Workshop: Considerations For EU Product Launch
Launching your product on to the European Market can present a real challenge if you are not familiar with the various country specific requirements. With its 28 member states, numerous official working languages and complex regulatory framework, this workshop will clarify the key requirements for a successful EU product launch.
Helping you to be better prepared for what is ahead and ensure your commercial launch is successful, our subject matter experts will guide you through the EU launch process, from submitting your MAA, to final distribution of drug product to the end-user.
Key workshop objectives:
- Understand the implications of Brexit on your EU product launch
- Unravel global serialization requirements
- Learn about the European regulatory framework
- Understand the importance of the role of the Qualified Person (QP)
- Find out about managing a complex EU supply chain and considerations for a temperature sensitive product
- Gain insight into the key differences between an EU and US product launch
Agenda![]()
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Almac Product Launch Workshop |
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Wednesday 27th June 2018 |
The Hilton Hotel, Dublin Airport |
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Time |
Topic |
Presenter(s) |
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08:45 – 09:15 |
Registration & Breakfast |
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09:15 – 09:30 |
Welcome & Introductions |
Maura McArdle, Business Development Manager, Almac |
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09:30 – 10:00 |
The Importance of Project Management to Ensure a Successful EU Product Launch |
David Finlay, Client Team Leader, Almac |
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10:00 – 10:45 |
Introduction to the EU Regulatory Framework |
David McCoubrey, Regulatory Affairs Lead, Almac |
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10:45 – 11:00 |
Tea / Coffee Break |
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11:00 – 11:45 |
Serialisation Solutions to Meet Global Requirements |
Robert Madden, Global Serialisation Operational Manager, Almac |
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11:45 – 12:30 |
EU Supply Chain Requirements & Considerations for a Temperature Sensitive Product |
Emma Jordan, Logistics Manager, Almac & Evelyn Kelly, Managing Director, Orphan Drug Consulting |
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12:30 – 13:00 |
Panel Discussion |
Almac & Orphan Drug Consulting |
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13:00 – 14:00 |
Lunch & Networking |
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14:00 – 14:45 |
Key Quality Considerations and The Role of the Qualified Person |
Donna McKenna Product Quality Operations Manager, Qualified Person, Almac |
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14:45 – 15:15 |
Analysis of the Key Differences Between an EU and a US Product Launch |
Rory Davidson, Business Support Manager, Almac |
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15:15 – 15:45 |
Implications of Brexit |
Brian Eastwood, Head of Business Development (EU), Almac |
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15:45 – 16:15 |
Panel Discussion |
Almac |
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16:15 – 16:30 |
Closing Remarks |
Maura McArdle, Business Development Manager, Almac |