[Technical Seminar] Quality Assessment of Biopharmaceuticals That Cannot Be Explained by GMP
Practical approaches and thinking methods regarding "gray zone quality" in biopharmaceuticals.
This seminar is a course that organizes practical thinking about "gray zone quality" in biopharmaceuticals such as antibody drugs, regenerative medicine products, and nucleic acid drugs, which cannot be judged solely by GMP and standards/procedures. It explains the differences between scientific rationality and regulatory rationality in situations where manufacturing results and quality data cannot be clearly defined, the roles of GMP documents and CTD (Module 3), and the differences in judgment among departments such as QA, CMC, research, and clinical. Participants will learn to view quality judgment as a responsibility of the entire company rather than just individuals, and will acquire perspectives that can be utilized for explainable judgment criteria and medium- to long-term quality strategies.
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basic information
Seminar Program (Tentative) Chapter 1: Why is it difficult to assess the quality of biopharmaceuticals? [Background and Assumptions] Chapter 2: Where do gray zone qualities originate? [Typical Patterns] Chapter 3: Reasons why scientifically correct explanations are not accepted [Regulatory Perspective] Chapter 4: The relationship between GMP documents and CTD [Exit for Quality Assessment] Chapter 5: How is judgment made in practice? [Reality of QA and Organization] Chapter 6: How does the company make judgments and fulfill its responsibilities? [Summary and Practice]
Price information
49,500 yen (including tax)
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Applications/Examples of results
Expected Effects - Gain a perspective on how to think about and judge "quality issues that cannot be determined solely by standards and procedures," which are unique to biopharmaceuticals. - Be able to organize judgments regarding gray zone quality, which cannot be captured by the binary of within standards/outside standards, in a way that can be explained to others, without relying solely on intuition or experience. - Understand the difference between scientifically accurate explanations and those that are acceptable to regulatory authorities, and be able to concretely envision how to construct quality explanations for approval applications and discussions with authorities. - Organize the different perspectives on quality judgment that vary by department (QA, CMC, research, clinical, etc.) and acquire a common language to facilitate discussions and consensus-building between departments. - Understand the concepts of quality design with an eye toward future process changes, scale-up, and post-marketing responses, enabling the development of medium- to long-term quality strategies that go beyond short-term responses.
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We support Japan's "monozukuri" (manufacturing) with reliable services ranging from patent research and other intellectual property business solutions to technical translation services and intellectual property/engineer education. We offer high-quality services backed by over 40 years of experience at reasonable prices.
