CMC Regulatory Requirements for Biological Drug Products Training Course
Online Event: April 23–24, 2026
ResearchAndMarkets.com has added the “Chemistry, Manufacture and Control (CMC) – Regulatory Requirements for Biological Drug Products” training course to its offerings. This course is designed to help professionals navigate the complex regulatory landscape for biological drugs, including advanced therapy medicinal products (ATMPs), and provides practical insights for compiling CMC documentation efficiently and accurately.
Why This Training Matters
Biological drug products face complex regulatory requirements. Pharmaceutical companies must ensure compliance across the product lifecycle—from early discovery to post-marketing surveillance. Detailed information on chemistry, manufacturing, and controls (CMC) is crucial for supporting clinical studies and marketing applications. This data evolves throughout a drug’s lifecycle, requiring ongoing updates in the submission dossier.
The quality module of the Common Technical Document (CTD) captures CMC data for both small and large molecules. Compiling this information accurately is essential for timely regulatory approval.
This course helps participants:
- Understand CMC requirements for biologics and ATMPs
- Differentiate regulatory approaches for small and large molecules
- Navigate CTD sections and development stages
- Implement effective change control strategies
Certifications
- CPD: 12 hours for your records
- Certificate of Completion
Who Should Attend
- Regulatory, Quality Assurance, and Manufacturing personnel
- Managers and project leads in CMC areas
- Quality Assurance managers for biological products
- New professionals entering the pharmaceutical industry
Key Topics
Day 1 – Understanding Biologics and CMC Guidelines
Biologics Overview
- Definition of biological products
- Advanced Therapy Medicinal Products (ATMPs)
- Differences between small and large molecules
CMC Regulatory Guidelines for Biological Products – Part 1
- Relevant laws, guidelines, and monographs (including ATMP and mRNA-specific guidance)
- ICH guidelines for recombinant proteins and ATMPs
- Overview of ICH membership and structure
- Focus on Q1–Q6B, Q7–Q12 requirements
CTD Quality Module – Part 1
- Quality Overall Summary (QOS)
- CMC section structure and roadmap
- Overview of Drug Substance sections and linkage to Drug Product
- Key considerations for Q11 development and manufacturing
- Regional differences: EU vs. US vs. JP
CMC Requirements Across Development Stages – Part 1
- Early-stage vs. late-stage development
- Modalities: mRNA, cell, and gene therapies
- Quality by Design (QbD) elements: QTPP, CQA, process characterization, and validation
- Starting materials: MCB and WCB, monoclonality, characterization, batch qualification
CMC Requirements Across Development Stages – Part 2
- Potency assay development and comparability
- Reference standards: primary and working
- Stability requirements and accelerated development concepts
- Comparability exercises per ICH Q5E
- Extended characterization and orthogonal methods
Day 2 – Advanced CMC Requirements and Dossier Preparation
CMC Requirements Across Development Stages – Part 3
- Review dimensions of the dossier
- Clinical linkage to formulation and analytical development
- Strategies to overcome regulatory challenges
Pharmaceutical Sections of the Dossier
- Development of biologics and ATMPs
- Importance of P2 and S26 sections
- Reviewer perspective: ensuring questions are addressed
Source Documents
- Overview and role of source documents
- Analytical data use and internal vs. external review needs
Change Control for Biological Products
- Impact of change control on the dossier
- Importance of comparability studies
- Practical exercises to demonstrate implementation
Speaker
Andrew Willis, Consultant (Independent)
Andrew Willis is an expert in global regulatory solutions and pharmaceutical development. Previously VP of Regulatory Affairs & Consulting Services at Catalent Pharma Solutions, he led regulatory teams and managed European MAA submissions.
He holds a chemistry degree from the University of Glamorgan and began his career in pharmaceutical research and manufacturing. With 28 years of industry experience, he has expertise in sterile, solid oral, inhalation, topical, and biotech products, including growth hormones, cancer therapies, and the first genetically modified live bacterium for treatment.
Andrew has significant experience in regulatory submissions, project management, and meetings with European and US health authorities. Notably, he successfully managed a large MAA involving full clinical data and mutual recognition across 26 European countries.
This training is a key opportunity for professionals in regulatory, quality, and manufacturing roles to gain practical knowledge, learn regulatory best practices, and engage with an experienced CMC expert.
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