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Controlling and processing data in EU clinical trials
  • McDermott Will & Emery
  • European Union
  • November 22 2010

The legal regime for the conduct of clinical trials of medicinal products for human use in the European Union is set out in Directive 200120EC (the Clinical Trials Directive


Snapshot of Sunshine rules in EU countries for the pharmaceutical industry part 1 - June 2014
  • McDermott Will & Emery
  • European Union, United Kingdom
  • June 12 2014

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. In 2013


The New EU Regulation on Medical Devices Aims at Enhanced Product Safety and Further Harmonization
  • McDermott Will & Emery
  • European Union, USA
  • May 9 2017

On May 5, 2017, the new Regulation on Medical Devices (MDR) and the new Regulation on In Vitro Diagnostics (IVDR) were published in the European


International news: focus on compliance - winter 2014
  • McDermott Will & Emery
  • China, European Union, Germany, Global, USA
  • December 2 2014

As regulatory oversight of companiesfrom Sarbanes Oxley and the Dodd-Frank Act to the Foreign Corrupt Practices Act (FCPA) and the UK Bribery


European Commission fines pharmaceutical companies for Citalopram pay-for-delay agreements
  • McDermott Will & Emery
  • European Union
  • June 30 2013

On 19 June 2013, the European Commission announced a fine of 93.8 million for H. Lundbeck AS (Lundbeck) and a further 52.2 million of fines levied


The new EU clinical trials regulation aims at harmonization and transparency
  • McDermott Will & Emery
  • European Union
  • October 20 2014

On June 16, 2014, Reg. (EU) No. 5362014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes


Are supplementary protection certificates keeping pace with drug development?
  • McDermott Will & Emery
  • European Union, United Kingdom
  • April 10 2007

The pharmaceutical and biotechnology industries are heavily dependent on patents as a means of securing future revenues


Commission dawn-raids pharmaceutical companies on eve of sector report
  • McDermott Will & Emery
  • European Union
  • November 28 2008

The European Commission has confirmed that on 24 November 2008, Commission officials started inspections at the premises of a number of pharmaceutical companies in several EU Member States


GlaxoSmithKline infringed competition rules by restricting parallel trade
  • McDermott Will & Emery
  • European Union, Greece
  • April 4 2008

Advocate General Ruiz-Jarabo has delivered a non-binding opinion to the European Court of Justice (ECJ), finding that GlaxoSmithKline Plc (GSK) abused its dominant position by limiting distribution of certain pharmaceuticals to Greek wholesalers


Repackaging and parallel import of pharmaceutical products
  • McDermott Will & Emery
  • European Union
  • May 22 2007

On 27 April 2007, the European Court of Justice (the “ECJ”) handed down yet another decision in the case of Boehringer Ingelheim & others v Swingward Ltd and Dowelhurst Ltd, Case C-34804 (“Boehringer II”