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Event Details
Launching your product on to the European Market can present a real challenge if you are not familiar with country specific requirements, particularly if you are based in the U.S. With its 27 member states, numerous official working languages and complex regulatory framework, this workshop will clarify the key requirements for a successful EU product launch.
This workshop will guide you through the EU product launch process, from submitting your MAA, to final distribution of drug product to the end-user.
Key Workshop objectives:
- Learn about the European Regulatory framework & the various market access strategies
- Understand the importance of the role of the Qualified Person (QP)
- Discover Financial considerations for launching a product into the EU
- Learn about various Packaging Selection and Design concepts.
- Managing a complex EU supply chain & considerations for a temperature sensitive product
- Listen to real life experiences from US Pharma companies.
Key guest speakers include: Seattle Genetics, VigiReg Consulting Ltd & Deloitte.
Workshop Agenda
|
Time
|
Topic
|
Presenters
|
|
08:30 – 09:00
|
Registration – Tea / coffee
|
|
09:00 – 09:15
|
Welcome & Introductions
|
Jim McGibbon
Director Business Development, Almac
|
|
09:15 – 10:15
|
Introduction to the Regulatory Framework in Europe
|
Ryta Kuzel
Director & Owner VigiReg Consulting Ltd
|
|
10:15 – 11:00
|
The role of the QP and Market access strategies including Named Patient Supply
|
Ian Markwell
VP Quality & Qualified Person, Almac
|
|
11:00 – 11:30
|
Tea break and networking
|
|
11:30 – 12:15
|
Key financial considerations for launching a product into the EU:
|
Shoab Malak & Robert Olson
Deloitte
&
Ian Mussen
Product Supply Manager, Almac
|
|
12:15– 12:45
|
Panel discussion
|
Almac, VigiReg Consulting and Deloitte
|
|
12:45 – 13:45
|
Lunch and networking
|
|
13:45 – 14:30
|
Considerations for Packaging Selection and Design
|
Michael Rooney
Product Supply Manager, Almac
|
|
14:30 – 15:15
|
Managing a complex EU supply chain & considerations for a temperature sensitive product
|
Randy Sittner
Logistics Manager, Seattle Genetics
&
Mark English
Distribution Manager, Almac
|
|
15:15 – 15:45
|
Panel discussion
|
Almac, Seattle Genetics and GSK
|
|
15:45 – 16:00
|
Closing remarks & Prize draw
|
Jim McGibbon
Director Business Development, Almac
|
|
16:00 – 17:00
|
Irish themed drinks reception
|
When & Where
1333 Bayshore Highway
Burlingame
San Francisco,
94010
Tuesday, March 13, 2012 at 8:30 AM (PT)
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