#Japan #Tokyo #JPI Seminar #E&L Regulations #FDA Requirements

Upcoming JPI Webinar on E&L Regulations

On September 3, 2025, Japan Planning Institute (JPI) will host an essential seminar focused on Extractables and Leachables (E&L) regulations, covering the overall landscape and FDA requirements. Dr. Kuroda, the Business Manager of Analysis Services at Omnipage Japan, will lead the session.

Overview of the Seminar

The necessity of E&L testing has become increasingly essential for drug approval applications in Europe and the United States. These evaluations involve assessing and managing compounds that can leach from packaging materials into pharmaceuticals. In Japan, particularly for high-risk injectable drugs, the submission of E&L test data is also a requirement. This presentation will delve into the various international guidelines surrounding E&L, including USP1663, USP1664, and more, as well as the ongoing creation of ICHQ3E guidelines.

During this webinar, Dr. Kuroda will present a comprehensive overview of E&L regulations, market trends, and notable guidelines supported by historical context and concrete examples.

Key Topics to Be Discussed

1. Overview of Extractables and Leachables (E&L Testing)
- What are E&L?
- Case studies of leaching from containers
- E&L testing flow for primary packaging materials

2. FDA's Requirements on E&L
- Regulatory mandates from the authorities
- Examples of FDA comments on E&L

3. Guideline Differences in Manufacturing Materials (USP665 vs. BPOG)
- Differences between USP665 and BPOG guidelines
- Market survey results related to USP665/1665

4. Related Q&A
Following the Q&A period, attendees will have the chance to engage in individual online discussions with the speaker.

Method of Attendance

Participants can choose between live streaming or archive viewing, available for two weeks, allowing for convenient, on-demand access. Please note that in-person attendance is not an option.

Seminar Fees

• - Individual: 37,480 yen (tax included)
• - For two or more individuals registering from the same company: 32,480 yen each.

For more details and to register, click here.

Benefits of Attending

• - Direct access to the speaker for questions post-seminar.
• - Opportunities to build networks among participants and the speaker, fostering new business collaborations.
• - Archived access to the session for later viewing.

Inquiry Information

Japan Planning Institute
106-0047 Tokyo, Minato, Minamiazabu 5-2-32, Kowa Hiroo Building
Telephone: 03-5793-9761
Fax: 03-5793-9767
Website: https://www.jpi.co.jp

About JPI

Founded over half a century ago, JPI has provided valuable insights for executives and senior management through exclusive seminars, bridging the gap among government, industry, and academia. Our mission is to promote national policies and projects through dissemination of knowledge.