Agenda for Knowledge & Network Day 2017
September 20, 08:30- 16:30
Søhuset Conference Center, Venlighedsvej 10, 2970 Hørsholm
Knowledge & Network Day aims to contribute to a higher level of insight and maturity in the Life Science industry - including companies, regulators and technology suppliers.
How can a one-day event accomplish this? By bringing together industry influencers, including you! Jump between four parallel tracks offering practical knowledge from subject matter experts, cases from global Life Science companies, and new technology information from suppliers. Check out the agenda, below. Get details by clicking on the track title.
Life Science companies are constantly bombarded with new regulations, new technology and new business initiatives. They must find the optimal balance between risk and efficiency so that regulatory compliance does not stand in the way of digitalization, analytics, patient-centricity, and more.
We hear serious questions from the industry:
- Are we overspending on time and resources, hampering efficiency and our bottom line?
- Are we underspending and running the risk of our compliance getting out-of-control?
Join this discussion for insights into this challenge, including concrete actions to help your company balance compliance efforts between risk and efficiency. Finding the optimal balance between these two extremes is critical, for it is here that compliance moves from being an obstacle into actually helping your company achieve your business goals.
Moderator: Rasmus Torp Kristensen, Team Manager, Epista Life Science
To reach the digital future, companies must become data-driven. Your data must be accessible, controlled, and secure. But in many companies, data is still scattered and inconsistent. Join the Data Track to hear the hot topics around data in the digital future. We'll tackle common problems, offer insight and solutions, and give a regulatory perspective on data.
We want to make this track work for you. You'll hear from SMEs and have plenty of time to ask questions and discuss your individual challenges and experiences. Have a question for one of the speakers or an issue you want addressed? Email email@example.com with the subject line 'Data Track Input'. We welcome your contributions.
Companies need to move from a system-centric approach to a data-driven one. Join this presentation to explore exactly what this means. Where are we now? Where are we going? What can we do differently in the future when we implement new systems? How can we structure our data to get more insight? Many questions – join the discussion.
Presentation 3: Data Integrity - A Practical Perspective
Keith Williams, Member of ISPE GAMP European Committee
Join this presentation to dive into data in the real world. What can and should we do - instead of what are all possible things we might do? Keith will discuss examples from manufacturing and labs, highlighting the differences in requirements of data integrity between GMP and GLP environments.
Join Ib Alstrup as he explores the expectations of the Danish Medicines Agency to procedures and functionality ensuring Data Integrity in regulated GMP/GDP environments. Don't miss this insight into a regulator's view of a Data Integrity inspection.
Moderator: Lars Moltke Hansen, Senior Consultant, Epista Life Science
Compliance is becoming increasingly complex, with ever changing requirements and new technology constantly creating challenges. How do you stay in control on the way to the digital future? We'll cover major developments in IT compliance focusing on practical information that you can use to add value when you get back to your office.
We want to make this track work for you. You'll hear from SMEs and have plenty of time to ask questions and discuss your individual challenges and experiences. Have a question for one of the speakers or an issue you want addressed? Email firstname.lastname@example.org with the subject line 'Advanced IT Compliance Track Input'. We welcome your contributions.
Presentation 1: CASE: Spot-on compliance – Finding the right balance between compliance and risk
Hanne Harbo Hansen, Principal Consultant, Epista Life Science
Join this presentation to hear the story of a Medical Device organization that turned a benchmarking exercise into a visual risk-based management tool. They aligned quality objectives across QA and operations. The focus was quality, and the result was efficiency. Learn exactly how they did it.
A significant number of life science organizations have now embraced cloud applications and are seeing greater compliance, improved quality, and reduced operational overhead. But, what’s next for the cloud? In this session, Jonathan Burd will explore how the cloud might evolve in future and its impact on IT complience and quality management. What are the possible directions that cloud development may take and what opportunities might be available as the cloud moves to the next level?
Join Susanne to learn from her experience with cloud solutions for more than 10 years in the Life Science industry. She'll share what she's learned from facing the practical challenges of staying in control, even while 'going cloud', in a regulated environment.
Join this presentation to hear how the upcoming General Data Protection Regulation (GDPR) was received and is being dealt with in a Medical Device organization. The stumbling startup, gaining understanding and organizational awareness, becoming part of a global Data Privacy program, the interference of two FDA inspections and the current progress of implementation activities.
Moderator: Christian Holse, Senior Consultant, Epista Life Science
Many companies are, by now, in the final stages of implementing their serialization program. These stages are crucial to the overall success of the projects, not only to optimize the processes and ensure smooth onboarding, but also to create a program that enhances your business. How can we ensure that serialization is actually supporting business goals? We'll discuss turning serialization into an asset through digitalization, data management, and other strategies to create value beyond compliance.
We want to make this track work for you. You'll hear from SMEs and have plenty of time to ask questions and discuss your individual challenges and experiences. Have a question for one of the speakers or an issue you want addressed? Email email@example.com with the subject line 'Serialization Track Input'. We welcome your contributions.
TraceLink's early project experience/learning with the top 30 pharma companies is that more than 50% of them have complex integration requirements due to the legacy ERP solutions in place. Even though GS1 standards such as EPCIS aim to standardize data exchange, there are still 3 versions to adhere to: EPCIS v1.0, 1.1 and 1.2. By integrating once and interoperating with your partner ecosystem, you can address the complexity of data exchange in a compliant, validated fashion. Learning how to do this will save you time and cost on an already expensive serialization project.
The Pharma industry is going through a large scale transformation with serialization projects. Is serialization just a project we need to perform to comply to regulations? Or can we get real business value out of the ongoing track & trace programs and create sustainable improvement at the supply chain? Driven by the track & trace requirements, at Supply Chain Wizard, we place innovation at the core of our projects to make positive impact to the day-to-day business operations of our clients while complying to the regulations. Please join us in this talk while we present the real life client case examples in digital transformation of factories and pharma supply chains.
As Validation Responsible for the Global Serialization Program and the Product Supply SAP Program in Novo Nordisk, Henrik has many lessons to share – from building the program from scratch through how to prepare for the Operation and Maintenance phase. Join us to learn from Henrik’s insights on challenges between Administrative IT versus Production IT, requirements from authorities and much more. Henrik also bring experience from his roles representing Novo Nordisk in the EFPIA Project and as Quality Assurance Manager for EMVS in the EMVO being involved building this organization's QMS with processes like Security Control and Change Control.
Presentation 4: Panel Discussion
Jesper Holm, Owner, Graphic West
Stanley Samuel, Group Manager - EMEA (CMO / 3PL), TraceLink
Evren Ozkaya, Founder and CEO, Supply Chain Wizard
Henrik Egede Hansen, Validation Lead at Novo Nordisk
Moderator: Karin Grostøl Nielsen, Principal Consultant, Epista Life Science
New medical device technology is driving the industry forward toward patient-centricity, value beyond the pill/device, and insightful new sources of data that can improve health and patient outcomes. However, with these advances comes increased attention and pressure from regulatory authorities, who have set newly high demands for Medical Device companies. How can we bridge the gap between rapidly advancing technology and regulatory requirements? In this track, we'll cover audits, apps, and new regulations, with the goal in mind of turning compliance efforts into business assets.
We want to make this track work for you. You'll hear case stories from SMEs and have plenty of time to ask questions and discuss your individual challenges and experiences. Have a question for one of the speakers or an issue you want addressed? Email firstname.lastname@example.org with the subject line 'Medical Device Track Input'. We welcome your contributions.
Join this case story to hear from Radiometer themselves about how they prepared for and successfully executed their recent FDA inspections. Learn from their experience and be ready to ask your own specific questions so you don’t have to reinvent the wheel.
Presentation 2: UDI Compliance in EU
Jesper will go beyond UDI basics. He'll explore UDI requirements around the world, drilling down into the EU requirements. And for a practical angle, he'll discuss how to use GS1 standards to become UDI compliant for the EU. You'll have a chance to ask specific questions about your own UDI challenges.
Join us to discuss the use of mobile technology in clinical trials and explore how Life Science companies and technology providers can work together to harvest the benefits while ensuring compliance.