Day 1 - Wednesday, 13 November
08:30 - 09:00
Registration & Welcome Coffee
refreshments catered
09:00 - 09:45
Movilitas: Who We Are
Mr. Ross young
ceo, Movilitas
09:45-10:30
SAP In The World Of Track & Trace
Mr. Thiam Hwa, Lim
SAP
10:30 - 11:00
Coffee Break
refreshments catered
11:00 - 11:45
Pharmaceutical Track & Trace: Ministry of Health Perspective
Mr. Mohd Azuwan Bin Mohd Zubir
Ministry of Health
11:45 - 12:30
The Good, The Bad and The Ugly Of Setting Up A Serialisation Programme
mr. Steve Holden
Recipharm
12:30 - 13:30
Lunch
refreshments catered
13:30 - 14:15
Challenges and Best Practices of Real-Life Serialization
mr. Volker Ditscher
wipotec-ocs
14:15 - 15:00
Global Track & Trace For Manufacturer, Wholesaler & Hospital Pharmacy Chain: How Did We Do It?
ms. Magdalena Wohlfarth
B. Braun
15:00 - 15:30
Coffee Break
refreshments catered
15:30 - 16:15
Global Regulations – The Wrestling With Data Integrity, System Integrations and Reporting
mr. Björn Adams
I2b
16:15 - 17:00
Added Value of Track & Trace Data in the Pharmaceutical Production
mr.Georg Schick & mr.David Haug
uhlmann
17:00 - 17:30
Closing Remarks
mr. marco steinkamp
movilitas
18:00 - 22:00
Drinks & Networking
refreshments catered
Serialization is maybe the most underestimated technical challenge of the century. It will continue to play a big role not only in pharma, but also in other industries. Implementing serialization programs is challenging and affects multiple departments of a company. Hence, it is important to understand not only best practices, and how to convey such a global Track & Trace expertise to other markets, but also the role of IoT technologies in optimizing global supply chains. In particular, OEE and Blockchain innovations will be very useful for preventive maintenance and linking end users to the lifecycle of products throughout the supply chain.
Join the session and discover how to drive serialization smoothly and how to benefit in the long run from innovations such as OEE and Blockchain.
What to expect?
Serialization is maybe the most underestimated technical challenge of the century. However, it will continue to play a big role not only in pharma, but also in other industries. Implementing serialization is a challenging and multidisciplinary project, affecting all departments. It’s important to understand the best practices and how to convey such global Track & Trace expertise to other markets.
Making use of IoT technologies is key to optimizing global supply chains. Especially OEE and Blockchain innovations will be very useful for preventive maintenance and linking end users to the lifecycle of products throughout the supply chain.
What to expect?
The Ministry of Health Malaysia (MOH) is planning to implement a pharmaceutical track & trace system in order to enable visibility and traceability along the entire life science supply chain. Thereby fake drugs will be eliminated and patient safety ensured. Such a system requires the cooperation of multiple stakeholders such as regulatory bodies, manufacturers, and distributors. It may come with new challenges and requirements, yet also with new possibilities to realize benefits beyond compliance.
What to expect?
With the customer in our focus, we as total solution provider improve the production of our customers. Through 20 years of software experience and 70 years of partnership to the pharmaceutical industry, we know the critical points in a track & trace system. Uhlmann Digital Solutions safeguard the necessary data security and ensure pharmaceutical safety over the whole production process - monitored and reliable production process from start to finish. Therefore, we have to eliminate all critical steps in a production process. Uhlmann Track & Trace delivers an added value for pharmaceutical manufacturers.
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Learn from our highly experienced experts what added value this is, how we approach your challenges together and offer you the best-in-class solution!
What to expect?
Discover how Recipharm set up and delivered a successful serialization program, and understand the challenges that lie ahead.
Recipharm is a Contract Development and Manufacturing Organization (CDMO) with over 200 customers requiring products to be serialized and / or aggregated. These customers have challenging requirements and high expectations. Steve Holden will share detailed insights into the challenges Recipharm faced, and the lessons learned during the various phases of the project.
What to expect?
The pharmaceutical world is facing new and complex regulatory requirements. Serialization is already touching almost every part of the IT infrastructure. Systems must be integrated, global solutions maintained, change processes followed, reporting channels established and facilitated.At the same time, all this must be compliant.
Learn more about change management and integration and benefit from i2B’s Computer System Validation approach.
What to expect?
Day 2 - Thursday, 14 November
08:30 - 09:00
Coffee & Welcome
refreshments catered
09:00 - 09:45
The World of GS1 Standards for Pharma
Tania Snioch
GS1
09:45 - 10:30
The Ministry’s Initiatives for Combating Counterfeit Products in Malaysia
Mr. Mohamed Aznan shah Bin Khalid,
Ministry of Domestic Trade & Consumer Affairs
10:30 - 11:00
Coffee Break
refreshments catered
11:00 - 11:45
Track & Trace in Tobacco – Probably the Most Challenging T&T Requirements in the World
Movilitas
11:45 - 12:30
Never Underestimate The Challenges of Serialization and Aggregation
mr. Harald Köhler
Hermos
12:30 - 13:30
Lunch
refreshments catered
13:30 - 14:15
Live Demo ATTP and Q&A
Mr. chin hun yong
movilitas
14:15 - 15:00
Meeting the regulatory and organisational needs of serialisation: Lessons from a two-year journey and an outlook
Mr. Andrew Robinson,
CSL Behring
15:00 - 15:30
Coffee Break
refreshments catered
15:30 - 16:15
Movilitas.Cloud Makes Compliance Simple
mr. marC blekkink
movilitas
16:15 - 16:30
Closing Remarks
mr. Stefan Hockenberger
Movilitas
Hermos as the world leading aggregation solution at tobacco industry will be able to deliver insights and learnings upon more than 700 production lines implemented. Spreading the wings into other industries already, executing consultancy for operating companies and investors, we will be able to show the necessary steps and timelines.
See showcases, technology examples and the wide product portfolio of Hermos as well as the generic software solutions for serialisation and aggregation.
What to expect?
Around the world, more and more healthcare stakeholders are understanding the benefits of unique product identification, serialisation and traceability, and as a result are adopting global standards to achieve these. Spanning every region, this presentation will discuss developments, trends and outcomes from such activities.
The practical considerations for all stakeholders in implementing global standards will be discussed, as will the possibilities that serialised unique identification can bring for the future – access to digital information, aiding increased patient empowerment, and much more.
What to expect?
Serialisation presents not only technical but also organisational challenges to a pharmaceutical company. As with all regulatory requirements, successful implementation requires close coordination of activities across the organisation and with that a clear definition of responsibilities.
The Serialisation story continues in daily operations. Processes and personnel are required to efficiently handle exceptions to ensure released goods can leave the manufacturer’s ramp and enter its Supply Chain. Where necessary, serialisation data is forwarded to the Supply Chain partners and/or uploaded to an agency cloud.
This presentation draws on hard-earned experience gathered during the implementation of serialisation requirements.