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European Drug Development: A Masterclass

Alacrita

Tuesday, January 29, 2019 from 11:30 AM to 3:00 PM (EST)

European Drug Development: A Masterclass

Ticket Information

Ticket Type Sales End Price Fee Quantity
General Admission Jan 28, 2019 $25.00 $3.16

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Event Details

Join Alacrita at the CIC on January 29th, 2019, for an educational session on European drug development and commercialization. You will learn about valuable insight into most challenging aspects of the European drug development process.

Ex-US markets can be lucrative, but the complexity and shifting dynamics in Europe can make the path complex to navigate, causing many emerging pharmaceutical companies to focus their development resources on the US. The result is often a protracted delay that diminishes a drug's global potential. In this seminar we will shed light on some of the most common issues.

We will be joined by Anna Casse-Sumeray, Managing Partner, Alacrita, who has launched more than 13 products in Europe in oncology and rare diseases. She will speak on topics such as partnering strategies, positioning, typical organizational structures, typical budgets, and benchmarks.

Julie Warner, senior consultant of regulatory affairs, will provide an update on the EU regulatory affairs landscape, including:

 - How to obtain scientific advice (and from whom)
 - Clinical trials
 - Fast track approval routes such as PIM and PRIME

Lastly, Tim Clackson, previously President of R&D & Chief Scientific Officer, ARIAD, will share his first-hand experience from ARIAD and their launch of ponatinib into the European market. 

After the presentations, the speakers will participate in a panel-discussion where they will take questions from the audience. 

Event Agenda

11:30PM - 12:00PM

Arrival and Networking | Lunch

12:00PM 12:45PM

Julie Warner, Senior Consultant of Regulatory Affairs | Topic: European Regulatory Affairs: A Changing Landscape

12:45PM - 1.30PM

Tim Clackson, Previous President of R&D & Chief Science Office, ARIAD | Case Study: EU Launch of Ponatinib 

1:30PM - 2.15PM

Anna Casse-Sumeray, Managing Partner, Alacrita Switzerland | Topic: EU Partnering Strategies and Timelines

2:15PM - 2.45PM

Panel Discussion

 

This Alacrita event is being planned in collaboration with the Cambridge Innovation Center. We look forward to seeing you there!

For more information on Alacrita Consulting, please click here.

Have questions about European Drug Development: A Masterclass? Contact Alacrita

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When & Where


Cambridge Innovation Center
1 Broadway
Cambridge, MA 02142

Tuesday, January 29, 2019 from 11:30 AM to 3:00 PM (EST)


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Organizer

Alacrita

Alacrita is life science consulting for a networked age, providing expert support to organizations of all sizes, primarily established companies, life science investors and selected academic institutes.

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