Knowledge & Network Day 2019

Regulator: Medical Device trends, focus areas, and implications for the industry

Thomas Wejs Møller, Section Manager for Medical Devices, Danish Medicines Agency - Lægemiddelstyrelsen

CASE: Novo Nordisk - Safety Risk Management with Focus on Software as a Medical Device

Jens Christian Andersen, Principle Systems Engineer, Device R&D, Novo Nordisk

Medical device software can take two forms: Stand-alone software (i.e. software as a medical device, SaMD) or software as part of a physical device (i.e. embedded software). We will have a look at the safety risk management process in general as well as the software perspective. As the subject is very broad and deep, we will cherry pick a few points for discussion:

• Is software really so special?
• Standards and regulations
• Safety versus reliability
• Safety mindset
• Sharks and tigers
• Modelling
• Software safety design patterns

AI and IoT: Inspiration for Digital Innovation from Outside the Life Science Industry

Max Sejbæk, CEO, ProActive A/S

How can you get the most value from digital innovation in your company? Sometimes it helps to take off the industry blinders and stir your creativity with input from the outside world. Join this presentation to learn from concrete cases in other industries.

CASE: Criterion AI - The journey to Good Machine Learning Practices

Sebastian Brandes, Co-Founder, Criterion AI

Andrea Bondi, Consultant, Epista Life Science

The use of AI is experiencing unprecedented growth in the Life Science industry. According to the FDA: “Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day.” But remember, as the saying goes: “Power is nothing, without control.” Join this case from Criterion to learn more about their manufacturing inspection platform and how they’re conforming AI to the strict regulations of the Life Science industry. In an interactive session, we’ll discuss:

• The ‘black box' of the AI algorithm
• Important considerations like intended use, stakeholders, risks/mitigations, and more
• Data – the key to AI. Structure, quantity, features, and bias
• GMLP (Good Machine Learning Practices)

CASE: Radiometer MDR/IVDR Program: Examples of a proactive approach towards medical device software

Karin Troelsen, Regulatory Affairs Specialist, Radiometer

Lasse Sohrt-Petersen, Regulatory Affairs Specialist, Radiometer

The time since the MDR/IVDR came into force has been characterized by uncertainty on how to interpret and handle the new requirements. Close collaboration with Notified Body, MedTech Europe, EU Commission and participation in working groups, has been invaluable for Radiometer to prepare for the new Regulations. Our proactive involvement in various working groups has helped us gather information, but also enabled us to influence the common understanding of the new requirements. In relation to medical device software we have obtained current knowledge about the MDR/IVDR definitions, learnt how to understand the impact of the new classification rule for software, and gained an overview of the labelling requirements for medical device software.

CASE: Genmab's considerations and lessons-learned from IT platform implementation across multiple business applications

Fiona Glenny Mogensen, Associate Director, Business System Process Management, Genmab

Jacob Ekstrøm, Manager of Regulatory Application Services, Epista Life Science

It’s a huge task to implement several business IT applications at the same time – both in terms of required resources and timing. Join this presentation to get inspiration from Genmab’s experience. You’ll get insight into the considerations and concerns in their implementation program of the Veeva Vault platform. Among other things, we’ll explore:

• What were the business drivers for choosing a particular solution (e.g. current and upcoming business requirements such as Regulatory Filing Readiness, and more)?
• What were the steps and considerations in deciding between multiple single IT applications or the platform solution?
• How do you ensure program progression and expertise to sculpt and configure an out of the box solution to meet your specific business needs while maintaining business continuity?
• What are the considerations for onboarding external partners and vendors to access your regulatory system?
• What does the future look like - evaluating usage of further applications on the platform.

Join us for this inspiring discussion about a challenging, and valuable, project.

Achieving regulatory approval with unified RIM: How to ensure organization compliance and cross-functional communication with ever-changing regulatory requirements

Katrin Spaepen, Director Strategy, Vault RIM at Veeva Systems

Traditionally, information and data flow from the regulatory affairs department to other parts of the organization have been hampered by the pace and complexity of the change demanded. This has led to an increased risk of non-compliance, that in the new world of directives such as FMD or regulations such as xEVMPD/IDMP will be unacceptable. This presentation will address the challenges of communicating regulatory approvals across the organization. We'll focus on ensuring timeliness, accuracy, and completeness within the manufacturing organization, so they are appropriately informed and can maintain compliance with the latest approved drug specifications. We'll also speak to the challenges that arise with post-approval variations and how to overcome them through business process improvements, appropriate change management, and the deployment of a unified RIM system. Key take-aways:

• Understand your regulatory data including its governance, structure and control model
• Learn how to accurately plan, track, and oversee post-approval changes so you have greater visibility into their current state
• Gain insight into how a unified RIM approach can simplify current complex processes
• Learn ways to free up resources dedicated to manual stakeholder management and refocus them on real-time, compliant regulatory data that can be consumed more broadly across the organization.

Regulatory Requirements: Cost or Opportunity?

Jason Berning, R&D Project Manager, LORENZ Life Science

In today's regulatory world, there's constantly a new specification or validation criteria version on the horizon. These changing regulatory requirements drive the way in which you create and validate, and agencies process and review, electronic submissions. Each of these updates, whether they come from a new country with an established specification or a country bringing out a new electronic submission specification, impact your IT system landscape. In this presentation, we'll discuss our experiences keeping abreast with the upcoming changes to eSubmission Regional Requirements, and how to ensure that validated IT systems remain up-to-date.

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Before Long Term Storage: Turn migration from legacy systems into an opportunity for efficiency

Ben Saxton, Head of Sales, Formpipe Life Science

Legacy systems occur in all businesses as they mature. Changes in technology, company growth, and many other factors can create a need to retire old systems. The important thing is to preserve the critical data from these systems for the long term. Instead of considering this challenge an obstacle, you can use it as an opportunity to create efficiency in your business. Join this practical discussion about important issues:

• Migrate documents and data from legacy systems to a preservation platform in order to retire the legacy systems
• Ensure all migration adheres to data integrity standards
• Enable easy search and retrieval of data and documents
• Set up efficient long-term document storage

We look forward to a great discussion, taking your specific questions and challenges!

CASE: Coloplast shares strategic considerations and practical experience with MDM

Helene Randal Huyzer, Senior Regulatory Affairs Manager, Coloplast

Master data management (MDM) enables an enterprise to link critical data to a common point of reference. Join this presentation to learn WHY and HOW Coloplast tackles this challenge. Helene will explore Coloplast’s strategic considerations of creating consistent and trusted master data. Why is it needed? What kind of overall business benefits are they hoping to achieve? She will also discuss lessons learned. How Coloplast has tackled this, so far. Furthermore, what kind of data is the focus of their MDM efforts? What are the challenges of cooperation between different systems/processes? And more. Don’t miss this chance to benefit from Coloplast’s experience and get inspiration for creating value with MDM in your own company.

Russian (Roulette) Serialization: Status update plus tips on how to meet the deadline

Pasi Kemppainen, Principal Advisor for Pharma Digitalization, Epista Life Science

The Russian serialization regulations and timetables are set. But what is the current state of the regulatory framework and technical guidelines? That’s still developing. You spent two years implementing FMD, and now you have only a few months to finalize compliance for the Russian market. Join this presentation for expert insight and best practices to reach the finish line in time. We’ll discuss:

• Status of the regulations and technical guidelines
• Impact on manufacturing and supply chain requirements
• Impact on IT landscape
• Supply chain integration (CMOs, 3PLs, etc)
• Real experiences from a company like yours

Serialization - Operation after "GO-LIVE"

Aytac Atac, Vice President, EMEA at Supply Chain Wizard

Congratulations – your Serialization System is live, aligned with regulatory authorities and partners, and tuned to your business goals…So you are all set for a lifeti..Wait a minute.. Good things in life cannot be that simple, can it? What if you have new SKUs coming in next month? What about the new CMO who is to be onboarded next year? Have you heard about the new release of your L4/L5 system? Let us take the time to re-align on what our day to day life would be in a serialized world. Also, let’s not forget, serialization introduces a lot of opportunities for more visibility and better management of your products. Let’s take a snapshot of what these benefits could be.

BLIND CASE: Achieve Scalability with Efficient Quality Processes

Robert Pettersson, Managing Director, Epista Life Science Sweden

Learn from the experience of several cases of companies striving to increase their revenue without increasing their workforce. With all of these specific cases, the way to achieve their final goal was to focus like a laser on their quality processes. They asked themselves: What were they spending in this area? Did their headcount and investments make sense? They had no tangible way to answer these questions, so these companies asked Epista for help. Find out how Epista made their compliance more transparent to identify roadblocks and bottlenecks. And discover how we turned this raw information into concrete roadmaps. Learn about the results these companies achieved and how they did it. We encourage specific questions about your challenges, as well. We look forward to the discussion!

BLIND CASE: Maintaining the validated state of Dynamics 365 

Klavs Esbjerg, CEO, Epista Life Science

Learn from a compilation of several Life Science cases about how to stay in control of Dynamics 365, efficiently while also boosting quality level and yes – even lowering cost of compliance. All of this, in the face of frequent and mandatory updates. It’s a bold claim, and you’ll get specific details on how these results have been achieved. We’ll discuss the challenges these companies faced (For example: “How can we possibly test the whole system so frequently?”) And the practical details of how they achieved these great results (Spoiler: the answer involves an automated testing platform - maximum control with minimum effort). Join this presentation for inspiration and a chance to ask questions about your specific challenges.

Trust is good - Automated testing is better

Lasse Bruhn, VP of Customer Operations, Columbus

Automated testing can reduce testing time by 65%, establish precise security permissions four times faster than previously (Microsoft Dynamics 365), and stress test systems at the same time. Learn how Life Science companies can implement automated testing across all their web-based applications to handle the frequent patches and upgrades of their systems. A company might have many servers that will receive different updates which will be restarted at different times. Timing is therefore everything in these situations. We’ll show how to create value with automated testing and give real life examples of how it works. Don’t miss this interactive discussion to find out! Questions about your specific challenges are encouraged.

Inspiration and solutions for the vexing question: Why do so many Life Science companies have such poor, old ERP system implementations?

Claes Östman, CEO, Anchor Management Consulting

Compared to other industries, Life Science companies seems to be in an old or inappropriate ERP system environment surrounded by a wide variety of locally used Excel files. Sharing real time data and having structured processes including roles and responsibilities in a Production environment does not seem to be a natural way of working. In other Industries, this is vital to reach Operational Efficiency. If you recognize this issue in your own company, join us for inspiration and solutions to make your ERP system work for your business goals.