Introduction: Welcome to the Fourth MAH Cooperation and CXO Industrialization Development and Compliance Forum! This prestigious event, hosted by Yunzi Pharmaceutical Technology Co., Ltd. and co-organized by Maiben Pharmaceutical Technology Co., Ltd., is set to take place on March 20, 2024, at the luxurious Shunhe International Hotel in Jinan.

Conference Overview: This forum aims to further implement the responsibilities of MAH holders in ensuring the quality and safety of pharmaceutical products throughout their entire lifecycle. The National Medical Products Administration has issued several crucial announcements, including Notice No. 126 of 2022 regarding the Supervision and Management Regulations for Implementing the Responsibilities of MAH Holders for Drug Quality and Safety, Notice No. 132 of 2023 concerning Strengthening the Supervision and Management of MAH Entrusted Production, and the Notification on Issuing Guidelines for On-site Inspection of MAH Entrusted Production Sites (Drug Comprehensive Management [2023] No. 81). These policies have significantly tightened the issuance of B certificates, leading to stringent scrutiny of application materials and on-site inspections, making it increasingly challenging for some MAH companies to obtain B certificates.

However, the forum aims to address these challenges by discussing strategies for strict compliance with these regulations. Key topics include identifying deficiencies in on-site inspections for B-certified enterprises, establishing robust quality systems, conducting audits for entrusted enterprises, risk mitigation strategies, and ownership transfer procedures.

In addition to compliance issues, the forum will explore the correct implementation of new regulations, tools, and technologies to ensure continuous compliance in drug research and quality management. Furthermore, it seeks to break information barriers and promote information resource integration by providing a platform for MAH holders, CROs, CMOs, and CDMO companies to showcase their supply-demand information and enterprise profiles. Industry experts will analyze and interpret the current status and trends of B certificate licensing, and the event will feature sessions for B-certified enterprises to release demands and project roadshows, facilitating discussions on the future development trends of the pharmaceutical industry.

Roundtable Discussions: The forum will feature engaging roundtable discussions on hot topics, inviting top executives from B-certified enterprises, CXO executives, and regulatory research experts to participate. These discussions will comprehensively explore enterprises' perspectives on hot issues, share successful experiences, and present practical case studies.

Don't miss this opportunity to join us at the forefront of compliance and industry development in the pharmaceutical sector. We look forward to welcoming you to the Fourth MAH Cooperation and CXO Industrialization Forum in Jinan!