The Commercialisation of Healthcare Global Guide provides a high level practical overview of the regulatory framework for the commercialisation of medical products in jurisdictions around the world, including key requirements for manufacturing, advertising and selling drugs, medical devices, biological products and natural health products.
Written by leading lawyers in their countries, contributors are ideally placed to provide clear, concise and practical commentary on the inner workings of their respective legal systems.
Jeffrey N Gibbs
Jeffrey N Gibbs is a Director at Hyman, Phelps & McNamara, PC, Washington, D.C. He has assisted device and pharmaceutical clients with a variety of FDA issues, including product approvals, clinical trials, advertising and promotion, enforcement actions, product classification, due diligence, and FDA-related transactional issues.
Mr Gibbs has written and lectured extensively on a variety of FDA topics. He was a member of the Editorial Advisory Board for the Food and Drug Law Journal and served as its chair from 2003 to 2004. Mr Gibbs also was a member of George Mason University's Human Subjects Research Board for eight years. Mr Gibbs currently serves as Secretary and General Counsel for the Food and Drug Law Institute, and is a guest lecturer on medical device law for the University of Maryland.
Mr Gibbs was Associate General Counsel for Enforcement at FDA, where he received an Award of Merit. He also was appointed Special Assistant US Attorney for the District of Columbia, and, earlier in his career, clerked for a US District Court Judge in New Jersey. He is a graduate of Princeton University and the New York University School of Law.
Jeffrey S Graham
Jeffrey S Graham is a Partner at Borden Ladner Gervais LLP. He is an attorney in both Canada and the US. His areas of practice include life sciences, biotechnology and pharmaceuticals.
Mr Graham acts for life sciences companies in commercial negotiations, including financial and commercial transactions, research and development, manufacturing and licensing. He acts for clients in the promotion and distribution of food, drug and natural health products and medical devices, including advising on the appropriate structure for transactions. He also guides clients through the regulatory approval processes with Health Canada, CFIA, CPMA and PMPRB and provincial regulatory agencies.
Mr Graham is the author of numerous publications regarding the commercialisation of healthcare. He is a graduate from McGill University, the University of Cambridge and Columbia University.
|Country Q&A||Contributing firm|
|Australia||Griffith Hack Lawyers|
|Austria||Fiebinger Polak Leon & Partner Rechtsanwälte||Brazil||Pinheiro Neto Advogados|
|Canada||Borden Ladner Gervais LLP|
|China||Orrick, Herrington & Sutcliffe LLP|
|France||Taylor Wessing - France|
|Germany||Ehlers, Ehlers & Partner|
|India||Nishith Desai Associates|
|Indonesia||Assegaf Hamzah & Partners|
|Ireland||Maree Gallagher Associates|
|Japan||Nagashima & Hashimoto|
|The Netherlands||Hogan Lovells International LLP|
|Poland||Domański Zakrzewski Palinka Sp. k.|
|Singapore||Drew & Napier LLC|
|South Africa||Webber Wentzel|
|South Korea||Kim & Chang|
|Switzerland||Lenz & Staehelin|
|Turkey||Gün + Partners|
|UK (England and Wales)||Hogan Lovells|
|United States||Hyman, Phelps & McNamara, PC|
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