PSCI June Supplier Newsletter
Read the PSCI June Supplier Newsletter below!
Access our full library of resources, register for events and webinars and share audits and other assessments
Join us on 24-26 September in Goa to learn from industry expert insights on important pharma-related topics, explore best practice and upcoming trends related to the PSCI Principles, and network with your peers.
Location: Radisson Blu Resort Goa Cavelossim Beach, South Goa
Please note that the conference will also feature an exhibition of pharmaceutical suppliers' good practices and success stories relevant to the PSCI Principles. If you are interested in showcasing your organization's work, please get in touch with us by emailing subhash.babu@issehs.com.
Finally, participants are invited to submit ahead of time any questions regarding the topics that will be covered during the conference which they'd like to see answered by the relevant speaker(s). Please click on this link to do so, and keep the questions as brief and focused as possible.
In case of any queries or doubts, please do get in touch with:
We request that each organization appoints a maximum of 2 (in exceptional cases 3) participants.
The conference agenda will be added in due course.
The PSCI at CDMO Live
PSCI Vice Chair, Rob Williams, will be speaking at CDMO Live on Strategies for Reducing Scope 3 Emissions with Manufacturing Partners. You can find out more here.
In the dynamic world of BioPharma, Contract Development and Manufacturing Organisations (CDMO) have become the catalyst that accelerates and enables innovation.
At a time when high-profile acquisitions and partnerships re-shaping the landscape of development and manufacturing, CDMO Live is an exclusive online event designed to put the spotlight on contract manufacturers and the pivotal role of outsourcing.
Taking place 13th June 2024, the event will help attendees to discover the latest trends in contract manufacturing and connect with potential partners. Through expert talks and workshops attendees will learn valuable insights into how to:
Creating Partnerships
At the core of the event is PartnerMatch, a carefully curated 1-to-1 meeting programme to connect outsourcing leaders with solutions to address their specific needs and challenges. Driven by AI-powered meeting platform and the PharmaSource concierge team, it is a highly efficient way to meet relevant potential partners.
Register to attend
CDMO Live is free to attend. Join us on 13th June 2024 by registering here.
About CDMO Live
CDMO Live is a new event from PharmaSource and Life Science Networks. Find out more by heading to PharmaSource.global.
During 2024 we will be updating/replacing The Link – the online platform by which we communicate with members and share audits.
We have today launched an open tender exercise to find the best provider. The attached documents have been sent to a small group of selected bidders.
We would welcome the widest possible range of submissions.
Supporting documents:
PSCI Link 2.0 RFP - via the download button below.
Link system map
Link 2.0 user requirements
For ease, please note the following:
Address for correspondence is: LinkRFP@pscinitiative.org
Please confirm your interest to participate by: 10th May 2024
Bid submission deadline: 31st May 2024
本线上研讨会由PSCI中国小组筹备,目标观众为中国供应商;会议语言为英语,欢迎国际观众注册参与。会议使用PPT为中英双语。
The webinar is sponsored by PSCI China regional team and targeting at suppliers in China.
The presentation will be delivered in English, and international audience is welcome to register & join. The presentation slides would be bilingual in Mandarin/ English.
研讨会话题
原料药和制剂生产中的活性物质操作
注册/登录PSCI账户后即可报名,报名将于5月21日下午17:00点截止。参会指引邮件将于5月22日发出。
线上研讨会话题简介
活性物质(API)的操作在药品生产过程中是一项具有挑战性的任务,一方面要避免操作人员过度职业暴露于活性物质,另一方面要避免药物交叉污染给用药患者带来不良的治疗影响。本次研讨会中,两位全球专家将基于现有GMP法规,阐述PDE和OEL值的理论设定; 从工业卫生(IH)和质量管理(GMP)领域的理论背景出发,深入探讨风险管理、遏制(containment)策略,以及相关的技术解决方案,并分享一些工程控制实例。
分享嘉宾
来自德国勃林格殷格翰总部的EHS 法规智能负责人Reinhold Maeck博士将介绍相关的原理和法规背景,来自瑞士罗氏制药全球工程咨询业务负责人Rainer Nicolai 博士将带来技术领域的深入分享。
会议语言
本次研讨会会议语言为英语。
Topic
Handling of Potent Compounds in the Manufacturing of APIs and Medicines
Please register your attendance before 21st May. We'll send out meeting instructions & link on 22nd May.
Introduction
The handling of potent compounds in the manufacturing of medicines is a challenging task. On the one hand there are operators to be protected from overexposure to materials handled, and on the other hand there are patients to be protected against false treatment due to cross contamination of medicines. In this seminar, not only both aspects will be addressed but also explained why the existing GMP regulations do help to ensure the OEL and PED values are available. Starting with the theoretical background and explaining what the expectations in the field of industrial hygiene (IH) and Good Manufacturing Practice (GMP) are, the seminar will dive into aspects of risk handling, containment strategies and technical solutions giving many examples of engineering controls to protect both - operators and patients - by technical means.
The first part on the theoretical background and the legislative situation will be covered by Dr. Reinhold Maeck, leading global EHS Regulatory Intelligence at Boehringer-Ingelheim.
The second part, diving into the technical aspects will be covered by Dr. Rainer Nicolai, Product Owner Engineering Consulting at Roche, Switzerland.
Your Presenters
PSCI has conducted a materiality review for the sector every few years (2013, 2017, 2020). We are pleased to publish our latest assessment, this time applying a double materiality framework. The assessment is specifically focused on supply chains for the Pharmaceutical & Healthcare industries, and takes into account member views and a range of outside sources.
“New regulations and investor demands are raising the bar for company reporting on supply chain responsibility. This year's assessment highlights the growing importance of robust supply chain programs, encompassing a wider range of issues. It also reflects the changing nature of the industry’s products and markets, with biosafety joining the list for the first time and the issue of substandard and falsified medicines gaining prominence. Tackling climate change remains essential, as does responsible business practice against bribery and corruption. The PSCI Board uses this assessment as a control point to guide its own strategy. It can be a valuable resource for member companies comparing their own assessments and for those outside the sector to understand how supply chain risks are viewed within the industry. I hope you find it useful.” Dr. Deirdre O’Reilly Global EH&S Supplier Operations and Business Development Lead, Viatris & PSCI Chair
We encourage members, suppliers and our other stakeholders and invited to read the report and use it as an input to their own planning processes.
For anyone with comments to the report, please contact Rosie.Towe@Carnstone.com.
The 2024 PSCI China Supplier Conference will continue to focus on supplier capability building in the areas of Health and safety, Environment, Human rights, Governance and Management Systems, and Ethics.
2024年 PSCI 年度供应商专业发展大会将继续围绕PSCI原则,关注供应商在健康与安全、环境、人权、治理与管理体系与商业道德方面的能力建设。我们邀请PSCI成员、供应商及行业专家为供应商解读上述领域的最佳实践,并探讨行业面临的挑战,也使供应商有机会了解同行、合作伙伴在相关领域的优秀实践,进一步发展专业知识。
目前多个议题的演讲嘉宾/讲师正在招募中,如您愿意作为讲师/参与互动分享,请联系PSCI秘书处 Simeng Wu (simeng.wu@carnstone.com); Danran Chen (danran.chen@carnstone.com). 嘉宾/讲师需求详见以下议程。
报名成功后,您的报名邮箱将收到系统自动发出的确认邮件。参会指引信息将于8月初发送至您的报名登记邮箱。您可点击如下 “Add to Calendar” 添加至日历提醒。若有任何注册相关问题,请联系秘书处 danran.chen@carnstone.com; simeng.wu@carnstone.com
建议参会人员:公司管理层、人力资源、环境战略部门
Recommended for: Senior management, HR, Environment departments
会议第一天,我们将邀请PSCI成员公司及供应商嘉宾进行主题演讲,旨在提高供应商在劳工权益、环境等方面的管理水平。
演讲内容将包含:PSCI审计问卷中治理&管理体系的部分内容更新、审计准备及常见审计发现项等;供应链企业的减碳措施;环境中的抗生素。更多内容正在筹备中。部分话题正在招募讲师,如您有意主讲,请联系秘书处Danran (danran.chen@carnstone.com)
暂定议程 Tentative agenda:
建议参会人员:EHS 管理人员、供应链经理等
Recommended for: EHS professionals, Supply chain managers
会议第二天,我们将邀请PSCI成员公司及供应商嘉宾进行主题演讲,旨在针对EHS领域(安全、工业卫生、环境)的重点议题及实践难点进行讲解和最佳实践分享,提高供应商EHS实践水平。
演讲内容将包含:工业卫生管理中的量化分析方法、安全文化建设及最佳管理实践、重要安全设施维护等。
部分话题讲师招募中,如您有意主讲,请联系秘书处Danran (danran.chen@carnstone.com)
暂定议程 Tentative agenda:
In the dynamic world of BioPharma, Contract Development and Manufacturing Organisations (CDMO) have become the catalyst that accelerates and enables innovation.
At a time when high-profile acquisitions and partnerships re-shaping the landscape of development and manufacturing, CDMO Live is an exclusive online event designed to put the spotlight on contract manufacturers and the pivotal role of outsourcing.
Taking place 13th June 2024, the event will help attendees to discover the latest trends in contract manufacturing and connect with potential partners. Through expert talks and workshops attendees will learn valuable insights into how to:
Creating Partnerships
At the core of the event is PartnerMatch, a carefully curated 1-to-1 meeting programme to connect outsourcing leaders with solutions to address their specific needs and challenges. Driven by AI-powered meeting platform and the PharmaSource concierge team, it is a highly efficient way to meet relevant potential partners.
Register to attend
CDMO Live is free to attend. Join us on 13th June 2024 by registering here.
The PSCI at CDMO Live
PSCI Vice Chair, Rob Williams, will be speaking at CDMO Live on Strategies for Reducing Scope 3 Emissions with Manufacturing Partners. You can find out more here.
About CDMO Live
CDMO Live is a new event from PharmaSource and Life Science Networks. Find out more by heading to PharmaSource.global.
Join us on May 9 15:00 – 16:00 (CET)
This webinar is a follow up from the first SafeBridge Session on OEBs held in November 2023.
This webinar will explain what Occupational Exposure Limits (OELs) are and how, when, and by whom they are established. It will also explain the differences between Occupational Exposure Bands (OEBs)/Occupational Health Categories (OHCs) and OELs and the relevance of OEL to support the adequate control of workplace exposure to APIs and the protection of workers.
Speakers:
This webinar will be recorded.
We look forward to seeing you there.