#Japan #Tokyo #JPI #ICH-Q3E #E&L Testing

Overview of the Upcoming Seminar on E&L Testing

JPI, the Japan Planning Institute, is set to host an insightful seminar on August 6, 2025, focusing on the latest developments in Extractables and Leachables (E&L) testing. The session will feature Yuta Sakamoto, Project Manager at Eurofins Analytical Science Institute, who will delve into regulatory requirements and practical approaches for industries preparing for ICH-Q3E compliance.

Seminar Details

• - Title: Latest Trends and Practical Points in E&L Testing Ahead of ICH-Q3E Compliance
• - Date: August 6, 2025
• - Time: 13:30 - 17:00 (Japan Time)
• - Format: Online participation only, with options for live viewing and archived access
• - Registration Fee: ¥50,000 (inclusive of tax) for one participant; ¥45,000 for additional participants from the same company
• - Link for Registration: JPI Seminar Registration

Why E&L Testing Is Critical

E&L testing has gained significant attention within the pharmaceutical sector in Japan as it becomes a regulatory requirement under ICH-Q3E. Although guidelines from the three major regions (Japan, the U.S., and Europe) are yet to harmonize completely, the necessity for E&L compliance has increased due to its critical role in drug development.

During the seminar, participants will learn about current guidelines and anticipated future regulations regarding E&L testing, detailing the necessary steps for compliance. The latter part of the session will spotlight common challenges faced in overseas applications, E&L testing missteps, and essential points to keep in mind for successful E&L testing.

Key Seminar Topics

The seminar will cover a comprehensive array of subjects:
1. E&L Guidelines Overview
- Historical Background
- Detailed explanation of the U.S. Pharmacopeia Guidelines
- Analysis of guidelines published by BioPhorum
- Future regulatory trends

2. Understanding Extractables and Leachables
- Origins of Extractables and Leachables
- Risks associated with Leachables

3. E&L Testing Process
- Risk evaluation of components
- Extractables testing
- Toxicity assessment
- Leachables testing
- Real-life examples

4. Case Discussions
- Detailed examination of different formulation patterns in simulated formulations

5. Common Pitfalls in the US
- Insights into criticisms faced during Extractables and Leachables testing
- Frequently encountered failures and misconceptions

6. Open Q&A
- Attendees will have the opportunity to engage directly with the speaker for personalized insights

Additional Information

Participants can choose to attend live or view archived sessions, available repeatedly over two weeks post-seminar. This flexibility ensures attendees can digest the material at their own pace.

Furthermore, the seminar fosters networking opportunities between the instructor and participants, which can lead to valuable collaborations and the establishment of new business ventures.

JPI's Commitment

The Japan Planning Institute has been delivering impactful seminars tailored for senior executives and managers for over fifty years, underpinning its commitment to fostering knowledge and innovation in national policies and projects. With a focus on bridging the gap between government, private sector, and academia, JPI strives to provide the highest quality training and consultation.

Contact Details

For inquiries, please reach out to:
Japan Planning Institute
106-0047 Tokyo, Minato-ku, Minamiazabu 5-2-32 Kowa Hiroo Building
TEL: 03-5793-9761
FAX: 03-5793-9767
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