Maintaining Regulatory Standards in the Wake of Global Trade Shortages and Infrastructure Decay
Fogler Rubinoff LLP, Toronto
by Harris M. Rosen
While at an education conference this year I had the pleasure of hearing former House Speaker Newt Gingrich talk about the changing face of education from a US perspective. He asked a group of 1700 delegates, each of them owners or operators of private vocational training institutions, whether they thought America could 'stay the course' and still maintain a competitive edge over countries like China and India during the next 25 years.
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Planning for Challenges of Global Clinical Trials
Epstein Becker & Green P.C., Washington D.C.
by Leah R. Kendall
Pharmaceutical and medical device companies are increasingly recognizing that international clinical studies offer important advantages to studies undertaken in the United States, but they are also recognizing that international studies present numerous complex legal challenges. In terms of advantages, studies conducted abroad can be a source of drug-naïve patients, which can be rare in the United States, and they can help to provide a large number of patients as well. Global studies can also help foster sponsors’ relationships with different clinical sites and investigators and with global thought leaders. Moreover, conducting research abroad allows companies that sponsor research to lay the groundwork for regulatory approvals in markets outside of the United States.
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Surprises for Publicly-Traded Multinational Employers: Complying with Section 409A of the U.S. Internal Revenue Code
Epstein Becker & Green P.C., New York
by Gretchen Harders
In the United States, the heads of human resources and their advisors are reviewing and amending all plans, agreements and related documents providing compensation to U.S. taxpayer employees to comply with Section 409A of the U.S. Internal Revenue Code (the “U.S. Code”). This review should not be limited to compensation plans, programs and arrangements in the United States. There are a number of compliance areas under Section 409A of the U.S. Code that have taken global employers by surprise. Section 409A of the U.S. Code includes certain provisions that impact the global compensation plans and programs of multinational employers. In particular, there are special requirements for multinational employers that are publicly-traded non-U.S. securities exchanges.
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Regulatory Uncertainty in Climate Change Initiatives
WolfBlock LLP, Philadelphia
by Lindsay P. Kern & Frances B. Stella
Climate change has become a topical issue both in the United States and around the world. Legal, political, and business leaders in the United States will have to address climate change in a more structured way. This article will highlight this issue using a comparison of Europe’s framework and that of the United States, which is still developing its own system.
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Threat To A National Icon
Fogler Rubinoff LLP, Toronto
by Nancy A. Miller
In June 2008, the front pages of newspapers and magazines from coast to coast in Canada warned of an imminent danger. Canadians were up in arms and the airwaves reflected their worry and concern. An environmental threat? A natural disaster? A business crisis? No, the threat Canada faced was the potential loss of a jingle, a theme song for Canada's hockey broadcast, a song so well-known and so loved by Canadians that it is referred to as Canada's second national anthem.
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