IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
The document provides an introductory overview of serialization for manufacturers, distributors, and retailers in the pharmaceutical industry, covering key areas like GS1 serialization standards, the serialization process, and US legal requirements for implementing serialization at the unit level by 2017 and traceability at the package level by 2023. It also introduces the speaker, Dr. Attilio Bellman, who has over 16 years of experience in supply chain management and traceability.
A Track and Trace system is a mass serialization solution for pharmaceutical and other industries that prints a unique identifying code onto each product after it has been packaged.
There has been a wave in the global pharmaceutical industry over the past several years, driven by the need for battling the scourge of spurious medicines, which take thousands of live each year. This wave has led to the evolution of technology to help regulators ensure that only genuine medicines are distributed within or imported in any market, and to empower patient to verify that the medicines they are taking are indeed what they claim to be. Serialization is one of the most widely adopted technologies in the new wave, and in this article we present an overview of this technology and its applications.
Traceability tools are needed in supply chains to address concerns about product safety, recalls, and regulations. They allow companies to quickly identify affected products during recalls to minimize costs. Technology tools for traceability include barcodes, RFID, and software to collect and manage traceability data throughout the supply chain. This data can improve operations and help meet requirements for documentation. The rise of IoT is further enabling real-time end-to-end visibility within supply chains using automated identification.
The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57.
The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to use a "set of common global standards for data elements, formats, and terminologies for the unique identification and exchange of information on medicines."
Complying with IDMP represents a massive increase in scope and complexity, in addition to previous iterations. The EMA has divided the timeline for meeting the new requirements into several phases, making this a multi-year project.
Perficient’s expert in IDMP and the EudraVigilance Medicinal Product Dictionary, Mark Thackstone, reviewed everything you need to know in order to successfully comply with IDMP by the fast-approaching deadline:
-Latest information and timelines
-Steps to take meet regulatory requirements
-Challenges and factors to consider
-What IDMP means in the real world of a typical pharma company
This presentation summarizes the key requirements of the EU Delegated Regulation on safety features for medicinal products. It describes the obligations to prevent falsified medicines, including applying a unique identifier and anti-tampering device. It outlines the core elements of the regulation, such as the composition of the unique identifier, end-to-end verification system, and establishment of repositories to store unique identifiers. The regulation aims to implement traceability systems to securely track medicinal products and help prevent entry of falsified medicines into the legal supply chain.
The document discusses the requirements and specifications for submitting applications to the FDA using the electronic common technical document (eCTD) format. It states that eCTD is the standard format for submissions to the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research. The document outlines the five modules that make up an eCTD submission and provides details on submission types, required formats, pre-submission requirements like obtaining an application number, and how to transmit submissions through the Electronic Submissions Gateway.
This document discusses risk management in logistics and supply chains. It defines risk as the possibility of harm or loss and risk management as reducing risks and their impacts. Effective risk management is important as companies now rely more on outsourcing and globalized supply chains, which can be brittle. The document outlines the risk management process of identifying risks, assessing them, treating risks, and continual monitoring. It discusses various internal and external risks to supply chains like natural disasters, supplier issues, and distribution problems. It emphasizes that risk management requires identifying past and potential future risks and developing strategies to avoid, mitigate, share or accept different risks.
The document provides an introductory overview of serialization for manufacturers, distributors, and retailers in the pharmaceutical industry, covering key areas like GS1 serialization standards, the serialization process, and US legal requirements for implementing serialization at the unit level by 2017 and traceability at the package level by 2023. It also introduces the speaker, Dr. Attilio Bellman, who has over 16 years of experience in supply chain management and traceability.
A Track and Trace system is a mass serialization solution for pharmaceutical and other industries that prints a unique identifying code onto each product after it has been packaged.
There has been a wave in the global pharmaceutical industry over the past several years, driven by the need for battling the scourge of spurious medicines, which take thousands of live each year. This wave has led to the evolution of technology to help regulators ensure that only genuine medicines are distributed within or imported in any market, and to empower patient to verify that the medicines they are taking are indeed what they claim to be. Serialization is one of the most widely adopted technologies in the new wave, and in this article we present an overview of this technology and its applications.
Traceability tools are needed in supply chains to address concerns about product safety, recalls, and regulations. They allow companies to quickly identify affected products during recalls to minimize costs. Technology tools for traceability include barcodes, RFID, and software to collect and manage traceability data throughout the supply chain. This data can improve operations and help meet requirements for documentation. The rise of IoT is further enabling real-time end-to-end visibility within supply chains using automated identification.
The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57.
The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to use a "set of common global standards for data elements, formats, and terminologies for the unique identification and exchange of information on medicines."
Complying with IDMP represents a massive increase in scope and complexity, in addition to previous iterations. The EMA has divided the timeline for meeting the new requirements into several phases, making this a multi-year project.
Perficient’s expert in IDMP and the EudraVigilance Medicinal Product Dictionary, Mark Thackstone, reviewed everything you need to know in order to successfully comply with IDMP by the fast-approaching deadline:
-Latest information and timelines
-Steps to take meet regulatory requirements
-Challenges and factors to consider
-What IDMP means in the real world of a typical pharma company
This presentation summarizes the key requirements of the EU Delegated Regulation on safety features for medicinal products. It describes the obligations to prevent falsified medicines, including applying a unique identifier and anti-tampering device. It outlines the core elements of the regulation, such as the composition of the unique identifier, end-to-end verification system, and establishment of repositories to store unique identifiers. The regulation aims to implement traceability systems to securely track medicinal products and help prevent entry of falsified medicines into the legal supply chain.
The document discusses the requirements and specifications for submitting applications to the FDA using the electronic common technical document (eCTD) format. It states that eCTD is the standard format for submissions to the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research. The document outlines the five modules that make up an eCTD submission and provides details on submission types, required formats, pre-submission requirements like obtaining an application number, and how to transmit submissions through the Electronic Submissions Gateway.
This document discusses risk management in logistics and supply chains. It defines risk as the possibility of harm or loss and risk management as reducing risks and their impacts. Effective risk management is important as companies now rely more on outsourcing and globalized supply chains, which can be brittle. The document outlines the risk management process of identifying risks, assessing them, treating risks, and continual monitoring. It discusses various internal and external risks to supply chains like natural disasters, supplier issues, and distribution problems. It emphasizes that risk management requires identifying past and potential future risks and developing strategies to avoid, mitigate, share or accept different risks.
Product lifecycle management: process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal.
It is mandatory for every medicine or pharma packaging to have a unique serial code or UID. Project is to build a web application that will provide tracking capabilities for the UID for pharma packaging of drugs. The track feature (TRACK n trace) will track the UID of each package by using vision based scanners, RFIDs, etc. and store the data into a local server. The server will be synced daily with a global server (we are looking for cloud based hosting platforms such as Windows Azure or amazon web services). We have to build the trace functionality (Track n TRACE) by building a web interface where a person with the UID can trace the shipment.
We have to keep historical records for as long as 10 years and build logic on basis of the UID state. We have to provide the details from the database as in when was this package manufactured, when was it shipped, etc. If the UID entered is faulty for example; it wasn’t ever manufactured or if it is over its expiration date then we have to generate corresponding errors and also maintain a log of such entries and send notification to the admins with details of IP, Geography or where the error generated.
This document provides an overview of medical coding and the process involved. It discusses the objectives of medical coding, which include standardizing medical terminology and ensuring data is mapped to standardized medical dictionaries. It also describes the pre-coding process and prerequisites for assigning codes, such as having clinical data and using standardized coding dictionaries. Finally, it reviews some common medical coding dictionaries like MedDRA and WHODD, how they are structured in a hierarchy, and how codes are assigned based on the dictionary terminology.
This document discusses Accenture's approach to helping companies comply with IDMP (Identification of Medicinal Products) regulations through data management and technology solutions. The four-phased approach involves:
1) Analyzing and mining existing data
2) Mapping and extracting data
3) Cleansing and enriching the data
4) Collecting and maintaining IDMP-compliant data for submission
Accenture aims to increase compliance efficiency and help clients digitize processes through this data-driven approach and the use of automation and AI tools.
This document discusses guidelines for post-approval changes to drugs in Canada. It outlines four levels of changes - supplements, notifiable changes, annual notifications, and record of changes - and the reporting requirements for sponsors for each level. Supplements require a new Notice of Compliance, notifiable changes require a No Objection Letter, annual notifications do not require prior review but must be reported annually, and record of changes do not require reporting but records must be maintained. The document provides guidance to sponsors on implementing post-approval changes according to these levels.
This document discusses quality metrics and their importance in measuring and improving pharmaceutical quality. It defines quality metrics as standards used to assess efficiency, performance, and quality. Quality metrics help ensure what is measured gets recorded, monitored, controlled, and improved. The document outlines key quality metrics like batch acceptance rate, product complaint rate, and invalid OOS rate. It also discusses FDA's guidance around voluntary submission of quality metrics data and the benefits this can provide manufacturers. Overall quality metrics are presented as an important tool for continual improvement and assurance of patient safety.
A supply chain is the network of organizations involved in producing and delivering a product, from raw materials to the end customer. It includes upstream suppliers, internal production and packaging, and downstream distribution centers and retailers. Effective supply chain management coordinates activities across this network to optimize material, information and financial flows. Key goals are reducing costs and uncertainties while improving customer service. Modern supply chains leverage information technology to facilitate coordination and information sharing among partners.
This document provides guidance on conducting pharmacovigilance audits according to international standards. It discusses the legal, technical, and scientific context of pharmacovigilance audits. A risk-based approach to auditing is recommended, focusing on high risk areas like critical processes, quality systems, and areas of noncompliance. Audit findings should be graded based on their criticality and risk level. Corrective actions should address critical and major issues to ensure patient safety and compliance.
This document discusses regulatory requirements and previous observations related to data integrity issues. It outlines criteria for integrity of laboratory data according to regulations. It also provides examples of possible data integrity problems that have been observed by regulators, such as altering raw data, manipulating test procedures to obtain passing results, and recording lab activities before they occur. FDA warning letters from 2013 are referenced that identified specific failures to record quality activities at the time they were performed.
This document discusses the importance of certifying vendors that supply raw materials for pharmaceutical manufacturing. Certification helps ensure high quality, safe medicines by preventing issues like contamination, recalls, deaths, and adverse events. It outlines six key steps in the vendor qualification process: 1) supplier selection, 2) due diligence, 3) quality assessment, 4) change control and production assessment, 5) supply chain security, and 6) ongoing monitoring and evaluation. Proper vendor certification and qualification of suppliers is necessary to maintain compliance and minimize risks to patients.
This document provides an overview of information technology management in supply chain operations, using Walmart as a case study. It discusses key concepts like traditional vs integrated supply chain views, the importance and benefits of IT in supply chain management. It also describes various types of IT systems used in supply chains, including ERP, transportation management, inventory management, EDI, barcoding, RFID and e-commerce systems. Finally, it discusses management of supply chain information systems and the development process.
Liberalization of economies across the globe has brought packaging technology to the forefront. Packaging being pervasive, in today’s business plays an important role and each member in the supply chain looks forward ‘to use packaging as a strategic tool for business development and improved business performance 1 under the present and future needs’.
This document discusses data integrity in pharmaceutical quality systems. It defines data and explains its importance in decision making and continual improvement. It notes that the FDA and EMA have issued warning letters and non-compliance reports for data integrity issues. Examples are provided of warning letters issued to two companies for violations like unauthorized data manipulation, lack of audit trails, and insufficient investigations. The causes of data integrity breaches are discussed. It emphasizes establishing a culture of integrity, security protocols, and complying with cGMP guidelines. It provides details on how to properly manage system access, data storage, backups, and recording data according to ALCOA principles. The importance of audit trail software is also covered.
This document discusses pharmacovigilance risk management audits. It defines an audit and explains why pharmacovigilance system audits are performed. It describes different types of audits, including global pharmacovigilance system audits, company affiliate audits, and marketing partner audits. It also outlines audit scheduling, fundamentals, reporting, corrective actions, follow-up, metrics, and inspection readiness best practices. The overall purpose of pharmacovigilance audits is to ensure compliance and patient safety.
This document discusses 21 CFR Part 11, which establishes criteria for electronic records and electronic signatures. It provides an overview of Novo Nordisk's compliance project to ensure their computer systems meet 21 CFR Part 11 requirements. The project involves identifying, prioritizing and evaluating systems, developing corrective actions, and gradually implementing procedural and technical solutions. Examples of evaluated systems and lessons learned are also presented.
The document discusses data integrity and recent regulatory approaches. It defines data integrity as the completeness, consistency, and accuracy of data throughout its lifecycle. Regulatory agencies are increasingly focused on data integrity due to its importance in ensuring product quality and safety. Common data integrity issues found by agencies include fabricated, falsified, or missing records. Ensuring data integrity requires effective quality management systems, risk management, technology solutions, and governance.
This rubric evaluates software based on 9 criteria: content, design, functionality, instructional design, interactivity, assessment, usability, technology, and accessibility. Software receives higher scores for providing accurate, reliable content aligned to standards. It also scores well for intuitive navigation, multimedia enhancements, feedback and support for learners, and easy integration into classroom activities. The rubric assesses whether the software engages students and allows teachers to track progress.
DSCSA and Blockchain, Global Governmental
perspective of Blockchain implementation in medtech Medtech
Possibilities
Information such as place of production
of active substances or component
parts, manufacturing locations, shipping
dates, batch numbers, expiry dates,
storage temperature and unique
identification numbers, could all be
stored and monitored on blockchain.
Blockchain has many potential applications in health including: medical research, information sharing/interoperability, digital identity management, supply chain management, and financial/insurance applications. Some exemplary uses are improving medical records management, clinical data collection, supply chain traceability for anti-counterfeiting, and life-cycle management of medical equipment. Key players like Merck, SAP, GSK and Pfizer are exploring blockchain for applications like supply chain management, fighting fake drugs, and traceability.
Product lifecycle management: process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal.
It is mandatory for every medicine or pharma packaging to have a unique serial code or UID. Project is to build a web application that will provide tracking capabilities for the UID for pharma packaging of drugs. The track feature (TRACK n trace) will track the UID of each package by using vision based scanners, RFIDs, etc. and store the data into a local server. The server will be synced daily with a global server (we are looking for cloud based hosting platforms such as Windows Azure or amazon web services). We have to build the trace functionality (Track n TRACE) by building a web interface where a person with the UID can trace the shipment.
We have to keep historical records for as long as 10 years and build logic on basis of the UID state. We have to provide the details from the database as in when was this package manufactured, when was it shipped, etc. If the UID entered is faulty for example; it wasn’t ever manufactured or if it is over its expiration date then we have to generate corresponding errors and also maintain a log of such entries and send notification to the admins with details of IP, Geography or where the error generated.
This document provides an overview of medical coding and the process involved. It discusses the objectives of medical coding, which include standardizing medical terminology and ensuring data is mapped to standardized medical dictionaries. It also describes the pre-coding process and prerequisites for assigning codes, such as having clinical data and using standardized coding dictionaries. Finally, it reviews some common medical coding dictionaries like MedDRA and WHODD, how they are structured in a hierarchy, and how codes are assigned based on the dictionary terminology.
This document discusses Accenture's approach to helping companies comply with IDMP (Identification of Medicinal Products) regulations through data management and technology solutions. The four-phased approach involves:
1) Analyzing and mining existing data
2) Mapping and extracting data
3) Cleansing and enriching the data
4) Collecting and maintaining IDMP-compliant data for submission
Accenture aims to increase compliance efficiency and help clients digitize processes through this data-driven approach and the use of automation and AI tools.
This document discusses guidelines for post-approval changes to drugs in Canada. It outlines four levels of changes - supplements, notifiable changes, annual notifications, and record of changes - and the reporting requirements for sponsors for each level. Supplements require a new Notice of Compliance, notifiable changes require a No Objection Letter, annual notifications do not require prior review but must be reported annually, and record of changes do not require reporting but records must be maintained. The document provides guidance to sponsors on implementing post-approval changes according to these levels.
This document discusses quality metrics and their importance in measuring and improving pharmaceutical quality. It defines quality metrics as standards used to assess efficiency, performance, and quality. Quality metrics help ensure what is measured gets recorded, monitored, controlled, and improved. The document outlines key quality metrics like batch acceptance rate, product complaint rate, and invalid OOS rate. It also discusses FDA's guidance around voluntary submission of quality metrics data and the benefits this can provide manufacturers. Overall quality metrics are presented as an important tool for continual improvement and assurance of patient safety.
A supply chain is the network of organizations involved in producing and delivering a product, from raw materials to the end customer. It includes upstream suppliers, internal production and packaging, and downstream distribution centers and retailers. Effective supply chain management coordinates activities across this network to optimize material, information and financial flows. Key goals are reducing costs and uncertainties while improving customer service. Modern supply chains leverage information technology to facilitate coordination and information sharing among partners.
This document provides guidance on conducting pharmacovigilance audits according to international standards. It discusses the legal, technical, and scientific context of pharmacovigilance audits. A risk-based approach to auditing is recommended, focusing on high risk areas like critical processes, quality systems, and areas of noncompliance. Audit findings should be graded based on their criticality and risk level. Corrective actions should address critical and major issues to ensure patient safety and compliance.
This document discusses regulatory requirements and previous observations related to data integrity issues. It outlines criteria for integrity of laboratory data according to regulations. It also provides examples of possible data integrity problems that have been observed by regulators, such as altering raw data, manipulating test procedures to obtain passing results, and recording lab activities before they occur. FDA warning letters from 2013 are referenced that identified specific failures to record quality activities at the time they were performed.
This document discusses the importance of certifying vendors that supply raw materials for pharmaceutical manufacturing. Certification helps ensure high quality, safe medicines by preventing issues like contamination, recalls, deaths, and adverse events. It outlines six key steps in the vendor qualification process: 1) supplier selection, 2) due diligence, 3) quality assessment, 4) change control and production assessment, 5) supply chain security, and 6) ongoing monitoring and evaluation. Proper vendor certification and qualification of suppliers is necessary to maintain compliance and minimize risks to patients.
This document provides an overview of information technology management in supply chain operations, using Walmart as a case study. It discusses key concepts like traditional vs integrated supply chain views, the importance and benefits of IT in supply chain management. It also describes various types of IT systems used in supply chains, including ERP, transportation management, inventory management, EDI, barcoding, RFID and e-commerce systems. Finally, it discusses management of supply chain information systems and the development process.
Liberalization of economies across the globe has brought packaging technology to the forefront. Packaging being pervasive, in today’s business plays an important role and each member in the supply chain looks forward ‘to use packaging as a strategic tool for business development and improved business performance 1 under the present and future needs’.
This document discusses data integrity in pharmaceutical quality systems. It defines data and explains its importance in decision making and continual improvement. It notes that the FDA and EMA have issued warning letters and non-compliance reports for data integrity issues. Examples are provided of warning letters issued to two companies for violations like unauthorized data manipulation, lack of audit trails, and insufficient investigations. The causes of data integrity breaches are discussed. It emphasizes establishing a culture of integrity, security protocols, and complying with cGMP guidelines. It provides details on how to properly manage system access, data storage, backups, and recording data according to ALCOA principles. The importance of audit trail software is also covered.
This document discusses pharmacovigilance risk management audits. It defines an audit and explains why pharmacovigilance system audits are performed. It describes different types of audits, including global pharmacovigilance system audits, company affiliate audits, and marketing partner audits. It also outlines audit scheduling, fundamentals, reporting, corrective actions, follow-up, metrics, and inspection readiness best practices. The overall purpose of pharmacovigilance audits is to ensure compliance and patient safety.
This document discusses 21 CFR Part 11, which establishes criteria for electronic records and electronic signatures. It provides an overview of Novo Nordisk's compliance project to ensure their computer systems meet 21 CFR Part 11 requirements. The project involves identifying, prioritizing and evaluating systems, developing corrective actions, and gradually implementing procedural and technical solutions. Examples of evaluated systems and lessons learned are also presented.
The document discusses data integrity and recent regulatory approaches. It defines data integrity as the completeness, consistency, and accuracy of data throughout its lifecycle. Regulatory agencies are increasingly focused on data integrity due to its importance in ensuring product quality and safety. Common data integrity issues found by agencies include fabricated, falsified, or missing records. Ensuring data integrity requires effective quality management systems, risk management, technology solutions, and governance.
This rubric evaluates software based on 9 criteria: content, design, functionality, instructional design, interactivity, assessment, usability, technology, and accessibility. Software receives higher scores for providing accurate, reliable content aligned to standards. It also scores well for intuitive navigation, multimedia enhancements, feedback and support for learners, and easy integration into classroom activities. The rubric assesses whether the software engages students and allows teachers to track progress.
DSCSA and Blockchain, Global Governmental
perspective of Blockchain implementation in medtech Medtech
Possibilities
Information such as place of production
of active substances or component
parts, manufacturing locations, shipping
dates, batch numbers, expiry dates,
storage temperature and unique
identification numbers, could all be
stored and monitored on blockchain.
Blockchain has many potential applications in health including: medical research, information sharing/interoperability, digital identity management, supply chain management, and financial/insurance applications. Some exemplary uses are improving medical records management, clinical data collection, supply chain traceability for anti-counterfeiting, and life-cycle management of medical equipment. Key players like Merck, SAP, GSK and Pfizer are exploring blockchain for applications like supply chain management, fighting fake drugs, and traceability.
A Closer Look At Brazil’s New Serialization RegulationShari Popovich
Brazil has gone through several attempts at defining its pharmaceutical serialization and traceability regulation. The newest version of the law requires ANVISA to develop new regulations, which should result in a more attainable architecture.
In this webinar, Dirk Rodgers, Regulatory Strategist at Systech International, will review the features of the new law and the recent draft of regulations from ANVISA. He will also give his quarterly overview of regulatory developments around the rest of the world.
This document discusses the development and regulatory requirements for digital therapeutics. It begins by defining key terms like digital health, digital medicine, and digital therapeutics. It then discusses the differences between digital solutions and digital therapies and provides examples of each. It outlines the regulatory landscape for digital therapeutics and software as a medical device, including FDA guidance and approval pathways. It also discusses collecting real-world data to monitor digital therapeutic performance after market approval.
The Drug Quality and Security Act grants the FDA more authority to regulate compounded drugs in response to a 2012 meningitis outbreak. The Act requires serialization of drug products, with serial numbers encoded in 2D barcodes by certain deadlines. This increases tracking of drugs throughout the supply chain. SAP Advanced Track and Trace for Pharmaceuticals provides a single platform to manage serial numbers, integrate serialization into business processes, simplify regulatory reporting to different countries, and scale to handle increasing serialization data volumes.
Digital Therapeutics Regulatory Process, Update and TrendsInsights10
The market for digital therapeutics (DTx) is expanding tremendously, aided by the increased popularity of decentralized medicine that the pandemic brought about. The global market for DTx was predicted to be worth $3.35 billion in 2021 and would grow to $12.1 billion by 2026. To get a report in detail, contact us at - info@insights10.com
Traceability in the food and beverage industryKaizenlogcom
Three key technological advancements are enabling complete traceability in the food and beverage industry:
1) Big data and the internet of things allow massive amounts of supply chain data to be collected and analyzed.
2) Cloud solutions provide storage for this large volume of data.
3) An agile ERP system is needed to incorporate these technologies and give manufacturers a 360-degree view of their supply chain.
Traceability in the food and beverage industryKaizenlogcom
Three technological advancements are enabling full traceability across food and beverage supply chains: big data, the Internet of Things, and cloud solutions. These technologies allow automatic collection and analysis of data from IoT devices to track products throughout the supply chain. An agile ERP system is needed to incorporate these technologies and give manufacturers a 360-degree view of their supply chain.
Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory CompliancePerficient, Inc.
IDMP (Identification of Medicinal Products), which will soon be mandated by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), will enable stakeholders to obtain a comprehensive view of each individual product (e.g., ingredients, marketing and medicinal information, contacts), based on unique codes.
While the journey towards IDMP compliance can be incredibly challenging, industry-specific knowledge and systems play an integral role in meeting the new requirements.
In our webinar, we discussed how the Oracle IDMP Enterprise Foundation Suite can help you be ready in time.
IRJET- Secure Authentication Scheme for Medicine Anti-Counterfeiting System i...IRJET Journal
1) The document proposes a secure authentication scheme for an anti-counterfeiting medicine system using IoT. It uses NFC tags embedded in medicines to store expiry and other drug details.
2) Currently, expired drugs are sometimes resold by changing the expiry date, endangering patients. The proposed system aims to prevent this by allowing stakeholders and patients to access real-time drug information from the NFC tags.
3) It uses security protocols like Diffie-Hellman key exchange and session keys to authenticate users and prevent attacks like replay and man-in-the-middle attacks. The system is verified for security using the AVISPA tool.
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
Major developments in point-of-care (POC) testing were highlighted at the 2015 American Association of Clinical Chemistry Annual Meeting:
1) Several companies announced new POC devices, including a low-cost, battery-powered molecular diagnostics platform from Cepheid and a smartphone-based chlamydia test.
2) Existing POC tests for influenza, diabetes, kidney disease, liver disease, and pregnancy from companies like Alere, DiaSys Diagnostics, and Abbott were demonstrated.
3) The large POC diagnostics market, estimated at $17 billion globally, was a focus for many exhibitors given the potential for rapid results at the point of care.
This document discusses the results of focus groups conducted for the Food Safety Market project. The focus groups provided feedback on business scenarios and user stories for various actors in the food supply chain, including retailers, food processors, certification bodies, and food safety authorities. Main concerns raised included convincing suppliers to participate, ensuring data security and privacy, and understanding costs. The focus groups found value in solutions that facilitate data sharing and help select the best certification options.
This document is a presentation on Quality by Design (QbD) in the pharmaceutical industry. It begins with an introduction comparing the traditional Quality by Test (QbT) approach to QbD. The presentation defines QbD and discusses ICH guidelines on QbD. It identifies key elements of QbD including Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters. The presentation outlines the steps for QbD implementation and importance of QbD in ensuring product quality and facilitating innovation.
In March 2011, the EMA and FDA launched a pilot program that aims at a parallel assessment by both agencies of certain quality/CMC sections which are relevant to Quality by Design (QbD). This voluntary pilot program is open. This presentation gives a summary of the FDA and EMA expectation for QbD submissions based on the pilot programme.
NEARCHAIN - Leveraging NFC and Blockchain in Pharmaceutical Supply chain to p...IRJET Journal
This document proposes a solution called NEARCHAIN that leverages NFC and blockchain technologies to track pharmaceutical drugs through the supply chain and prevent counterfeiting. It describes how counterfeit drugs are a major problem, affecting up to 25% of medicines in poor countries. The complex pharmaceutical supply chain makes it difficult to track counterfeits. The proposed solution uses NFC tags on drug packages and publishes the tag information and details to the blockchain at each supply chain stage using smart contracts. This provides transparency and prevents counterfeiting by allowing verification of authentic drugs at any point. The solution aims to improve reliability, scalability and efficiency in the pharmaceutical supply chain.
The document discusses key changes and requirements regarding the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) and the European database on medical devices (Eudamed). Some of the main points discussed include:
- Eudamed will contain integrated electronic systems for European UDI, registration of devices and economic operators, scrutiny applications, certificates, clinical investigations, vigilance, and market surveillance.
- Traceability requirements will require manufacturers, distributors, and importers to cooperate to achieve appropriate traceability levels and identify economic operators in the supply chain.
- Unique Device Identification (UDI) must be assigned and placed on labels and packaging. Registrations of devices and economic
This document provides an introduction to Issue 8 of the Global Standard for Food Safety. Key points include:
- Issue 8 focuses on encouraging a strong food safety culture, expanding environmental monitoring requirements, and adding clarity for high-risk production areas and pet food manufacturers.
- The Standard is based on senior management commitment and a HACCP-based food safety system, and specifies requirements for food safety, quality, and legal compliance.
- Certification benefits companies by reducing audits, allowing use of the BRC logo, and helping meet legal requirements and customer demands. The Standard can be audited via announced or unannounced audits.
The document discusses serialization requirements being implemented globally to combat counterfeiting of pharmaceutical products. It provides an overview of regulations and timelines for serialization in various countries and regions. The benefits of serialization are described as combating counterfeits, optimizing supply chain operations, protecting brand value, and improving sales planning. The document emphasizes that manufacturers should take a 360 degree approach to serialization implementation and addresses how it affects all aspects of production, packaging, and distribution.
Similar to Session 2: Mike Rose, Johnson & Johnson / Serialization and Traceability GS1 Standards: A Manufacturer’s Perspective (20)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatory Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines.
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatorz Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
The document discusses psoriasis, a chronic skin condition affecting over 125 million people worldwide. Psoriasis causes thickened, red, scaly skin patches that often itch and bleed. It can also cause joint pain and increase risks for other health issues. The document outlines pharmaceutical company efforts to develop new drug treatments for psoriasis, including topical treatments, biologics, and oral medications currently in clinical trials. It emphasizes the need for comprehensive care that coordinates treatment from specialists and considers patients' needs to best manage psoriasis as a chronic condition.
The document provides an overview of the International Psoriasis Council (IPC) and their partnership with ILDS and IFPA to execute the Global Psoriasis Atlas project. The IPC is a nonprofit organization comprised of the world's leading experts in psoriasis. They aim to advance knowledge of psoriasis and enhance patient care through research, education, and clinical practice guidelines. The document notes that worldwide prevalence and incidence of psoriasis is poorly understood currently. The Global Psoriasis Atlas project aims to address this through collecting epidemiological data on psoriasis prevalence, burden, and natural history across countries to inform policy and improve care.
IFPMA Geneva Pharma Forum on 9 May 2014
Bringing Psoriasis into the Light
Presentation of Professor Mahira Hamdy El Sayed
Dermatology and Venereology, Ain Shams University
David K. Robinson, Ph. D.Vice President, BiologicsHead and Executive Director, Biologics and Vaccines CMC RegulatoryMerck & Co, Inc.
Presenting on behalf of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)WCBP CASS, Washington DC, USAJanuary 2014
This document is comprised of copyright notices from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) spanning the years 2014 through 2018, suggesting it contains content owned by IFPMA over those years. No other substantive information is provided in the document.
NAVIGATING THE HORIZONS OF TIME LAPSE EMBRYO MONITORING.pdfRahul Sen
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These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
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2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Computer in pharmaceutical research and development-Mpharm(Pharmaceutics)MuskanShingari
Statistics- Statistics is the science of collecting, organizing, presenting, analyzing and interpreting numerical data to assist in making more effective decisions.
A statistics is a measure which is used to estimate the population parameter
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“Psychiatry and the Humanities”: An Innovative Course at the University of Mo...Université de Montréal
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Travel Clinic Cardiff: Health Advice for International TravelersNX Healthcare
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Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
Summer is a time for fun in the sun, but the heat and humidity can also wreak havoc on your skin. From itchy rashes to unwanted pigmentation, several skin conditions become more prevalent during these warmer months.
5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
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Discover the benefits of homeopathic medicine for irregular periods with our guide on 5 common remedies. Learn how these natural treatments can help regulate menstrual cycles and improve overall menstrual health.
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Are you looking for a long-lasting solution to your missing tooth?
Dental implants are the most common type of method for replacing the missing tooth. Unlike dentures or bridges, implants are surgically placed in the jawbone. In layman’s terms, a dental implant is similar to the natural root of the tooth. It offers a stable foundation for the artificial tooth giving it the look, feel, and function similar to the natural tooth.
Know the difference between Endodontics and Orthodontics.Gokuldas Hospital
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Session 2: Mike Rose, Johnson & Johnson / Serialization and Traceability GS1 Standards: A Manufacturer’s Perspective
1. Serialization and Traceability
GS1 Standards: A Manufacturer’s Perspective
Mike Rose
Johnson & Johnson Health Care Systems Inc.
Vice President, Supply Chain Visibility
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Topics
• Protecting patients and consumers
• What is serialization and track & trace?
• Importance of GS1 standards
• Public-Private Partnerships
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Helping Patients and Consumers Receive
Genuine Products
People
Policy
Process
Information
Technology
Enforcement
Requires a
multi-layered approach
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Detecting Counterfeit Products
The Role of Serialization and Bar Codes
Provides an additional identification
feature to more accurately identify a
package
Must use the GS1® Standards
Enables authentication of the package
However, does not ensure the contents
are genuine
Must use with additional processes,
security features and measures
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Serialization and Track & Trace
Manufacturer Implications
• Developing public-private partnerships, e.g.,
APEC, ESM, PDSA
• Responding to different regulatory
requirements
• Building new, agile, cost effective capabilities
for serialization and traceability
• Standardizing identifiers for all products (i.e.,
GS1 standards)
• Modifying existing processes, procedures and
IT systems while conforming to GMPs and
GDPs
• Maintaining operational efficiency in
manufacturing as well as distribution
• Integrating with external manufacturers,
customers and regulatory systems
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Pharmaceutical Item Level Product Serialization
Changes the way we handle our products
A unique serial identification number is assigned to each item identifying it with a product number
and associated serial number.
It’s applied at every package level (bottle, case, and pallet).
These unique numbers are uploaded into a database and can provide timely product intelligence
from manufacturing to the patient.
PREZISTA® 600mg serialized label with 2D data matrix
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12 serialized &
aggregated
Prezista
bottles in a case
261 cases to a
pallet. Each case
has the parent serial
number
Pallet is shipped
(truck, boat, or
airplane) to DC
DC where
individual cases
get pulled from
the pallet ,
scanned and
shipped to
Customer
Wholesaler
Customer
receive products,
scans every case
and ships to
pharmacies,
hospitals, etc.
Wholesaler
ships product
to pharmacies,
hospitals, etc.
They scan bar code
with serial number
Rx
Pharmaceutical Supply Chain
Future with Serialization and Traceability
Regulatory mandates are
demanding visibility of products
from point of packaging to
point of dispense.
• These mandates demand improved
supply chain visibility
• Products are identified, serialized,
authenticated, tracked & traced
• What product? Where has it been?
Where is it going? How long has it
been there?
• Using data captured as product
moves through the supply chain,
answers questions as to the
disposition of inventory
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Using GS1 compliant barcodes (UCC-EAN13)
Each product SKU has one relative barcode
(UCC-EAN13)
Download E-code from website client.
Every E-code is unique
However, every carton has their different, unique
E-code though they have the same UCC- EAN13
China Electronic Tracking Code (E-Code)
• E-code code (serial number) according to code 128C standard
• The electronic tracking code doesn’t follow the GS1 standard – that is, E-code is not
GTIN, SSCC, GLN etc.
• The E-code is given by E-code website client managed by 21th century,
Acquired by Alibaba which was on IPO in US
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Public-Private Partnerships Needed for Success
APEC Business Advisory Council – Regulations,
Standards and Track & Trace
European Stakeholder Model (ESM) – European
Medicine Verification System for EU Falsified Medicines
Directive
Pharmaceutical Distribution Security Alliance (PDSA) –
US Drug Supply Chain Security Act Consortium
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Industry
Consumer
Government
Public-Private-Consumer Partnerships
Enabling Environment
Enforcement & Prosecution
Zero Tolerance
Awareness Campaigns
International Cooperation
Global Standards
Awareness
Verification
Reporting
Monitoring & Reporting
Awareness Programs for
Consumers & Professionals
Implementation
Global Standards
21 countries
13. APEC Business Advisory Council
Global Data Standards: Supply Chain Integrity for
Pharmaceutical Products
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APEC Business Advisory Council (ABAC)
Global Standards: Serialization and Track & Trace Pilot
Several pharmaceutical manufacturer participants
Facilitated by University of Tennessee Health Science
Center and Memphis University with involvement from
GS1 Global
Phase I - Assessed status of need for global healthcare
standards (report drafted…finalize in next 1-2 months)
Phase II – Developing serialization and track & trace
pilot
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ABAC – Phase II Project Planning
The goal of Phase II is to develop a pilot for the
utilization of an appropriate standard
o GS1 Healthcare Standards
The project objective is to demonstrate visibility across
the pharmaceutical supply chain from manufacturer to
patient
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ABAC – Phase II Project Planning
Phase II Project Roadmap
o Identification of products with GS1 Standards
o Include automatic identification and data capture (AIDC)
technologies and business-to-business electronic messaging
(eCom)
o Identification of pharmaceutical companies (multinational/local) as
voluntary participants in the large-scale pilot project
o Identification of specific products
o Identification of at least two APEC countries and destination cities
within those countries for participation in the project
o Identification of wholesalers/distributors and their respective
drugstores and/or healthcare provider institutions for participation
o Determination of period of execution of the project
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ABAC – Phase II Project Planning
Identification of success indicators including:
o Effectiveness of receipt process and forwarding of information to a
traceability web platform for
– Manufacturers
– Wholesalers/Distributors
– Pharmacies
– Healthcare providers
o Capabilities to trace medications by supply channel, commercial
and institutional
o Query capabilities for inspection, oversight, and Control process
o Product recall simulation results
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EU Falsified Medicines Directive
Requires serialization by manufacturers, and verification
at the point of dispense by pharmacists
Tamper evident features must be applied by
manufacturers
Mandates manufacturers to fund the medicines
verification system
Information can be used by competent authorities for
other purposes – e.g., reimbursement,
pharmacoepidemiology studies
In response, EFPIA formed the European Stakeholder Model (ESM)
bringing together all the relevant stakeholders to be proactive in securing the legal
supply chain and to protect patients
20. ESM STAKEHOLDERS HAVE A COMMON
VISION OF MEDICINES VERIFICATION
Protect patients
Secure the legal supply chain
Be proactive as market
partners
Set up a stakeholder-
governed model that is
Functioning
Harmonised
Cost-effective
Inter-operable
20
21. FUNDAMENTAL PRINCIPLES FOR
MEDICINES VERIFICATION IN THE EU
•Unique identifier with randomised serial number + tamper evident packaging
•Check of pack’s authenticity at point of dispense
SAFETY
FEATURES
•Transactional data belongs to stakeholder that generated it, e.g. pharmacists for
dispensing data
•No access to data of other stakeholders except for verification purposes
DATA
•Systems governed by independent non-profit organisations, established and
managed by relevant stakeholders
•Systems supervised by EU and/or national authorities
•Data accessible for competent authorities for reimbursement,
pharmacovigilance & pharmaco-epidemiology purposes
GOVERNANCE
•Coding system harmonised across Europe based on ISO-standards allowing
integration of existing national codes
•Flexible to implement national solutions within an EU technical framework
•Interoperable between different national systems through European Hub
SYSTEM
DESIGN
21
22. COMMON BASIC CONCEPT: UNIQUE IDENTIFIER
Data-Matrix code, developed to ISO-standards
Supports GS1 standards
Key data elements:
Product code (GTIN/NTIN)
Randomised unique serial number
Expiry date
Batch number
National health number (where necessary)
Product #: 09876543210982
Batch: A1C2E3G4I5
Expiry: 140531
S/N: 12345AZRQF1234567890 Expected to be required by
Delegated Act
22
24. European Medicines Verification System
Design for Interoperability and Efficiency
Germany
National
System
Pharmacy
Wholesaler
Pharmaceutical
Manufacturer
Parallel
Distributor
National
System
European
Hub
24
National Blueprint
System
National Blueprint
System
National Blueprint
System
National Blueprint
System
Blueprint template to reduce cost of national
systems and to ensure interoperability
25. GOVERNANCE STRUCTURE ALLOWS FOR
EFFECTIVE MANAGEMENT OF VERIFICATION
SYSTEM
GENERAL PRINCIPLE
System management and governance by not-for-profit
organisation under supervision of relevant competent authority
EU level and national level organisations cooperate on the basis of
service level agreements
NATIONAL LEVEL
National Medicines Verification
Organisations (NMVO), e.g.
in Germany: securPharm e.V.
EU LEVEL
European Medicines
Verification Organisation
(EMVO, to be founded)
25
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Summary
• Growing awareness and
support from regulators for
GS1 standards
• Benefits include:
• Improves patient safety
• Helps fight against counterfeit
products
• Improves supply chain integrity
• Accurately identifies product for
evidence-based medicine,
adverse event reporting
• Helps ensure the 5 R’s, e.g.,
right product, right dosage,
right patient, right route, right
time
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7 Billion Reasons to Care
Serialization and Traceability Will Benefit
Patients and Consumers Around the Globe
29