News | March 28, 2017

Workshop: Considerations For EU Product Launch

Source: Almac Group

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



Almac Product Launch Workshop

Wednesday 27th June 2018

The Hilton Hotel, Dublin Airport




08:45 – 09:15

Registration & Breakfast

09:15 – 09:30

Welcome & Introductions

Maura McArdle, Business Development Manager, Almac

09:30 – 10:00

The Importance of Project Management to Ensure a Successful EU Product Launch

David Finlay, Client Team Leader, Almac

10:00 – 10:45

Introduction to the EU Regulatory Framework

David McCoubrey, Regulatory Affairs Lead, Almac

10:45 – 11:00

Tea / Coffee Break

11:00 – 11:45

Serialisation Solutions to Meet Global Requirements

Robert Madden, Global Serialisation Operational Manager, Almac

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

12:30 – 13:00

Panel Discussion

Almac & Orphan Drug Consulting

13:00 – 14:00

Lunch & Networking

14:00 – 14:45

Key Quality Considerations and The Role of the Qualified Person

Donna McKenna

Product Quality Operations Manager, Qualified Person, Almac

14:45 – 15:15

Analysis of the Key Differences Between an EU and a US Product Launch

Rory Davidson, Business Support Manager, Almac

15:15 – 15:45

Implications of Brexit

Brian Eastwood, Head of Business Development (EU), Almac

15:45 – 16:15

Panel Discussion


16:15 – 16:30

Closing Remarks

Maura McArdle, Business Development Manager, Almac