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European Life Sciences Legal Update Day

February 5, 2014
Arnold & Porter LLP
555 12th Street, NW
Washington, DC

Arnold & Porter's EU Life Sciences team and the Biotechnology Industry Organization (BIO) are pleased to invite you to a European life sciences legal update conference. Sessions will include a variety of topical EU regulatory, competition and intellectual property updates of interest to in-house US biopharmaceutical and medical device legal, regulatory, compliance and business professionals.

Joe Damond, Senior Vice President, International Affairs, BIO, will lead a special discussion on the TTIP treaty negotiations between the US and EU and the future of harmonization, with observations from Lincoln Tsang, Partner, EU Life Sciences, Regulatory, Arnold & Porter (UK) LLP.

Breakfast and lunch will be provided followed by a reception at the end of the program.

This event is for US-based industry professionals interested in keeping current on EU developments. Arnold & Porter's Life Sciences partners from London and Brussels will discuss EU perspectives on the following topics:

  • Regulatory data protection: key developments and pending litigation.
  • Disclosure by regulatory authorities of pre-clinical and clinical data: EMA policy and the issues in the pending proceedings before the European Court.
  • Update on the EU regulatory landscape: biosimilars, medical devices and drug device combinations.
  • Pricing and reimbursement trends in the EU by reference to the major markets, including the implications of patient access schemes in reference pricing.
  • The current EU product liability litigation landscape and future developments in relation to collective redress.
  • Recent developments in EU competition law in the pharma sector, including pharma supply chain and parallel trade issues in Europe.
  • Key developments on patent term extensions and the IP/regulatory interface: Supplementary Protection Certificates, pediatric extensions and unified European patent court developments.
  • Compassionate use and "named patient" supply of unlicensed products in the EU.

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