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Agenda Day 2

8:30 AM - 10:00 AM Breakfast Briefing Workshop: Serialisation: Remaining Challenges, Future Opportunities

The challenges of serialisation don’t stop when you print your first codes. As projects progress, many companies are uncovering subtle new process linkages and data dependencies that need to be worked through. Mark will catalyse a working discussion of how these are being addressed. He will also look at some upside potential that is starting to emerge.
Attend this workshop to:
  • Get an industry overview as serialisation starts to mature
  • Learn from your peers’ experience
  • Take away some new ideas for driving ROI

Mark Davison is CEO of Blue Sphere Health, an international healthcare consultancy focusing on traceability and authentication of medicines. His career includes GlaxoSmithKline, contract research organisations, biotechnology companies and security vendors. Mark works with drug companies, distributors, technology suppliers and public sector organisations to prepare for FMD and DSCSA compliance and to identify added-value commercial opportunities with traceable supply chains. Mark is the author of “Pharmaceutical Anti-Counterfeiting” (published by Wiley, New York).

10:00 AM - 10:05 AM Chairman's Opening Address

10:05 AM - NaN:NaN AM GS1: Serialisation and Traceability


- Hear from GS1 about the foreseeable regulatory landscape focusing on the development of track and track systems
- Determine how to effectively utilize track and trace and further the work needed to obliterate counterfeit medicine
-Highlight how patient safety can be affected when serialisation goes wrong

10:40 AM - 11:15 AM What Are The Benefits Beyond Serialization and Traceability Compliance

-Utilise serialization and traceability beyond industry requirements in order to build the relationship between manufacturer and consumer
-Understand how to generate better communication internally and enhance the new capabilities
-Anticipate how future solutions can benefit and overcome challenges in adapting the use of your traceability system

11:15 AM - 11:45 AM Coffee Break

11:45 AM - 12:20 PM Fishbowl Discussion: Maximising ROI From Serialisation

This session will focus on how to ensure ROI can be achieved and managing budgets with 100% efficiency in Serialisation. Observe or participate depending on which ring you sit in. Whether you want to actively voice your view or hear from others before forming an opinion, this is the most inspiring way to get a crucial discussion under way.

12:20 PM - NaN:NaN AM From South Korea to Europe - Keeping Up With Serialisation As A Mid-size CMO

- Manage bias between cost efficiency and customer requirements
- Understand impact on running processes (Process Instruction Sheets, SOP, etc)
- Implement serialisation on multiple lines with a market by market approach including South Korea and USA
- Getting ready for Falsified Medicine Directive in Europe

12:55 PM - 1:55 PM Lunch

1:55 PM - 2:30 PM How to Maximise ROI for your Traceability System

-Decipher how to leverage interconnectivity and interoperability for improved marketing analytic potential
-Strategise the best way to improve the production cycle with the addition of the serialisation system
-Plan for the future in determining how to improve product visibility in distribution allowing you to understand where progress in serialisation can be made

2:30 PM - 3:05 PM Level 5: Developing External Integration of Serialisation

-Recognise the shortcomings of relational databases and understand the benefits of external integration
-Respond and react to the ever-evolving global track and trace landscape in the most effective way possible
-Manage successful engagement in business continuity, enabling effective alignment and management of the trace and trace system externally

3:05 PM - 3:35 PM Coffee Break

3:35 PM - 4:10 PM Anti-Coutnerfeting: Gain Clarity Amongst The Chaos

- Highlight how patient safety can be effected when serialisation goes wrong
-Question how Brexit and the new UK law will add to regulatory maneuverability and affect all area of communication levels
- Determine how to effectively utilise track and trace and further the work needed to obliterate counterfeit medicine

4:10 PM - NaN:NaN AM Q&A Session With All Speakers

Use this final opportunity to ensure complete understanding in maintaining effective track and trace operations and ask missed questions with the opportunity to address all members of the speaker faculty

4:25 PM - 4:30 PM Chairman's Closing Remarks

4:30 PM - 6:30 PM Afternoon Workshop