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
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
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 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 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
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 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/
Why is Regulatory Information Management (RIM) Important?Appian
How can you be you are compliant with all regulations when there are so many to manage? Learn how leading life sciences companies are using new processes, as well as new technologies to create tailor-made solutions, enabling global strategies in regulatory operations in this complimentary on-demand webinar: http://ap.pn/2eLrMAP
Your next RIM solution - 3 key considerations for your moveV E R A
Considering to move to a new Regulatory Information Management system? Have a look at our pick of the 3 key considerations while moving to a new RIM system.
If you wish to receive more information - write us at info@cunesoft.com or visit our page https://cunesoft.com/en/products/rim/
EU and US Procedures for API Registration - Commonalities and DifferencesMilliporeSigma
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, we’ll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, we’ll discuss the eCTD roadmap for the future and the end of paper submissions.
Pharmacovigilance "Module I" Pharmacovigilance system & their quality systemMohamed Raouf
This Module contains guidance for the establishment and maintenance of quality assured Pharmacovigilance systems for marketing authorization holders (MAHs) and national medicine authorities (NMAs).
Reference:- Guideline on good pharmacovigilance practices (GVP) version no.3
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...Perficient, Inc.
Ever since the European Union (EU) introduced new legislation that requires life sciences companies to proactively detect, prioritize, and evaluate safety signals, there has been an increased interest, not only from sponsors and CROs in the EU, but globally, in pharmacovigilance systems that can assist with the signal management process.
Perficient's Chris Wocosky, an expert in signal detection and management, shows how your organization can use Empirica Signal, Oracle's state-of-the-art signal detection system to data mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. This presentation and demonstration willhelp you bettter understand how this solution can be used in daily pharmacovigilance activities.
GMP Guidelines for Nutraceuticals - Indian And EuropeanVarshaJindaniya
This GMP Guidance Document covers the entire manufacturing process of Health Supplements/ Nutraceuticals in the form of Powders, Tablets, Capsules, Soft Gel Capsules and Liquids starting from procurement of raw materials to despatch of finished product.
Contact me: www.linkedin.com/in/varsha-jindaniya
Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...Torben Haagh
Want to learn more about how to cover gaps for IDMP implementation until July 1st 2016? Then join experts at the International Conference IDMP Implementation - Impact on Data, Systems and Processes taking place in Berlin from 24 – 25 June 2015.
There are limited places available, so make sure you secure your conference ticket today! Learn more here.
Don't miss this unique opportunity to hear expert presentations, take part in interactive workshops and meet with IDMP experts from around the world including participation from:
• Pfizer Inc. • Boehringer-Ingelheim Pharma GmbH & Co. KG • F. Hoffmann-La Roche Ltd. • Marr Consultancy Ltd • GE Healthcare • A.E.Tiefenbacher GmbH & Co. KG • Bundesinstitut für Arzneimittel und Medizinprodukte • Bundesverband der Arzneimittel-Hersteller e.V. • MEDA Pharma GmbH & Co. KG • Mylan EPD, Inc. • Janssen Pharmaceuticals, Inc. • Novartis Pharma AG and many more.
Want to know more regarding this topic area? Then join us at our
IDMP Implementation - Impact on Data, Systems and Processes
24 – 25 June 2015 | Steigenberger Hotel Berlin, Germany
For more information take a look at our agenda here: http://bit.ly/IDMP_agenda
Or visit our website: http://bit.ly/IDMP_website
Why is Regulatory Information Management (RIM) Important?Appian
How can you be you are compliant with all regulations when there are so many to manage? Learn how leading life sciences companies are using new processes, as well as new technologies to create tailor-made solutions, enabling global strategies in regulatory operations in this complimentary on-demand webinar: http://ap.pn/2eLrMAP
Your next RIM solution - 3 key considerations for your moveV E R A
Considering to move to a new Regulatory Information Management system? Have a look at our pick of the 3 key considerations while moving to a new RIM system.
If you wish to receive more information - write us at info@cunesoft.com or visit our page https://cunesoft.com/en/products/rim/
EU and US Procedures for API Registration - Commonalities and DifferencesMilliporeSigma
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, we’ll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, we’ll discuss the eCTD roadmap for the future and the end of paper submissions.
Pharmacovigilance "Module I" Pharmacovigilance system & their quality systemMohamed Raouf
This Module contains guidance for the establishment and maintenance of quality assured Pharmacovigilance systems for marketing authorization holders (MAHs) and national medicine authorities (NMAs).
Reference:- Guideline on good pharmacovigilance practices (GVP) version no.3
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...Perficient, Inc.
Ever since the European Union (EU) introduced new legislation that requires life sciences companies to proactively detect, prioritize, and evaluate safety signals, there has been an increased interest, not only from sponsors and CROs in the EU, but globally, in pharmacovigilance systems that can assist with the signal management process.
Perficient's Chris Wocosky, an expert in signal detection and management, shows how your organization can use Empirica Signal, Oracle's state-of-the-art signal detection system to data mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. This presentation and demonstration willhelp you bettter understand how this solution can be used in daily pharmacovigilance activities.
GMP Guidelines for Nutraceuticals - Indian And EuropeanVarshaJindaniya
This GMP Guidance Document covers the entire manufacturing process of Health Supplements/ Nutraceuticals in the form of Powders, Tablets, Capsules, Soft Gel Capsules and Liquids starting from procurement of raw materials to despatch of finished product.
Contact me: www.linkedin.com/in/varsha-jindaniya
Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...Torben Haagh
Want to learn more about how to cover gaps for IDMP implementation until July 1st 2016? Then join experts at the International Conference IDMP Implementation - Impact on Data, Systems and Processes taking place in Berlin from 24 – 25 June 2015.
There are limited places available, so make sure you secure your conference ticket today! Learn more here.
Don't miss this unique opportunity to hear expert presentations, take part in interactive workshops and meet with IDMP experts from around the world including participation from:
• Pfizer Inc. • Boehringer-Ingelheim Pharma GmbH & Co. KG • F. Hoffmann-La Roche Ltd. • Marr Consultancy Ltd • GE Healthcare • A.E.Tiefenbacher GmbH & Co. KG • Bundesinstitut für Arzneimittel und Medizinprodukte • Bundesverband der Arzneimittel-Hersteller e.V. • MEDA Pharma GmbH & Co. KG • Mylan EPD, Inc. • Janssen Pharmaceuticals, Inc. • Novartis Pharma AG and many more.
Want to know more regarding this topic area? Then join us at our
IDMP Implementation - Impact on Data, Systems and Processes
24 – 25 June 2015 | Steigenberger Hotel Berlin, Germany
For more information take a look at our agenda here: http://bit.ly/IDMP_agenda
Or visit our website: http://bit.ly/IDMP_website
This slide show reflects general considerations of Bio-availability & Bio-equivalence studies for orally administered drugs. The presentation also accommodates US - FDA's approach and specific recommendations for such studies.
This presentation aims at boosting your creativity, whether you need it for your innovation processes, for your marketing and sales or for other purposes.
It will inform you about:
- what the creativity process is
- how creativity was perceived in history
- what are the main scientific discoveries about creativity
- what cutting edge creativity building techniques exist today
- practical information about these techniques, for instance :
- brainstorming and related approaches
- innovation games
- lateral thinking, 6 hats
- mindmaps
- improvisation derived approch
- who have been the main innovators in creativity techniques and what they have developped
By the way, I practice these techniques and teach them to companies and at the "Ecole Supérieure de Ventes" of Saint Germain en Laye.
A summary presentation of some of the key things to take note of when creating your Veeva presentation and how you can structure your eDetail, so that navigating the content is a breeze.
Rheological test can be very helpful tools for polymer processing and development. This presentation is designed to be an informative introduction and guide to rheological tests, and finding correlations between equipment and processing techniques.
Pyxa Solutions is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs.
Pyxa was founded in 2012 to provide our clients a refreshing consulting experience, through engagement with experienced industry leaders and consultants by delivery of high-quality deliverables and unique services. Pyxa is managed by a team of three seasoned partners with prior blended expertise in industry and management consulting.
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.
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.
It includes information about regulatory bodies, role of drug Regulatory professional, countries with their regulatory bodies, intellectual property rights, terminologies related to DRA, drug approval process, event regarding lack of Drug regulatory affairs
The world of Regulatory convergence: an Australian reflectionTGA Australia
This presentation provides an overview on recent advances and initiatives on regulatory convergence and the impact on Australian, European and international regulation of therapeutic goods.
Hi, everyone i am providing you the best presentation about the Pakistan relate Drug regulatory affairs and the concept of regulatory affairs of Pharmaceuticals
History and Progress of Pharmacovigilance, Significance of Safety Monitoring, Pharmacovigilance in India And International Aspects, WHO International Drug Monitoring Programme, WHO and Regulatory Terminologies of ADR, Evaluation of Medication Safety, Establishing Pharmacovigilance Centres in Hospitals, Industry and National Programmes Related to Pharmacovigilance, Roles and Responsibilities in Pharmacovigilance, International Non-Proprietary Names for Drugs, International Classification of Diseases, Passive and Active Surveillance, Comparative Observational Studies, Targeted Clinical Investigations and Vaccine Safety Surveillance, Aris G Pharmacovigilance, VigiFlow, Statistical Methods for Evaluating Medication Safety Data
International regulatory cooperation: more important than everTGA Australia
The presentation was given by the TGA at the 2014 ARCS Scientific Congress, and covers the importance and future of international regulatory cooperation
The world is quite a different place than it was six months ago, and with the 2020 holiday season fast approaching, the pressure is on to meet revenue goals in what’s been an uncertain year.
In August, we surveyed 154 marketing executives to find out what they think is likely to happen this holiday season and how they are preparing for it. The results are fascinating, and we’ve distilled them into clear actions you can take right now to adapt and prepare for a very different 2020 holiday season.
In this webinar, Eric Enge (Principal, Digital Marketing at Perficient) and Jim Hertzfeld (Chief Strategist, Digital at Perficient) discussed:
How marketers have already adapted and where they see the most opportunity moving forward
What will be different this holiday season and how to adjust your strategy accordingly
Ways to identify and meet changing customer expectations, wants, and needs
How to determine if your priorities or investments should change
What actions you can take right now to be successful
Transforming Pharmacovigilance Workflows with AI & Automation Perficient, Inc.
Medical information call centers have an opportunity to transform the way they capture, code, and analyze adverse events (AEs) and product quality complaints (PQCs) with artificial intelligence (AI) and automation.
The use of such innovative technology improves data quality and consistency, compliance, and operational efficiency. It helps reduce the frequency of your pharmacovigilance (PV) operations resources going home, saying, “I have more to do at the end of the day than I did when I started."
Our one-hour, on-demand webinar shows you how you can use AI and automation to turbo-charge your end-to-end PV system. Use cases and demonstrations will include:
Analyzing safety data
Auto-coding verbatim terms to official medical dictionary terms
Auto-creating an AE case in your database
Converting speech to text
The Secret to Acquiring and Retaining Customers in Financial ServicesPerficient, Inc.
Data, when leveraged effectively, can help you segment and target customers, analyze spending habits, and can create a personalized experience that builds value and customer loyalty.
Without a 360-degree view of your customers, you can’t properly target them with real-time personalized offers, advice, and other services. In addition, lack of customer intelligence creates lost opportunities for banks and insurers to cross-sell and upsell new products and services.
Our one-hour webinar covered how customer intelligence platforms can help you engage, acquire, and retain customers.
Oracle Strategic Modeling Live: Defined. Discussed. Demonstrated.Perficient, Inc.
The only thing certain about forecasting in a volatile economy is that the future is unpredictable. Historically, organizations have effectively utilized statistical techniques for short-term business planning, but leveraging actuals no longer allows us to predict the future. The ability to be prepared, responsive, and agile under these conditions is becoming a crucial success factor. Oracle Strategic Modeling can help you better navigate change to cope with uncertainty.
If your CFO’s questions regarding earnings, liquidity, and cash flow are unceasing and far-reaching, watch our on-demand webinar for a deep dive into strategic modeling. We modeled real-world scenarios to show how you can:
Quickly and easily develop a hierarchical model of your business
Leverage multiple pre-built functions to forecast key performance drivers
Provide transparency on forecasted financials via audit trail
Utilize goal seek to set financial targets and estimate the financials drivers necessary to achieve it
Perform sophisticated “what-if” analysis via simulations to improve the accuracy of your forecast
Use built-in dashboard functionality to deliver powerful reporting capabilities
While many stay-at-home orders have been lifted, consumers’ new digital buying behaviors and habits are here to stay. Watch our panel discussion on the accelerated need for commerce and learn how commerce and content can transform our digital economy.
Topics include:
-What is the “experience economy” and how do you leverage it? -If you move beyond product and price, what’s next?
-How business models have shifted and what you can do to break down silos and leverage new processes to capture the digital dollar.
-How organizations have built agile teams to address the ever-changing needs of customers, including responsive approaches that address the omnichannel consumer.
-Technologies that are best suited to enable your business and customers – and how headless commerce has changed the game.
-How the future of commerce is changing, and what you should do now to prepare.
Our panel features Jordan Jewell, IDC Research analyst known for his insight into the commerce industry. Joining him from Perficient is general manager Brian Beckham, who brings deep expertise in content management and empowering organizations in their digital transformations. Rounding out the panel is Episerver’s Joey Moore, who has spent the last decade helping organizations across the globe advance their digital maturity.
Centene's Financial Transformation Journey: A OneStream Success StoryPerficient, Inc.
Centene, a large multi-line managed care organization, was looking to modernize and streamline its corporate performance management (CPM) applications.
Centene had to move data between platforms multiple times during the close process so that close data could be fully consolidated and made available for reporting. This process had numerous challenges and inefficiencies that Centene wished to improve upon so that they could provide a more streamlined and more transparent process to the functional teams that leverage consolidated financials in their systems for reporting and analysis.
Centene chose OneStream XF for global and US consolidations, currency conversion, eliminations, and ownership percentage.
Michael Vannoni, director, financial systems solutions discussed the migration to OneStream XF including:
-Factors leading to the selection of OneStream XF
-Details of the solution design
-Benefits realized with global consolidation implementation
-Future planned enhancements
WHODrug Koda, developed by Uppsala Monitoring Centre (UMC), is an automated coding service, which uses artificial intelligence (AI) to automate the coding of drug names and ATC selections, improving consistency and operational efficiency. It can also be used to accelerate dictionary upgrades, including the transition from WHODrug B2 format to B3.
Through API (Application Programming Interface) web services, the coding engine can be integrated with custom or off-the-shelf drug safety, medical coding, or data management systems.
In this webinar, Perficient and UMC discussed WHODrug Koda and how you can integrate it into your medical coding activities.
Preparing for Your Oracle, Medidata, and Veeva CTMS Migration ProjectPerficient, Inc.
There are multiple reasons why companies migrate to a new clinical trial management system (CTMS). Still, the two most common are mergers and acquisitions (i.e., CTMS consolidation) and the desire to switch CTMS vendors. Regardless of the reason, many of the best practices, processes, and tools are the same.
In this webinar, we looked at the migration approaches taken across several case studies. You’ll come away with an understanding of:
Pros and cons of each CTMS migration method
Types of migration tools, including APIs, ETL tools, and adapters
Approximate timelines and costs associated with each migration method
The topics discussed in this webinar can be applied to any CTMS migration project, whether you’re moving to or from Oracle’s Siebel CTMS, Medidata’s Rave CTMS, and Veeva’s Vault CTMS.
Accelerating Partner Management: How Manufacturers Can Navigate Covid-19Perficient, Inc.
The pandemic has ushered in a new normal for manufacturers, and the impact of digital communication is more important than ever.
View our on-demand webinar with Tony Kratovil, Regional Vice President of Manufacturing at Salesforce, and Eric Dukart, National Sales Executive at Perficient. They covered why the right digital strategies are critical for manufacturers in the wake of COVID-19.
Our webinar covered:
Current challenges with forecasting, collaboration, and disruptions to distribution networks.
Insights for stabilizing operations, accelerating partner management, and developing a digital strategy that differentiates your business.
Candid Q&A with real-world examples.
New Work.com resources to help manufacturers restart safely and rebuild.
Tools and resources to move forward – fast.
The Critical Role of Audience Intelligence with Eric Enge and Rand FishkinPerficient, Inc.
Things move quickly in marketing. How do you identify what your customers need and how you can help? Now more than ever, audience intelligence is the key.
Audience intelligence is about understanding your target customers, their needs, what resonates with them, and how you can reach them. Eric Enge (Digital Marketing Principal, Perficient) and Rand Fishkin (Co-Founder & CEO, SparkToro) discussed this topic live on May 7, 2020. Watch to hear tactics for gaining a better understanding of your customers, how to use audience intelligence to optimize your marketing now, and more.
Cardtronics, the global leader in ATM deployment and management, decided to retire its on-premises Hyperion solution to gain the operational efficiencies, features, and functionality provided by a best-in-class cloud solution.
Cardtronics chose Oracle EPM Cloud including Financial Consolidation and Close, Planning, Management Reporting, Account Reconciliation, Enterprise Data Management, as well as Oracle Analytics Cloud.
In this video, project owner Richard Ng, director, financial systems, Cardtronics, discusses the migration to Oracle EPM Cloud including:
Multi-release 18-month deployment schedule across multiple countries
Benefits of a global Chart of Accounts for ERP and EPM
Seamless integration across ERP Cloud, HCM Cloud, and EPM Cloud
Preparing for Project Cortex and the Future of Knowledge ManagementPerficient, Inc.
Microsoft has turned traditional enterprise content management on its head with its recent announcement of Project Cortex.
Project Cortex uses advanced artificial intelligence to harness collective knowledge from across the enterprise and automatically organize it into shared topics like projects, products, processes, and customers. Using AI, Cortex creates a knowledge network based on relationships among topics, content, and people and delivers it in the apps you use every day – Office, Outlook, and Teams.
This webinar examined Project Cortex in more detail, including:
• What is Project Cortex?
• Why is Project Cortex different than other knowledge network projects previously introduced?
• How does incorporating AI and automation change the game?
• What is possible with Project Cortex?
• What can you do to prepare?
Utilizing Microsoft 365 Security for Remote Work Perficient, Inc.
With an increasingly mobile workforce, and the spread of shadow IT, the rapid rise of cybercrime - companies must find unique ways to effectively manage their sprawling SaaS portfolio.
Encryption in Microsoft 365 - ExpertsLive Netherlands 2024Albert Hoitingh
In this session I delve into the encryption technology used in Microsoft 365 and Microsoft Purview. Including the concepts of Customer Key and Double Key Encryption.
Key Trends Shaping the Future of Infrastructure.pdfCheryl Hung
Keynote at DIGIT West Expo, Glasgow on 29 May 2024.
Cheryl Hung, ochery.com
Sr Director, Infrastructure Ecosystem, Arm.
The key trends across hardware, cloud and open-source; exploring how these areas are likely to mature and develop over the short and long-term, and then considering how organisations can position themselves to adapt and thrive.
Builder.ai Founder Sachin Dev Duggal's Strategic Approach to Create an Innova...Ramesh Iyer
In today's fast-changing business world, Companies that adapt and embrace new ideas often need help to keep up with the competition. However, fostering a culture of innovation takes much work. It takes vision, leadership and willingness to take risks in the right proportion. Sachin Dev Duggal, co-founder of Builder.ai, has perfected the art of this balance, creating a company culture where creativity and growth are nurtured at each stage.
Dev Dives: Train smarter, not harder – active learning and UiPath LLMs for do...UiPathCommunity
💥 Speed, accuracy, and scaling – discover the superpowers of GenAI in action with UiPath Document Understanding and Communications Mining™:
See how to accelerate model training and optimize model performance with active learning
Learn about the latest enhancements to out-of-the-box document processing – with little to no training required
Get an exclusive demo of the new family of UiPath LLMs – GenAI models specialized for processing different types of documents and messages
This is a hands-on session specifically designed for automation developers and AI enthusiasts seeking to enhance their knowledge in leveraging the latest intelligent document processing capabilities offered by UiPath.
Speakers:
👨🏫 Andras Palfi, Senior Product Manager, UiPath
👩🏫 Lenka Dulovicova, Product Program Manager, UiPath
SAP Sapphire 2024 - ASUG301 building better apps with SAP Fiori.pdfPeter Spielvogel
Building better applications for business users with SAP Fiori.
• What is SAP Fiori and why it matters to you
• How a better user experience drives measurable business benefits
• How to get started with SAP Fiori today
• How SAP Fiori elements accelerates application development
• How SAP Build Code includes SAP Fiori tools and other generative artificial intelligence capabilities
• How SAP Fiori paves the way for using AI in SAP apps
A tale of scale & speed: How the US Navy is enabling software delivery from l...sonjaschweigert1
Rapid and secure feature delivery is a goal across every application team and every branch of the DoD. The Navy’s DevSecOps platform, Party Barge, has achieved:
- Reduction in onboarding time from 5 weeks to 1 day
- Improved developer experience and productivity through actionable findings and reduction of false positives
- Maintenance of superior security standards and inherent policy enforcement with Authorization to Operate (ATO)
Development teams can ship efficiently and ensure applications are cyber ready for Navy Authorizing Officials (AOs). In this webinar, Sigma Defense and Anchore will give attendees a look behind the scenes and demo secure pipeline automation and security artifacts that speed up application ATO and time to production.
We will cover:
- How to remove silos in DevSecOps
- How to build efficient development pipeline roles and component templates
- How to deliver security artifacts that matter for ATO’s (SBOMs, vulnerability reports, and policy evidence)
- How to streamline operations with automated policy checks on container images
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
Epistemic Interaction - tuning interfaces to provide information for AI supportAlan Dix
Paper presented at SYNERGY workshop at AVI 2024, Genoa, Italy. 3rd June 2024
https://alandix.com/academic/papers/synergy2024-epistemic/
As machine learning integrates deeper into human-computer interactions, the concept of epistemic interaction emerges, aiming to refine these interactions to enhance system adaptability. This approach encourages minor, intentional adjustments in user behaviour to enrich the data available for system learning. This paper introduces epistemic interaction within the context of human-system communication, illustrating how deliberate interaction design can improve system understanding and adaptation. Through concrete examples, we demonstrate the potential of epistemic interaction to significantly advance human-computer interaction by leveraging intuitive human communication strategies to inform system design and functionality, offering a novel pathway for enriching user-system engagements.
Transcript: Selling digital books in 2024: Insights from industry leaders - T...BookNet Canada
The publishing industry has been selling digital audiobooks and ebooks for over a decade and has found its groove. What’s changed? What has stayed the same? Where do we go from here? Join a group of leading sales peers from across the industry for a conversation about the lessons learned since the popularization of digital books, best practices, digital book supply chain management, and more.
Link to video recording: https://bnctechforum.ca/sessions/selling-digital-books-in-2024-insights-from-industry-leaders/
Presented by BookNet Canada on May 28, 2024, with support from the Department of Canadian Heritage.
Elevating Tactical DDD Patterns Through Object CalisthenicsDorra BARTAGUIZ
After immersing yourself in the blue book and its red counterpart, attending DDD-focused conferences, and applying tactical patterns, you're left with a crucial question: How do I ensure my design is effective? Tactical patterns within Domain-Driven Design (DDD) serve as guiding principles for creating clear and manageable domain models. However, achieving success with these patterns requires additional guidance. Interestingly, we've observed that a set of constraints initially designed for training purposes remarkably aligns with effective pattern implementation, offering a more ‘mechanical’ approach. Let's explore together how Object Calisthenics can elevate the design of your tactical DDD patterns, offering concrete help for those venturing into DDD for the first time!
Observability Concepts EVERY Developer Should Know -- DeveloperWeek Europe.pdfPaige Cruz
Monitoring and observability aren’t traditionally found in software curriculums and many of us cobble this knowledge together from whatever vendor or ecosystem we were first introduced to and whatever is a part of your current company’s observability stack.
While the dev and ops silo continues to crumble….many organizations still relegate monitoring & observability as the purview of ops, infra and SRE teams. This is a mistake - achieving a highly observable system requires collaboration up and down the stack.
I, a former op, would like to extend an invitation to all application developers to join the observability party will share these foundational concepts to build on:
2. 2
ABOUT PERFICIENT
Perficient is the leading digital transformation
consulting firm serving Global 2000 and enterprise
customers throughout North America.
With unparalleled information technology, management consulting,
and creative capabilities, Perficient and its Perficient Digital agency
deliver vision, execution, and value with outstanding digital
experience, business optimization, and industry solutions.
3. 3
PERFICIENT PROFILE
Founded in 1997
Public, NASDAQ: PRFT
2015 revenue $473.6 million
Major market locations:
Allentown, Atlanta, Ann Arbor, Boston, Charlotte, Chattanooga,
Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax,
Houston, Indianapolis, Lafayette, Milwaukee, Minneapolis,
New York City, Northern California, Oxford (UK), Southern California,
St. Louis, Toronto
Global delivery centers in China and India
>2,800 colleagues
Dedicated solution practices
~90% repeat business rate
Alliance partnerships with major technology vendors
Multiple vendor/industry technology and growth awards
5. 5
FEATURED SPEAKER
Mark Thackstone
Senior Business Consultant
• Specializes in the implementation, support, and development of software
used in the collection, management, and analysis of medical product
information data
• Expertise in the EVMPD/IDMP arena
• Many years of experience working in pharmacovigilance
6. 6
AGENDA
• A brief history of IDMP
• IDMP in Europe
• Timelines and milestones
• Is IDMP a problem?
• What are the ISO standards?
• Where is the data?
• Solutions
• Technological aspects
• Organizational and project aspects
• A introduction to the Oracle IDMP offering
• Summary
7. 7
IDMP HISTORY
• Like all problems, started with
• “I think things could be better.”
• Since the 80’s – safety databases were growing
• MCA/MHRA – Sentinel
• FDA AERS
• EudraVigilance
• No common standard; meta analysis handicapped by
the lack of common standards
• ISO IDMP
8. 8
IN EUROPE…
• IDMP falls with in a series of initiatives under the
EU Telemetrics Strategy
• Other initiatives include management of clinical
trials, monitoring of pharmacovigilance literature,
provision of a single portal for drug authorization
applications
• IDMP is unique in several ways,
• It is multi-disciplinary
• It underpins several of the other applications
• And it is part of a joint initiative between the
members of the International Conference on
Harmonisation (ICH)
9. 9
IN EUROPE…
• Regulation (EC) No. 726/2004/EU, Article 57 & Regulation (EU) No520/2012 (articles
25 and 26)
• Mandated that Marketing Authorisation Holders (MAH) are
required to submit electronically information on all medical
products for Human use
• Since 02-Jul-2012 according to a standard described by
the EMA – EVMPD
• Since 16-Jun-2014 MAHs needed to update to a new
standard– xEVMPD (eXtended EVMPD)
• As of July 2016, MAHs need to move to the next standard
• This standard is EVMPD compliant with the relevant
ISO standards
• DON’T PANIC – it is accepted that this legal requirement
is unachievable and an incremental plan has been put in
place reach the objective
10. 10
IN EUROPE…
• I won’t say anything about the impact of Brexit!
• Who knows what is going to happen next!!
11. 11
SO, WHAT IS IDMP?
• EVMPD on Steroids!
• Application of ISO standards to Article 57 product data
collection
• This standard was developed in response to a worldwide
demand for internationally harmonised specifications for
medicinal products. It is one of a group of five standards
which together provide the basis for the unique
identification of medicinal products.
• It provides data elements and structures for unique
identification and exchange
12. 12
GOALS OF IDMP
• Increased patient safety
• Identification of counterfeit medicines
• Enhanced signal detection
• Increased transparency
• Increase consistency of the regulation of pharmaceuticals
• With in the EU
• With the USA (and ultimately other regions that adopt ISO IDMP.
13. 13
Industry and Medical
Research
Competent Authorities
EXCHANGE AND INTEROPERABILITY
USA FDA EMA
Pharma
CompanyRegulators
/ Medicines
Agency
Sponsor
Other
Stakeholders
Health Service
providers –
e.g. NHS
Other Agents
e.g. CROs
Assignment of
new
substance
identifier
14. 14
ISO STANDARDS
ISO 11615
Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and
exchange of regulated medicinal product information
ISO 11240
Health informatics — Identification of medicinal products —
Data elements and structures for the unique identification
and exchange of units of measurement
ISO 11238
Health informatics — Identification of medicinal products —
Data elements and structures for the unique identification
and exchange of regulated information on substances
ISO 11616
Health informatics — Identification of medicinal products
— Data elements and structures for the unique
identification and exchange of regulated pharmaceutical
product information
ISO 11239
Health informatics -- Identification of medicinal products --
Data elements and structures for the unique identification
and exchange of regulated information on pharmaceutical
dose forms, units of presentation, routes of administration
and packaging
15. 15
ISO STANDARDS
Product Package
ISO 11616
regulated pharmaceutical product information
ISO 11615
regulated medicinal product
information
ISO 11238
substances
16. 16
ISO STANDARDS
Product Package
ISO 11239
dose forms,
units of presentation,
routes of administration
packaging
ISO 11240
units of measurement
ISO 11616
regulated pharmaceutical product information
ISO 11615
regulated medicinal product
information
ISO 11238
substances
18. 18
SPOR AND MASTER DATA MANAGEMENT
• One thing that is apparent is a large amount of the data is shared or common
• Some of these data types are well defined, controlled, and managed in dictionaries
and code lists
• MedDRACountry and language lists (ISO 3166 and ISO 639)
• International units
• ATC
• Where these exist IDMP adopts them
• However what to do about those that are common data points, but are not defined?
• This was one of the lessons learned from previous iterations of the Art. 57
database, and the EMA have accepted responsibility for organizing and
harmonizing codes for data points such as substances
19. 19
SPOR AND MASTER DATA MANAGEMENT
Referencials
Organisation
Products
Substances• Substance - describing the ingredients of a
medicine;
• Product - describing the marketing and
medicinal information relating to a product;
• Organisation - providing the contact details
of organisations and individuals responsible
for various aspects of a medicine;
• Referential, providing controlled
vocabularies (e.g. dosage, pharmaceutical
forms, country codes, package codes, weight
codes) for a medicine, which are explicitly
defined for use in Europe.
20. 20
TIMELINES AND MILESTONES
• The legal deadline for the move
to IDMP is July 2016…but don’t
panic!
• Following the experience of the
regulators and the industry, this
was identified as unachievable
• The EMA has developed as
strategy of moving in stages or
Iterations
• The first Iteration is planned to
kick off in Q2 2018 and become
enforceable Q4 2018
28. 28
FULL PRODUCT LIFE CYCLE - MAINTENANCE
CTA
Withdrawal
MAH
Development
Marketed
1. Triggers for a new
or updated record?
2. How to make
update?
3. QMS?
4. Metrics/Oversight
29. 29
DBs
DBs
DBs
IDMPIDMP Solution
WHERE DO YOU WANT TO END UP?
DBs
DBs
DBs
IDMPIDMP Solution
IDMP Solution
DBsDBsDBs
IDMP
Master
Data
Management
Regulatory
Information
Management
30. 30
WHERE DO YOU WANT TO END UP?
Advantages Disadvantages
Master Data
Management
• Possibly faster
• Doesn’t require different
departments to change their
processes
• Policing the master data
• Poor control
• Need to maintain multiple
systems
Regulatory
Information
Management
• Maintenance of a single
repository
• Intrinsic master data
management
• Inter-departmental inertia
• Costly
• Potentially slower to deploy
• May not meet niche needs
IDMP
IDMP
MDM
RIM
31. 31
TEAMS
Design and Build
•Existing headcount
•Multi-disciplinary teams
•Business SMEs, IT & Project Management
•What about their day jobs?
•IDMP-focused teams
•Budget
•Do you have the necessary expertise?
•External support/Consulting
IDMP processing
•Extend existing roles
•Training/Procedures
•Resource – do you officers have
enough time?
•Dedicated IDMP department
LEADERSHIP
33. 33
SUMMARY
• IDMP is the application of ISO standards to the Art 57 (EVMPD) Medical Product
Dictionary
• It is a legal requirement in the EU from July 2016, but it is being released in
iterations.
• Time lines are short and guidance is unclear.
• Gap analysis, Data gathering, technical solution design are key early phases for
project success, but don’t lose sight of the long term solution and ensure to factor in
the people and procedural component
• Because of the nature of the project – support of senior leadership is critical for
success.
So, IDMP, the Identifications of Medical Products, Like all problems down through history, started with, someone, somewhere thinking to themselves, “hmmm, I think things could be better”
Now I don’t know if it was some lonely regulator buried under paper in some medicines agency; I don’t know if the idea came to multiple people at different times and faded away, and I don’t know how it came to be but gradually this idea developed a head of steam and started to change from a meme into an tangible project.
So what was the problem? Since the 80’s safety database were becoming prevalent around the world, collating large amounts of important safety data, and they have been responsible for the identification of many important safety signals. But while these databases were useful, it was obvious that if it were possible to combine these disparate databases, far more powerful statistically analysis could be performed. Also, even if the database remained separate, if they were to remain separate, signals found in one database could be verified or corroborated in another, if it was know that the database were homogenous, and constructed according to the same rules.
So those of you who have been through the mill before, IDMP is EVMPD on Steroids
Application of ISO standards to Article 57 product data collection
This standard was developed in response to a worldwide demand for internationally harmonised specifications for medicinal products. It is one of a group of five standards which together provide the basis for the unique identification of medicinal products.
It provides data elements and structures for unique identification and exchange
So ISO IDMP is made up of a cluster of 5 separate standards.
ISO 11615 deals with Regulated medicinal Product Information and gives us the MPID – Medical Product Identifier
ISO 11616 Deals with the regulated pharmaceutical product information and gives us the PhPID – So you are probably wondering what’s the difference between the MPID and PhPID – well hold that thought and I’ll try and un pick that in a moment.
ISO 11238 deals with the substances that make up medicinal products
ISO 11239 defines how to describe dose form, units fo presentation, routes of administration and packaging.
And lastly, ISO 11240 describes how units of measure will be incorporated into the IDMP ISO standard.
So how does IDMP related to the real world?
Imagine you had a headache and you reach into the medicine cabinet for some analgesia – and in you hand is a small box. You look at the box and it has all kinds of information on it. Probably the first thing you see is the brand name. If you have any kind of medical background you skip over this and look at the generic drug name, and the strength and formulation. If you working in pharmacovigilance you look to see who the manufacturer is.
Already I think you would agree, we have encountered a huge amount of information and we haven’t even opened the packet yet. What ISO IDMP does is describe all this information in a standardized way.
We open the box and pull out a strip of tablets in their blister packet and pop a couple of tablets out. Now they look fairly no descript – but still they are amazingly complex objects – ISO IDMP has a way to describe them – so we know their pharmaceutical product characteristics – from the outer coating of the tablet right down to the chemical structure level.
So ISO 11615, dealing with the Regulated Medical Product Information gives us the registered detail of that specific licenced product and allocates it an MPID (code).
ISO 11616 describes the pharmaceutical product and for want of a better term this is the generic information – what’s common to say Ibuprofen from one company verses another company. This is the PhPID.
There is a relationship between the codes –part of the data associated with the MPID is the pharmaceutical product – so the PhPID is referenced and part of the MPID data set. In this way we can cross reference different aspects of the data constellation.
In addition to this ISO IDMP gives us standards for how we describe these entities- what constitutes a particular dose form, how we record the route of administration and how we can describe the packaging.
And so that we can qualify all this information, ISO IDMP gives us a standard for units of measure. Now we all know that units of measure exist outside ISO IDMP, so this standard describes how units will be incorporated into IDMP reports, provides mappings between different unit vocabularies and languages(Translations) and provides traceability back to the reference standard.
So when all the data points are gathered together ISO IDMP organizes this information into a constellation of interrelated and cross referenced data points, which can be mapped out something like this.
Now please note this is an extremely simple version of an IDMP report, which does not extend to the lowest levels of complexity. For example if we where looking at a biosimilar or a vaccine, potentially information under stub stances could be far more complex.
The legal deadline for the move to IDMP is July 2016….but don’t panic!
Following the experience of the regulators and the industry, this was identified as unachievable.
The EMA has developed as strategy of moving in stages or Iterations.
The first Iteration is planned to kick off in Q2 2018 and become enforceable Q4 2018
The lag between release of guidelines and the kick off is minimal so industry is expected to design it’s solutions from first principles and then tweak it to fit the EU interpretation of IDMP> THIS IS GOING TO BE TIME PRESSURED
The best time to plant a tree is thirty years ago, the second best time is now. – if you haven’t already started, you should asap.
So once it was decided to move forward in iterations, it had to be decided what would be in each iteration. This went out to consultation between the EMA and a selection of member states, - there was a scoring process and in upshot was 79 data elements were identified as necessary. I don’t believe this has been formally published as yet so this is a working list.
This is road map from the EMA website and I have just put it up for illustrative purposes to demonstrate that there a lot of moving parts!
So once it was decided to move forward in iterations, it had to be decided what would be in each iteration. This went out to consultation between the EMA and a selection of member states, - there was a scoring process and in upshot was 79 data elements were identified as necessary. I don’t believe this has been formally published as yet so this is a working list.
So IDMP is data, just data and only data, right?
Wrong, when you start getting into the portfolio, you realise that the data has dimensions that you may not have considered import that have a direct bearing on the IDMP project.
All these data attributes have to be taken into consideration.
One IDMP record might be made of data elements that come from diverse sources.
For examples: on product might have the product name in the structured fields in the regulatory affairs database, but the indication is in text in the SmPC which is an electronic document based on the Core labelling which is controlled from Pharmacovigilance. Artwork have the packaging information and the marketing status is maintained by Sales on a SAS database. Manufacturing hold the information about the excipients except for one which is bought in house from an external supplier who hold the substance information on paper.
That’s for one product. Across a companies portfolio, this could be repeated in multiple variations.
A factor critical to IDMP success is getting a measure of the portfolio data universe using these dimensions
These data points are not static and move within their own quality management systems – the status of the data within the life cycle needs to be considered.
The same data points can also exist in multiple sources, therefore it is necessary to identify the authoritative source, or if you use a secondary source, you need confirmation of its veracity against the primary
IDMP follows the entire product life cycle – from development through to withdrawal. The important point to note is this is an iterative process and leads to 4 points that need to be addressed,
How do you know you need another iteration? This breaks down into 2 part – a) what constitutes the threshold for creating another iteration and b), how will you know that you have reached that threshold to trigger the update? – is it going to be automated in your IT solution or is it going to be part of a business process. Scale and organization of the company are factors that come play here – for example a change in the marketing status of a product would be know in the sales department of a company, but how does that information get to the IDMP team? To accurately address this, it is important to look at the business process as well as the IT solution.
How do you make and track the updates? Who’s going to do it? Is it the data owner/authoritive source – remember people who use a system occasionally are more likely to make mistakes – so will the updates to their native system get transmitted to the IDMP system? Or will the changes get communicated to the IDMP data entry team – who are specialists but who will manage the logistics of the communication?
QMS – Quality management system – Some quality checks can be programmed in, but who is going to reconcile the source data against the output?
Management metrics – what views, dashboards reports and processes in place to identify bottle necks early and ensure that compliance is maintained.
So we have talked about solution phases and the basic architecture of a solution – basically you need to drag together a wide variety of data points from disparate and far flung sources, you’ve squeezed it all into an IDMP report, flung it through the gateway, the EMA have uploaded it into their database. Their happy, you’re happy, you can go back to saving the world by making those vital medicines and the regulators can go back to whatever they do…right? Well, not entirely.
The problem is, data doesn’t stay the same, it changes. Drugs get new indications, naming conventions for substances change, you may switch manufacturer for an excipient, or you may want to move your registered office (if you are thinking of leaving the UK, please don’t!
So the data needs maintenance, and as those changes happen, every time those changes happen, that whole procedure of getting the information in to IDMP starts again.
Now basically there are 2 strategies. The first one is that you continue to use your existing databases and whenever there is an update in one, it gets fed into the IDMP solution.
Alternatively, once you have all your data in one place, why not keep it there? Retire your old database, and have massive system for every one to used.
So we have talked about solution phases and the basic architecture of a solution – basically you need to drag together a wide variety of data points from disparate and far flung sources, you’ve squeezed it all into an IDMP report, flung it through the gateway, the EMA have uploaded it into their database. Their happy, you’re happy, you can go back to saving the world by making those vital medicines and the regulators can go back to whatever they do…right? Well, not entirely.
The problem is, data doesn’t stay the same, it changes. Drugs get new indications, naming conventions for substances change, you may switch manufacturer for an excipient, or you may want to move your registered office (if you are thinking of leaving the UK, please don’t!
So the data needs maintenance, and as those changes happen, every time those changes happen, that whole procedure of getting the information in to IDMP starts again.
Now basically there are 2 strategies. The first one is that you continue to use your existing databases and whenever there is an update in one, it gets fed into the IDMP solution.
Alternatively, once you have all your data in one place, why not keep it there? Retire your old database, and have massive system for every one to used.
It’s all very well talking about technological solutions but sooner or late its going to have to involve that other dimension- People.
You can break this down it to 2 phases or parts
Who is going to build it
And
Who is going to work it.
Looking at the build are you going to use existing headcount? Because of the nature of IDMP it’s going to be a multi displinary team – SMEs, IT PM. – Who is going to do there day job? This is a big project so they are not going to be around as much as they were.
May be you will carve them out entirely and have a dedicated IDMP team. You need to think about budget – are you going to be able to quickly access this – remember budgets are defined a year in advance.
You might want to think about pulling in external support – consultants can be very useful – they have a broader view point of what is going on in the industry and sometime the independence from the internal pharma company structures can be useful.
Secondly, you need someone to do the work. – You either want to extend existing roles, in which case you are going to need to train them and revise their procedure. Also, have a good look at the amount of work they will need to do – you will probably need to revise resource levels and performanace metrics.
Alternatively, you may want a dedicated IDMP department – you might feel that it is adventagous to have an in house (or out house) team of experts.
Lastly. –
LEADERSHIP
This is going to be difficult
This is going to be big
This is going to be complex
This is going to be time pressured.
It will involve a lot of different people and department going through change
You need at least the support and sponsorship of the most senior person that you can get to listern to you. I’m not thinking the QPPV or the head of regulatory, I’m thinking the a senior president or the CEO - someone who holds sway over all the departments that IDMP is going to make life difficult to for the next 2 to 4 years. It might be a difficult conversation, but the conversation could be more difficult later!
So, let’s take a brief look at Oracle’s proposed offering to support clients in the realm of IDMP. So those of us who have engaged with Oracle before might be seeing some familiar faces here. This is because Oracle solution is built around leveraging 4 existing platforms.
Agile – Data repository.
OBI (Oracle Business intelligence) - Dashboard
EQD (Enterprise Data Quality
TMS – Dictionary Management.
So by doing this, Oracle is giving us all the components that are needed to meet the technological needs for IDMP.
An then there is a 5th component the IDMP Enterprise Foundation Pack - this is the module that will bring together all the other functionality and turns it into a machine to meet the IDMP challenge. Or at least that is the plan. I know Oracle are busy bringing this to market, they launched it in DD-MMM-YYYY, and we are eagerly awaiting further developments.