Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices by Gary Walsh, John J. Tobin

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices Gary Walsh, John J. Tobin ebook
Publisher: Wiley-VCH
Page: 298
Format: pdf
ISBN: 3527318771, 9783527318773

The Interaction of the Proposed LDC Extension Request and the 2016 Pharmaceutical Product Extension. Regina Au is a strategic marketing consultant at BioMarketing Insight with 20 years experience in the biotechnology, pharmaceutical, medical device, and diagnostic industries. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people. In terms of access to affordable “non-pharmaceutical” health commodities and technologies, e.g., diagnostic machines, lab equipment, medical devices, etc., the proposed Extension Request has clear advantages. She helps companies evaluate their technology upfront This ensures that the technology is the right product for the right market in meeting a critical unmet need and that the market potential for the product meets the business goals of the company. A game changer, at least in certain geographies. Karen Long is Regulatory Affairs Specialist at Angiotech Pharmaceuticals. The proposed regulation includes several important new categories of products that are either currently outside the scope of the European medical device directives or where there is doubt of coverage. Drawing Parallels Between the PIP and the Mediator Affairs The PIP implant health scare could be to the medical device industry what Mediator was to the pharmaceutical industry, i.e. These include: The expert knowledge would need to be demonstrated by either specified educational qualifications or five years of professional experience in regulatory affairs or in quality management systems related to medical devices.