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Category Archives: European Union

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Susan Winckler Featured Keynote Speaker This Week at 8th Annual Pharmaceutical and Medical Device Conference in Chicago on November 10

Posted in Advertising and Promotion, Animal Drugs, Antitrust, Biological Products, Clinical Studies, Drugs, Emerging Growth, Enforcement, European Union, FDA Organization, Healthcare, Intellectual Property, Legislation, Litigation, Medical Devices, Meetings, Patents, Regulation

159161119On November 10, 2016, McGuireWoods LLP and McGuireWoods Consulting (“McGuireWoods”) will be holding its 8th Annual Pharmaceutical and Medical Device Conference in Chicago.  Kicking off the Conference will be Keynote Speaker, Susan Winckler, the Chief Risk Management Officer for Continue Reading

International Council on Harmonisation (ICH) Includes Generic and Biosimilars Trade Organization (IGBA) for the First Time

Posted in Biological Products, Biosimilars, Drugs, European Union, Generic Drugs

ThinkstockPhotos-179040440On June 15, 2016, the International Council for Harmonisation (ICH) (formerly the International Conference on Harmonisation) announced that the International Generic and Biosimilars Medicines Association (IGBA) could join ICH as an Assembly Member.  For the first time, an association representing … Continue Reading

IGBA and Medicines for Europe Hold Joint Annual Meeting in Dubrovnik, Croatia, in June 2016 – Part 2 of 2

Posted in Biosimilars, European Union, Generic Drugs, Meetings

croatiaThis is a continuation of coverage of the International Generic and Biosimilars Association (IGBA) (formerly known as the International Generic Pharmaceutical Alliance (IGPA)) and Medicines for Europe (formerly known as the European Generic and Biosimilars Association (EGA)) joint 19th IGBA Continue Reading

IGBA and Medicines for Europe Hold Joint Annual Meeting in Dubrovnik, Croatia, in June 2016 – Part 1 of 2

Posted in Biosimilars, European Union, Generic Drugs, Meetings

croatiaOn June 8-10, 2016, the International Generic and Biosimilars Association (IGBA) (formerly known as the International Generic Pharmaceutical Alliance (IGPA)) and Medicines for Europe (formerly known as the European Generic and Biosimilars Association (EGA)) held a joint 19th IGBA Continue Reading

European Commission Seeking Comments on Draft Text Laying Out the Safety Features to Appear on Pharmaceutical Packaging

Posted in Drugs, European Union, Labeling

EU building (vertical)On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human use. The EUDA was a response … Continue Reading

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part Two of Two

Posted in Biosimilars, Clinical Studies, Drugs, European Union, Generic Drugs, Litigation, Meetings, Rare Diseases

EGA Legal Affairs ForumOn the second day of the 11th Annual Legal Affairs Forum held by the European Generic and Biosimilar Medicines Association, additional exclusivity and intellectual property concerns were covered, including key case updates and strategies (see here for a … Continue Reading

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part One of Two

Posted in Biosimilars, Drugs, European Union, Generic Drugs, Meetings, Patents

EGA Legal Affairs ForumOn March 26-27, 2015, the European Generic and Biosimilar Medicines Association (“EGA”) held its 11th Annual Legal Affairs Forum. The Forum kicked off with an introduction by Sergio Napolitano, Legal Affairs and Trade Director, EGA, who organized this … Continue Reading

EGA’s 11th Legal Affairs Forum in Brussels Later This Week: Still Time to Register!

Posted in Biosimilars, Drugs, European Union, Generic Drugs, Intellectual Property, Legislation, Litigation

EGA Legal Affairs ForumLater this week in Brussels, Belgium, the European Generic and Biosimilar Medicines Association (EGA) will host its 11th Legal Affairs Forum. The Forum will be held on March 26-27, 2015 utilizing an interactive format that provides ample opportunities … Continue Reading

11th Legal Affairs Forum in Brussels, Belgium on March 26-27, 2015

Posted in Biological Products, Biosimilars, Drugs, European Union, Generic Drugs, Intellectual Property, Litigation, Meetings, Patents

EGA Legal Affairs ForumOn March 26-27, 2015, the European Generic and Biosimilar Medicines Association (EGA) will host its 11th Legal Affairs Forum in Brussels, Belgium. The Forum will focus particularly on:

–       EGA 2020: Where Are the Latest Trends Leading this Sector?

A … Continue Reading

McGuireWoods’ Brian Malkin Speaks on Biosimilars Patent Litigation at EGA’s Legal Affairs Forum in Brussels on March 27, 2015

Posted in Biological Products, Biosimilars, Drugs, European Union, Generic Drugs, Meetings

EU buildingOn March 27, 2015, McGuireWoods’ Brian J. Malkin will be speaking on “Biosimilars Patent Litigation” at the European Generic Medicines Association’s (EGA’s) Legal Affairs Forum in Brussels, Belgium. The Legal Affairs Forum highlights trends in the generic sector leading to … Continue Reading

McGuireWoods Becomes Media Partner of FDLI’s Europe v. U.S. Food, Drug, and Device & Tobacco Regulations and Policy: Emerging Issues and Comparative Analysis Conference

Posted in European Union, Meetings

We are excited to announce that McGuireWoods is a proud media partner of The Food and Drug Law Institutes’ (FDLI) Europe v. U.S. Food, Drug, and Device & Tobacco Regulation & Policy:  Emerging Issues and Comparative Analysis in Brussels, Belgium Continue Reading