Workshop Day

This workshop will provide you with:
  • Overview of the new regulation and the impacts on serialisation globally
  • What are the key learnings and experiences from other countries and regions?
  • Project planning and implementation: Strategy, resourcing, technology & vendor selection, cost control and implementation best practice
  • Understanding data and how it can be used effectively: Creating interconnectivity across the supply chain
  • Common pitfalls throughout each project phases: How can they be avoided?
  • Technology and digitisation: Emerging issues, challenges and opportunities for serialisation
  • Industry collaboration: How can the industry help drive standards and harmonisation
  • Evaluating project phases and optimisation

9:00 AM - 11:00 AM Implementation 101: A Step by Step Guide

Mark Willis, Global Director, Program Management Office, Fresenius
Organisations of all sizes are at varying stages of serialisation readiness and meeting regulatory requirements globally. The sheer complexity behind the regulation and
the strategy for implementation can cause potential issues with a timely delivery, which could have huge impacts on the ability to continue doing business.
This workshop will guide through the entire serialisation process, providing key insights to ensure you can meet the required deadlines cost effectively.

Mark Willis

Global Director, Program Management Office

This workshop will provide you with:
  • An overview of how the issues of Falsified Medicines has evolved in recent years: Statistics and implications at a global level
  • Overview of the key sections of the FMD Delegates Act
  • Key tips on how to successfully implement your serialisation strategy

11:15 AM - 1:15 PM EU FMD Guide: Understanding and Navigating the Regulatory Landscape

Poor visibility across the supply chain has led to proliferation of drug-related criminal activities but it has also caused inefficiencies to surface across supply chain
This not only hampers the brand equity of pharmaceutical companies but also put the life of patients in serious danger.
Because of the growing number of counterfeit pharmaceuticals entering the market, the EU has introduced a Falsified Medicines Directive (FMD) that stipulates that by
February 2019 all pharmaceutical manufacturers must implement serialisation systems.

This workshop will provide you with:
  • Reviewing the most common investments and cost elements in serialisation and traceability compliance implementation
  • Developing an accurate and cost effective budget for your serialisation project
  • Ensuring flexibility in the plan: Anticipating changes in schedule, solution requirements and specifications to manage potential expenditure increases
  • How to plan and execute a sustainable strategy for the cost-effective implementation and driving ROI
  • ROI beyond compliance: Improving business performance in reimbursement/chargeback programs, production analytics, supply chain management and facilitating innovations in patient care and clinical development

2:15 PM - 4:15 PM Future Proofing and Cost-Effective Serialisation And Traceability Strategies

Pasi Kemppainen, Executive Consultant, Pharma Serialization and Traceability,, Entrepreneur
Future Proofing and Cost-Effective Serialisation And Traceability Strategies
When planning your serialisation and traceability strategy, it is fundamental to understand in detail how the different company operations, processes and systems will
be affected. This not only helps to specify the required cross-company support for the implementation – and also the system and data dependencies – but also the
total expenditures associated with the implementation. This can be an expensive process since the implementation requires resourcing and investments usually outside
of the current budgets in the respective organisation.

Pasi Kemppainen

Executive Consultant, Pharma Serialization and Traceability,

4:15 PM - 4:20 PM End of the Workshop Day