Annual Conference on EU Law in the Pharmaceutical sector

27.02.2014 - 28.02.2014

This annual conference aims at keeping legal practitioners working with the pharmaceutical sector up-to-date on the latest relevant regulatory developments, legislative initiatives and case law. A particular focus will be on implications for the sector of recent EU activities in the fields of competition law, intellectual property, data protection and privacy as well as pharmaceutical law.

Key topics
 

Competition law and patents
 

  • Reverse payment settlements in the US and in Europe and current activities from the European Commission in the field of competition law
  • Interim and cross-border injunctions against infringement of pharmaceutical patents
  • Preparing for the EU unitary patent system: update on recent developments

Data protection and privacy

  • Access to clinical trials data: the General Court decision in InterMune (T-73/13R)
  • Proposal for modification of the General Data Protection Regulation (COM(2012)11): implications for the life science sector
  • Cloud computing health services and data protection

EU pharmaceutical law round-up

  • Update on EU legislative proposals: clinical trials, in vitro diagnostics, orphan drugs
  • Major developments in the fight against falsified medicinal products
  • Drug device combination products and data exclusivity
  • Off-label use and the CJEU case Novartis Pharma v Apozyt (C-535/11)
  • Orphan medicinal products and the recent decision in Laboratoires CTRS (T-301/12)

Visit the ERA website for more information.