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Results: 1-10 of 52

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

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 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

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

Advocate General Jääskinen gives Georgetown University SPC opinion

  • McDermott Will & Emery
  • -
  • European Union, Netherlands, United Kingdom
  • -
  • December 16 2013

On 14 November 2013, Advocate General (AG) Jääskinen's opinion in the Dutch supplementary protection certificate (SPC) referral, Georgetown

EMEA and FDA focus on clinical research safety and enforcement

  • McDermott Will & Emery
  • -
  • European Union, USA
  • -
  • August 20 2009

Recent policy changes emphasize the need for sponsoring organizations to be even more vigilant in establishing, updating and monitoring their systems for compliance with clinical research requirements, whether conducted domestically or in a foreign locale

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

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

EPO Enlarged Board of Appeal invites the public to determine whether stem cells are contrary to morality

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • July 30 2008

On 24 and 25 June 2008, in a public hearing on Wisconsin Alumni Research Foundation (WARF) Stem Cell patent application (G-0206), the European Patent Office (EPO) took the usual step of asking the public to assist it in making a determination regarding a patent application involving an invention in the controversial area of stem cell patenting

Mergers: Commission approves Nestlé’s acquisition of Novartis' Medical Nutrition business

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • July 6 2007

The European Commission has cleared the merger of Nestlé S.A. and Novartis' Medical Nutrition business (NMN) following a first phase investigation