この講演の言語は日本語です
This presentation will be delivered in Japanese

テーマ
AMRの脅威と製薬企業の責任：製薬業界をあげた活動とSHIONOGIグループの取り組み

PSCIアカウントに登録／ログイン後、申し込みができます。申し込みは12月17日午後5時までとなります。参加ガイドメールは12月18日に送信されます。

講演者
徐 文嘉, アソシエイトディレクター（MSD グローバル安全・環境）| PSCI 能力委員会 共同リード
Wenjia は MSD のグローバル安全・環境部門に所属し、API／中間体サプライヤー、製剤メーカー、そして買収・統合プロジェクトに対する EHS のデューデリジェンスおよび評価を担当しています。BASF、ロシュ、J&J での勤務経験を含め、Wenjia は化学・製薬業界で 20 年にわたり EHS の専門家として従事してきました。特に過去 8 年間では、複数の PSCI 監査および能力強化活動に参画しており、PSCIの原則について深い知見を有しています。

大橋 興三，コーポレートガバナンス部 総務EHS担当者
SHIONOGIグループにおけるEHS（環境・健康・安全）統括組織での3年間の経験を有し、AMR（薬剤耐性）対策における責任ある製造の推進を担当。AMR Industry AllianceのManufacturing Working Groupメンバーとして、国際的な枠組みにおける製造環境改善にも取り組んでいる。以前は18年間にわたり臨床開発部門にて新薬の開発業務に従事し、抗菌薬の開発にも携わる。

概略
薬剤耐性菌（AMR：Antimicrobial Resistance）は、世界の医療に深刻な影響を及ぼす重要な課題です。本Webinarでは、AMRの基本的な知識をわかりやすく解説し、製薬業界がどのように対応すべきかをご紹介します。
具体的には、AMR Industry Allianceによる抗菌薬製造基準（Antibiotic Manufacturing Standard）や、新たな認証制度を取り上げ、業界全体で進められている取り組みを理解します。
さらに、SHIONOGIグループが推進する具体的な施策についてもご紹介し、持続可能な医療の実現に向けた道筋を考えます。
AMR問題の本質と解決へのアプローチを学ぶ貴重な機会です。ぜひご参加ください。

Topic
PSCI Introduction, the Threat of AMR and Pharmaceutical Responsibility: Industry-Wide Initiatives in the Pharmaceutical Sector and SHIONOGI Group’s Commitment

Presenter
Wenjia Xu, Associate Director, Global Safety and Environment, MSD| PSCI capability committee co-lead
Wenjia is a part of MSD Global safety and environment, responsible for performing EHS due diligence and assessment for API/Intermediate suppliers, formulation manufactures and acquisition & integration projects. Including previously being with BASF, Roche, and J&J, Wenjia has been working as EHS professional in chemical and pharmaceutical industries for 20 years, . Among that, in the last 8 years, Wenjia was engaged in several PSCI audits and capability activities, which makes him have strong insights on PSCI principles.

Kozo Ohashi, EHS Management Group Member, Corporate Governance Department, Shionogi
Kozo Ohashi has three years of experience in the Environmental, Health, and Safety (EHS) management division of the SHIONOGI Group, where he led initiatives for responsible manufacturing in the context of antimicrobial resistance (AMR). He is also a member of the Manufacturing Working Group of the AMR Industry Alliance, contributing to global efforts to improve manufacturing practices in the fight against AMR. Prior to this role, he spent 18 years in clinical development, contributing to the research and development of new drugs, including antibiotics.

Introduction
Antimicrobial Resistance (AMR) is a critical global challenge that poses serious threats to healthcare systems worldwide. This webinar will provide a clear overview of the fundamentals of AMR and outline how the pharmaceutical industry should respond to this pressing issue.
It will introduce the Antibiotic Manufacturing Standard developed by the AMR Industry Alliance and highlight emerging certification schemes designed to ensure responsible practices across the industry. In addition, key initiatives led by the SHIONOGI Group will be presented, illustrating the path toward sustainable healthcare.
This session offers a valuable opportunity to deepen your understanding of AMR and explore practical approaches to addressing this global concern. We look forward to your participation.

About: As pharmaceutical supply chains continue to expand and grow in complexity, creating safe, resilient, and learning-driven operations has never been more important. Human and Organizational Performance (HOP) offers a framework for understanding how people actually work within complex systems - and how organisations can respond to incidents and failures in ways that strengthen, rather than weaken, safety performance.

In this PSCI webinar, our speakers will demystify HOP through real stories, practical examples, and behavioural science insights. Participants will explore what a HOP response to failure looks like in practice, how it differs from other safety approaches, and how adopting HOP principles can enhance both operational reliability and worker well-being across the supply chain.

Speakers:

• Andrea (Andy) Baker
  Andrea Baker is a leading practitioner of Human and Organizational Performance (HOP), with experience implementing HOP principles across global manufacturing, assembly, and distribution environments. She has supported more than 90 companies across 9 industries and 16 countries in embedding operational learning. Andrea co-authored Bob’s Guide to Operational Learning and co-hosts A HOP Podcast.
• Matt Florio
  Matt Florio brings a background in education, training, and executive leadership to the HOP space, helping organisations understand and apply HOP concepts beyond traditional safety contexts. He has partnered with 34 companies across 10 industries and is a co-host of A HOP Podcast.

PSCI invites our approved audit firms and interested external firms to participate in the next audit firm quarterly virtual meeting on December 11th between 1-2 pm CET. The meeting is a great chance to connect with the Audit Committee Leads and stay informed about the latest developments in the audit program.

Agenda

• Updates on the use of data sharing agreement (DSA) of PSCI audits
• Incident escalation process
• Link 2.0 updates
• Auditor Q&A

About: Human rights have become a critical priority for the Indian pharmaceutical industry as global expectations, regulatory requirements and stakeholder scrutiny continue to intensify. Demonstrating respect for human rights across operations and supply chains is now essential for maintaining market access, meeting ESG commitments, and building trust with international partners.

This PSCI webinar will offer a practical introduction to key human rights considerations for suppliers operating in India. Participants will gain clarity on what responsible business conduct looks like in practice and learn how to strengthen their human rights approach across daily operations. The session will cover:

• An overview of key labour and human rights issues relevant to India’s pharmaceutical sector, including working conditions and fair wages
• Indian and global expectations for human rights due diligence in supply chains
• How to identify, prevent, and address human rights risks across operations and value chains
• Building a culture of dignity, fairness, and respect through strong governance and continuous improvement

This session is especially relevant for teams in Procurement, Supply Chain, HSE & Sustainability, Human Resources, Legal & Compliance, Industry Relations, and Operations at PSCI supplier companies and member organisations.

Speakers

• Archana Panda
  Senior Manager (Assurance) & Senior Lead Accreditation Auditor, SAAS (Social Accountability Accreditation Services)
  With more than 26 years of experience in safety, environment, and social accountability auditing, Archana has conducted over 5,000 audits across India, China and Vietnam. She leads accreditation audits and unannounced audits globally, supports living-wage projects with multinational brands, and contributes to the development of international social accountability standards. Her extensive field experience provides suppliers with practical insights into meeting evolving human rights expectations.

Join us for the final in-person technical workshop in our India supplier series - a comprehensive two-day learning event designed to strengthen supplier capabilities in workplace safety and risk management.

Day 1: Industrial Hygiene – 10 December 2025

This session focuses on Industrial Hygiene, offering participants a practical, hands-on understanding of workplace health and safety practices. Attendees will learn how to identify, evaluate, and control occupational hazards and understand how these practices contribute to compliance and overall safety performance.

Highlights:

• Practical examples and case studies
• Interactive Q&A and discussion

Limited to 50 in-person participants for focused engagement

Day 2: Hazardous Area Classification & LHR – 11 December 2025

Day two covers Hazardous Area Classification and Labor Human Rights (LHR). The session provides essential knowledge for maintaining safe operations in high-risk environments, including risk assessment, regulatory requirements, and practical mitigation strategies.

Highlights:

• Hands-on learning through interactive sessions
• Virtual access available for the LHR session
• Limited to 50 in-person participants to ensure active participation

Mode of Training:
Classroom (in-person) for both days, with a virtual option available for the LHR session only.

Please register only if you plan to attend in person. For virtual participation in the LHR session, please email us here

CPHI & PMEC India unites South Asian pharma excellence. Join the event to discover innovation and connect face-to-face. Connect with thousands of industry leaders and expand your network with endless opportunities to learn, innovate, and collaborate online and in-person.

CPHI facilitates opportunities for you to grow your business and develop meaningful connections at the heart of pharma in India. Experience the latest industry trends, groundbreaking innovations, and informative sessions while networking in our match and meet lounge.

The PSCI will be speaking at CPHI & PMEC India and is delighted to be supporting the event as an Association Partner for the second year.

Please consult the agenda for further details.