Regulating Medicines in a Globalized World The Need for Increased Reliance Among Regulators (2020) / Chapter Skim
Currently Skimming:
Appendix E: Committee Member Biographies
Appendix E: Committee Member Biographies
Pages 141-148
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 141... ...
, was professor of both medicine and pharmacology at Vanderbilt University Medical School and served as assistant vice chancellor for clinical research and associate dean, Vanderbilt Medical School, before being appointed emeritus professor of medicine and emeritus professor of pharmacology in 2006. He was a partner at Symphony Capital LLC, a private equity company investing in the clinical development of novel biopharmaceutical products, from 2006 to 2018.
|
From page 142... ...
He is a globally recognized leader in health care policy, pricing, intellectual property, government affairs, regulatory affairs, health care economics, and product commercialization. In addition, having spent two decades as part of the senior management teams for Amgen and Genentech, the two largest biotechnology companies in the world, he contributes invaluable perspective regarding strategy for entrepreneurial biotechs, the needs of potential acquirers, and the global health care industry in general.
|
From page 143... ...
Agency for International Development. He has been a consultant to the Bill & Melinda Gates Foundation and a temporary legal advisor to the World Health Organization.
|
From page 144... ...
Mr. Cockburn joined the UK Medicines & Healthcare products Regulatory Agency as a principal medicines inspector and spent 14 years there before moving to EMA for 15 years and becoming head of manufacturing and quality compliance.
|
From page 145... ...
He has expertise in such areas as health law and ethics, global health and global governance, AIDS law and ethics, human rights, privacy, and consent. In his previous positions, he served as associate dean for research at Georgetown Law; on the WHO director-general's Advisory Committee on Reforming the World Health Organization; and on numerous WHO expert advisory committees, including committees on the Pandemic Influenza Preparedness
|
From page 146... ...
(Geneva) , the Pan American Health Organization, the WHO Regional Office for Africa, regulatory regionalization initiatives, and national regulatory agencies in all parts of the world to make more efficient and effective (without sacrificing product quality, efficacy, or safety)
|
From page 147... ...
While previously at WHO, he worked on activities related to international nonproprietary names, quality assurance, pharmacovigilance, regulatory support, fighting falsified medicines, and prequalification of medicines. His previous positions include professor of clinical pharmacology at Tartu University; founder and first director general of the Estonian Drug Regulatory Authority, State Agency of Medicines; coordinator of the Quality Assurance and Safety: Medicines team at WHO; and head of WHO's Regulation of Medicines and Other Health Technologies unit.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.