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Increased Evolution of Regulations Affecting the Pharmaceutical Law Practice
The increase of regulations over the last two to five years for pharmaceutical companies has become a nightmare for sales representatives working for those companies and for internal staff charged...Read more
Jean Frydman
Partner, Fox Rothschild , USA
US and International Codes on Pharmaceutical Marketing Practices and Interaction with Healthcare Professionals - A Comparative Analysis and Outlook on Harmonization by FCPA Enforcement
In recent years, there has been an increasing focus on pharmaceutical marketing practices and interactions between pharmaceutical companies and healthcare professionals. Concerns about real and perceived improprieties have led to...Read more
Roy Birnbaum
Counsel, Human Health International, Merck & Co, Inc., USA
The Impact of the Fraud and Abuse Laws on Pharmaceutical Advertising and Marketing Compliance: A Manufacturer's Perspective
The intersection between the health care fraud and abuse laws and pharmaceutical marketing practices in the U.S. raises interesting compliance issues for pharmaceutical manufacturers, particularly in light of the newly...Read more
Leslie Restaino
General Counsel, Validus Pharmaceuticals, USA
Pharmaceutical Advertising in Denmark - Where did Freedom of Expression go?
Differences in the legal approach to advertisement of pharmaceuticals still exist within the European Union even though Directive 2001/83/EC of the European Parliament and of the Council of 6 November...Read more
Nicolai Ellehuus
Attorney-at-Law, Novo Nordisk Inc, USA
The Globalization of Clinical Trials - Challenges, Opportunities and a Path Forward
In recent years, pharmaceutical companies have expanded clinical research in emerging markets around the world and increasingly involving populations that traditionally have had limited or no access to clinical trials...Read more
Marc Wilenzick
Chief Compliance Counsel, R&D, Pfizer Inc, USA
Justin McCarthy
SVP Global Policy and International Public Affairs, Pfizer Inc., USA
Cara Cuenot
Lead counsel for the BioCorrection Research Unit, Pfizer Inc, USA
Left to Their Own Devices
The European Union (“EU”) has among its most fundamental goals and principles a convergence of the economies of, and a weakening of internal frontiers between, its member states. Economic...Read more
Patrik Plöen
Head of Legal, Internationa, Markets, Nestlé Skin Health, Sweden
More Than Words: Reflections of a General Counsel
As we approach the second decade of the 21st century, general counsel have a unique opportunity to pause and reflect. We began the previous decade with a stock market crash...Read more
Hassan Hassan
Associate General Counsel, Mars, UAE
Standing The Test of Time: Important Considerations in Long-Term Partnering Transactions
In the integrated global economy that has emerged over the last two decades, companies in all industries require a network of partners to discover, develop, manufacture, market, sell, supply and...Read more
Gilbert Labrucherie
Senior Vice President and General Counsel, Nektar Therapeutics, USA
Frank Curtis
Vice President-legal Commercial and Regulatory, Nektar Therapeutics, USA
Enlightening The Jungle: The German Rules on Advertising Pharmaceuticals
The legal rules applying to advertising medicines in Germany resemble a jungle. While a Medical Products Advertising Act (hereafter the Act) has been put in place, which concentrates on rules...Read more
Thorsten Witt
Corporate Counsel, Celesio, Germany
An Effective, Practical Approach to International Competition Law Compliance
The traditional approach to antitrust or competition law compliance is to start with the parade of horribles that can flow from a violation (jail, fines, damages, bad press), then stress...Read more
Kent Bernard
Member, Bar of the Commonwealth of Pennsylvania, U.S.A., Kent Bernard, USA