Willkommen bei ERA – Europäische Rechtsakademie

Objective

This conference will offer an overview of the latest developments in EU legislation and the most important recent case law of the Court of Justice of the EU affecting the pharmaceutical sector.

There will be a special focus on the legal issues raised by emerging new frontiers in pharmacogenomics related to personalised medicines and companion diagnostics and by the increasing relevance of drug-device combinations.

Key topics

New frontiers of pharmaceutical law

• Patent law issues related to new frontiers in pharmacogenomics: conditions of patentability in Europe and in the USA, best practice for agreements between university and industry
• Supplementary protection certificates
• The borderline between pharmaceutical products and medical devices
• Revision of the EU legislation on medical devices and in vitro diagnostics
• Personalised medicines
• Data protection issues: bio-banking and data protection of biomarkers
  

Recent legislative developments

• The implementation of the new legislation on pharmacovigilance (Regulation 1235/2010 and Directive 2010/84)
• Adoption of Directive 2011/62 on the prevention of the entry into the legal supply chain of falsified medicinal products
• Update on recent developments in EU competition law
• Information to patient and publicity
  

Who should attend?

Lawyers in private practice, in-house counsel and other practitioners of law dealing with pharma-ceuticals and medical devices, patents and consumer law.