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Online Seminar on CMC, Regulatory Affairs, and Quality Assurance Fundamentals

The IR Technical Educators Research Institute is organizing an informative online seminar for intellectual property (IP) professionals. The seminar will focus on the essential knowledge required for pharmaceutical development, including Chemistry, Manufacturing, and Controls (CMC), regulatory affairs, quality assurance, and IP practices. This educational opportunity is particularly vital as drug development encompasses not only groundbreaking inventions and patents but also strategic development planning that adheres to CMC, regulatory requirements, and quality assurance standards.

Many IP professionals are well-versed in patent law and application practices; however, there are limited opportunities for them to gain systematic knowledge in manufacturing, quality control, and regulatory affairs. As the modalities in drug development become increasingly diverse—including nucleic acid medicines, antibody medications, and regenerative medicine products—it is essential for IP executives to properly understand and safeguard the intellectual property that emerges beyond the research stage. This includes manufacturing methods, analysis methods, formulation techniques, and proprietary knowledge.

Seminar Overview

Seminar Name: Fundamentals and Practices of CMC, Regulatory Affairs, and Quality Assurance for IP Professionals
Format: Online (Live Zoom Broadcast/Archive Distribution)
Date and Time:
- LIVE Broadcast: November 30, 2026: 10:00 AM to 5:00 PM
- Archive Distribution: December 2 to December 16, 2026
Registration Fee: ¥49,500 (tax included) per person (discounts available for multiple participants)
Instructor: Satoshi Suzuki, Ph.D./MBA/Pharmacist (Japan Pharmaceutical Support Association)

Course Details

In this seminar, participants will begin with an overview of drug development and the role of the IP department, covering foundational topics in CMC, manufacturing methods, formulation technology, analysis methods, and intellectual property generated through these processes. Additionally, the seminar will delve into distinguishing between patents and trade secrets, alongside covering the fundamentals of regulatory affairs and quality assurance.

The seminar will also include how to read CTD (Common Technical Document) and PMDA (Pharmaceuticals and Medical Devices Agency) review reports, comparability assessments, technology transfer, CDMO (Contract Development and Manufacturing Organization) collaborations, licensing agreements, and intellectual property strategies pertinent to advanced modalities. This structure aims to facilitate the practical thinking necessary for bringing research outputs to commercialization.

Seminar Program

1. Relationship between Drug Development and Intellectual Property
Development overview, approval processes, role of the IP department
2. Fundamentals of CMC
Active pharmaceutical ingredients, formulations, analysis and quality standards, QbD
3. Intellectual Property Arising from CMC
Manufacturing methods, formulation and analysis techniques, manufacturing know-how
4. Patents and Trade Secrets
Patent filing, managing trade secrets, preventing technology leakage
5. Role of the Regulatory Affairs Department
PMDA consultations, CTD submission processes, change management
6. How to Read CTD and PMDA Review Reports
CTD Module 3, quality information, competitive analysis
7. Quality Assurance (QA) Concepts
GMP, GCTP, deviations, CAPA, risk management
8. Comparability Assessments
Manufacturing modifications, scaling up, analysis strategies
9. Technology Transfer, CDMO, and Licensing
Technology transfer practices, utilizing CDMOs, contract and IP management
10. Intellectual Property Strategies for Advanced Modalities
Nucleic acids, antibody therapeutics, gene and cell therapies, regenerative medicine products
11. Case Studies
Manufacturing modifications, PMDA correspondence, trade secrets management
12. Summary and Discussion
Development strategies, interdepartmental collaboration, IP management

Target Audience

This seminar is aimed at:

• - IP and research planning professionals in pharmaceutical companies and biotech ventures.
• - Individuals engaged in CMC, regulatory affairs, quality assurance, and business development.
• - Professionals involved in technology transfer and academia-industry partnerships in patent offices, universities, and research institutions.

For more details about the seminar, visit: IR Technical Educators Research Institute.

The IR Technical Educators Research Institute is dedicated to providing relevant knowledge and skills through educational services, including seminars, e-learning, training, and publications targeted at the manufacturing sector.

Japan IR Corporation has a history of over 50 years, offering specialized services in patent and intellectual property solutions, technical information research and analysis, education for technical professionals in manufacturing, and creating technical content. For further information, visit our website: Japan IR.
Address: 3rd Floor, CYK Kanda-Iwamotocho Building, 15-1 Kanda-Iwamotocho, Chiyoda City, Tokyo 101-0033
Phone: 03-6206-4966