4XScience 2018 E2E Supply Chain Serialization Benchmark Workshop
ON INVITATION ONLY
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 of EMVO & NMVOs.
This first topic will cover the onboarding status including the NMVO status' in the 32 European countries. Current views on potential delays will be shared and discussed. This will be followed by an industry benchmark and moderated discussion to better understand the position and approach of the industry:
- 4X Insights & Benchmarking EU FMD regulatory landscape and status.
- Mr. Pieter Boudrez, BeMVO Chairman, will provide the latest status update and challenges of the European NMVOs, including experiences from mature countries managing serialized products over the last few years (e.g. Belgium).
- Mr. Mihai Rotaru, European Federation of Pharmaceutical Industries and Associations (EFPIA), will provide an overview on the status, position and working groups from the EMVO & EU Commission.
- Moderated Q&A on regulatory perspectives - open discussion on presentation and benchmark results.
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:
- 4X Insights & Benchmarking EU FMD industry readiness status.
- Mr. Filippo Dal Maso, GlaxoSmithKline Vaccines, Global Program Lead Serialization, will share experiences with serialization projects for vaccines over the last 4 years and related business pressure and impacts for EU.
- Mrs. Lydia Hemphill, BioMarin Pharmaceutical, Senior Manager Supply Chain Business Operations, will share insights, challenges and complexities of EU FMD for US based companies that supply low volume products under supervised suppply chains.
- Moderated Q&A on manufacturer status - open discussion on presentation and benchmark results.
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.
- 4X Insights & Benchmarking EU FMD logistics providers, wholesalers and distributors.
- Mr. Niels van Namen, UPS, Vice President Healthcare Europe, will provide an overview of the unique EU FMD capabilities for logistic partners managing the entire supply chain for freight forwarding, storage & distribution, wholesaler and pharmacy services.
- Mrs. Magda Grozavu Savin, Head of Serialization Implementation, PHOENIX Group, will share insights into the experiences, challenges and opportunities for one of the largest pharmaceutical trading companies in Europe with respect to FMD.
- Mr. Heinz Kobelt, Director European Affairs, European Association of Euro-Pharmaceutical Companies (EAEPC), will explain the challenges, experiences, impact and readiness status of the parallel distributors in Europe for EU FMD.
- Q&A - open discussion on presentation and benchmark results on 3PLs & wholesalers status.
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.
- 4X Insights & Benchmarking EU FMD Hospital & Pharmacies status.
- Mr. Robert Moss, Board Member European Association Hospital Pharmacies (EAHP), will lead us through the status, implications, practical concerns and issues on verification and decommissioning of the hospital pharmacies in Europe (EU FMD) and rest of the world.
- Mr. Jan Depoorter, Director Association Belgian Pharmacies (APB), vice-president of BeMVO and member of the Pharmaceutical Group of the EU (PGEU) will inform on the readiness, challenges and experiences of the European pharmacies for EU FMD.
- Q&A - open discussions on presentations and benchmark results for EU FMD Hospital & Pharmacies status.
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 - 09.00 Introduction: objectives & agenda of day 2
09.00 - 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.
- 4X Insights & Benchmarking US DSCSA status and application within the industry.
- Mr. Scott Mooney, Vice President Distribution Operations & Assurance, McKesson Pharmaceutical, will share his insights into the status and experiences from one of the largest US wholesalers on the implementation of the US DSCSA.
- Mrs. Rebecca Hehnly, North America Regional Lead end-to-end traceability, Johnson & Johnson US, will explain JnJ's current status and market introduction approach for US DSCSA given the new FDA guidelines on grandfathering and enforcements.
- Q&A - open discussion on presentation and benchmark results on US DSCSA status
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.
- 4X Insights & Benchmarking world wide regulations, speaker to be announced.
- Mr. Evgeny Belov, Head of Engineering & Technology, Bayer Moscow, with his view, latest updates and lessons learned from the Russian pilot conducted since 2017 till January 2018.
- Mr. Leandro Oliveira, Senior Supply Chain Manager Product E2E Traceability, Johnson & Johnson Brazil, will provide an update on the Brazilian & Russian regulation status; and share learnings from pilots in these markets.
- Q&A - open discussion on presentation and benchmark results on world wide status.
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.
- 4X insights & Benchmarking on value beyond compliance.
- Mr. Eddy Gilissen, Vice President Supplier Alliances, IQVIA (IMS Health & Quintiles), will explore the potential value of big data from serialization activities - which insights are required by the industry and how could future serialization data deliver new value?
- Mrs. Els van der Wilden, MD, MPH, GS1 Director Healthcare Providers, will give and overview and walkthrough of some pragmatic real use cases on value beyond comliance in hospitals across the globe as result of barcoding.
- Q&A - open discussion on presentation and benchmark results on value beyond compliance.
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
Hilton Brussels Grand Place
Carrefour de l'Europe 3, Brussels, 1000, BRABANT, Belgium