April 17, 2014

Europe vs. United States: Compulsory Early Outcome Assessments for New Pharmaceutical Products

McDermott Will & Emery is pleased to present this complimentary webcast that will focus on the compulsory early outcome assessments and subsequent compulsory price negotiations applicable to new pharmaceutical products in Germany under the so-called Neuordnung des Arzneimittelmarktes (AMNOG) regulation.     

As pharmaceutical prices in Germany have in the past been the starting point for discounts granted in many other European countries, the AMNOG regulation can affect prices in many European countries.  Join our panel for a lively and dynamic discussion of important considerations and factors relevant to the medical device industry. 

This webcast is geared toward medical device and pharmaceutical companies, health systems, management boards and management employees within health care organizations. Specifically, this webcast will be of interest for any medical device or pharmaceutical company conducting business in Germany. 

The webcast will cover the following: 

  • Legal overview of the new compulsory early outcome assessment proceedings and subsequent price determination
  • Pricing and reimbursement in the United States and Europe
  • Legal overview, practice issues and implications on international reference pricing under the German AMNOG regulation 
  • Practical issues in connection with submitting a dossier under the German AMNOG regulation –compared with submission of technology assessments or payer dossiers in the United States 
  • Comparison of proceedings before the National Institute for Health and Clinical Excellence in the United Kingdom


Simone Breitkopf, Head of Governmental Affairs and Pricing, Alcon Laboratories Inc. and Paul W. Radensky, Partner, McDermott Will & Emery 


Stephan Rau, Partner, McDermott Will & Emery 

For more information, please contact McDermott Events

© 2014 McDermott Will & Emery

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