Conference Day One
8:30 am - 8:55 am Morning Coffee and Registration
8:55 am - 9:00 am PharmaIQ Welcome
9:00 am - 9:15 am Chairman's Opening Remarks
9:15 am - 9:45 am Icebreaker: What are Your Event Objectives?
To boost networking and interactivity, the conference will being with an opportunity for everyone to find out who is at the same stage of serialisation implementation as themselves. This will be your chance to network with peers and find out who are facing the same challenges and help overcome the hurdles in running an efficient serialisation process. At the end of the second day the objectives will be reviewed and there will be further opportunity to discuss any remaining points.
9:45 am - 10:25 am How To Prepare For Delivery Of The FMD On Time And Final Considerations To Be Made
-Determine what the final recommendations would be to be compliant with the FMD
- Understand how to fast track implementations processes and what to consider in the short run
-Learn how the FMD can allow you to review business strategies and gain ROI
10:20 am - 10:50 am KEEP CALM And Get Why It Is Not Too Late
· Half a year to go – is there still a chance to meet the timeline?
· Which are my priorities now?
· Understand the possible alternatives.
10:50 am - 11:20 am Coffee Break
11:20 am - 12:00 pm Final Countdown-Focus Areas For A CDMO Before February 2019
v Determine how to get everyone on board in due time
v Hear how to finalise projects within the global program
v Learn how to transfer the global program to local site and central maintenance organisation
v Discuss how to achieve serialisation beyond compliance
12:00 pm - 12:40 pm Panel Discussion: How does a CMO prepare for the FMD and Implement Sustainable Serialisation Strategies?
-Discuss how to prepare for serialisation as a CMO
-Determine how to connect to the EU hub and role of MAHs
-Understand how to manage Serialisation as a CMO
12:40 pm - 1:20 pm How Ready is the EU for the FMD?
-Reflect on current market readiness for the FMD
-Define what to prioritise now and how GS1 can help
-Determine how to align expectations across all parties involved in your serialisation strategies
1:20 pm - 2:20 pm Networking Lunch Break
2:20 pm - 3:00 pm Case Study: DSM Sinochem Pharmaceuticals’ Approach To Serialisation Implementation
- Hear the current experiences at DSM Sinochem on implementing serialisation processes
- Understand what has been learned through the implementation processes
-Take home first hand recommendations of how to enhance serialisation strategies
3:00 pm - 3:40 pm Case Study: How to Begin Implementing Serialisation for a Global Supply Chain
-Hear what initial considerations were made to start implementing serialisation processes
-Discuss how to approach the different regulatory requirements
-Establish the timeline used to have serialisation systems installed in time for regulatory deadlines
3:40 pm - 4:10 pm Networking Coffee Break
4:10 pm - 5:20 pm Roundtable Discussions:
Use this opportunity to discuss with peers key strategies in implementing serialisation in time for the FMD. Led by our facilitators, each roundtable discussion will last for 35 minutes with the opportunity to rotate to a second discussion point, followed by a chance to feed back key discussion points
Roundtable 1:
Managing serialisation as a mid-size CMOMatthias Korbl , Head Supply Chain Management, Arena Pharmaceuticals
Roundtable 2:
What final considerations should I be making to be ready for the FMD?
Staffan Widengren, Director Corporate Projects, Recipharm
Roundtable 3:
Readiness of MAHs and CMOs for Serialisation
Michael Unbehaun, Manager Engineering Projects, R-pharm
Roundtable 4:
What are the lessons learned for implementing serialisation strategies?
Alexander Frey , Project Manager Track and Trace , Process Design & Digitalization , Global Manufacturing Pharmaceuticals, Fresenius Kabi Deutschland GmbH
Alexander Frey
Process Design & Digitalization , Global Manufacturing PharmaceuticalsFresenius Kabi