DUBLIN–(BUSINESS WIRE)–The “Chemistry, Manufacture and Control (CMC) – Regulatory Requirements for Biological Drug Products Training Course (Apr 23rd – Apr 24th, 2026)” training has been added to ResearchAndMarkets.com’s offering.
The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance.
Information regarding chemistry, manufacturing, and controls (CMC) for drugs is an important and detailed section in the dossier to support clinical studies and marketing applications. This data must be updated as more information is gained throughout a drug’s lifecycle.
The quality module of the Common Technical Document (CTD) presents the CMC data in the submission dossier for small and large molecules. Compiling the CMC regulatory material is challenging; however, this needs to be completed with efficiency and accuracy to gain fast approval.
This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches that reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.
This is a key opportunity to learn from an expert in the field of CMC requirements and compliance, and discuss the complexities involved.
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Who Should Attend:
- Regulatory, Quality Assurance and Manufacturing personnel
- Managers of a CMC area
- CMC Project Managers
- Quality Assurance Managers for Biological Products
- Individuals who are new to drug companies
Key Topics Covered:
Day 1
Understanding Biologics
- Understanding what a Biological Product is
- Defining ATMPs
- The difference between small and large molecules
CMC Regulatory Guidelines for Biological Drug Products – Part 1
- Relevant laws, main guidelines & monographs, specifically for biologics (i.e. ATMP guideline and other relevant guidelines for mRNA products)
- ICH guidelines specific to different modalities (i.e. recombinant proteins, ATMP)
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Brief background on ICH (e.g., countries belonging to ICH, full membership, observers etc.)
- Q1-Q6B (no focus on New Chemical Entities (NCEs))
- Q7-Q12 (requirements due to Q12 revision)
Understanding the Key CMC Aspects of the Common Technical Document (CTD) – Part 1
- Quality Overall Summary (QOS)
- Examining the structure and content of the CMC sections – developing a CTD Roadmap
- Overview of the Drug Substance Sections for biologics
- Examine the linkage to the Drug Product Section
- Examine some basic rules for Q11 development and manufacture of drug substances
- Significant differences between EU & US & JP (e.g. P.3.5 FDA expectation)
CMC Regulatory Requirements During Different Stages of Development – Part 1
-
Understand the definition and requirements at different stages of development (early stage, linked to clinical trials) as well as for different modalities (mRNA vs. Cell and gene)
- QbD elements: QTPP, CQA, Process Characterization and Validation, Control Strategy
- Starting materials: MCB and WCB (monoclonality, characterization, follow-up batch qualification)
CMC Regulatory Requirements During Different Stages of Development – Part 2
- Potency assay: development, inter-assay comparability, critical reagent
- Reference standard: Primary & working standard (re- & follow-up qualification)
- Stability requirements & resulting concept (accelerated development): development batch, technical batch, pre-validation batch, PPQ batches
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Comparability exercise for biologics according to ICH Q5E
- Extended characterization: early versus late phase development
- Orthogonal methods
Day 2
CMC Regulatory Requirements During Different Stages of Development – Part 3
- The Review dimensions of the dossier
- Clinical stages and linkage to formulation / analytical development
- Develop strategies to overcome challenges
Building the Pharmaceutical Sections of the Dossier
- Examining the importance of development biologics/ATMPs
- Review of the sections on development biologics/ATMPs (P2 and S26)
- Understanding the reviewer’s perspective, highlighting methods to ensure we answer the reviewer’s questions
Understanding Source Documents
- Overview of source documents
- Understanding the reviewer’s perspective (Using analytical data as an example)
- Highlight the needs of internal teams versus external reviewers
- Reviewer’s questions to be answered
Change Control for Biological Products
- Change control and the impact of your dossier
- The importance of comparability
- Practical exercise on change control
Speakers:
Andrew Willis
Consultant
Independent
Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services. Catalent is the world’s leading contract manufacturer and distributor of pharmaceuticals, and he was head of a team of internal and external regulatory affairs consultants. He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He has 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs.
He currently has a total of 28 years pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many Biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities. Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.
For more information about this training visit https://www.researchandmarkets.com/r/u9pxka
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