A presentation given by ReAgent's Systems Manager, Graham Bayliss. The presentation was given at an event run by Chemicals Northwest in Runcorn. It discusses how REACH impacts at ReAgent and other ways it is used in industry.
Wipro helped a medical equipment client become 70% compliant with REACH and RoHS directives by developing an integrated model. Wipro analyzed over 80,000 part numbers using SAP tools to identify non-compliant components. They worked with vendors to obtain certification documents and developed alternatives to bring products into compliance. This reduced costs by 30% and improved data disclosure from 18% to 97% over 5 years.
Andwin Scientific specializes in Clinical Supplies and Equipment product manufacturing, sourcing, procurement, storage and distribution as a supplier to global life science organizations and a distributor to direct end using companies (including sites). This makes Andwin Scientific the only company that offers true consolidation for clinical studies by facilitating the purchase of products from various suppliers in one transaction.
Honeywell offer a wide range of Research Chemicals under their own brands Burdick & Jackson™, Fluka™, Honeywell™,Riedel-de-Haën™, Chromasolv™, Hydranal™, LabReady™ Blends, TraceSLECT™. Covering all applications, including, Bioanalysis, Biosynthesis, Chemical Synthesis, Chromatography, Electrophoresis, Karl Fischer Titration, Octane Determination, Spectroscopy, Titration, Trace Analysis and Wet Chemistry.
The document is a corporate presentation that summarizes a company's mission, capabilities, and growth platforms. The company is a global leader in serving science with $10.5 billion in annual revenues. It provides analytical instruments, equipment, reagents, consumables, software and services to over 350,000 customers in research, analysis, discovery and diagnostics across many fields of science. The company focuses on areas like life sciences, diagnostics, environmental and safety applications through its analytical technologies in areas such as mass spectrometry, chromatography, and molecular spectroscopy.
SMi Groups Highly Potent Active Pharmaceutical Ingredients (HPAPI)Dale Butler
This document provides an agenda for a conference on highly potent active pharmaceutical ingredients (HPAPIs) being held May 22-24, 2017 in London. The conference will address containment strategies, cross contamination risks, challenges in scaling up HPAPIs, improving contract manufacturing strategies, and risk assessment. Interactive half-day workshops on May 24 will focus on preventing cross contamination and employee exposures, and conducting a HAZOP risk assessment for HPAPIs. The event is aimed at sharing best practices for safely manufacturing these potent compounds.
Opportunities and Challenges Associated with Novel Companion Diagnostic Techn...L.E.K. Consulting
L.E.K. Managing Director Alex Vadas spoke at a BDA workshop on "How to Mature Emerging Technologies into Companion Diagnostics?" See his presentation here.
The document provides guidance for SVTC's 2018 Solar Scorecard, which will score and rank solar companies based on their sustainability practices. It outlines 8 criteria for scoring companies, including extended producer responsibility, chemical use and emissions reporting, worker health and safety, supply chain management, energy and greenhouse gas emissions, water use, packaging, and life cycle assessments. The scorecard will report on the top 40 solar companies based on their websites, surveys, interviews and publicly available data. The guidance also provides the specific points-based scoring methodology for each criteria.
Wipro helped a medical equipment client become 70% compliant with REACH and RoHS directives by developing an integrated model. Wipro analyzed over 80,000 part numbers using SAP tools to identify non-compliant components. They worked with vendors to obtain certification documents and developed alternatives to bring products into compliance. This reduced costs by 30% and improved data disclosure from 18% to 97% over 5 years.
Andwin Scientific specializes in Clinical Supplies and Equipment product manufacturing, sourcing, procurement, storage and distribution as a supplier to global life science organizations and a distributor to direct end using companies (including sites). This makes Andwin Scientific the only company that offers true consolidation for clinical studies by facilitating the purchase of products from various suppliers in one transaction.
Honeywell offer a wide range of Research Chemicals under their own brands Burdick & Jackson™, Fluka™, Honeywell™,Riedel-de-Haën™, Chromasolv™, Hydranal™, LabReady™ Blends, TraceSLECT™. Covering all applications, including, Bioanalysis, Biosynthesis, Chemical Synthesis, Chromatography, Electrophoresis, Karl Fischer Titration, Octane Determination, Spectroscopy, Titration, Trace Analysis and Wet Chemistry.
The document is a corporate presentation that summarizes a company's mission, capabilities, and growth platforms. The company is a global leader in serving science with $10.5 billion in annual revenues. It provides analytical instruments, equipment, reagents, consumables, software and services to over 350,000 customers in research, analysis, discovery and diagnostics across many fields of science. The company focuses on areas like life sciences, diagnostics, environmental and safety applications through its analytical technologies in areas such as mass spectrometry, chromatography, and molecular spectroscopy.
SMi Groups Highly Potent Active Pharmaceutical Ingredients (HPAPI)Dale Butler
This document provides an agenda for a conference on highly potent active pharmaceutical ingredients (HPAPIs) being held May 22-24, 2017 in London. The conference will address containment strategies, cross contamination risks, challenges in scaling up HPAPIs, improving contract manufacturing strategies, and risk assessment. Interactive half-day workshops on May 24 will focus on preventing cross contamination and employee exposures, and conducting a HAZOP risk assessment for HPAPIs. The event is aimed at sharing best practices for safely manufacturing these potent compounds.
Opportunities and Challenges Associated with Novel Companion Diagnostic Techn...L.E.K. Consulting
L.E.K. Managing Director Alex Vadas spoke at a BDA workshop on "How to Mature Emerging Technologies into Companion Diagnostics?" See his presentation here.
The document provides guidance for SVTC's 2018 Solar Scorecard, which will score and rank solar companies based on their sustainability practices. It outlines 8 criteria for scoring companies, including extended producer responsibility, chemical use and emissions reporting, worker health and safety, supply chain management, energy and greenhouse gas emissions, water use, packaging, and life cycle assessments. The scorecard will report on the top 40 solar companies based on their websites, surveys, interviews and publicly available data. The guidance also provides the specific points-based scoring methodology for each criteria.
Top Risks in Global Supply Chains: Primary-Source Intelligence and Recommenda...Sustainable Brands
The globalization of supply chains, occurring in many industries these days, has created unforeseen challenges in ensuring the workers and environments by which products are now manufactured are treated ethically and responsibly. For a long time supplier audits used to be just paper- or spreadsheet-based, without much accompanying data analysis, aggregation or trending. That is now beginning to change, leading to new levels of sophistication in extracting intelligence from supply chain data. For this session, we are joined by two organization leading this shift: Intertek, the largest and longest running CSR auditing body conducting over 60,000 such audits each year and author of the Intertek Workplace Conditions Assessment (WCA), the fastest growing CSR audit report with over 15,000 participating factories to date; and Sedex, the world's largest collaborative platform for sharing supply chain data, with over 36,000 participating organizations representing 30 industry sectors and more than 24 million workers in more than 160 countries. The two will combine their latest observations for an analysis of critical supply chain risks around the world that executives should keep top of mind.
The Life Science Accelerator aims to foster innovation in life sciences by bringing together key actors in Turku, Finland. It will mine for ideas from university research, hospitals, and companies to boost their transition to commercial viability and accelerate the growth of young life science companies. The accelerator will provide intensive mentoring, infrastructure support, and connections to private and public funding and other stakeholders to help ideas and projects reach proof-of-concept and experience faster business success. It has signed interest from several pharmaceutical and biotech companies and is building international collaborations with other accelerators.
Getting A Grip On Chemical Inventory - The New World of GHSSteve Gaitten
Katie McGee, Regulatory Content Manager at SiteHawk explores the reality of compliance in the "post-GHS" landscape and suggests actionable strategies to help Safety Manager's move closer to full compliance.
Domainex Ark Press Release June 2009 Finaldikheidi
Domainex Ltd and Ark Therapeutics have extended their drug discovery agreement. Domainex will continue providing hit-finding and lead optimization services for Ark's therapeutic targets. The companies have worked together successfully for years, combining Domainex's drug design expertise with Ark's disease expertise. Dr. Trevor Perrior of Domainex commented that their collaboration has already achieved breakthroughs against challenging goals, and they look forward to further developing programs to deliver new disease treatments.
YASH Technologies was selected as the long-term MSDS authoring partner for their ability to bring the necessary domain expertise as well as deep SAP EH&S knowledge to manage and maintain the MSDS creation process. Bringing a partner on board would eliminate the need to invest in data import/export procedures as all authoring would be done on Dow’s internal system.
Webinar: Driving Operational Agility with Digital Quality ManagementVeeva Systems
Watch the webinar here: https://go.veeva.com/Driving-Operational-Agility_webinar
This presentation is from a Veeva Systems Quality Team webinar series hosted by Contract Pharma.
Is the disconnected technology landscape slowing down operations and draining resources?
New-market demands, increasingly complex supply chains, and changing regulations will continue as the norm. Modern technologies can help manufacturers manage these external forces effectively, enabling them to be more agile, data-driven, and future-ready.
Today many manufacturers are digitizing quality management to increase operational agility and supply chain collaboration, meeting continually-changing market and customer demands.
Join Veeva experts in this webinar to learn how digitalizing quality management bridges gaps between manufacturing and quality management, improving cycle times and agility.
In this webinar, you will learn:
- About the opportunities to transform quality management
- How the right technology streamlines global quality processes, increasing automation and operational agility
- The industry best practices for driving successful digital transformation
This document provides an overview of supply chain management concepts. It discusses how supply chain management focuses on the total costs across the entire supply chain rather than just the initial costs. It also describes how supply chain management analyzes the flow of goods and information from the original supplier to the ultimate customer. The document outlines principles for ethical behavior in supply chain management and techniques for vendor selection and evaluation.
5th Annual Pre-Filled Syringes East CoastTeri Arri
This document provides an agenda for the Pre-Filled Syringes East Coast conference taking place on April 10-12, 2018 in Boston. The agenda includes workshops on human factors for connected drug delivery systems and design considerations for drug delivery outside the clinic on April 10th. The main conference on April 11-12th will feature sessions on regulatory updates, manufacturing challenges and solutions, trends toward biologics, and human factors considerations. Speakers will address topics such as syringe filling of high concentration formulations, safety evaluation of leachables, quality by design principles, and the future of digital monitoring biomarkers.
ScienceCloud: Collaborative Workflows in Biologics R&DBIOVIA
The life sciences industry has undergone dramatic changes and effective global collaboration has become a key success factor in this new age. BIOVIA is providing a hosted and comprehensive solution stack for externalized, collaborative research for pharma/biotech and CROs to address these new challenges. Recently we added the support for biologics data management and IP capture. In this talk we will present collaborative and comprehensive capabilities in antibody characterization and development: capabilities to analyze, annotate and predict developability as part of a framework that facilitates secure data sharing and collaboration.
Structure-Based Drug Design Facts & Figures InfographicJames Prudhomme
Among 32 pharma and biotech companies surveyed, structure-based drug design is the most prevalent activity with the most players emphasizing the fragment-based variation.
Advert_LDS Cosmetik Consulting_21 July 2015Leticia Smith
This document provides an overview of services offered by LDS Business Partners including cosmetic product development, packaging design and regulatory advice, stability testing, ingredient listing and claims advice, GMP compliance, quality management systems, and small scale manufacturing. The company offers these services to support partners in cosmetic product development and success.
Agilent Technologies is a global company that provides analytical solutions including instrumentation, consumables, and services. In fiscal year 2014, it had revenues of $4 billion with approximately 12,000 employees located around the world. It serves customers in industries like pharmaceuticals, diagnostics, chemicals, food safety, and more. Agilent offers a full portfolio of solutions including liquid chromatography, mass spectrometry, spectroscopy, automation, and informatics software to help customers optimize their laboratory performance.
Driving Sustainable Product Design through Standardization and New End-of-Lif...Sustainable Brands
This document summarizes Robert Predale's presentation on driving sustainable product design through standardization and new end-of-life metrics at Johnson & Johnson. The presentation discusses developing new metrics like the Global Aquatic Ingredient Assessment (GAIA) score to measure and reduce the environmental impact of product ingredients. It outlines J&J's focus on making packaging more sustainable through strategies like eliminating unnecessary materials, increasing recycled content, and ensuring recyclability. The presentation also notes J&J's efforts to optimize manufacturing processes, increase transparency, and set rules to require new products meet minimum sustainability targets.
11 Methods You Can Use to Meet the RoHS Declaration RequirementJim Kandler
There is more than one way to ‘skin a cat’.
While this presentation is focused on RoHS II, many of the declaration acquisition concepts presented may also be applied to other substance regulations.
Responsibly Managing Supply Chain Chemical Compliance in the Decade of Regula...Baytouch Solutions
Presented by Baytouch CEO, Malcolm Pollard, at Chemspec Europe 2014 in Budapest. In this presentation Malcolm examines the challenges facing chemical handling companies in keeping regulatory data up-to-date, accessible and accurate in an era where failing to do so can considerably impact their licence to operate.
Chemical inventory management is often a confusing and labor-intensive exercise. This webinar will shed light on how to build, operationalize, and improve a chemical inventory program. We will dissect the many nuances of a chemical inventory, and offer innovative, service-based solutions to help you successfully manage your chemical inventory program.
A practical approach to 3TG risk assessment and mitigation in conflict affect...RCS Global
An international trading company implemented a 3TG due diligence program to address risks in its supply chain and meet regulatory requirements. The program included identifying high-risk areas using conflict risk maps and country lists, enhancing know-your-customer procedures for new suppliers, requiring local certification for sourced materials, and conducting independent risk assessments of a percentage of suppliers. Initial results found risks being addressed and assurance provided to company leadership, while independent assessments helped improve the program's design and implementation. The company found that due diligence takes time but is worthwhile, and more guidance is still needed for practical upstream risk assessments and audits.
Chemical inventory management is often a confusing and labor-intensive exercise. This webinar sheds light on how to build, operationalize, and improve a chemical inventory program. We will dissect the many nuances of a chemical inventory, and offer innovative, service-based solutions to help you successfully manage your chemical inventory program.
Safeguarding Chemical Regulations Compliance throughout the Supply ChainBaytouch Solutions
Malcolm Pollard, CEO of Baytouch Ltd, discusses the need for robust management system processes to safeguard supply chain chemical compliance. He notes the increasing complexity of global regulations and challenges of managing supplier information and changes. ProductTraq, Baytouch's product regulatory data storage and management solution, aims to automate otherwise manual processes for collecting, validating, and updating supplier documentation to facilitate compliance. When implemented properly, such systematic approaches can help companies increase response rates, improve change management, and lower risks to support best practices and sustainability.
There is a major shift in the business operating requirements. This is caused by a critical shift in the mindset of the modern customer, who requires products and services produced in business cultures that are socially responsible.
- The document discusses managing supplier performance through scorecards and key performance indicators (KPIs). It provides examples of typical scorecard components like delivery, quality, and qualitative measures.
- Scorecards aim to drive continuous improvement across the supply chain through monitoring KPIs. While good for transparency and improvement, scorecards have limits in quickly replacing underperforming suppliers.
- The discussion includes questions from the audience about supplier performance management technology.
Top Risks in Global Supply Chains: Primary-Source Intelligence and Recommenda...Sustainable Brands
The globalization of supply chains, occurring in many industries these days, has created unforeseen challenges in ensuring the workers and environments by which products are now manufactured are treated ethically and responsibly. For a long time supplier audits used to be just paper- or spreadsheet-based, without much accompanying data analysis, aggregation or trending. That is now beginning to change, leading to new levels of sophistication in extracting intelligence from supply chain data. For this session, we are joined by two organization leading this shift: Intertek, the largest and longest running CSR auditing body conducting over 60,000 such audits each year and author of the Intertek Workplace Conditions Assessment (WCA), the fastest growing CSR audit report with over 15,000 participating factories to date; and Sedex, the world's largest collaborative platform for sharing supply chain data, with over 36,000 participating organizations representing 30 industry sectors and more than 24 million workers in more than 160 countries. The two will combine their latest observations for an analysis of critical supply chain risks around the world that executives should keep top of mind.
The Life Science Accelerator aims to foster innovation in life sciences by bringing together key actors in Turku, Finland. It will mine for ideas from university research, hospitals, and companies to boost their transition to commercial viability and accelerate the growth of young life science companies. The accelerator will provide intensive mentoring, infrastructure support, and connections to private and public funding and other stakeholders to help ideas and projects reach proof-of-concept and experience faster business success. It has signed interest from several pharmaceutical and biotech companies and is building international collaborations with other accelerators.
Getting A Grip On Chemical Inventory - The New World of GHSSteve Gaitten
Katie McGee, Regulatory Content Manager at SiteHawk explores the reality of compliance in the "post-GHS" landscape and suggests actionable strategies to help Safety Manager's move closer to full compliance.
Domainex Ark Press Release June 2009 Finaldikheidi
Domainex Ltd and Ark Therapeutics have extended their drug discovery agreement. Domainex will continue providing hit-finding and lead optimization services for Ark's therapeutic targets. The companies have worked together successfully for years, combining Domainex's drug design expertise with Ark's disease expertise. Dr. Trevor Perrior of Domainex commented that their collaboration has already achieved breakthroughs against challenging goals, and they look forward to further developing programs to deliver new disease treatments.
YASH Technologies was selected as the long-term MSDS authoring partner for their ability to bring the necessary domain expertise as well as deep SAP EH&S knowledge to manage and maintain the MSDS creation process. Bringing a partner on board would eliminate the need to invest in data import/export procedures as all authoring would be done on Dow’s internal system.
Webinar: Driving Operational Agility with Digital Quality ManagementVeeva Systems
Watch the webinar here: https://go.veeva.com/Driving-Operational-Agility_webinar
This presentation is from a Veeva Systems Quality Team webinar series hosted by Contract Pharma.
Is the disconnected technology landscape slowing down operations and draining resources?
New-market demands, increasingly complex supply chains, and changing regulations will continue as the norm. Modern technologies can help manufacturers manage these external forces effectively, enabling them to be more agile, data-driven, and future-ready.
Today many manufacturers are digitizing quality management to increase operational agility and supply chain collaboration, meeting continually-changing market and customer demands.
Join Veeva experts in this webinar to learn how digitalizing quality management bridges gaps between manufacturing and quality management, improving cycle times and agility.
In this webinar, you will learn:
- About the opportunities to transform quality management
- How the right technology streamlines global quality processes, increasing automation and operational agility
- The industry best practices for driving successful digital transformation
This document provides an overview of supply chain management concepts. It discusses how supply chain management focuses on the total costs across the entire supply chain rather than just the initial costs. It also describes how supply chain management analyzes the flow of goods and information from the original supplier to the ultimate customer. The document outlines principles for ethical behavior in supply chain management and techniques for vendor selection and evaluation.
5th Annual Pre-Filled Syringes East CoastTeri Arri
This document provides an agenda for the Pre-Filled Syringes East Coast conference taking place on April 10-12, 2018 in Boston. The agenda includes workshops on human factors for connected drug delivery systems and design considerations for drug delivery outside the clinic on April 10th. The main conference on April 11-12th will feature sessions on regulatory updates, manufacturing challenges and solutions, trends toward biologics, and human factors considerations. Speakers will address topics such as syringe filling of high concentration formulations, safety evaluation of leachables, quality by design principles, and the future of digital monitoring biomarkers.
ScienceCloud: Collaborative Workflows in Biologics R&DBIOVIA
The life sciences industry has undergone dramatic changes and effective global collaboration has become a key success factor in this new age. BIOVIA is providing a hosted and comprehensive solution stack for externalized, collaborative research for pharma/biotech and CROs to address these new challenges. Recently we added the support for biologics data management and IP capture. In this talk we will present collaborative and comprehensive capabilities in antibody characterization and development: capabilities to analyze, annotate and predict developability as part of a framework that facilitates secure data sharing and collaboration.
Structure-Based Drug Design Facts & Figures InfographicJames Prudhomme
Among 32 pharma and biotech companies surveyed, structure-based drug design is the most prevalent activity with the most players emphasizing the fragment-based variation.
Advert_LDS Cosmetik Consulting_21 July 2015Leticia Smith
This document provides an overview of services offered by LDS Business Partners including cosmetic product development, packaging design and regulatory advice, stability testing, ingredient listing and claims advice, GMP compliance, quality management systems, and small scale manufacturing. The company offers these services to support partners in cosmetic product development and success.
Agilent Technologies is a global company that provides analytical solutions including instrumentation, consumables, and services. In fiscal year 2014, it had revenues of $4 billion with approximately 12,000 employees located around the world. It serves customers in industries like pharmaceuticals, diagnostics, chemicals, food safety, and more. Agilent offers a full portfolio of solutions including liquid chromatography, mass spectrometry, spectroscopy, automation, and informatics software to help customers optimize their laboratory performance.
Driving Sustainable Product Design through Standardization and New End-of-Lif...Sustainable Brands
This document summarizes Robert Predale's presentation on driving sustainable product design through standardization and new end-of-life metrics at Johnson & Johnson. The presentation discusses developing new metrics like the Global Aquatic Ingredient Assessment (GAIA) score to measure and reduce the environmental impact of product ingredients. It outlines J&J's focus on making packaging more sustainable through strategies like eliminating unnecessary materials, increasing recycled content, and ensuring recyclability. The presentation also notes J&J's efforts to optimize manufacturing processes, increase transparency, and set rules to require new products meet minimum sustainability targets.
11 Methods You Can Use to Meet the RoHS Declaration RequirementJim Kandler
There is more than one way to ‘skin a cat’.
While this presentation is focused on RoHS II, many of the declaration acquisition concepts presented may also be applied to other substance regulations.
Responsibly Managing Supply Chain Chemical Compliance in the Decade of Regula...Baytouch Solutions
Presented by Baytouch CEO, Malcolm Pollard, at Chemspec Europe 2014 in Budapest. In this presentation Malcolm examines the challenges facing chemical handling companies in keeping regulatory data up-to-date, accessible and accurate in an era where failing to do so can considerably impact their licence to operate.
Chemical inventory management is often a confusing and labor-intensive exercise. This webinar will shed light on how to build, operationalize, and improve a chemical inventory program. We will dissect the many nuances of a chemical inventory, and offer innovative, service-based solutions to help you successfully manage your chemical inventory program.
A practical approach to 3TG risk assessment and mitigation in conflict affect...RCS Global
An international trading company implemented a 3TG due diligence program to address risks in its supply chain and meet regulatory requirements. The program included identifying high-risk areas using conflict risk maps and country lists, enhancing know-your-customer procedures for new suppliers, requiring local certification for sourced materials, and conducting independent risk assessments of a percentage of suppliers. Initial results found risks being addressed and assurance provided to company leadership, while independent assessments helped improve the program's design and implementation. The company found that due diligence takes time but is worthwhile, and more guidance is still needed for practical upstream risk assessments and audits.
Chemical inventory management is often a confusing and labor-intensive exercise. This webinar sheds light on how to build, operationalize, and improve a chemical inventory program. We will dissect the many nuances of a chemical inventory, and offer innovative, service-based solutions to help you successfully manage your chemical inventory program.
Safeguarding Chemical Regulations Compliance throughout the Supply ChainBaytouch Solutions
Malcolm Pollard, CEO of Baytouch Ltd, discusses the need for robust management system processes to safeguard supply chain chemical compliance. He notes the increasing complexity of global regulations and challenges of managing supplier information and changes. ProductTraq, Baytouch's product regulatory data storage and management solution, aims to automate otherwise manual processes for collecting, validating, and updating supplier documentation to facilitate compliance. When implemented properly, such systematic approaches can help companies increase response rates, improve change management, and lower risks to support best practices and sustainability.
There is a major shift in the business operating requirements. This is caused by a critical shift in the mindset of the modern customer, who requires products and services produced in business cultures that are socially responsible.
- The document discusses managing supplier performance through scorecards and key performance indicators (KPIs). It provides examples of typical scorecard components like delivery, quality, and qualitative measures.
- Scorecards aim to drive continuous improvement across the supply chain through monitoring KPIs. While good for transparency and improvement, scorecards have limits in quickly replacing underperforming suppliers.
- The discussion includes questions from the audience about supplier performance management technology.
Guide for executives in small and emerging pharmaceutical and biotech companies to select contract development and manufacturing organization (CDMO) and contract research organization (CRO) partners
Why Social Compliance, Sustainability & Traceability MatterDorien Mouthaan
Clay E. Hickson
Senior Director, Strategy and Business Development
Worldwide Responsible Accredited Production (WRAP)
Clay Hickson helps develop and refine WRAP’s vision and strategy; specifically, focusing on managing relationships with global brands and retailers and with governmental organizations. He has extensive experience in international marketing, corporate communications, strategic planning and cross-cultural communications. Mr. Hickson has developed and taught training programs that have prepared executives for doing business in international environments, and he is fluent in Chinese.
RoHS2 and REACH: The good, the bad and the ugly of product substance restrict...Society of Women Engineers
This document discusses product substance restrictions like RoHS and REACH from three perspectives: the good, the bad, and the ugly. Regulations can drive safer products by eliminating hazardous substances, but they also force costly product redesigns and create complex compliance challenges for manufacturers due to differing rules around the world. As regulations increase at a faster pace than companies can respond, manufacturers must make significant investments in product stewardship to understand and provide content information for the substances in their products sold internationally.
Part two of the compliance webinar series will be about customizing your solution to meet your specific needs in compliance. This will include the use of process extension and data import tools that assist with bringing all your compliance information into the Agile system.
TransCelerate is a nonprofit organization that aims to accelerate medical research by improving collaboration across the pharmaceutical industry. It has developed a Common Protocol Template (CPT) to standardize clinical trial protocols. The CPT provides a streamlined template for protocol content and format to make protocols easier to interpret, reduce complexity and costs, and enable automation. The CPT benefits various stakeholders by improving efficiency and quality. Its adoption by sponsors is valuable as it leverages industry expertise, supports compliance, and balances quality improvements with efficiency gains over time.
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
This document discusses preparing for the upcoming EU Medical Device Regulation (MDR), which aims to improve patient safety but remains incomplete. It outlines an agenda including introductions, a discussion of MDR's likely impact on clinical evidence, transparency, and traceability, and common CEO questions. The discussion covers basic compliance questions companies should consider, mapping a compliance plan over the transition period, and notes that companies should start preparing now rather than waiting for full clarity.
New standards for registered pharmacies – sept 2012GPhC
The General Pharmaceutical Council (GPhC) has approved new outcome-focused standards for registered pharmacies that will come into effect after a 12-month transition period. The standards aim to strengthen pharmacy regulation by holding owners and superintendents accountable for meeting five principles focused on patient safety. The principles cover governance, staff competency, premises safety, service delivery, and equipment use. A consultation on new Rules to enforce the standards will occur before they become fully enforceable in October 2013.
Innovation Outsourcing Part 1 - Boosting Innovation SuccessMarkus Henrich
A consulting firm recommends aligning a service provider's full capabilities with a client's needs to boost innovation. A service provider often has decades of experience across multiple clients, giving them insights into emerging trends, competitors' strategies, and industry standards that exceeds a client's own expertise. Outsourcing through lowest-bid approaches limits benefits, while a "source-of-knowledge" model shares challenges and strategies between client and provider to support the most effective solutions. Perfectly aligning expertise and insights between the two partners can maximize innovation success.
On March 31, 2010 there was a DEA revision to give physicians the choice of writing prescriptions for controlled substances the traditional method or through the electronic system. This will provide a reduction of paperwork and will mitigate the risk of forgery.
This overview will outline
• The EPCS Process
• Who Must Comply and
• Audit Phases
Case studies-Promotional supply optimization, procurement transformationJohn William
This case study focuses on providing information about promotional supply optimization and procurement transformation. To know more visit: http://www.dragonsourcing.com/china-sourcing-company/
Case Studies - Promotional supply optimization; procurement transformationJohn William
This case study focuses on providing necessary information about promotional supply optimization and procurement transformation for our prospective client. The industrial sector was food and beverages. Get details more here: https://www.dragonsourcing.com/china-sourcing-company/
Why Psychological Safety Matters for Software Teams - ACE 2024 - Ben Linders.pdfBen Linders
Psychological safety in teams is important; team members must feel safe and able to communicate and collaborate effectively to deliver value. It’s also necessary to build long-lasting teams since things will happen and relationships will be strained.
But, how safe is a team? How can we determine if there are any factors that make the team unsafe or have an impact on the team’s culture?
In this mini-workshop, we’ll play games for psychological safety and team culture utilizing a deck of coaching cards, The Psychological Safety Cards. We will learn how to use gamification to gain a better understanding of what’s going on in teams. Individuals share what they have learned from working in teams, what has impacted the team’s safety and culture, and what has led to positive change.
Different game formats will be played in groups in parallel. Examples are an ice-breaker to get people talking about psychological safety, a constellation where people take positions about aspects of psychological safety in their team or organization, and collaborative card games where people work together to create an environment that fosters psychological safety.
This presentation by Tim Capel, Director of the UK Information Commissioner’s Office Legal Service, was made during the discussion “The Intersection between Competition and Data Privacy” held at the 143rd meeting of the OECD Competition Committee on 13 June 2024. More papers and presentations on the topic can be found at oe.cd/ibcdp.
This presentation was uploaded with the author’s consent.
XP 2024 presentation: A New Look to Leadershipsamililja
Presentation slides from XP2024 conference, Bolzano IT. The slides describe a new view to leadership and combines it with anthro-complexity (aka cynefin).
This presentation by OECD, OECD Secretariat, was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
This presentation by Professor Alex Robson, Deputy Chair of Australia’s Productivity Commission, was made during the discussion “Competition and Regulation in Professions and Occupations” held at the 77th meeting of the OECD Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found at oe.cd/crps.
This presentation was uploaded with the author’s consent.
This presentation by Yong Lim, Professor of Economic Law at Seoul National University School of Law, was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
This presentation by OECD, OECD Secretariat, was made during the discussion “Competition and Regulation in Professions and Occupations” held at the 77th meeting of the OECD Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found at oe.cd/crps.
This presentation was uploaded with the author’s consent.
This presentation by Nathaniel Lane, Associate Professor in Economics at Oxford University, was made during the discussion “Pro-competitive Industrial Policy” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/pcip.
This presentation was uploaded with the author’s consent.
This presentation by OECD, OECD Secretariat, was made during the discussion “Pro-competitive Industrial Policy” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/pcip.
This presentation was uploaded with the author’s consent.
This presentation by OECD, OECD Secretariat, was made during the discussion “The Intersection between Competition and Data Privacy” held at the 143rd meeting of the OECD Competition Committee on 13 June 2024. More papers and presentations on the topic can be found at oe.cd/ibcdp.
This presentation was uploaded with the author’s consent.
This presentation by Professor Giuseppe Colangelo, Jean Monnet Professor of European Innovation Policy, was made during the discussion “The Intersection between Competition and Data Privacy” held at the 143rd meeting of the OECD Competition Committee on 13 June 2024. More papers and presentations on the topic can be found at oe.cd/ibcdp.
This presentation was uploaded with the author’s consent.
Suzanne Lagerweij - Influence Without Power - Why Empathy is Your Best Friend...Suzanne Lagerweij
This is a workshop about communication and collaboration. We will experience how we can analyze the reasons for resistance to change (exercise 1) and practice how to improve our conversation style and be more in control and effective in the way we communicate (exercise 2).
This session will use Dave Gray’s Empathy Mapping, Argyris’ Ladder of Inference and The Four Rs from Agile Conversations (Squirrel and Fredrick).
Abstract:
Let’s talk about powerful conversations! We all know how to lead a constructive conversation, right? Then why is it so difficult to have those conversations with people at work, especially those in powerful positions that show resistance to change?
Learning to control and direct conversations takes understanding and practice.
We can combine our innate empathy with our analytical skills to gain a deeper understanding of complex situations at work. Join this session to learn how to prepare for difficult conversations and how to improve our agile conversations in order to be more influential without power. We will use Dave Gray’s Empathy Mapping, Argyris’ Ladder of Inference and The Four Rs from Agile Conversations (Squirrel and Fredrick).
In the session you will experience how preparing and reflecting on your conversation can help you be more influential at work. You will learn how to communicate more effectively with the people needed to achieve positive change. You will leave with a self-revised version of a difficult conversation and a practical model to use when you get back to work.
Come learn more on how to become a real influencer!
The importance of sustainable and efficient computational practices in artificial intelligence (AI) and deep learning has become increasingly critical. This webinar focuses on the intersection of sustainability and AI, highlighting the significance of energy-efficient deep learning, innovative randomization techniques in neural networks, the potential of reservoir computing, and the cutting-edge realm of neuromorphic computing. This webinar aims to connect theoretical knowledge with practical applications and provide insights into how these innovative approaches can lead to more robust, efficient, and environmentally conscious AI systems.
Webinar Speaker: Prof. Claudio Gallicchio, Assistant Professor, University of Pisa
Claudio Gallicchio is an Assistant Professor at the Department of Computer Science of the University of Pisa, Italy. His research involves merging concepts from Deep Learning, Dynamical Systems, and Randomized Neural Systems, and he has co-authored over 100 scientific publications on the subject. He is the founder of the IEEE CIS Task Force on Reservoir Computing, and the co-founder and chair of the IEEE Task Force on Randomization-based Neural Networks and Learning Systems. He is an associate editor of IEEE Transactions on Neural Networks and Learning Systems (TNNLS).
This presentation by Thibault Schrepel, Associate Professor of Law at Vrije Universiteit Amsterdam University, was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
This presentation by Juraj Čorba, Chair of OECD Working Party on Artificial Intelligence Governance (AIGO), was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
2. • Graham Bayliss
• Reagent Chemical Services Ltd trades under
the brand of Reagent
• SME of approx. 30 employees
• Based on Whitehouse Industrial Estate in
Runcorn
Introduction
3. • Founded by Derek Millard and his wife Norma in 1979.
• Ex ICI employee who bought out the old Standards Laboratory
at Winnington, Northwich.
• Initially local business, mainly ICI.
• Developed into multi-million pound turnover.
• ReAgent is now in the third generation of management.
• Recent success due largely to website and e-commerce.
Company History
4. • Core business is chemical blending
• Highly accurate standard solutions and general chemical
reagents
• Strength is flexibility to manufacture bespoke products to
customers individual needs.
• Supply automotive, aerospace, pharmaceutical industry and
MoD
• Batch manufacture size from millilitres to several thousand
litres.
• Facilities to fill sachets and ampoules
What services Does ReAgent Offer?
5. Certification
• ISO 9001 Quality Standard
• ISO 14001 Environmental Standard
• Investors in People
• Working towards OHSAS 18001
• Home Office and Local Authorities
6. My Role at ReAgent
• Trainee laboratory technician progressed to supervisory and
managerial roles
• Part-time study to achieve MRSC CChem status
• Works Manager then switched to Quality Manager
• Systems Manager responsible for QHSE management systems
to ISO standards, compliance with relevant legislation and
Investors in People.
• Implementation of new EU legislation, CLP 1272/2008 and of
course REACH.
7. How Does REACH Affect ReAgent?
• We are a Downstream User (DU)
• Not classed as a manufacturer so no duty to register products
• NOT REMOVED FROM DUTIES UNDER REACH
• Supply of information up and down the supply chain
• Only use substances registered with our intended uses
• Provision of Safety Datasheets (SDS) with our products
• Ensure supplier SDS are made available to all who need them
• Implement the necessary Risk Management Measures
8. How Does ReAgent Comply?
• Identification of all raw material suppliers and notification of
our intended uses with standard Descriptor Codes.
• All supplier details are held on company intranet system
• Only REACH compliant companies are used
• Simple questionnaire to identify compliance
• Safety Datasheets are generated from software linked to the
product classification
• Consider restrictions on use and SVHC’s
9. Problems Meeting Compliance
• Time and resources
• Fitting in between other responsibilities
• FAILURE TO COMPLY IS NOT AN OPTION
• Label classification and SDS generation
• Finding sources of information
• Communication within the business
• Maintaining awareness of the directors when making future
business decisions
• Integration with other legislation, CLP etc
• Consistency between information sources
10. Effects of CLP on ReAgent
• Impact has been as big if not greater than REACH
• Several hundred products to be re-classified by June 2015
• Large changes to label design and SDS format
• REACH and CLP legislation is massive and time consuming to
understand
• Increase in the amount of hazard categories
• Choice of most appropriate P statements
• Under new classification criteria there are potentially more
products that will be classed as hazardous.
• Effect on transportation costs eg. Corrosive products.
11. Information Sources and Inconsistency
• In theory REACH and CLP (GHS) are designed to achieve
consistency, in practice still far from this
• Available sources of Information
Supplier SDS
ECHA website
ESIS (European Substances Information System) website
The CLP Regulation
• If the theory worked then all the above would agree, however
this is not the case
• Substance classifications can differ between a) Suppliers
b) Suppliers and ECHA c) ECHA and ESIS
• The CLP Regulation only contains Partial classifications
12. Information Sources and Inconsistency
• Headache for SDS compilation, especially mixtures
• Which one is correct?
• Under REACH downstream users must compile their SDS and
classify products on information received from suppliers.
• Discrepancies can be passed further down the supply chain
• Personal experience has indicated the greatest potential for
difference is in self classification from set criteria
13. Information Sources and Inconsistency
• Tin Dichloride Dihydrate or Stannous Chloride
• Supplier
H314 – Causes severe skin burns and eye damage
• ECHA
H315 – Causes skin irritation
H317 – May cause an allergic reaction
H319 – Causes serious eye irritation
H332 – Harmful if inhaled
H335 – May cause respiratory tract irritation
H341 – Suspected of causing genetic defects
H361 – Suspected of damaging fertility or the unborn child
H373 – May cause damage to organs
H410 – Very toxic to aquatic organisms with long lasting effects
14. Information Sources and Inconsistency
• Third party supplier
H302 – Harmful if swallowed
H314 – Causes severe skin burns and eye damage
Toxicological and Ecotoxicological Data
• Required for sections 11 and 12 of the SDS
• Again information can be different between suppliers and ECHA
• Which do we use?
• ECHA score data with a reliability rating of 1 to 4
• Should use supplier data but ECHA often has information quoted
with a lower LD50 value – more appropriate?
15. Information Sources and Inconsistency
• SDS Format
Many are still in the older format
Incomplete
Include the statement ‘No information available’
• The whole process of classification and SDS generation can be
difficult and confusing
• Contradicts what it sets out to achieve
16. Overcoming Problems of REACH and CLP
• Unfortunately there is no easy answer
• Generic e-mail sent to all suppliers with intended uses and
check our sales to customers were for registered uses
• Product classification and SDS generation assisted by software
• This must be updated and installed before June 2015
• Best to classify from scratch applying the new criteria rather
than use the translation table
• Software manufactures have released a new package but it
comes at a price
• IT staff have helped to design new label templates
• Training has been a key issue throughout the business
• Several hundred products have been removed
• Where possible generic SDS are used
17. Do SDS serve their purpose?
• Probably not taken as seriously in the past
• Since introduction of REACH this appears to be changing
• More customers actually question the content than in the
past
• The answer must be ‘Yes’
• This places pressure on the authors to get information correct
• Risk assessments rely on their content
• Misleading information may have serious consequences
18. Future Outlook and Conclusion
• NO OPTION BUT TO COMPLY – TIME, MONEY AND EFFORT
• ReAgent will continue to introduce new products and remove
those that are uneconomical
• To achieve consistent information transfer I estimate about 10
years
• Exposure scenarios are currently very limited and will need to
be included as part of the SDS
• REACH and CLP must be good for the chemical industry but
can be a real burden
• Our own SDS will need to be constantly updated as more
Registration Numbers become available
19. Future Outlook and Conclusion
• In the short-term REACH will be costly and a drain on
resources
• With threats of prosecution and damage to company image
pressures to comply increase
• In the long-term REACH can only be beneficial to us all for
identification of chemical hazards
20. Contact Us
For more information about ReAgent, please visit
www.ReAgent.co.uk
We’d love to hear from you. Send us an email at
enquiries@reagent.co.uk or call us on 0800-9555-798