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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


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


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


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


CJEU Georgetown University SPC judgment
  • McDermott Will & Emery
  • European Union
  • January 22 2014

Following hot on the heels of the 14 November 2013 opinion given by the Advocate General in Georgetown University C-48412, the Court of Justice of


High Court of England and Wales has jurisdiction to try pan-European declaration of non-infringement action
  • McDermott Will & Emery
  • European Union, United Kingdom
  • January 9 2013

In Actavis Group HF v Eli Lilly and Company 2012 EWHC 3316 (Pat) the High Court of England and Wales has held that, in cases where there is no challenge


What did you say? $31 million awarded for infringement of hearing aid patent
  • McDermott Will & Emery
  • European Union
  • November 29 2012

In a case involving the alleged infringement of two patents related to hearing aids, one of which was found under judgment as a matter of law (JMOL) to not be infringed


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


EC introduces major changes to medical device regulation
  • McDermott Will & Emery
  • European Union
  • December 17 2012

The European Commission has issued two proposals that, if approved, will fundamentally amend EU law on medical devices and in vitro diagnostics


EU Japan agreement on information exchange concerning medicines
  • McDermott Will & Emery
  • European Union, Japan
  • February 9 2007

After lengthy discussions, the European Union and Japan have reached an agreement on the exchange of confidential information about the authorisation and safety of medicines