The presentation complemented a 60 minutes webinar on ISO IDMP provided by Cunesoft in May 2015. Benefits of a regulatory master data management system are being analyzed. The entire webinar was recorded. The latest information on IDMP can be accessed on our website: https://www.phlexglobal.com/idmp
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.
The IDMP Challenge - Whitepaper on ISO IDMP by CunesoftV E R A
The updated whitepaper on ISO IDMP - learn what you need to know during this transition. And how Cunesoft's cune-IDMP can help your organization: https://cunesoft.com/en/products/idmp/
The document provides an overview of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards. It discusses the origin and purpose of IDMP, which is to uniquely identify regulated pharmaceutical products across their lifecycle using standardized data. Key points include:
- IDMP consists of 5 ISO standards and 4 implementation guides to define over 500 standardized data fields for describing medicinal products, substances, organizations, and controlled vocabularies.
- Implementation will be phased and is intended to facilitate data exchange between organizations and regulators for activities like clinical trials, pharmacovigilance, and regulatory submissions.
- Challenges to implementation include standardized structuring of existing unstructured data and linking product
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
The document discusses challenges related to IDMP compliance, including information stored across different systems and formats, duplication of data, lack of integration between processes. It then outlines potential solutions to these challenges like entity extraction to transform unstructured data, master data management to connect siloed structured data, reference data management to handle semantic issues, and linked data approaches to publish structured, interconnected data using common standards and identifiers. The value of these solutions beyond mere compliance is also discussed in terms of transparency, risk reduction, efficiency and collaboration.
1) IDMP and RIM aim to harmonize product and regulatory information management but face challenges due to conflicting data sources and definitions between organizations and regions.
2) Implementing IDMP requires mapping diverse internal data systems and formats to a common IDMP data model and identifiers, which is complicated by varying data quality, timeliness, and ownership.
3) A master data management approach is needed to define authoritative sources, ownership, validation requirements, and change control to accurately populate the IDMP data containers and address issues across multiple systems over time.
This document discusses the synergies between regulatory information management (RIM) and identification of medicinal products (IDMP). It argues that RIM and IDMP should be considered together, not separately, as IDMP expands on product data beyond what was traditionally included in RIM. The implementation of IDMP standards will converge various regulatory data initiatives and shape future regulatory submissions that will utilize structured IDMP data instead of documents. RIM systems will benefit from using the IDMP data model to standardize product information captured across systems and sources.
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 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.
The IDMP Challenge - Whitepaper on ISO IDMP by CunesoftV E R A
The updated whitepaper on ISO IDMP - learn what you need to know during this transition. And how Cunesoft's cune-IDMP can help your organization: https://cunesoft.com/en/products/idmp/
The document provides an overview of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards. It discusses the origin and purpose of IDMP, which is to uniquely identify regulated pharmaceutical products across their lifecycle using standardized data. Key points include:
- IDMP consists of 5 ISO standards and 4 implementation guides to define over 500 standardized data fields for describing medicinal products, substances, organizations, and controlled vocabularies.
- Implementation will be phased and is intended to facilitate data exchange between organizations and regulators for activities like clinical trials, pharmacovigilance, and regulatory submissions.
- Challenges to implementation include standardized structuring of existing unstructured data and linking product
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
The document discusses challenges related to IDMP compliance, including information stored across different systems and formats, duplication of data, lack of integration between processes. It then outlines potential solutions to these challenges like entity extraction to transform unstructured data, master data management to connect siloed structured data, reference data management to handle semantic issues, and linked data approaches to publish structured, interconnected data using common standards and identifiers. The value of these solutions beyond mere compliance is also discussed in terms of transparency, risk reduction, efficiency and collaboration.
1) IDMP and RIM aim to harmonize product and regulatory information management but face challenges due to conflicting data sources and definitions between organizations and regions.
2) Implementing IDMP requires mapping diverse internal data systems and formats to a common IDMP data model and identifiers, which is complicated by varying data quality, timeliness, and ownership.
3) A master data management approach is needed to define authoritative sources, ownership, validation requirements, and change control to accurately populate the IDMP data containers and address issues across multiple systems over time.
This document discusses the synergies between regulatory information management (RIM) and identification of medicinal products (IDMP). It argues that RIM and IDMP should be considered together, not separately, as IDMP expands on product data beyond what was traditionally included in RIM. The implementation of IDMP standards will converge various regulatory data initiatives and shape future regulatory submissions that will utilize structured IDMP data instead of documents. RIM systems will benefit from using the IDMP data model to standardize product information captured across systems and sources.
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
Pistoia Alliance Debates: IDMP: It’s all about the patient: enhancing patient...Pistoia Alliance
This webinar discusses IDMP (Identification of Medicinal Products) and focuses on substances and their implementation. It provides background on IDMP, timelines for implementation in the EU which is driving standardization, and an example substance record for Brentuximab Vedotin to illustrate the level of detail in substance definitions. The goal of IDMP is to improve patient safety through standardized identification and exchange of information on medicines and ingredients.
The document provides an overview of the key aspects of the European Union's General Data Protection Regulation (GDPR). It discusses definitions like personal data, the rights of individuals as data subjects, and key principles of GDPR around consent, data breaches, international transfers, the right to be forgotten, and privacy by design. It outlines actors like controllers and processors, their obligations, and components of GDPR compliance like impact assessments, authorities, and fines for non-compliance.
The document discusses Generis's Intelligent Content Services Platform and CARA software. It provides an overview of CARA's capabilities for regulatory information management, submissions management, and other regulatory and clinical processes. It highlights CARA's flexibility and ability to support multiple use cases across the product lifecycle from development through commercialization. Examples of large life sciences companies using CARA for regulatory information management and submissions are also provided.
How to identify the correct Master Data subject areas & tooling for your MDM...Christopher Bradley
1. What are the different Master Data Management (MDM) architectures?
2. How can you identify the correct Master Data subject areas & tooling for your MDM initiative?
3. A reference architecture for MDM.
4. Selection criteria for MDM tooling.
chris.bradley@dmadvisors.co.uk
Top 7 Capabilities for Next-Gen Master Data ManagementDATAVERSITY
This session will discuss how the master data management platforms are evolving to meet needs of digital economy. A modern master data management platform incorporates graph technology, infuses insights from the data using advanced analytics and ML, and offer big data scale performance in the cloud. Join this webinar to learn about these and other critical capabilities that power connected customer experience, compliance, and business alignment.
Appalla Venkataprabhakar and I presented this at the Oracle\'s Annual Clinical Development and Safety Conference 2010 at Hyderabad, India on 6th October 2010.
The presentation discusses master data management and reference data. It covers defining key data, assessing the impact of MDM, creating a common data quality vision, and the importance of an enterprise data model. Specific topics include the data architecture, mapping vendor data to standard definitions, how MDM provides a single customer view, the role of the customer master index, and how MDM supports both CRM and BI applications.
The document discusses regulatory intelligence and its importance. It defines regulatory intelligence as gathering and analyzing publicly available regulatory information, communicating implications, and monitoring regulations for opportunities. Sources of information discussed include regulatory authority websites, agency meeting minutes, previous drug approvals, and social media. Regulatory intelligence is used by pharmaceutical companies for product planning, regulatory agencies to consider precedents, and lawyers to interpret laws. The document encourages sharing knowledge and regulatory intelligence methods.
Forget Big Data. It's All About Smart DataAlan McSweeney
This proposes an initial smart data framework and structure to allow the nuggets of value contained in the deluge of largely irrelevant and useless data to be isolated and extracted. It enables your organisation to ask the questions to understand where it should be in terms of its data state and profile and what it should do to achieve the desired skills level across the competency areas of the framework.
Every organisation operates within a data landscape with multiple sources of data relating to its activities that is acquired, transported, stored, processed, retained, analysed and managed. Interactions across the data landscape generate primary data. When you extend the range of possible interactions business processes outside the organisation you generate a lot more data.
Smart data means being:
• Smart in what data to collect, validate and transform
• Smart in how data is stored, managed, operated and used
• Smart in taking actions based on results of data analysis including organisation structures, roles, devolution and delegation of decision-making, processes and automation
• Smart in being realistic, pragmatic and even skeptical about what can be achieved and knowing what value can be derived and how to maximise value obtained
• Smart in defining an achievable, benefits-lead strategy integrated with the needs business and in its implementation
• Smart in selecting the channels and interactions to include – smart data use cases
Smart data competency areas comprise a complete set of required skills and abilities to design, implement and operate an appropriate smart data programme.
This document discusses safety data exchange agreements (SDEAs). It outlines the stakeholders involved in managing SDEAs, including legal, pharmacovigilance, sales, marketing, and business partners. SDEAs can be between two parties or involve more complex agreements between multiple affiliates, subsidiaries, vendors, and other partners. The key sections of an SDEA address legal matters, information exchange procedures, and safety responsibilities. Proper review and execution of SDEAs by authorized representatives helps ensure legal and company interests are protected.
The document discusses the electronic common technical document (eCTD) format for regulatory submissions to agencies like the FDA. It describes the structure of an eCTD, which includes five modules containing administrative information, summaries, quality details, nonclinical studies, and clinical studies. It also discusses the process of developing and submitting an eCTD, including using XML and PDF files. Regulatory agencies in countries like the US, EU, Japan and Canada accept eCTD submissions for applications like new drug applications.
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
Hexaware is a leading global provider of IT and BPO services with leadership positions in banking, financial services, insurance, transportation and logistics. It focuses on delivering business results through technology solutions such as business intelligence and analytics, enterprise applications, independent testing and legacy modernization. Hexaware has over 18 years of experience in providing business technology solutions and offers world class services, technology expertise and skilled human capital.
Safety Data Exchange Agreements (Brief)
An integral part of enterprise risk management systems
Strategic management framework
Governance model
Standards, mechanisms, and metrics for management oversight
Roles and responsibilities
Stakeholder collaboration
Procedural documents and SDEA templates
CAPA management processes
Supporting systems
Document repositories
We are publishing a draft of the technical standards of the Personal Health Records (PHR) component of the National Health Stack (NHS)!
As a refresher, these standards govern the consented sharing of health information between Health Information Providers (HIPs) - like hospitals, pathology labs, and clinics - and Health Information Users (HIUs) like pharmacies, medical consultants, doctors, and so on. The user’s consent to share their health data is issued via a new entity called a Health Data Consent Manager (HDCM).
The problem today is that the electronic health records listed in one app or ecosystem are not easily portable to other systems. There is no common standard that can be used to discover, share, and authenticate data between different networks or ecosystems. This means that the electronic medical records generated by users end up being confined to many different isolated silos, which can result in frustrating and complex experiences for patients wishing to manage data lying across different providers.
With the PHR system, a user is able to generate a longitudinal view of their health data across providers. The interoperability and security of the PHR architecture allows users to securely discover, share, and manage their health data in a safe, convenient, and universally acceptable manner. For instance, a user could use a HDCM to discover their account at one hospital or diagnostic lab, and then select certain electronic reports to share with a doctor from another hospital or clinic. The flow of data would be safe, and the user would have granular control over who can access their data and for how long. Here is a small demo of the PHR system in action.
The standards in the draft released today offers a high-level description of the architecture and flows that make this possible.
Building a Foundation for Proactive and Predictive PharmacovigilanceVeeva Systems
Learn how PV teams can easily keep up with evolving compliance requirements with modern safety applications that provide better data control and drive greater efficiencies.
View on-demand session: https://bit.ly/3vIzQG9
Clinical data transparency - EMA Policy 0070Qdossier B.V.
This document provides an overview of EMA Policy 0070 on the publication of clinical data for medicinal products. It discusses the redaction of personal protected data and commercially confidential information from clinical reports. It also outlines the technical requirements and submissions process for proposed and final redaction packages.
Geek Sync | Data Architecture and Data Governance: A Powerful Data Management...IDERA Software
You can watch the replay for this Geek Sync webcast, Data Architecture and Data Governance: A Powerful Data Management Duo, on the IDERA Resource Center, http://ow.ly/95yL50A4rZg.
Batman and Robin. Han Solo and Chewbacca. Mario and Luigi. Just like these famous pairings, so it is for data architecture and data governance — they’re aligned to support each other in a variety of ways. Like data governance, data architecture as a practice can be leveraged to identify and enforce standards within the systems landscape to support business objectives. And data architecture certainly benefits from sound business oversight and stakeholder influences inherent in a successful data governance program.
Join Kelle O’Neal to learn about the critical aspects of aligning data architecture and data governance, with a specific focus on:
-Why aligning data architecture and data governance is important
-The key intersections of people, processes and technology between data architecture and data governance
-How data architecture and data governance work together to enforce standards
-The capabilities that data governance can apply to data architecture without interfering
-How your project and development methodologies can help drive alignment
Webinar: How Banks Manage Reference Data with MongoDBMongoDB
1. MongoDB is well-suited for reference data solutions due to its dynamic and flexible schema, built-in replication and high availability features, and tag aware sharding which allows for geographic distribution of data.
2. A case study of a global broker dealer showed how MongoDB could replace expensive and complex ETL processes for distributing reference data, saving over $40 million over 5 years.
3. Key benefits included real-time data distribution, faster querying of local data, and avoiding regulatory penalties from delays in data distribution.
Database Designing in Clinical Data ManagementClinosolIndia
When designing a Clinical Data Management (CDM) database, several key considerations should be taken into account to ensure efficient data capture, storage, and retrieval. Here are some important aspects to consider in CDM database design:
Define Study Requirements:
Understand the specific requirements of the study and the data to be collected. This includes variables, data types, formats, and any specific rules or calculations required for data validation and derivation. Consult with the study team and stakeholders to determine the necessary data elements.
Data Model Design:
Develop a data model that represents the structure and relationships of the data. Use standard data models, such as CDISC (Clinical Data Interchange Standards Consortium) standards, as a foundation. Define entities (e.g., patients, visits, assessments) and attributes (e.g., demographics, lab results) and establish relationships between them.
Data Dictionary:
Create a comprehensive data dictionary that provides a detailed description of each data element, including its name, definition, data type, length, format, allowable values, and any validation or derivation rules. The data dictionary serves as a reference for data entry and validation checks.
Database Schema:
Design the database schema based on the data model and data dictionary. Identify the tables, fields, and relationships needed to store the data. Determine primary and foreign keys to establish relationships between tables. Normalize the schema to reduce redundancy and improve data integrity.
Data Capture Forms:
Design user-friendly data capture forms to facilitate efficient and accurate data entry. Align the form layout with the data model and data dictionary. Include necessary data validation checks and provide clear instructions or prompts for data entry.
Data Validation and Quality Checks:
Incorporate data validation checks to ensure data accuracy and completeness. Implement range checks, format checks, consistency checks, and logic checks to identify and prevent data entry errors. Include data quality control processes to identify and resolve data discrepancies or anomalies.
Security and Access Controls:
Implement appropriate security measures to protect the confidentiality, integrity, and availability of the data. Define user roles and access levels to control data access and modification. Employ encryption, authentication, and audit trails to ensure data security and compliance with regulatory requirements.
Data Extraction and Reporting:
Consider the need for data extraction and reporting capabilities. Design mechanisms to extract data from the database for analysis or reporting purposes. Implement data export functionalities in commonly used formats, such as CSV or Excel, or integrate with reporting tools or systems.
Getting IDMP Ready via Modern Product Data ManagementCognizant
For life sciences and pharma companies, compliance with the identification of medicinal products (IDMP) mandate is best achieved by building on an existing IDMP-compliant data management platform that can integrate all product master data.
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.
Pistoia Alliance Debates: IDMP: It’s all about the patient: enhancing patient...Pistoia Alliance
This webinar discusses IDMP (Identification of Medicinal Products) and focuses on substances and their implementation. It provides background on IDMP, timelines for implementation in the EU which is driving standardization, and an example substance record for Brentuximab Vedotin to illustrate the level of detail in substance definitions. The goal of IDMP is to improve patient safety through standardized identification and exchange of information on medicines and ingredients.
The document provides an overview of the key aspects of the European Union's General Data Protection Regulation (GDPR). It discusses definitions like personal data, the rights of individuals as data subjects, and key principles of GDPR around consent, data breaches, international transfers, the right to be forgotten, and privacy by design. It outlines actors like controllers and processors, their obligations, and components of GDPR compliance like impact assessments, authorities, and fines for non-compliance.
The document discusses Generis's Intelligent Content Services Platform and CARA software. It provides an overview of CARA's capabilities for regulatory information management, submissions management, and other regulatory and clinical processes. It highlights CARA's flexibility and ability to support multiple use cases across the product lifecycle from development through commercialization. Examples of large life sciences companies using CARA for regulatory information management and submissions are also provided.
How to identify the correct Master Data subject areas & tooling for your MDM...Christopher Bradley
1. What are the different Master Data Management (MDM) architectures?
2. How can you identify the correct Master Data subject areas & tooling for your MDM initiative?
3. A reference architecture for MDM.
4. Selection criteria for MDM tooling.
chris.bradley@dmadvisors.co.uk
Top 7 Capabilities for Next-Gen Master Data ManagementDATAVERSITY
This session will discuss how the master data management platforms are evolving to meet needs of digital economy. A modern master data management platform incorporates graph technology, infuses insights from the data using advanced analytics and ML, and offer big data scale performance in the cloud. Join this webinar to learn about these and other critical capabilities that power connected customer experience, compliance, and business alignment.
Appalla Venkataprabhakar and I presented this at the Oracle\'s Annual Clinical Development and Safety Conference 2010 at Hyderabad, India on 6th October 2010.
The presentation discusses master data management and reference data. It covers defining key data, assessing the impact of MDM, creating a common data quality vision, and the importance of an enterprise data model. Specific topics include the data architecture, mapping vendor data to standard definitions, how MDM provides a single customer view, the role of the customer master index, and how MDM supports both CRM and BI applications.
The document discusses regulatory intelligence and its importance. It defines regulatory intelligence as gathering and analyzing publicly available regulatory information, communicating implications, and monitoring regulations for opportunities. Sources of information discussed include regulatory authority websites, agency meeting minutes, previous drug approvals, and social media. Regulatory intelligence is used by pharmaceutical companies for product planning, regulatory agencies to consider precedents, and lawyers to interpret laws. The document encourages sharing knowledge and regulatory intelligence methods.
Forget Big Data. It's All About Smart DataAlan McSweeney
This proposes an initial smart data framework and structure to allow the nuggets of value contained in the deluge of largely irrelevant and useless data to be isolated and extracted. It enables your organisation to ask the questions to understand where it should be in terms of its data state and profile and what it should do to achieve the desired skills level across the competency areas of the framework.
Every organisation operates within a data landscape with multiple sources of data relating to its activities that is acquired, transported, stored, processed, retained, analysed and managed. Interactions across the data landscape generate primary data. When you extend the range of possible interactions business processes outside the organisation you generate a lot more data.
Smart data means being:
• Smart in what data to collect, validate and transform
• Smart in how data is stored, managed, operated and used
• Smart in taking actions based on results of data analysis including organisation structures, roles, devolution and delegation of decision-making, processes and automation
• Smart in being realistic, pragmatic and even skeptical about what can be achieved and knowing what value can be derived and how to maximise value obtained
• Smart in defining an achievable, benefits-lead strategy integrated with the needs business and in its implementation
• Smart in selecting the channels and interactions to include – smart data use cases
Smart data competency areas comprise a complete set of required skills and abilities to design, implement and operate an appropriate smart data programme.
This document discusses safety data exchange agreements (SDEAs). It outlines the stakeholders involved in managing SDEAs, including legal, pharmacovigilance, sales, marketing, and business partners. SDEAs can be between two parties or involve more complex agreements between multiple affiliates, subsidiaries, vendors, and other partners. The key sections of an SDEA address legal matters, information exchange procedures, and safety responsibilities. Proper review and execution of SDEAs by authorized representatives helps ensure legal and company interests are protected.
The document discusses the electronic common technical document (eCTD) format for regulatory submissions to agencies like the FDA. It describes the structure of an eCTD, which includes five modules containing administrative information, summaries, quality details, nonclinical studies, and clinical studies. It also discusses the process of developing and submitting an eCTD, including using XML and PDF files. Regulatory agencies in countries like the US, EU, Japan and Canada accept eCTD submissions for applications like new drug applications.
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
Hexaware is a leading global provider of IT and BPO services with leadership positions in banking, financial services, insurance, transportation and logistics. It focuses on delivering business results through technology solutions such as business intelligence and analytics, enterprise applications, independent testing and legacy modernization. Hexaware has over 18 years of experience in providing business technology solutions and offers world class services, technology expertise and skilled human capital.
Safety Data Exchange Agreements (Brief)
An integral part of enterprise risk management systems
Strategic management framework
Governance model
Standards, mechanisms, and metrics for management oversight
Roles and responsibilities
Stakeholder collaboration
Procedural documents and SDEA templates
CAPA management processes
Supporting systems
Document repositories
We are publishing a draft of the technical standards of the Personal Health Records (PHR) component of the National Health Stack (NHS)!
As a refresher, these standards govern the consented sharing of health information between Health Information Providers (HIPs) - like hospitals, pathology labs, and clinics - and Health Information Users (HIUs) like pharmacies, medical consultants, doctors, and so on. The user’s consent to share their health data is issued via a new entity called a Health Data Consent Manager (HDCM).
The problem today is that the electronic health records listed in one app or ecosystem are not easily portable to other systems. There is no common standard that can be used to discover, share, and authenticate data between different networks or ecosystems. This means that the electronic medical records generated by users end up being confined to many different isolated silos, which can result in frustrating and complex experiences for patients wishing to manage data lying across different providers.
With the PHR system, a user is able to generate a longitudinal view of their health data across providers. The interoperability and security of the PHR architecture allows users to securely discover, share, and manage their health data in a safe, convenient, and universally acceptable manner. For instance, a user could use a HDCM to discover their account at one hospital or diagnostic lab, and then select certain electronic reports to share with a doctor from another hospital or clinic. The flow of data would be safe, and the user would have granular control over who can access their data and for how long. Here is a small demo of the PHR system in action.
The standards in the draft released today offers a high-level description of the architecture and flows that make this possible.
Building a Foundation for Proactive and Predictive PharmacovigilanceVeeva Systems
Learn how PV teams can easily keep up with evolving compliance requirements with modern safety applications that provide better data control and drive greater efficiencies.
View on-demand session: https://bit.ly/3vIzQG9
Clinical data transparency - EMA Policy 0070Qdossier B.V.
This document provides an overview of EMA Policy 0070 on the publication of clinical data for medicinal products. It discusses the redaction of personal protected data and commercially confidential information from clinical reports. It also outlines the technical requirements and submissions process for proposed and final redaction packages.
Geek Sync | Data Architecture and Data Governance: A Powerful Data Management...IDERA Software
You can watch the replay for this Geek Sync webcast, Data Architecture and Data Governance: A Powerful Data Management Duo, on the IDERA Resource Center, http://ow.ly/95yL50A4rZg.
Batman and Robin. Han Solo and Chewbacca. Mario and Luigi. Just like these famous pairings, so it is for data architecture and data governance — they’re aligned to support each other in a variety of ways. Like data governance, data architecture as a practice can be leveraged to identify and enforce standards within the systems landscape to support business objectives. And data architecture certainly benefits from sound business oversight and stakeholder influences inherent in a successful data governance program.
Join Kelle O’Neal to learn about the critical aspects of aligning data architecture and data governance, with a specific focus on:
-Why aligning data architecture and data governance is important
-The key intersections of people, processes and technology between data architecture and data governance
-How data architecture and data governance work together to enforce standards
-The capabilities that data governance can apply to data architecture without interfering
-How your project and development methodologies can help drive alignment
Webinar: How Banks Manage Reference Data with MongoDBMongoDB
1. MongoDB is well-suited for reference data solutions due to its dynamic and flexible schema, built-in replication and high availability features, and tag aware sharding which allows for geographic distribution of data.
2. A case study of a global broker dealer showed how MongoDB could replace expensive and complex ETL processes for distributing reference data, saving over $40 million over 5 years.
3. Key benefits included real-time data distribution, faster querying of local data, and avoiding regulatory penalties from delays in data distribution.
Database Designing in Clinical Data ManagementClinosolIndia
When designing a Clinical Data Management (CDM) database, several key considerations should be taken into account to ensure efficient data capture, storage, and retrieval. Here are some important aspects to consider in CDM database design:
Define Study Requirements:
Understand the specific requirements of the study and the data to be collected. This includes variables, data types, formats, and any specific rules or calculations required for data validation and derivation. Consult with the study team and stakeholders to determine the necessary data elements.
Data Model Design:
Develop a data model that represents the structure and relationships of the data. Use standard data models, such as CDISC (Clinical Data Interchange Standards Consortium) standards, as a foundation. Define entities (e.g., patients, visits, assessments) and attributes (e.g., demographics, lab results) and establish relationships between them.
Data Dictionary:
Create a comprehensive data dictionary that provides a detailed description of each data element, including its name, definition, data type, length, format, allowable values, and any validation or derivation rules. The data dictionary serves as a reference for data entry and validation checks.
Database Schema:
Design the database schema based on the data model and data dictionary. Identify the tables, fields, and relationships needed to store the data. Determine primary and foreign keys to establish relationships between tables. Normalize the schema to reduce redundancy and improve data integrity.
Data Capture Forms:
Design user-friendly data capture forms to facilitate efficient and accurate data entry. Align the form layout with the data model and data dictionary. Include necessary data validation checks and provide clear instructions or prompts for data entry.
Data Validation and Quality Checks:
Incorporate data validation checks to ensure data accuracy and completeness. Implement range checks, format checks, consistency checks, and logic checks to identify and prevent data entry errors. Include data quality control processes to identify and resolve data discrepancies or anomalies.
Security and Access Controls:
Implement appropriate security measures to protect the confidentiality, integrity, and availability of the data. Define user roles and access levels to control data access and modification. Employ encryption, authentication, and audit trails to ensure data security and compliance with regulatory requirements.
Data Extraction and Reporting:
Consider the need for data extraction and reporting capabilities. Design mechanisms to extract data from the database for analysis or reporting purposes. Implement data export functionalities in commonly used formats, such as CSV or Excel, or integrate with reporting tools or systems.
Getting IDMP Ready via Modern Product Data ManagementCognizant
For life sciences and pharma companies, compliance with the identification of medicinal products (IDMP) mandate is best achieved by building on an existing IDMP-compliant data management platform that can integrate all product master data.
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.
Infodream, is the European leader in the quality software for 27 years. We are specialized in monitoring and improving quality in manufacturing.
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ISO standards for identification of medical products (IDMP) are set to require pharmaceuticals companies to comply with medicinal identification standards. We explain how to get started and navigate a smooth IDMP transition.
Focus on the real-life case study E-reputation for Air France, a company that is innovative in their use of social media, following conversations in order to better understand their clients who express themselves spontaneously on blogs, forums, advice websites, Twitter, Facebook etc.
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Coca-Cola Hellenic, one of the largest Coca-Cola bottlers worldwide, has started a three year long project to substitute all legacy systems with a SAP implementation called Wave 2, in order to maximize efficiencies in use of resources and apply common best practices and polices accross the group.
"Implementing a lean approach in IT operations and infrastructure" by Philipp...Institut Lean France
The document discusses implementing a Lean approach in IT operations and infrastructure at BNP Paribas. It describes how BNP Paribas IT Group Production delivers services to numerous BNP Paribas entities with over 1,500 employees and 5 strategic datacenters. It implemented a new continuous improvement approach called ACE to address increasing complexity, need for agility, and cost control challenges. ACE projects follow a 13-week process involving teams, coaches, and sponsors to identify improvements through analyzing processes and collaborator involvement. Initial projects showed significant benefits like improved performance metrics, problem resolution, and collaborator understanding of processes.
beCPG PLM - R&D and Quality software for Food & Beverage industriesbeCPG
In a few words, beCPG is an open source PLM offering the following features:
- Product specification management
- Formula and recipe management
- Project portfolio management for new product development from idea generation to product launch on the market
http://www.becpg.net
Best ERP Software Company in Delhi, NCRDennis Mark
Our ERP solutions simplify key business operations whilst improving operational efficiency. Our web based ERP solution in India consists of several key modules such as finance/accounting, sales/marketing, purchase, inventory and much more making it a perfect pick for businesses involved in diverse industry verticals in whole India. For more details please visit our website www.brinnam.com
The document discusses the Identification of Medicinal Products (IDMP) standards which will replace the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD). IDMP has a broader scope than XEVMPD and encompasses regulatory, pharmacovigilance, quality and manufacturing data. It consists of five interrelated standards and will require companies to locate data from across their organizations to comply. Implementation is driven by EU legislation and is scheduled for July 1, 2016, requiring companies to begin strategic preparation now to have systems in place to manage IDMP data.
Sanofi Aventis Analytics Journey: Transforming Big PharmaYuri Kudryavcev
This document discusses Sanofi-Aventis' transformation of its financial performance management in Asia Pacific through the deployment of a standardized core model in IBM Cognos TM1. Key points:
- Sanofi-Aventis is a global healthcare leader with diversified medicines and vaccines in 100+ countries.
- Previously, each local operation had different non-standard planning and reporting processes, making regional visibility difficult.
- The project aimed to build an analytics platform for standardized planning/reporting across APAC, going mobile, and accelerating key finance processes.
- PMsquare partnered with Sanofi to deploy the core TM1 model to 3 countries every 6 months, balancing standardization
The document provides an overview of IT solutions for emissions monitoring and reporting under the EU Emissions Trading Scheme. It summarizes a survey conducted by PricewaterhouseCoopers of six software vendors: Pavilion, ESP, Promasys, EPM, CRS, and TechniData. The document describes the key drivers for using specialized software over spreadsheets for emissions monitoring and reporting. It provides high-level descriptions of the software solutions and their functionalities. The document also discusses factors to consider when selecting an emissions monitoring and reporting software solution.
Applying Technologies Across the End-to-End Pharmacovigilance Process to Incr...MyMeds&Me
MyMeds&Me CEO Andrew Rut and Oracle Health Science's Director of Safety Analytics, Michael Braun-Boghos review the positive impacts of technology on current pharmacovigilance processes.
Corporate presentation (short with examples)PCA Services
PCA Services is a commercial entity focused on industrial data interoperability. It aims to facilitate sharing of precise data between organizations through projects that apply standardized reference data. Two example projects are ILAP, which uses semantic technology to integrate lifecycle asset planning data across different software tools, and STI, which seeks to standardize definitions and formats for technical information on common equipment in the oil and gas industry. PCA Services provides a reference data library and technical platform to enable broad application of standardized data between domains and systems.
Building a guided analytics forecasting platform with KnimeKnoldus Inc.
Maintaining inventory and ensuring that stock is consumed efficiently is a key decision that many companies - particularly those in retail - have to make. Explore how you can do it easily with KNIME Platform.
It strategy for life sciences david royleDavid Royle
An Information Technology strategy for contract research organisations in Life Sciences. A layered approach to building an Information Technology platform.
110818 leitfaden datenschutz_englisch_finalPhong Ho
This document provides data protection guidelines for implementing SAP ERP 6.0 systems in compliance with German data protection laws. It is intended for data protection officials and others responsible for installing and configuring SAP applications. The document covers key requirements around collecting, processing, transferring and using personal data. It also provides guidance on rights of data subjects, documentation requirements, technical and organizational security measures, and the role of the data protection officer in ensuring compliance throughout the SAP implementation and use.
This document provides information on ROLLINGDICE's multilingual call center solutions and PV247 pharmacovigilance software. ROLLINGDICE offers multilingual call center services through its subsidiary Fusion BPO Services, which has facilities in North America, India, the Philippines, and El Salvador. PV247 is a hosted pharmacovigilance system that provides drug safety software and eliminates the need for large upfront costs compared to traditional systems.
SOMLink the Innovator in Suspicious Order MonitoringKelly Forrester
We created the innovator in suspicious order monitoring software. Our SOMLink is backed by 16 defensible algorithms and equips companies with the necessary tools to monitor and catch all orders of interest for prescription drugs. SOMLink is a suite of tools that uses statistical analysis to comply with Federal DEA 1301.74b regulation for controlled substances. SOMLink can be installed as a software or controlled in the cloud, and installs easily on the DEA's Registrant server for maximum compliance.
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Zodiac Signs and Food Preferences_ What Your Sign Says About Your Tastemy Pandit
Know what your zodiac sign says about your taste in food! Explore how the 12 zodiac signs influence your culinary preferences with insights from MyPandit. Dive into astrology and flavors!
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Top mailing list providers in the USA.pptxJeremyPeirce1
Discover the top mailing list providers in the USA, offering targeted lists, segmentation, and analytics to optimize your marketing campaigns and drive engagement.
Building Your Employer Brand with Social MediaLuanWise
Presented at The Global HR Summit, 6th June 2024
In this keynote, Luan Wise will provide invaluable insights to elevate your employer brand on social media platforms including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok. You'll learn how compelling content can authentically showcase your company culture, values, and employee experiences to support your talent acquisition and retention objectives. Additionally, you'll understand the power of employee advocacy to amplify reach and engagement – helping to position your organization as an employer of choice in today's competitive talent landscape.
Digital Marketing with a Focus on Sustainabilitysssourabhsharma
Digital Marketing best practices including influencer marketing, content creators, and omnichannel marketing for Sustainable Brands at the Sustainable Cosmetics Summit 2024 in New York
How are Lilac French Bulldogs Beauty Charming the World and Capturing Hearts....Lacey Max
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Best practices for project execution and deliveryCLIVE MINCHIN
A select set of project management best practices to keep your project on-track, on-cost and aligned to scope. Many firms have don't have the necessary skills, diligence, methods and oversight of their projects; this leads to slippage, higher costs and longer timeframes. Often firms have a history of projects that simply failed to move the needle. These best practices will help your firm avoid these pitfalls but they require fortitude to apply.
Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...my Pandit
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How to Implement a Real Estate CRM SoftwareSalesTown
To implement a CRM for real estate, set clear goals, choose a CRM with key real estate features, and customize it to your needs. Migrate your data, train your team, and use automation to save time. Monitor performance, ensure data security, and use the CRM to enhance marketing. Regularly check its effectiveness to improve your business.
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[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
This presentation is a curated compilation of PowerPoint diagrams and templates designed to illustrate 20 different digital transformation frameworks and models. These frameworks are based on recent industry trends and best practices, ensuring that the content remains relevant and up-to-date.
Key highlights include Microsoft's Digital Transformation Framework, which focuses on driving innovation and efficiency, and McKinsey's Ten Guiding Principles, which provide strategic insights for successful digital transformation. Additionally, Forrester's framework emphasizes enhancing customer experiences and modernizing IT infrastructure, while IDC's MaturityScape helps assess and develop organizational digital maturity. MIT's framework explores cutting-edge strategies for achieving digital success.
These materials are perfect for enhancing your business or classroom presentations, offering visual aids to supplement your insights. Please note that while comprehensive, these slides are intended as supplementary resources and may not be complete for standalone instructional purposes.
Frameworks/Models included:
Microsoft’s Digital Transformation Framework
McKinsey’s Ten Guiding Principles of Digital Transformation
Forrester’s Digital Transformation Framework
IDC’s Digital Transformation MaturityScape
MIT’s Digital Transformation Framework
Gartner’s Digital Transformation Framework
Accenture’s Digital Strategy & Enterprise Frameworks
Deloitte’s Digital Industrial Transformation Framework
Capgemini’s Digital Transformation Framework
PwC’s Digital Transformation Framework
Cisco’s Digital Transformation Framework
Cognizant’s Digital Transformation Framework
DXC Technology’s Digital Transformation Framework
The BCG Strategy Palette
McKinsey’s Digital Transformation Framework
Digital Transformation Compass
Four Levels of Digital Maturity
Design Thinking Framework
Business Model Canvas
Customer Journey Map