Transatlantic Cooperation on Biotechnology: Biosimilars and Orphan Medicines     Print Email
Thursday, 10 May 2007

Georgette Lalis, Director for Consumer Goods, DG Enterprise and Industry, European Commission, outlined the European Union’s policy on the authorization of bio-similars and expressed her wish to continue and improve transatlantic dialogue on the subject. Dr. Murray Lumpkin, Deputy Commissioner for International and Special Programs, U.S. Food and Drug Administration presented the U.S. perspective was. The discussion was centered on the topic of regulatory frameworks for authorizing the marketing of follow-on biologics, referred to in Europe as bio-similars. The meeting was moderated by Charles Ludolph, Senior Vice President of Stonebridge International, LLC.

 
  • World Radio Conference Outcomes

    By Patricia Paoletta, Washington DC

    The latest World Radiocommunication Conference (WRC) wrapped up in late November after four long weeks of negotiations between 3400 delegates from around 165 Member States. All in all, the WRC resulted in positive outcomes for both 5G and Wi-Fi, and will benefit both the U.S. and Europe's communications agendas, particularly with respect to the decisions on spectrum to be allocated for the all-important 5G service. The effect will be to ensure the more rapid development of the next generation of mobile broadband in a manner consistent with U.S. planning and existing development.  Debates on 5G dominated the conference, but allocations for high-altitude platform stations (“HAPS”) sought by U.S. based firms were also favorable. As a result, plans to provide additional internet service to underserved areas may be accelerated.

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UMD Jean Monnet Research Project

Infrastructure Planning and Financing: Lessons from Europe and the United States

The University of Maryland has received a Jean Monnet grant from the EU to conduct a series of policy exchanges between Europe and the US on filling infrastructure needs and the utility of public/private partnerships as the financing mechanism. If interested in participating in or receiving more information about these exchanges, please contact Rye McKenzie (rmckenzi@umd.edu).

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New from the Bertelsmann Foundation

The Bertelsmann Foundation is an independent, nonpartisan and nonprofit think tank in Washington, DC with a transatlantic perspective on global challenges.

"Edge of a Precipice" by Nathan Crist

"Newpolitik" by Emily Hruban

 

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