enhanced SOP Flowcharts: Strengthening Compliance in the Age of Artificial Intelligence

  • August 10, 2026
  • 60 Minutes

Regulatory Intelligence: Setting Up a Proactive Surveillance System

  • August 12, 2026
  • 60 Minutes

Moving Beyond Minimum GMP Compliance: Navigating the FDA’s QMM Framework

  • August 14 , 2026
  • 60 Minutes

How to Make Efficient FDA-Compliant Clinical Protocol Amendments

  • August 14, 2026
  • 60 Minutes

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

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

On Demand Topics

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