Time Topic
8:00-10:00 Registration
8:00-10:00 Pre-Conference Networking Breakfast
10:00-11:00 Keynote & Build-a-thon Kick-off
James Kelleher Max Kelleher
11:00-11:30 Roadmap for the CARA Core Platform
Max Kelleher
11:30-12:00 Coffee Break
12:00-12:45 The CARA Hub
James Kelleher
12:45-13:30 Lunch
13:30-14:00 Managing EDMS for Global Pharmaceutical companies
Sasikanth Godavarty
14:00-14:30 Data as Objects - Benefits of a New Approach, and the Realities of Ultra Performance

Abstract: Learn how CARA is creating a new paradigm for how we think about fixing problems, managing processes, doing our work, and recording outcomes in a digitised workplace

Max Kelleher
14:30-15:00 Use of a database for the management of pharmacovigilance agreements

Abstract: The presentation introduces SAMS, a validated document management system for the management of Pharmacovigilance Agreements (PVAs). The presentation also covers various features of SAMS, such as viewing PVAs, generating PVA overview reports, and creating PSMF Annexes of PVA Agreements, demonstrating how a large number of Pharmacovigilance Agreements and related documents can be managed efficiently and transparently in the system. It also explains how stakeholders use SAMS at Merck. The advantages of using SAMS are highlighted, including time-saving, automated processes, transparent document overview, and easy access.

Marko Strott
15:00-15:30 Unlocking the potential of data assets by making data Findable, Accessible, Interoperable and Reusable (FAIR) (MAIN5)

Abstract: The pharmaceutical industry generates vast amounts of data throughout the drug development maintenance processes. Ensuring that this data is Findable, Accessible, Interoperable, and Reusable (FAIR) is crucial for advancing research, enhancing collaboration, and maximizing the value of data-driven insights. We will discuss the key components of the FAIR data principles and share practical strategies for implementing FAIR data practices. Additionally, we will explore the challenges and opportunities associated with FAIR data, including issues related to data management, standardization, and sustainability. By embracing FAIR data principles, pharmaceutical companies can unlock the full potential of their data assets, drive scientific discovery, and ultimately improve patient outcomes.

Dominik Gigli
15:30-15:45 Docs from Data: New Ways of Working

Abstract:The best way to achieve accuracy and consistency in our businesses is to use and re-use pure data, but the narrative, context, and creative presentation of that we get from content is still a vital and mandated part of how we work with information. Learn how CARA makes it easier to turn the data we use into the content we need.

Jack Kelleher
15:45-16:00 Coffee Break
16:00-16:30 Transformative strategies - Balance GxP compliance with business agility, Automate compliance activities, Enable GxP compliant use of data assets and AI [Deloitte]

Abstract: We will showcase transformative solutions to navigate GxP complexity:
- Balance GxP compliance with business agility: The historically grown legacy in Quality and Compliance systems is an increasing burden.The ability to manage GxP complexity in an agile way is becoming a true differentiator in the market.
- Automate compliance activities: Emerging technologies such as Generative AI are showing significant potential to reduce compliance cost. Freeing up resources for high value activities is also key to address the increasing shortage in skilled labor.
- Enable GxP compliant use of data assets and AI: The Life Science industry is discovering the value of their data assets and is building GxP compliant data platforms and GxP controlled AI models while facing new legislation around data and AI.

Christian Schiel
16:30-17:00 Driving Digital Transformation: overcoming challenges and maximizing efficiency in highly regulated industries. (Userlane)

Abstract: In the fast-evolving digital landscape, companies are increasingly adopting a digital-first strategy, focusing on integrating Software as a Service (SaaS). Yet, 96% of organizations face challenges in digital adoption, from increased support tickets to cultural resistance. Tom Farrow, Director of International Sales at Userlane, addresses the complexities of digital transformation, software adoption strategies, and the crucial role of SaaS implementations. In his session, Tom will uncover strategies to improve productivity and optimize IT spending through data-driven decisions, high software adoption, efficient software landscape discovery, and enhanced improvements within the software. Moreover, the presentation highlights a strategic partnership between Generis and Userlane, merging the CARA platform for regulated industries with Userlane's Digital Adoption Platform (DAP). This partnership enables CARA Platform users to speed up user adoption, increase investment returns, and simplify compliance procedures. Join Tom Farrow as he demonstrates the significance of software adoption analytics, showcased through Userlane's digital adoption success stories. Learn how CARA and Userlane can help organizations understand software utilization, uncover new opportunities, and reduce digital hurdles. Discover strategies to minimize software waste and boost employee productivity, positioning your organization at the forefront of the digital transformation.

Tom Farrow
17:00-17:30 Optimizing Regulatory Strategies and Processes: Maximizing a RIM Platform's Potential (EXTEDO)

Abstract: With the introduction of the eCTD standard, the days of stacking folders prior to submitting a dossier are gone. However, life sciences companies are still looking to streamline their operational processes and adapt their IT landscape to support them. The goal: Regulatory Excellence, i. e. high productivity, assured compliance, and reduced workload for Regulatory Affairs. Together, we explore the capabilities of a comprehensive end-to-end solution like EXTEDOpulse powered by CARA to identify potential opportunities for simplification and automation. By connecting (master) data with documents to create submissions, we discover how to reduce complexity and prepare for future requirements. Let us find out which processes can be easily simplified to quickly create a compliant and successful submission!

Nicole Sagner
17:30-18:00 The New Way: Modernizing Document Management [Adlib]

Abstract: Join Anthony to learn how not to get left behind times with outdated document management strategy. While digital transformation has been top of mind for many business leaders and is now a leading concern (surpassing cybersecurity and cloud), it is still very common to find knowledge workers performing highly-repetitive manual tasks when it comes to document processing and management. How is this possible? With all kinds of BPA solutions out there, companies stil struggle with curtailing manual effort and process inefficiencies associated with meeting regulatory requirements and processing documentation. In this talk, Anthony will outline the new technologies disrupting industry-specific automation in document management.

Anthony Vigliotti
18:00-19:30 Drink Reception & Build-a-thon Results in Hotel
Time Topic
9:00-10:00 Introduction & Roadmap for CLS
Max Kelleher James Kelleher
10:00-10:30 Customer Presentation AbbVie

Abstract: AbbVie implemented CARA in 2022 and will discuss our journey to solving our needs with CARA Life Sciences, our benefits of CARA Life Sciences and how meaningful the CARA Regulatory Working Group can be.

Tommy Lacey
10:30-10:45 Coffee Break
10:45-11:15 Drivers for Structured Data beyond the current IDMP Standard and how they will shape the Future of RIM Systems

Abstract: The application of IDMP in regulatory practice is advancing, in particular in Europe with EMA’s Product Management System and Product User Interface taking shape. The presentation will shed light on what happens meanwhile in the background. Authority projects like FDA’s Project Orbis and industry projects like Accumulus Synergy’s cloud-based platform pave the way to submissions consisting exclusively of structured data. Such developments put a constant evolutionary pressure on RIM systems like Generis Cara to adapt.

Felix Spenkuch
11:15-11:45 Data Quality Improvement Journey (MAIN5)

Abstract: "The report I am using just does not make sense, the quality of the data is so poor that I better rely on my Excel..." - does it ring a bell, sound familiar? How to build trust in the structured data stored in our RIM solutions? How to improve the data quality, how to overcome impediments and user reluctance in data quality projects? How to build an effective data quality framework and introduce a data quality culture? This presentation will be a practical user guide on how to embark on the data quality improvement journey and run efficient data quality projects. All of this to obtain trustworthy data and meaningful reporting in the regulatory area supporting CMC, safety, labelling as well as regulatory compliance, along with IDMP, PMS and PLM requirements on the horizon. We will be setting-up a data quality forum, we will profile the data, define and classify the pain points, formulate the data quality rules, introduce a cultural change and monitor the results.

Joanna Borkowicz
11:45-12:15 Joining up Processes - connectivity of CLS

Abstract: A dive into the world of interconnected processes and information shows how you can join your teams and their work to deliver new efficiency and digital transformation with CLS. The AI Roadmap for CARA

James Cook | Naomi Bradley
12:15-13:00 Lunch
13:00-13:30 Five Practices to increase Global RIM Program Performance

Abstract: Steve Gens and Preeya Beczek will jointly present 5 key practices to improve how regulatory information is effectively managed globally. This will be based on Gens & Associates research of over 140 organization, 320 local affiliates, and the speakers’ practical experiences. This dynamic session will incorporate audience participation via real-time polling with focus on improving: 1) process efficiency, 2) data quality and governance practices, and 3) technology application. Steve will also provide a glimpse of the early results to the 2024 World Class RIM: Extending the Power of RIM benchmark.

Steve Gens | Preeya Beczek
13:30-14:00 Onboarding a very large user number to a single enterprise-wide platform

Abstract: How to onboard a large number of users to a single enterprise-wide platform is already a challenge. If the basis from where you start is a complex system of responsibilities and a matrix organization with many layers of hierachy it adds some challenges. And if you start to rebuild the overall operating model of the company in paralell the challenge is perfect. The presentation show how we handle that and why a high flexibility and agility on all ends of the project is important.

Michael Bald
14:00-14:30 Global Data Standards: Charting the Course for Life Science Companies

Abstract: Data standards are the bedrock of global digital transformation. In this presentation, we will explore the current state of data standards on a global scale, with a particular focus on their impact on life science companies. We will discuss how these standards are facilitating enhanced interoperability, improving efficiency, and driving innovation in the life sciences sector. Furthermore, we will dive into the impact of the latest developments from EMA and the EU Network on the data and document management capabilities and (future) requirements. This presentation aims to provide an insightful overview of the data landscape and the impact in shaping the future of life sciences, while offering guidance for companies navigating this complex, yet compelling domain.

Remco Munnik
14:30-15:00 CARA for Safety Label Changes and Electronic Product Information

Abstract:The labeling process requires the orchestration of requirements such as regulatory affairs, marketing and production talking in different "languages". We will talk about the challenges to define one harmonized and efficient process for labeling, the role of safety label changes as specific process requirements and electronic product information as future requirements.

Dennis Will Dr. Sabine Schneider
15:00-15:30 Regulatory Excellence in Practice

Abstract: Syneos Health regulatory consulting discusses the impact of implementing the Heads of RegOps (HeRO) - defined regulatory excellence framework from a talent, delivery and data perspective. This framework covers:
Talent and Organizational Excellence: Establishing a fit for purpose Reg organization, ops model & workforce equipped to achieve Reg Excellence Delivery Excellence: Optimizing submission strategy, compliance, process & technology to ‘get submissions right the first time’. Enabling process simplification and automation groups to streamline ways of working, embracing digitization through standardized and emerging technologies (e.g., RIM, AI, BPM) Data Excellence: Having the right data, in the right format, that’s reusable, driven by a robust data governance model

Caroline Masterman-Smith
15:30-16:00 The AI Roadmap for CARA

Abstract: Hear about our philosophy and approach to implementing successful AI solutions with CARA, and where we’re going in the future

Max Kelleher
16:00-16:30 Coffee Break
16:30-17:00 Utilizing Large Language Models (LLMs) and Natural Language Processing (NLP) Models in Real-World Data and Patient Safety in the Life Science Industry

Abstract: A study found that only 40% of ~300 data points required for clinical decision support and real-world evidence were available in structured data. So where is the clinically relevant data? It’s often found in unstructured clinician notes. This session will discuss examples of successfully utilizing NLP in the Life Science industry to extract valuable data for real-world evidence. Topics covered will include Observational Safety in Mental Health, Adverse Drug Event Detection and Building Patient Cohorts.

Karen Sundstrom Thomson
17:00-17:30 Classifying Documents Using AI NLP

Abstract: The ability of natural language processing makes it possible operate documents and texts with minimal human effort. This can be used for classifying and analyzing documents upon entry into your company and system environment. By developing a machine learning method and algorithm for document classification, which is trained locally in your environment, it constantly becomes more aware of company specifics constraints, which are relevant for the algorithm to make "good" decissions. The direction application of this method can be:
- INTAKE SOLUTION: CRO delivers documents in another datamodel than your DMS, use AI to get all relevant data and organize it before automatically uploading to your own system - CUSTOMER CASE ANALYSIS: Analyse requests, complaints or inquiries being made to your company from customers, authorities and stakeholders. NLP Organize them by criticality, urgency and responder. Automation will start relevant workflow and inform intended responder.

Peter Smedegaard Andersen
17:30-18:00 Accelerating Innovation – It’s about way more than the technology

Abstract: Innovation is often synonymous with the deployment of a new technology, application, or approach. We hear lots of talk about it, particularly from software vendors and consulting firms, but it can be months or years later before we really know whether we have achieved something meaningful, whether it can really be attributed to an innovative process, and usually all for a significant unaccountable investment. I have spoken on the topic of Innovation in the past. These talks have included reviewing technologies, use cases, investment criteria and the business economics of innovation. But there is little emphasis on the success factors of innovation, its collaborative and motivational attributes, and often we rush into things because a cool new technology emerges, or our peers are doing it. Do we really understand what makes innovation work? In this presentation, I will explore how 12 business success factors can influence innovation acceleration, the origins of which are based in academic research and the application of which has been tested in other industries. I will describe a methodology of assessing a company’s readiness for innovation, providing a benchmark upon which to improve, and how this methodology can be an accountable innovation accelerator across the enterprise.

John Cogan
19:00-Late Dinner outside of hotel
Time Track 1 Track 2 Track 3
9:00-12:00 Regulatory Working Group Quality Working Group Dev Drop In
12:00-13:00 Lunch
13:00-14:00 Closing Remarks
14:00-17:00 Private meeting time : Dev drop in, Senior leadership drop in

Session timings are subject to adjustments. Please contact [email protected] with any questions.

What to expect:



Revolutionary Product Launch

Formally unveiling the CARA Hub™ – secure and compliant collaboration with partners, suppliers, and service providers

Explore the CARA Life Sciences Platform™

Find out what CLS means for you, learn about the roadmap, and contribute live with your peers

Discover the Potential of CARA™

Meet the architects, take in the exciting roadmap, learn about building with CARA, and get to grips the powerhouse behind Digital Transformation

Check out our Build-a-thon

Watch as our configuration team battle to create whole systems from scratch in just a few hours!


Understand the Generis Approach

We’ll explain our approach to AI with CARA, present our roadmap for AI enabled solutions, and discuss how we can implement for our customers

Deep Technical Expertise

We’ve partnered with some of the most trusted and successful AI developers in our industry who will talk about real, exciting examples and how to get there

Meet the Ecosystem

Find out about the new ecosystem of AI solutions that will be supporting CARA, ask questions, and learn how these new tools can accelerate your work

Register Free Now

Industry Insight

Hear the Data News from Industry Experts

Get the latest information on data standards, ontologies, implementation timelines, and best practices from people working closely with the agencies

Pick Up Business Process Tips

Hear from the industry’s leading professionals on digital transformation, change management, and business process optimisation

Get Actionable Advice

Learn strategies for improving your data management, fighting sprawls of content, and working smarter not harder

Meet the Enablers

Find the answers from our knowledgeable partners, thought leaders, and subject matter experts


Hear from your Peers

Hear other customers’ experiences, learn and share best practices and keys to success

Working Groups

Take advantage of the full 1/2 day Regulatory and Quality Working Groups, drop in to our Technical Round table with the Generis Development team, or find out how our partners can support you with CARA

Chat with our Leadership

Meet the full Generis senior leadership and C-level team, ask questions, share your ideas, and learn about our growth and vision for the next 3 years

Register Free Now

Why Attend Generate?

New product announcements ・ Face time with our leadership team  ・ Share your experience  ・  Learn best practices  ・  Guidance on regulations ・ Influence the direction of the CARA Platform ・ Network with peers

We are continuously improving, developing and adding to CARA, this is made possible due to the invaluable feedback we get from our customers. We see Generate not only as an opportunity to tell you what we’ve been working on, but also to get feedback. We will have drop-in sessions and roundtables on different topics, including our Regulatory Working Group. This gives our customers the opportunity to talk to each other, compare their success stories and take this knowledge back to their organisations to continue improving their usage of CARA.