Agenda Day 1

8:00 AM - 8:05 AM Welcoming Address from Pharma IQ

7:30 AM - 8:00 AM Registration and Morning Coffee

8:15 AM - 8:25 AM Chairman’s Welcome & Opening Remarks

8:30 AM - 9:10 AM Post Brexit Challenges: Overcoming the Obstacles Associated with Implementation

Sultan Dajani, UK Representative, Pharmaceutical Group of the European Union
· Industry overview: Where are we at currently?
· Objectives and aims from Government
· Reviewing the different sections of FMD: Gaining an understanding of what is required and creating a standardised communication approach
· Reviewing tools that coincide with FMD including data and its potential use case
· Objectives and aims for improved saleability of products and services

Sultan Dajani

UK Representative
Pharmaceutical Group of the European Union

9:10 AM - 9:45 AM Status on Serialization in Emerging Markets

Marcel De Grutter, Liaison Regulatory and Government Affairs, Abbott Laboratories
In a fast moving market where the regulatory landscape and other areas are constantly changing, the content of this presentation will be developed in the last couple of weeks. Marcel de Grutter, a well-known Expert on the topic and Liaison Regulatory and Government Affairs at Abbott, will ensure this this presentation will utilize 100% up to date information, findings and topics that will ensure the session is current, relevant and attractive.

Marcel De Grutter

Liaison Regulatory and Government Affairs
Abbott Laboratories
  • The EU experience - the road to FMD implementation
  • Different reasons for track and trace (counterfeits, taxation, rational use policies, digital health)
  • Adapting solutions to different health systems - the example of Russia
  • Learning from other sectors (where already 100+ billion packs are serialised every year)

Richard Bergström

former Director General EFPIA and co-founder of EMVO
former Director General EFPIA (European Federation of Pharmaceutical Industries and Associations) and co-founder of EMVO (European Medicines Verification Organisation

10:20 AM - 10:55 AM GS1 Standards for Serialisation and Traceability Around the World

Tania Snioch, Director Healthcare, GS1
  • Understanding GS1 and its role
  • What serialisation and traceability means in developed and developing markets?
  • Interesting progress from around the world
  • Considerations for successful implementation for all stakeholders

Tania Snioch

Director Healthcare
GS1

10:55 AM - 11:25 AM EU FMD 02/2019: Are You Prepared As Your Peers Are?

Liam O'Riordan, Serialization Director, Enterprise System Partners (ESP)
As the February 2019 deadline for European compliance governed by the Falsified Medicines Directive draws ever closer, ESP in conjunction with their partners GS1 surveyed
the industry to establish their market readiness. In this presentation we discuss those findings and what they mean for the industry:
• How prepared is the industry in terms of product supply?
• How is the industry prepared for conformity to national systems?
• How will manufacturers prepare for their master data management strategy?

Liam O'Riordan

Serialization Director
Enterprise System Partners (ESP)

11:25 AM - 11:55 AM Networking Coffee Break

11:55 AM - 12:25 PM OPC Foundation and the OPC UA Standardisation

Oliver Nürnberg, Chief Product Owner, SAP Life Sciences and OPC Representative
  • Overview of OPCF: The interoperability standard for the secure and reliable exchange of data
  • Detailed overview of the OPC UA
  • Goals and concept of Open-SCS: Open Serialisation Communication Standard
  • SAP’s commitment to OPC UA

Oliver Nürnberg

Chief Product Owner
SAP Life Sciences and OPC Representative

12:30 PM - 1:05 PM The Growing Threat of Falsified Medicines: Managing Patient Safety and Consumer Risk

Mike Isles, Executive Director, European Alliance for Access to Safe Medicines
• Highlighting the current threat of falsified medicines and how it has increased in recent times
• Understanding how the internet is putting vulnerable patients and consumers at risk
• Industry collaboration as a tool and solution to address and reduce the risks

Mike Isles

Executive Director
European Alliance for Access to Safe Medicines

1:05 PM - 2:05 PM Networking Lunch

2:05 PM - 2:50 PM Group Discussion: Design Your Own Discussion Group:

By now, you have discussed your event objectives and uncovered a common theme running throughout both days. However, you will have a unique challenge or problem that needs solving, and it is critical that we seek out those gold nuggets of information that will really help drive improvement at all stages of Serialisation.

These sessions are designed by you, for you, and you will be encouraged throughout the day to text your specific challenges, which will then be analysed by our team of project facilitators and used as the basis and structure of the group discussion.

Each group will be required to document these ideas on a flipchart with a nominated presenter providing a two minute overview of the key points made.

*All information documented will be collated, typed up and provided to every delegate post event*


TOPICS COVERED:

  • Regulatory Landscape Across the Globe
  • EU Hub Regional Challenges
  • Implementation: Planning, Resourcing, Cost Control and Deployment
  • Anti Counterfeiting
  • Global Serialisation: Implementation Across Multiple Sites
  • Challenges and Opportunities Beyond Compliance
  • Challenges and Opportunities Beyond 2017
  • Aggregation: Decision Making,Strategy and Process
  • IT Implementation and Data Management
  • Serialisation in Emerging Markets

2:50 PM - 3:30 PM Quick Fire Technology and Product Demonstrations.

This is your opportunity to meet with the vendors in our exhibition hall to learn more about the current and emerging technology that can help solve your issues. These tech demos will last approximately 10 minutes on four cycles with the opportunity to continue your discussions throughout the lunch break at their exhibition stands.

3:30 PM - 4:00 PM Serialisation Project Completion: Opportunities and Challenges Beyond 2019

Hermann Schaefer, Managing Director, Systec & Services
  • The importance of planning and looking beyond 2019: Understanding how to organise and manage the hyper-care phase
  • Ensuring the configuration of the installed devices: How to harmonise software and firmware releases
  • Managing spare parts effectively
  • Leveraging serialisation data to increase productivity and manage predictive maintenance

Hermann Schaefer

Managing Director
Systec & Services

4:00 PM - 4:30 PM Networking Coffee Break

4:30 PM - 5:05 PM Planning, Cost Control, Decision Making and Execution: Strategic Vision and a Step by Step Implementation

Staffan Widengren, Director, Corporate Projects, Recipharm
• The importance of understanding key requirements and defining the project scope and implementation plans: Design, build, test and implementation phases
• Equipment selection: Cost control and optimisation through identifying possible upgrade and retrofitting vs. new equipment
• Integration of existing equipment into a serialisation solution
• Best practice project control: Tips to successfully deliver the project on time and within budget

Staffan Widengren

Director, Corporate Projects
Recipharm

5:05 PM - 5:40 PM Cost Effective Approaches for Effective Implementation

Matthias Korbl, Head Supply Chain Management, Arena Pharmaceuticals
· Understanding the full scope of investments and costs associated with the end-to-end implementation of serialisation
· Effective planning to determine accurate costs from the start and set an accurate budget
· The importance of internal collaboration to mitigate risks and expenditure during and after implementation has occurred
· Identifying and mapping company operations, process and systems for smooth delivery
· Evaluating the project and finalising costs: Ensuring accuracy

Matthias Korbl

Head Supply Chain Management
Arena Pharmaceuticals

5:45 PM - 6:45 PM Networking Drinks

The day maybe over, but with the evening comes a whole host of new opportunity: a chance to absorb and reflect on the knowledge gained from the day and network with the industry leaders in serialisation. What better way to reflect than with a cold beverage and a room full of the most influential people in the field? Grab a glass and loosen your tie as some of the more fruitful and controversial topics come to light.
Make the most of this opportunity to get acquainted with the people who are going to continue to be the driving force behind the industries developments and get to the bottom of those challenges closest to you.

5:55 PM - 6:00 PM Chairman’s Close of Day One