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4XScience 2018 E2E Supply Chain Serialization Benchmark Workshop

4XScience BVBA

Tuesday, March 27, 2018 at 8:30 AM - Wednesday, March 28, 2018 at 6:00 PM (CEST)

4XScience 2018 E2E Supply Chain Serialization...

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General Admission Mar 26, 2018 €500.00 €20.99 €109.41

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Event Details


DAY 1: Tuesday March 27, 2018

Implementing EU Falsified Medicines Directive DR 2016/161

2018 industry status and positions


08.30 - 09.15   Welcome & networking

09.15 - 09.30   Introduction: objectives & agenda of the conference

09.30 - 10.30   Topic 1: Will the deadline for EU FMD be postponed? A regulatory perspective and status update from EMVO & NMVOs.

This first topic will cover the EMVO onboarding status including the NMVO status' in the 32 European countries. This will be followed by an industry benchmark and moderated discussion to better understand the position and approach of the industry towards a potential delay. We welcome presentations from EMVO/NMVO members, followed by an open Q&A discussion moderated by 4XScience.

10.30 - 11.00   Networking

11.00 - 12.30   Topic 2: Leveraging experiences, challenges and readiness of pharmaceutical manufacturers after years of implementation efforts. Are we finally getting this under control?

What is the readiness status of the industry per end of March 2018? What are the main challenges brand owners and generics manufacturers are still facing today? What is the readiness level of the contract manufacturers and (re-) packers? Are serialization projects under control? We will use this session to understand stakeholders' readiness via online benchmarking, followed by a moderated discussion. Brand owners, generics, CMOs, CPOs will share insights. 

12.30 - 13.30    Lunch

13.30 - 15.00    Topic 3: What is the readiness status of our logistics distribution supply chain? How to explain the differences across the wider supply chain of logistics providers, wholesalers and distributors?

Previous benchmark data shows significant differences across and within the wider scope of logistics providers, wholesalers, and distributors. Some are ready, some just started. What are the main challenges and how should they be addressed? We will open this session with an introduction by 4X, continued by presentations from 3PLs & wholesalers. 

15.00 - 15.30   Networking

15.30 - 17.00   Topic 4: What is the impact of EU FMD for Hospitals, Pharmacies and import/export companies? What about specific products such as vaccines or individual patient products?

Hospital pharmacies are disappointed the directive is mainly focused on single point-of-dispense principles. The regulation does not take into account the working practicalities for dispensing large volumes accommodating the specifics of hospitals or institutions. For example, vaccines are distributed through many different channels which creates additional challenges and workload. Similarly for companies exporting or importing large volumes of products into Europe, the regulation creates extra burden. We invite pharmacies, hospitals and importers for an open discussion on their specific challenges.

17.00 - 17.15   Close out of day 1

18.00 - 21.00   Evening drink & dinner


DAY 2: Wednesday March 28, 2018

The landscape of T&T regulations and opportunities

From 2018 into the future


08.30 - 09.15   Introduction: objectives & agenda of day 2

09.15 - 10.30   Topic 5: The US DSCSA FDA enforcement and grandfathering rules. Appreciated extra delay for most stakeholders or just a few outsiders? 

Are the US DSCSA enforcement guideline and the updated grandfathering rules for products before November 2018 perceived as a blessing for many companies? How has the industry been acting upon these guidelines, how much of the SKUs are actually being serialized today? What main challenges are manufacturers still facing? Did companies really need the additional year? Is aggregated data being shared to wholesalers before 2019? Is there a difference in status between US based manufacturers and external companies? How are companies preparing for 2023? Benchmarking and moderated discussions. Industry presentations from brand owners. Q&A discussion and work session.

10.30 - 11.00   Networking

11.00 - 12.30   Topic 6: Latest status update on track & trace regulations for Russia, Egypt, Brazil and the many others that are following. Are we at the end or are we still at the beginning? 

New countries, new regulations, new requirements are entering the business landscape. Have you received requests from legal teams on what to do for Russia, Egypt or other middle-eastern countries? Wondering on the next steps for Brazil? Open discussion and sharing insights on the current initiatives and pilots across the world. Status update on serialization requirements, a deeper understanding of the current directions and consequences for your company. Time for all your unanswered questions during our moderated Q&A session.

12.30 - 13.30   Lunch

13.30 - 15.00   Topic 7: Dreaming of "value beyond compliance" or shocked by "supply chain disruption"? What is next and how is this linked to track & trace? Define your own future using serialization investments.

Beyond compliance applications of serialization are no longer considered taboo. More companies are now leveraging their serialization activities for new processes such as increased monitoring of cold chain products beyond the borders of their own supply chains. In parallel, new disruptors are entering our supply chains: digitalization, block chain, data intelligence, #hash graph are examples of new technology concepts. Magic for some, a true mystery to others. Let’s engage in discussions on how to leverage serialization for newer applications. What is the future potential? How to use serialization as a starting point to take advantage of these new digital trends? Let’s clear up some fuzz and present realistic and pragmatic use cases. Open discussion, quizzing and a last benchmarking exercise.

15.00 - 15.30   Networking

15.30 - 16.45   Topic 8: Conclusions from End-to-End Supply Chain panel discussions

We conclude the day with a group debate on five hot topics. This session will bring together pharmaceutical brand owners, manufacturers, CMO’s, 3PLs, wholesalers, hospitals and pharmacies in an end-to-end supply chain discussion. What is the position of each partner on the following topics?

  • Do we have a fair and balanced contribution stakeholder model for all supply chain partners?
  • Will these regulations do what they are intended for i.e. reducing falsified/counterfeit medicines?
  • Safety versus costs pressures on medicines via the increased prescription of generics?
  • Will serialization result in enhanced supply chain integration? “Yes, we can” vs “No, thank you”
  • Amazon and others are entering in the healthcare arena with advanced T&T. Are we ready? 

16.45 - 17.00   2018 Serialization Benchmark conference close out

16.45 - 17.30   Networking drinks

Have questions about 4XScience 2018 E2E Supply Chain Serialization Benchmark Workshop? Contact 4XScience BVBA

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When & Where

Hilton Brussels Grand Place
Carrefour de l'Europe 3
1000 Brussels

Tuesday, March 27, 2018 at 8:30 AM - Wednesday, March 28, 2018 at 6:00 PM (CEST)

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4XScience BVBA

We envision a world with improved product integrity across the supply chain.

In today's environment it is becoming more difficult to ensure products stay authentic and safe when they reach customers. Integrity issues are increasing as supply chains are more complex, products cross more borders, not everyone is following the rules, technology is advancing very fast. Due to this complexity, we have only one focus: helping our clients with improving integrity across the entire supply chain. A problem having our full attention. 

4XScience is a management-consulting firm with the mission to improve product integrity across global supply chains by leveraging business, technology and regulatory know-how. We have a clear end-to-end vision on how to implement the right processes and technologies leading to a win-win relationship between customers, industries and governments.  

We focus on 7 capabilities: Authentication, Serialization, Labeling, Traceability, Security, Efficiency, Intelligence. While technology will be replaced at some point, our thought leadership and no nonsense delivery will stay forever. We define, execute and deliver hand in hand. We successfully deliver services from strategy to implementation.

We have enjoyed the completion of implementations at multiple sites for markets such as China, South Korea, India, Brazil, Saudi Arabia, US, EU and Russia. We are working for several of the top 50 pharmaceutical industry and their supply chain partners. Over 40 companies in our network relying on our experiences. We help to protect products using the best available technology in the most efficient way while meeting all worldwide regulations. We need to be top in our field at global level. We master all of this. 

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4XScience 2018 E2E Supply Chain Serialization Benchmark Workshop
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