Understanding the Revised Pharmaceutical Affairs Law: A Seminar for Researchers and Professionals

Discovering the Revised Pharmaceutical Affairs Law: A Seminar for Researchers

The CIBER Pharmaceutical Affairs Law Seminar is designed for professionals involved in biotechnology and drug development. With recent amendments to the Pharmaceutical Affairs Law (PAL), understanding its implications is essential for researchers, developers, and those working in related fields.

Background of the Seminar

Published in May this year, the revisions to the PAL will take effect in 2025. These changes focus on streamlining the examination system for pharmaceuticals and medical devices, and reinforcing safety measures. This makes it crucial for anyone in the drug development sector to be aware of these regulations from the initial phases of research onwards. In this seminar, attorney Ayuko Nemoto will provide a clear breakdown of these legal modifications, making it an excellent opportunity for all attendees to equip themselves with necessary knowledge.

Seminar Overview

The seminar consists of two parts: an introductory session and an advanced application session.

Introductory Session

- Date: September 3, 2025, from 18:00 to 19:00

In this session, participants will gain an understanding of the basics of PAL. The discussion will cover the law’s objectives, the governing bodies involved, and a general overview. Additionally, it will address the types of products regulated by the PAL, the different types of licenses required, and what actions are mandated or prohibited concerning these products, supplemented with practical examples.

Advanced Application Session

- Date: September 10, 2025, from 18:00 to 19:00

During this session, we will delve deeper into the recent PAL amendments, particularly how they influence the manufacturing and sales of pharmaceuticals, medical devices, regenerative medicine products, and cosmetics. Attendees will learn about the implications for companies and academia following these legal updates. This session will equip participants with insights into how they can prepare and adapt to these changes effectively. It is vital for professionals in these fields to consider how to respond to the revised regulations moving forward.

Target Audience

This seminar is recommended for:

- Researchers and developers from academia or companies involved in drug and medical device production.
- Business planners related to pharmaceuticals, medical devices, and in vitro diagnostic drugs.
- Young professionals in CRO, legal, quality assurance, and regulatory departments.
- Supporters of startups focussing on bridging regulation and technology.

Registration Details

To participate, please click on the provided link to join the external application platform. Note that creating an initial account is necessary. The fee for attending both sessions is ¥19,800 (tax included), with discounts available for individuals enrolled in the Biomedical Seminar.

Participants will also receive 5 BiTA points upon completion of the seminar.

Additional Information

Both sessions will be conducted via Zoom Webinar, with materials distributed after the presentation. Moreover, on-demand playback will be available until November 30, allowing participants to revisit the content as often as they wish. This flexibility makes it an exceptional learning opportunity.

Speakers

- Introductory Session: Kazuhiro Okano (CIBER Director / Agilent Technologies)
- Advanced Session: Hiroyuki Kobayashi (CIBER Director / Shionogi Pharmaceutical Co., Ltd.)

Closing Note

With the landscape of pharmaceutical regulation evolving, staying informed is pivotal for anyone involved in drug development and medical technologies. This seminar promises a wealth of practical knowledge and insights into adapting to the revised Pharmaceutical Affairs Law. Don’t miss this opportunity to enhance your professional knowledge and network with colleagues in the field.

For further inquiries, please contact the CIBER Secretariat located in Chiyoda, Tokyo, or visit our website for additional information on the association and its activities.
CIBER Website