Deep Dive into Regulatory Solutions at DIA RSIDM 2025

Deep Dive into Regulatory Solutions at DIA RSIDM 2025

by | Jan 6, 2025 | Business Consulting, Events, Migration Services, Regulatory

This February, DIA RSIDM 2025 returns to Bethesda, MD, reaffirming its reputation as the premier event for regulatory professionals to exchange the best solutions for managing complex regulatory submissions. At fme, we specialize in helping pharmaceutical and biotechnology companies navigate regulatory challenges with expertise in selecting, planning, and migrating to RIM solutions tailored to their unique data, documents, and workflows. Visit us at Booth #315 during the RSIDM forum—we’d love to discuss your challenges and plans for 2025!

Operational Efficiency is Critical

Every day, pharmaceutical companies strive to demonstrate the efficacy of new discoveries and deliver life-changing medications to patients in need. To accelerate time-to-market and ensure safety, timely and high-quality regulatory submissions to health authorities are critical for review and approval.

However, the process is fraught with challenges. The sheer volume and complexity of data, documents, and information exchanged among multiple stakeholders and systems create significant hurdles in maintaining accurate, up-to-date documentation. Errors, omissions, or inconsistencies can lead to costly delays and disrupt expected release timelines.

Seasoned regulatory professionals recognize the importance of operational efficiency in managing regulatory information effectively throughout the development cycle, ensuring smooth and successful submissions.

Keys to RSIDM Efficiency and Success

Efficiency and success in regulatory operations depend on seamlessly aligning people, processes, and technology throughout a medication’s journey—from conception to patient use. With years of experience and a proven track record, fme has gained deep insights into the complexities of every phase of this journey. This expertise has enabled us to develop and refine methodologies that:

  • Analyze existing systems and workflows
  • Align requirements with tailored technology solutions
  • Ensure data and documents are accurately classified for discovery and use

fme’s experts combine a deep understanding of the product development lifecycle with extensive experience in regulatory projects. Staying ahead of evolving data standards, requirements, and technology trends, we guide clients toward the best solutions for today while future-proofing their decisions to deliver long-term ROI.

Download this overview to see how fme can help you achieve regulatory excellence and why we are recognized as a leader in content management solutions for regulatory environments.

Download Overview

Connect with fme at DIA RSIDM 2025

Last year, fme’s David Gwyn spoke on “Leveraging Structured Content Authoring in Regulatory Submissions: Real-World Experience, Industry Insights and Tools.” This presentation focused on the latest EDM Structured Reference Model team developments, showcasing how their work influences industry-wide adoption. For more information, view the full details of the session here.

For 2025, David will be joined by RIM experts Jonathan Byars and Frank D’Entrone to provide their expertise on effective strategies to align people, processes, and technology for RIM success. fme’s experience across platforms, industries, and global territories gives us unparalleled insights into the best strategies and solutions and how to ensure a successful journey to regulatory excellence.

What are your challenges for 2025? Use the form below to request a no-cost discovery session and we’ll schedule a time to discuss your concerns and possible solutions. If you are attending RSIDM 2025, join us at Booth #315 and we can start the conversation in person! If you can’t attend this year, download the overview and let us know if you’d like to talk.

Contact us

The DIA RSIDM 2025 Educational Tracks

The educational tracks for this year’s conference reflect the continued integrated communication challenges regulatory professionals face within a quickly evolving technology landscape. Download the overview above to learn more about how we can support your team in each.

  • Track 1: Building and Sustaining Successful RSIDM Foundations
    • This track is designed for attendees who are either new to the field or seek a comprehensive review of the evolving dynamics and intricacies that shape their day-to-day work.
  • Track 2: Optimizing Processes and Procedures
    • This track is tailored for intermediate-level professionals and focuses on what is needed to improve processes, procedures, and data to foster a culture of innovative practices and forward-thinking. Learn proven industry best practices and discuss the impact of new global regulations on your organization’s processes and procedures.
  • Track 3: Adopting Innovative Technologies
    • This intermediate to advanced track provides first-hand knowledge from global regulatory health authorities on the implementation of new technologies, policies, and guidelines. It also includes perspectives on how to incorporate technology advancements like artificial intelligence and automation, and how to assess their effectiveness and impact.
  • Track 4: Achieving Regulatory Excellence
    • This advanced track is designed for leadership roles, and includes examples and use cases from organizations that have achieved regulatory excellence. It covers a wide range of practical implementation strategies to support vision, cultural change, and commitment to innovation.

We are excited to participate in these valuable conversations with regulatory thought leaders and re-connect with industry colleagues! Find the full RSIDM 2025 agenda here, and contact us if you have any questions about the specific tracks or sessions offered. We look forward to seeing you there!

1 Step 1

Solve your regulatory challenges. 

fme has clear methodologies to stay ahead of quickly evolving data standards, complex requirements and changing technology options. Learn the first steps and get started today. 

Download Regulatory Excellence Overview
keyboard_arrow_leftPrevious
Nextkeyboard_arrow_right
FormCraft - WordPress form builder
Transforming Your Quality Management System Selection with SelectAssist℠

Transforming Your Quality Management System Selection with SelectAssist℠

by | Aug 14, 2024 | Business Consulting, Datasheet, Life Sciences, Quality

Navigating the complexities of selecting the right Quality Management System (QMS) and Quality Document Management System (QDMS) can be daunting, especially for Life Sciences companies. These industries are highly regulated and require specialized software solutions to manage intricate processes and extensive documentation. You’re not alone if you’re feeling overwhelmed by the selection process. This is where SelectAssist steps in to simplify the journey and ensure you make a choice that supports your current and future needs.

What is SelectAssist?

SelectAssist is a specialized methodology designed specifically for life sciences companies to streamline the QMS and QDMS solutions selection process. Choosing the right software is more than just ticking boxes; it’s about ensuring the solution integrates seamlessly with your existing systems and meets your business’s critical needs.

At the core of our approach is the belief that stakeholder involvement is paramount. Engaging key stakeholders throughout the decision-making process not only promotes higher adoption rates but also significantly enhances the success of the implementation. By listening to the voices that matter most—your end-users—we tailor the selection process to ensure that your chosen software solution is the best fit for your organization. Download our datasheet for specific details >>

The Challenges You Face

Life Sciences companies face unique challenges when selecting software due to the sector’s highly regulated nature. Compliance with multiple quality standards, the need to manage vast amounts of documentation, and the necessity of integrating new solutions with existing software stacks are just a few of the hurdles that must be overcome.

Moreover, understanding the end-to-end quality management experience is crucial to minimizing manual activities and maximizing efficiency. The selection process can be time-consuming, costly, and risky without a methodology that considers these factors.

How SelectAssist Solves These Challenges

SelectAssist addresses these challenges head-on with a comprehensive, industry-tailored approach. Our methodology prioritizes understanding your quality and document management requirements while ensuring seamless integration with your current systems. We focus on both the technical fit and the critical business needs, providing a balanced view that encompasses technical capabilities, financial stability, and the vendor’s commitment to future development.

Our approach begins with involving critical stakeholders from the outset. By incorporating their insights and needs, we ensure the selected software aligns with user expectations and organizational goals. This inclusive decision-making process fosters ownership and ensures higher adoption rates and successful implementation.

The Integration Advantage

An integrated QMS and QDMS offer significant advantages. When your QMS is tightly coupled with your QDMS, you gain enhanced compliance, improved efficiency, greater visibility, and enhanced collaboration. Documents supporting quality processes are directly tied to the processes themselves, providing a comprehensive solution that streamlines operations and effectively meets regulatory requirements.

Our Comprehensive Offering

The SelectAssistSM process is designed to support every stage of the software selection process. From developing a business case and executing a Request for Information (RFI) process to evaluating proposals through scripted demos and Software Verification Workshops (SVWs), we ensure a thorough and informed decision-making process.

Our methodology also includes a future-state assessment of potential vendors, evaluating their commitment to innovation and customer success. This thorough vetting process ensures that the chosen vendor is technically capable and aligned with your organization’s long-term goals.

Benefits You Can Expect

  • Tailored Fit: Aligns QMS and QDMS solutions with your strategic objectives while accommodating your unique regulatory compliance needs.
  • Seamless Integration: Identifies early integration requirements to ensure a smooth user experience.
  • Engaged Stakeholders: Fosters ownership and acceptance among end-users through inclusive decision-making.
  • Balanced Insights: Combines technical capabilities with broader business impacts for well-rounded decisions.
  • Future-proof Solutions: Ensures the software can adapt to regulatory changes and business growth.

Discover More about SelectAssist

Are you ready to transform your QMS and QDMS selection process? Download the datasheet below and contact us to learn how SelectAssist can provide the clarity and confidence you need to make the right choice for your organization. Don’t leave your software selection to chance—let SelectAssist guide you to the solution that fits your needs today and tomorrow.

Download Datasheet
1 Step 1

Solve your QMS challenges. 

fme has clear methodologies to stay ahead of quickly evolving data standards, complex requirements and changing technology options. Learn the first steps and get started today. 

Download the datasheet
keyboard_arrow_leftPrevious
Nextkeyboard_arrow_right
FormCraft - WordPress form builder

Why Choose fme?

Our approach is distinguished by our emphasis on understanding the technological and human factors involved in QMS and QDMS package selection. Successful implementation is not just about the software; it’s about aligning with people’s work, integrating into existing systems, and adapting to future changes. With fme, you’re not just choosing a service provider; you’re choosing a partner committed to ensuring your solution is a resounding success. Contact us today to get started.

Contact Us
Navigating the Maze of Regulatory Information Management (RIM) Package Selection: The fme Approach

Navigating the Maze of Regulatory Information Management (RIM) Package Selection: The fme Approach

by | May 31, 2024 | Business Consulting, Datasheet, Life Sciences, Regulatory

Regulatory Information Management (RIM) remains critical in today’s ever-evolving pharmaceutical industry. It involves maintaining licensure across countries and publishing the necessary information for health authority approvals. Selecting the right RIM package isn’t just about integrating technology; it’s about ensuring the solution meets complex business requirements and gains widespread user acceptance. This is where fme steps in, employing a meticulous approach to guide companies through the RIM package selection and evaluation process.

1. Understanding the Complexity of RIM

Regulatory Information Management manages and publishes licensure information across multiple countries. As such, purpose-built solutions tailored to these unique demands are required. fme recognizes this need and offers services that understand the intricacies of RIM and the integration challenges with existing software stacks.

2. fme’s Approach to Software Selection

fme’s approach is characterized by a systematic methodology designed to capture both current and future requirements of RIM and publishing. Here’s how we do it:

  • Define Requirements: Before proceeding with solution selection, we work closely with clients to define their current and future RIM requirements, ensuring that any solution aligns with their business objectives.
  • Identify Candidate Solutions: Leveraging our industry expertise, we identify potential solutions that could integrate well with the client’s existing software stack.
  • Drive Evaluation and Selection: Through a series of evaluations, we ensure that all critical voices from the user community are heard, ensuring that the solution meets technical requirements plus user needs and preferences.
  • Support Decision Making: We assist clients in the final decision-making using quantitative and qualitative measures to compare potential solutions.

3. Engaging Key Client Team Members

A unique aspect of our approach is the emphasis on stakeholder engagement. We understand that for any solution to be successfully adopted, it must receive widespread acceptance from its end-users. Therefore, we:

  • Organize Requirement Gathering Sessions: We facilitate sessions with various stakeholder groups to ensure all needs and concerns are captured.
  • Promote Participation in the Selection Process: From defining requirements to evaluating demos and participating in hands-on pilot tests, we ensure key client team members are actively involved in every step.

4. Ensuring a Tailored Fit

Our methodology doesn’t just stop at selecting a package; it ensures the solution is tailored to the client’s organization. This includes:

  • Building the Business Case: We help clients articulate the strategic objectives and analyze financial implications, ensuring the solution delivers value.
  • Narrowing Down Vendors through RFI/RFP Processes: We ensure that only the most suitable vendors are considered through a structured RFI and RFP process.
  • Testing the Solutions: We ensure the solution meets the listed requirements and works seamlessly in the client’s real-world environment through scripted demos and client-driven pilot tests.

5. Finalizing the Selection

The final stage involves a comprehensive vendor assessment, looking at financial stability, product roadmap, and customer references. This thorough analysis ensures the final decision is well-informed and geared towards long-term success.

Learn More

For more details about fme SelectAssist, and how it can benefit your organization download the SelectAssist for RIM datasheet, and contact us to discuss your current challenges.

Download Datasheet

Why Choose fme?

Our approach is distinguished by our emphasis on understanding the technological and human factors involved in RIM package selection. Successful implementation is not just about the software; it’s about aligning with people’s work, integrating into existing systems, and adapting to future changes. With fme, you’re not just choosing a service provider; you’re choosing a partner committed to ensuring your RIM package selection is a resounding success. Join us in navigating the complexities of RIM, and let’s ensure your regulatory information management is robust, compliant, and efficient. Contact us today to get started.

Contact Us
Optimize and Improve Your RIM System with HealthCheckAssist℠

Optimize and Improve Your RIM System with HealthCheckAssist℠

by | Mar 6, 2024 | Business Consulting, dqMan, Life Sciences, Veeva

Regulatory compliance is more complex and crucial than ever, and organizations are under immense pressure to manage their regulatory information efficiently. In addition, the stakes have increased as health authorities responding to public pressure have become increasingly rigorous in their evaluations, issuing more fines and penalties than ever. The health authorities are also striving to standardize data submissions in ways that organizations may not be ready to meet.

Common Regulatory Challenges

Organizations face numerous immediate challenges in managing regulatory information:

  • High volume of data and documents
  • Data fragmentation over time and platforms
  • Adherence to evolving standards
  • Inefficient processes across teams
  • Compliance risks
  • Legacy systems being consolidated into new platforms
  • Frequent RIM platform updates to stay current with complex and changing regulatory environments from multiple Health Authorities worldwide

As companies grow, merge, and acquire new data, many struggle to maintain operational efficiency and ensure compliance with mission-critical global regulatory requirements.

Modern Platforms: A Double-edged SaaS

There’s no question that today’s cloud-connected SaaS solution platforms are a fantastic leap forward in technology. Unfortunately, their undeniable benefits also come with their own challenges that IT teams need to be prepared to address.

For example, today’s leading platform in regulatory information management Veeva introduces three product releases per year where the RIM Vault is enhanced with new features. Compared to historic on-prem solutions that started to become out of date the month after purchase, this is a fantastic capability. The challenge now is that new features, bug fixes, and enhancements are automatically turned on and/or configurable and have a critical go-live date regardless of whether the organization is ready. The volume of changes can be significant, and some organizations fall behind in implementing the configurable features. In addition, many configurable features are not immediately beneficial but are utilized to build a foundation for future innovations that provide additional efficiencies.

Security can be another significant challenge. An overly complex security scheme can stunt the utilization of the solution, preventing the use of features and functionality intended to provide significant user efficiency. A properly configured and maintained RIM solution should allow all its users to easily find the information necessary to complete current Regulatory tasks. Often, during solution implementations, an organization will try to configure a security scheme that is far too granular, complex, and not conducive to efficient collaboration. The overly complex security will cause frustration and loss of user adoption of the solution. It can also cause burdensome administrative overhead and limit the available scope of change requests from the user community.

The Solution – HealthCheckAssist

Implementing your RIM solution took time and money. As an experienced regulatory information management solution provider and proven migration, technology, and services partner on the Veeva platform, fme is ready to help our clients make the most of their investments. We are proud to introduce HealthCheckAssist, a comprehensive service solution meticulously designed for users of Veeva Vault RIM.

In the often-convoluted landscape of regulatory information management, HealthCheckAssist is a surgical toolbox of optimization, offering a suite of services tailored to dissect and enhance the intricate mechanisms of Vault RIM. Through in-depth stakeholder interviews and system analysis, HealthCheckAssist delves into different departments’ unique needs and challenges to develop a complete streamlining and optimization pathway that aligns perfectly with organizational objectives.

In the dynamic environment of regulatory information management, features and functionalities evolve rapidly. A standout feature of HealthCheckAssist is its rigorous review of new feature capabilities. This ensures that your organization remains at the forefront of the latest changes, leveraging the latest updates to streamline processes and enhance efficiency.

Moreover, HealthCheckAssist strongly emphasizes manageable security, with comprehensive assessments to safeguard critical regulatory data, ensure proper accessibility, and promote effective information exchange and collaboration. Shifting the focus to a manageable and sufficiently open security model is a cornerstone of any robust regulatory information management strategy. Properly executed, this security approach eliminates over-engineered access schemas and protects your information and users in an age where data breaches can have catastrophic consequences.

Benefits of HealthCheckAssist

The benefits of HealthCheckAssist are multifaceted. Organizations can expect a significant uplift in data and document quality, driven by optimizing the features and functionalities of Vault RIM. This enhancement in data and document quality is not just about accuracy; it’s about ensuring that your regulatory information is comprehensive, up-to-date, and readily accessible, facilitating swift decision-making and compliance processes.

HealthCheckAssist also includes access to fme’s unique professional administration tool for the Veeva platform, dqMan. With dqMan, HealthCheckAssist dramatically reduces the need for manual intervention and automates and optimizes key processes to free up valuable resources. Your team can focus on strategic initiatives rather than getting bogged down in routine data and document management tasks. This shift boosts productivity and enhances job satisfaction among team members, who can engage in more meaningful and impactful work.

The strategic advantage offered by HealthCheckAssist cannot be overstated. In the competitive regulatory compliance landscape, staying ahead requires keeping pace with regulatory changes and preempting them. HealthCheckAssist empowers organizations to do just that, providing a competitive edge that can make all the difference in a competitive and highly regulated industry.

Conclusion

HealthCheckAssist by fme is not just a solution; it’s a strategic partnership in your journey through the complexities of regulatory information management. Its comprehensive suite of services focuses on optimizing Vault RIM and make it an indispensable tool for any organization looking to excel in regulatory compliance.

We invite you to contact us to learn more about HealthCheckAssist’s transformative potential for your organization. Discover how it can streamline your regulatory information management processes, enhance both data and document quality, and provide a strategic advantage in the fast-paced world of regulatory compliance.

Download the HeathCheckAssist Datasheet

Added Bonus – Veeva Vault Edition of dqMan

As an additional bonus, we will also include a single-user annual license for dqMan as part of the engagement.

dqMan is a professional administration tool designed to boost productivity and maximize your efficiency as a Veeva Vault expert. Carefully crafted on the robust dqMan platform, this tool reveals the true power of the VQL (Vault Query Language) and MDL (Metadata Definition Language). It provides users with exclusive capabilities and a broad feature set while enhancing user accessibility and streamlining operations alongside the comprehensive functionalities offered by Veeva Vault Admin. Seamlessly installable on any Windows machine, our enterprise-grade software solution boasts an intuitive user interface, delivering a great user experience.

Say goodbye to manual, time-consuming tasks and focus on what truly matters—efficiently managing your Veeva Vault applications.

Seamless Integration: Transforming CRO to Sponsor Data Transfers with fme and JiT

Seamless Integration: Transforming CRO to Sponsor Data Transfers with fme and JiT

by | Feb 5, 2024 | Business Consulting, Life Sciences

In the dynamic realm of clinical research, the partnership between fme and Just in Time GCP (JiT) emerges as a beacon of innovation, particularly with their recent unveiling of CROAssist. This collaboration is not just a merging of two entities; it’s a fusion of expertise and technology to redefine the landscape of Trial Master File (TMF) management in clinical trials.

The inception of CROAssist™ is a testament to the forward-thinking approach of both JiT and fme. JiT brings to the table its unparalleled expertise in risk-based TMF management approaches, which are crucial for maintaining compliance and ensuring inspection readiness. On the other hand, fme contributes its vast experience in system migrations, a critical aspect in the seamless data transfer across platforms.

Automated Transfer of Trial Data from CRO to Sponsor

The core of CROAssist’s innovation lies in its ability to automate the transfer of trial data from Contract Research Organizations (CROs) to sponsor systems like Veeva Vault eTMF. This automation is a game-changer, addressing the traditional pain points of TMF management, such as data integrity, standardization, and compliance with regulatory standards. By minimizing human intervention, CROAssist significantly reduces the risk of errors and inconsistencies, ensuring that the TMF is always audit-ready.

Beyond automation, CROAssist stands out for its comprehensive TMF strategy. It’s not just about transferring data; it’s about transforming how it is managed, analyzed, and utilized. The platform employs sophisticated algorithms and artificial intelligence to enhance data integrity and compliance. These advanced technologies enable a proactive approach to TMF management, identifying potential issues before they become significant problems.

Benefits of CROAssist

The benefits of CROAssist extend beyond operational efficiencies. By streamlining TMF management, the platform enables sponsor organizations to focus more on the scientific aspects of their trials, rather than being bogged down by administrative tasks. This shift in focus can lead to faster trial completions, quicker time-to-market for critical medications, and ultimately, a more significant impact on patient health.

The partnership between JiT and fme, culminating in the creation of CROAssist, is a reflection of a broader trend in the pharmaceutical industry towards collaboration and technological innovation. In a sector where the stakes are incredibly high, with patient health and safety at the forefront, such innovations are not just welcome; they are essential.

The significance of CROAssist goes beyond its technical capabilities. It represents a paradigm shift in TMF management, where technology and expertise converge to create a more efficient, reliable, and compliant clinical trial environment. As the industry continues to evolve, partnerships like that of JiT and fme, and solutions like CROAssist, will be critical in navigating the complexities of clinical research, ensuring that life-saving treatments can be delivered to those in need more swiftly and safely than ever before.

QUICKFACTS

  • Efficient TMF Management: Automates and streamlines Trial Master File processes.
  • Management: Seamlessly coordinates data between sponsors and CROs.
  • Integration with Veeva Vault eTMF: Ensures validated data import for enhanced integrity.
  • Operational Burden Reduction: Alleviates complex TMF tasks from businesses.
  • Scalable Solution: Adapts to varying trial sizes and complexities.

In conclusion, the collaboration between JiT and fme and their development of CROAssist is a shining example of how strategic partnerships and technological advancements can address longstanding challenges in clinical trials. As this partnership continues to bear fruit, the industry can look forward to a future where TMF management is no longer a hurdle but a facilitator of scientific discovery and medical breakthroughs.

Learn More About CROAssist

Whether you are a sponsor or a CRO, the efficiency and accuracy gained through CROAssist will streamline your data transfer and minimize the obstacles to your trial’s success. Learn more at the SCOPE Summit for Clinical Trial Executives, or contact us directly to get all the details on CROAssist and how this new approach to TMF management can benefit your patient health and business goals.

Contact us
Download Datasheet
Will we see you at DIA RSIDM 2024?

Will we see you at DIA RSIDM 2024?

by | 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
View Session >>
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