Events Archive - FME US, llc

Solutions for the CARA Platform at Generis Generate 2024

by The fme Team | Mar 20, 2024 | Events, Generis

fme is excited to be presenting our CARA Platform success stories and solutions at Generate 2024 in Lisbon, Portugal this April. As a certified Generis partner, we’ll be contributing to the discussions and sessions focused on maximizing the value of The CARA Platform and The CARA Life Sciences Platform, specifically built for Life Sciences applications.

Here are a few of the topics we’ll be sharing. Contact us below to schedule a custom presentation on how fme can serve your CARA Platform needs.

Successful Migrations to The CARA Platform

The fme team are experts at migrating data, documents and content into, out of, and within the leading content management platforms in the most complex regulated industries. We bring all our experience and know-how to The CARA Platform and have earned our Certified Partner badge year after year.

Whether you are moving to CARA for the first time, consolidating repositories, or upgrading to the newest release, fme understands the possibilities and pitfalls of the platform, and can ensure you have a smooth transition that delivers the maximum ROI while minimizing downtime. Our business consulting and technology services teams work together to provide end-to-end CARA implementation support to ensure your configuration and integration is effectively aligned with your business processes and goals.

Custom-built Tools and Solutions

fme has built a portfolio of proprietary tools and services to streamline and accelerate migration initiatives that we apply to CARA Platform initiatives. Each of these solutions has been tested, refined, and proven through years of client projects.

migration-center™: Save you 60% in costs and 80% in project duration with migration-center, our proprietary migration tool that is CARA ready, allowing you to minimize risks while migrating from any source system into CARA with ease. Learn more >>

MetadataAssist℠: Leverage the power of guided AI and NLP to identify and rescue disconnected content. MetadataAssist supplements your team’s expertise to accelerate the analysis, identification, categorization, and updating of metadata on millions of documents in a fraction of the time. We ensure all your information is fully organized and accessible. Learn more >>

HealthCheckAssist℠ for Generis: Don’t guess at how to improve – HealthCheckAssist tells you where you are and where you should go next based on your own priorities and business goals. Our experts analyze and evaluate your current system and provide a prioritized roadmap for best next steps to enhance efficiency and effectiveness. Learn more >>

PlatformAssist℠ for Generis: Reduce your platform management costs. PlatformAssist provides in-depth vendor release management, application change management, application and admin support and more for carefree, cost-effective management of your CARA platform. Learn more >>

compliance-center℠: Streamline, simplify, and accelerate your validation workflows. Built on the CARA platform and based on the CSA guidelines plus our 25 years of working with global pharmaceutical firms, compliance-center’s intuitive interface and clear instructions guides you through your validation process, providing detailed direction on when you can take advantage of CSA, when traditional CSV is required, and when a hybrid approach is possible. Learn more >>

Let’s Connect at Generate 2024!

If you are attending Generate, contact us so we can connect at the booth and join us for our VP of Business Consulting David Gwyn’s presentation on Insights and Best Practices for Maximizing the Value of The CARA Platform. We look forward to seeing you there!

Let's Connect at Generate!

Not attending? No Problem!

If you aren’t able to attend Generis Generate this year, we still have you covered! Connect with us below and we’ll send you the conference slides, and schedule a customized introduction to our CARA Platform solutions.

I'm Interested in CARA Solutions

Will we see you at DIA RSIDM 2024?

by The fme Team | Jan 18, 2024 | Business Consulting, ECM, Events, Life Sciences

Will you be attending DIA RSIDM 2024 in Bethesda, MD in February? This annual event is the premier gathering for professionals working in the pharmaceutical, biotechnology, and regulatory industries, focusing on the critical aspects of submissions, information management, and document compliance.

The importance of operational efficiency across the full process and technology environment that enables the management of regulatory information cannot be understated. It is vital to provide timely, quality regulatory submissions to health authorities in order for drug companies to accelerate the delivery of therapeutics and vaccines to their patients. At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum, industry and regulatory stakeholders collaborate to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related people, processes, and technology.

If you’ve attended in the past, the 2024 Forum includes a refreshed set of tracks and focus areas that will provide invaluable insights on how to build and sustain successful RSIDM foundations, optimize their current processes and procedures, adopt innovative technologies, and achieve regulatory excellence. You’ll also have ample opportunities for networking, knowledge sharing, and education for both business and technology-focused topics at all levels.

Connect with fme’s David Gwyn at DIA RSIDM 2024

This year, fme’s own VP of Business Consulting David Gwyn will be attending DIA RSIDM @presenting and contributing to the many discussions with industry and regulatory stakeholders covering the effective strategies to align related people, processes, and technology for business success.

Use the contact form below to get connected before the event, or make plans to join his session on February 14:

Leveraging Structured Content Authoring in Regulatory Submissions: Real-World Experience, Industry Insights and Tools
View Session >>
Feb. 14, 8:30am
Bethesda North Marriott Hotel and Conference Center
Brookside (Lower Level)

Other Essential Sessions

If you haven’t reviewed and selected your sessions yet, here are just a few we feel are worth the time to attend. Hope to see you there, and let us know if you have any questions on these topics!

Fostering Trustworthy and Responsible AI
View Session >>
Keynote Address
New and emerging technologies like AI have undeniably proven their potential in optimizing processes, improving decision-making, and enhancing the collection and management of data across the lifecycle. Reggie Townsend, VP of Data Ethics Practice at SAS, will share insights on how AI and other emerging technologies can be responsibly leveraged in regulatory affairs and operations.

The Future of Regulatory Submissions: Innovation of the Possible using a Non-disruptive Framework
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Technology may be disruptive and revolutionary but must be introduced in a non-disruptive way to a highly regulated environment. Innovation within the CTD / eCTD v4.0 framework including cloud computing provides exactly this vehicle for change.

Shaping and Overseeing Regulatory Strategy, Operations, and Vendor Relationships
View Session >>
Enable high-quality relationships between clients and vendors in the regulatory submissions space, and successfully shifting from a vendor-based RIM model to an in-house operation. We will also delve into acquisitions and mergers/partnerships as they relate to strategy and execution in submissions operations.

So, You Think Technology Solutions are Failing your Content Transformation? Did You Set Them up for Success?
View Session >>
The most successful intelligent automation implementation teams think content before software: a software-agnostic mindset is key to success. This session will discuss how applying a software-agnostic methodology can supports effective content transformation across people, processes, technology, and data/content.

We are excited to participate in these valuable conversations with regulatory thought leaders, and re-connect with industry colleagues! Find the full schedule here, and contact us if you have any questions about the specific tracks or sessions offered. We look forward to seeing you there!

Contact us

Join fme in Boston at the Veeva Summit: R&D and Quality

by The fme Team | Aug 10, 2023 | Events, Life Sciences, Technology Services, Veeva

fme has been selected as a Gold Sponsor for the Veeva Summit: R&D and Quality for Boston this September, and we are looking forward to sharing our experience and strategies with the Veeva community. We enjoyed June’s European summit in Madrid, and are honored to be recognized in an elite group of certified partners invited to participate in the North American event.

We’d love for you to join us to explore how to leverage the power of the Veeva platform to achieve your business goals.

Join fme at the Veeva Summit!

fme specializes in the end-to-end implementation, integration, and support of the Veeva platform. At the summit our team of experts will be answering questions, discussing our capabilities, and proving how our partnership can guide organizations to new heights of efficiency and productivity. We will also be highlighting our newest offerings that deliver exceptional benefit to our Veeva clients:

fme PlatformAssist™ – A comprehensive set of modular building blocks that provide you with the unique end-to-end services needed for carefree post go-live management of your Veeva platform.
dqMan for Veeva Vault – Modeled after our popular dqMan for Documentum, our new version is focused on the specific requirements of Veeva clients, eliminating time-consuming and repetitive tasks and making admin and data management easy.
If you are attending the summit, contact us and let’s set up a time to meet so you can get the most value from the summit.

If you are attending the summit, contact us and let’s set up a time to meet so you can get the most value while we’re there together.

Contact us to learn more

fme delivers the end-to-end knowledge and support you need to maximize the value of the Veeva platform. We’d love the opportunity to share our experience on how to best configure, utilize, and support Veeva for the unique challenges of your organization.

fme's Veeva Solutions

Contact us to schedule a personalized presentation aligned with your unique challenges. To schedule a discovery meeting with fme’s Veeva experts, reach out to our Global Sales Director René Rosenberg at r.rosenberg@fme-us.com.

Schedule a time to talk

Join fme at the Veeva Summit: R&D and Quality in Madrid

by The fme Team | May 2, 2023 | dqMan, Events, Life Sciences, Veeva

Veeva Services Partner Migration-Certified

The 2023 Veeva Summit: R&D and Quality for clients and partners is fast approaching, and fme has been selected to share our experience and strategies as a Gold sponsor. Only a select group of certified partners are invited to participate, and fme is honored to be recognized as part of this elite group. We cordially invite you to join us to explore how we can work together to leverage the power of the Veeva platform to achieve your business goals.

Proven Success Strategies

The Veeva Conference is a fantastic opportunity to learn about the most effective trends and best practices for content management, network with industry professionals, and engage in insightful discussions. Since fme specializes in the implementation, integration, and support of Veeva content management solutions, we’ll be sharing our experience on how to best configure, utilize, and support Veeva for the unique challenges of your organization.

The Veeva Summit provides unique value to attendees:

Gain insights into the latest features and enhancements of Veeva’s content management solutions, how they can help you achieve your IT and business goals.
Understand how fme provides tailored IT consulting services to optimize your Veeva solutions, ensuring seamless operation and maximum ROI.
Network with other professionals to exchange ideas and learn from their experiences, helping you stay ahead of industry trends and competition.

Join fme at the Veeva Summit or Contact Us Today!

If you attend or not, take full advantage of the Veeva Conference for valuable learning opportunity it provides. Our team of experts will be answering questions, demonstrating our capabilities, and proving how our partnership can bring your organization to new heights. We will also be introducing new offerings that will bring exceptional benefit to our Veeva clients:

fme PlatformAssist™ – A comprehensive set of modular building blocks that provide you with the unique end-to-end services needed for carefree post go-live management of your Veeva platform.
dqMan – Modeled after our popular dqMan for Documentum, our newest version is focused on the specific requirements of Veeva clients, eliminating time-consuming and repetitive tasks and making admin and data management easy.
fme MetatdataAssist™ – Reconnect lost documents without the frustration, time, or costs to your key business resources. Let fme’s life science experts quickly and efficiently update your legacy document’s metadata to ensure they are properly classified and discoverable in your Veeva system.

If you aren’t attending, contact us to schedule a personalized presentation on how fme can provide the end-to-end knowledge and support you need to maximize the value of your information with the Veeva platform.

fme and Veeva Facts

To learn what fme can do as your end-to-end Veeva partner and to get more details on the conference, view our Veeva Summit summary here. To schedule a discovery meeting with fme’s Veeva experts, use the form on the page above, or reach out to me or our Global Sales Director René Rosenberg at r.rosenberg@fme-us.com.

Veeva Summit Details

DIA RSIDM ’23 in Bethesda, Maryland

by Daniel Chaparro | Jan 16, 2023 | ECM, Events, Life Sciences

Will you be attending DIA RSIDM next month? We’re looking forward to being (safely) back in person to discuss the challenges and opportunities within regulatory information and document management.

Visit us at Booth #202 to discuss recently updated strategies and solutions, the advantages of CSA validation, and to learn more about the meetup on the EDM Structured Submission Reference Model organized by fme’s own David Gwyn. You may have seen him presenting recently on building a more effective and efficient data-centric approach to document management in RIM.

Essential Sessions

If you haven’t reviewed and selected your sessions yet, here are just a few we feel are well-worth the time to attend. Hope to see you there!

Driving Performance from RIM

Enhance your processes to drive ultimate performance from your RIM technology. While describing the road to high performance, the speakers in this session will provide clear examples of regulatory metrics that will demonstrate a high performing RIM technology and how to make the most of country affiliates.

Is It Time to Streamline Your Processes with Structured Content Management?

The current standard processes for document management are no longer sufficient for streamlining submissions or able to support the level of content management, collaboration, and re-use that is possible with the transition from documents to data. This session focuses on practicalities and benefits of structured content management (SCM), including the benefits of transitioning from documents to data-centric processes, and practical use cases and key success factors for SCM.

IDMP Ontology: Semantic Interoperability Throughout the Entire Medicinal Product Lifecycle

This session outlines the implementation challenges of ISO IDMP standards at pharma companies and showcases how an ontology can help achieve semantic interoperability of product data.

How Innovative Collaboration Supports Compliance Across the Regulatory Ecosystem

This session will explore ways sponsors can achieve both greater control and compliance as well as improving their way of working together with health authorities to expand access to medicines.

Visit us at Booth #202

We are excited to participate in these valuable conversations with regulatory thought leaders, and re-connect with industry colleagues! Contact us to schedule a time to talk, or stop by Booth #202 to talk with our solution experts, and share your perspective and questions with the fme team. We look forward to speaking with you!