Main Conference Day One

8:30 am - 9:00 am Morning Registration and Coffee

8:55 am - 9:00 am PharmaIQ Welcome

9:00 am - 9:10 am Chairwoman's Opening Remarks

9:10 am - 9:10 am Data Management for Efficient and Informative Lab Based Environments

Key Takeaways:

• Benchmark your companies data management strategies by considering the roles and integration of structured and unstructured data sets

• Build a robust data management roadmap to FAIRize your data, efficiently utilise your Metadata and generate real time data insights

• Analyse the latest technology from the industries leading solution and software providers to pinpoint valuable new solutions to address your biggest data utilisation gaps

9:10 am - 9:30 am People Bingo: Interactive Speed Networking

A highlight of Pharma IQ events, now at Future Laboratory Informatics. Be ready to meet your peers and share best practices. You will have several two

minute conversations to introduce yourself to your peers and add to your contact pool. There is a prize in it for the winner so get networking

Please Share:

1. Who you are

2. The scope of your job role

3. What you plan to achieve from attending this event

4. Your number one challenge

9:30 am - 10:10 am Success Begins With Your Strategy: Building Your Data Management Capabilities For An Analytical Environment

• Discuss critical success factors for an effective data management strategy to ensure end to end systems and user compliance

• Examine the transition to an automated and analytical environment – what are the data management requirements and restrictions that need to be considered?

• Enhance your informatics systems: integrating analytical capabilities to utilise your data as next steps to optimising ongoing data management

10:10 am - 10:50 am Product Vs. Promise: What Will Solve Your Data Management Challenges

Burkhard Schaefer - Head of BSSN, Merck


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Burkhard Schaefer

Head of BSSN
Merck

10:50 am - 11:20 am Morning Coffee Break

11:20 am - 12:00 pm Tackling Systems Retirement From The Data Management Perspective

Dora Endreffy - Senior Manager, QA, GBS QA Quality Governance Risk & Compliance, Global Records Manager, ICON

• Incorporate disruptive systems retirement in accordance with well-defined and documented processes through a case study of retiring systems containing regulated records

• Assess – and plan for – the consequences of systems retirement on systems usability and capacity

• Discuss recommendations and tools for retirement including risk assessments, and lessons

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Dora Endreffy

Senior Manager, QA, GBS QA Quality Governance Risk & Compliance, Global Records Manager
ICON

12:00 pm - 12:00 pm Optimising Data Integrity And User Compliance For Systems Excellence

Key Takeaways:

• Discuss how to foster user engagement and data integrity without impacting your laboratory digitalisation strategies to embed compliance as you build your capabilties

• Avoiding Failure At The Last Point – build a data integrity strategy to accompany digital engagement

• Dissect the role of process automation in enhancing data integrity and minimising the risk of human error

• FAIRize your data – is it the future of data management or have we been here before?

12:00 pm - 12:40 pm Combining The FAIRificafion Of Fermentation Data And User Experience In Software Development

• Look at how FAIRification and usability can be combined to enhance both your software capabilities and your user compliance

• Explore how FAIRification can enhance comparability of analytical results across platforms and sites

• Discuss the role of user experience testing in enhancing systems compliance and data utilisaton

12:40 pm - 1:40 pm Networking Lunch Break

1:40 pm - 2:20 pm Panel Discussion: User Engagement – Can You Leverage This To Increase Systems Compliance And Data Integrity

• Analyse how user experience interacts with the growing number of software, algorithmic tools and databases – Where does the balance lie to achieve a unified informatics management system?

• Discuss the role of systems automation in facilitating both data integrity and effective user engagement

2:20 pm - 3:00 pm Implementing A Laboratory Execution System: Managing Change To Ensure Integrity

• Assess the migration and implementation steps to build effective change management processes

• Mitigate foreseen hurdles to cooperation and coordination

• Discuss why an agile approach to systems implementation can help ensure your laboratory execution system rollout is both flexible and compliant

3:00 pm - 3:40 pm TECHNOLOGY INNOVATION SHOWCASE

Hear from three leading informatics systems and software providers on the latest technology innovations and systems capabilities to give you a clearer

understanding of what is available. Take this opportunity to meet with companies showcasing their capabilities at the forum.

3:40 pm - 4:10 pm Afternoon Coffee Break

4:10 pm - 5:40 pm In Conference Workshop: Data Integrity, Data Verification And Effective Data Management For Lab Based Environments

Data Integrity continues to be a focal topic within the highly regulated and analytical environments

such as R&D and manufacturing labs. With threats and deficiencies heavily impacting product quality

and patient safety, developing a proactive and end to end data integrity strategy continues to be a high

priority for all industries.


This interactive workshop will focus on how to interpret and apply standards within lab based environments

to ensure that there isn’t just an effective data management strategy in place, but an implementation of

processes that will actively enhance your verification processes and lab wide data integrity.


Focusing on WHAT we can do to improve data integrity now, this interactive workshop will:

• Set you up for success: utilise a systems assessment to outline current capabilities, threats and weaknesses to compliance and opportunities for systems and process optimisation

• Provide a practical and hands on understanding of data integrity challenges within highly regulated environments

• Map out potential data integrity breaches to move towards a proactive identification, assessment and prevention strategy

• Provide opportunity to benchmark your current strategies with a cross-section of industry approaches and brainstorm ways to enhance your end to end integrity

5:40 pm - 6:10 pm Chairwoman's Summary of Day One