Phase-Appropriate Regulatory& Compliance Expectations

Phase-Appropriate Regulatory & Compliance Expectations for Biopharmaceuticals

Days

Hours

Minutes

Seconds

This course includes:

Collaborative environment that
encourages interaction
Case studies and Q&A sessions
Training materials
Tools and techniques to apply
immediately in your role
Recording access
Certificate of completion

Course outline

This two-day expert-led masterclass is designed to help pharmaceutical and biotech professionals navigate the complex and evolving regulatory landscape for biopharmaceuticals. It focuses on phase-appropriate Chemistry, Manufacturing, and Controls (CMC) strategies, GMP compliance, and regulatory expectations across different clinical development phases.

You will explore regulatory requirements across EMA and FDA, examine ICH guidelines (Q8–Q12), and understand analytical, stability, and data integrity expectations. Real-world case studies and practical examples will help bridge theory and application in real-time settings.

What You’ll Gain

A comprehensive understanding of ICH guidelines relevant to CMC development (Q8–Q12).
Clarity on EMA and FDA expectations during biopharma clinical phases.
Practical insights on phase-appropriate GMP and quality systems.
Strategies for managing CMC data integrity from R&D to GMP.
Actionable knowledge to apply compliance best practices within your organization.

Why This Masterclass?

Expert-Led Instruction
Delivered by one of the industry’s most accomplished biopharmaceutical experts, Dr. Margit Holzer.
Real-World Application
Includes interactive sessions, examples, and case studies to reinforce practical implementation.
Industry-Relevant Topics
Covers the latest compliance expectations, aligned with global regulatory trends and updates.

Who Should Attend?

Regulatory Affairs
Quality Assurance
CMC Project Management
GMP Compliance
Analytical Development
Biopharmaceutical R&D
Pharmaceutical Quality Control
Process Development

Agenda Highlights

Day 1

Overview of CMC regulatory requirements for biologics in the US and EU.
Understanding ICH CTD content (Q8–Q12) and phase-appropriate expectations.
CMC content development across milestones – drug substance and drug product.
Analytical and stability study requirements during clinical development.

Day 2

Sliding scale GMP and its application for clinical trial material production.
Phase-specific quality system and laboratory controls.
Minimum quality standards for R&D labs and GMP transitions.
Data integrity: challenges, best practices, and regulatory expectations.
Final Q&A with practical case studies and takeaway messages.

About Trainer

Dr. Margit Holzer is a globally recognized biopharmaceutical expert with over 25 years of experience. She has worked on the development of more than 50 biopharmaceutical products, holding senior leadership roles at Boehringer Ingelheim and NOVASEP. Dr. Holzer currently operates her own consultancy, specializing in process development, analytical strategies, and regulatory compliance across all phases of bioprocessing. Her masterclasses are enriched with real-world case studies and practical knowledge, making them highly relevant and impactful.