LEXISNEXIS LIFE SCIENCES SOLUTIONS
Webinars
Stay ahead with LexisNexis Life Sciences Solutions webinars on Pharmaceutical & Medical Device regulations.
WEBINAR
DMFs, Manufacturer Listings, and eCTD:
Avoiding Common Submission Pitfalls
Drug Master Files (DMFs), manufacturer listings, and eCTD submissions are foundational to regulatory compliance—but even experienced teams encounter avoidable errors that can delay approvals and trigger costly rework. As global requirements continue to evolve across the FDA, EMA, Health Canada, and other regulatory authorities, ensuring accuracy, consistency, and alignment across these components is more critical than ever.
We’ll explore the most common pitfalls organizations face when preparing and submitting DMFs, managing manufacturer data, and compiling eCTD sequences across regions. From structural and formatting issues to data inconsistencies and lifecycle management challenges, we’ll highlight where things typically go wrong—and how to get them right the first time.
You’ll learn how to:
- Avoid common DMF submission and referencing errors across global regulatory frameworks
- Ensure accurate and consistent manufacturer listings across submissions and regions
- Identify and resolve eCTD structural, validation, and lifecycle management issues
- Align data and documentation to meet evolving global authority expectations (FDA, EMA, Health Canada, and more)
- Streamline submission workflows to reduce delays, rework, and compliance risk
Gain practical insights that will help you improve data quality, accelerate approvals, and build more efficient, globally compliant submission processes.
Register to the on-demand webinar DMFs, Manufacturer Listings, and eCTD: Avoiding Common Submission Pitfalls
Panelist
Samantha Bettinger, PhD, is a Senior Specialist in Regulatory Affairs with expertise in global regulatory submissions and post-approval lifecycle management. She facilitates global applications, manages Drug Master Files, and assesses the regulatory impact of changes to facilities, processes, and products.
She collaborates with global teams and pharma partners to develop regulatory strategies and support technology transfers for new projects. Samantha leads a comprehensive Regulatory Intelligence Monitoring Program, delivering targeted training, enhancing SOPs, and conducting ongoing surveillance to support proactive compliance. She also interprets evolving regulatory requirements, advises cross-functional teams, and drives continuous improvement initiatives across global regulatory operations.
Robin Schilling is the Head of Regulatory Compliance Services for LexisNexis Life Sciences Solutions, Robin drives innovation, strategic planning, and cross-functional collaboration across life sciences and global markets. With expertise in regulatory strategy, stakeholder engagement, and risk management, she builds global teams and positions organizations for long-term success.
Adam Randall is a pharmaceutical manufacturing and regulatory affairs professional with more than 25 years of experience in GMP environments. His background spans manufacturing operations, product control, quality assurance, document control, regulatory operations, and global regulatory publishing. Adam has held roles including Encapsulation Machine Operator, Product Control Analyst, Quality Assurance Specialist, Document Control Specialist, Regulatory Affairs Operations Specialist, and Senior Global Regulatory Affairs Publisher, bringing a broad understanding of quality systems, compliance, and regulatory submission processes.