RAPS – Time to elevate.
It’s time to go even further. 2012 RAPS will deliver the knowledge, competence development and resources you need to design effective solutions to complex challenges, seize opportunities and lead.
Join us at 2012 RAPS in Seattle!
J&J opens Chinese innovation center
Johnson & Johnson has opened an innovation center in China to design and develop medical devices and diagnostic products for Asia’s emerging markets–primarily China and India.
The J&J Medical Companies Asia Pacific Innovation Center, located in Suzhou, China, is part of a Market Appropriate Innovation strategy aimed at better serving the people of Asia Pacific. “Both China and India are experiencing an increase in the metabolic and chronic conditions such as cardiovascular disease, diabetes, obesity and cancer that many of our products diagnose or treat,” Alex Gorsky, vice chairman of the executive committee, J&J. “With 125 years experience we believe Johnson & Johnson is uniquely positioned to help address the Asia’s changing and growing health needs.”
Essential Ingredients for Orthopedic Implants
Metal is no longer the only material option when discussing orthopedic implants. A variety of polymers are being indicated for both long term and bioresorbable devices. Additives and active pharmaceutical ingredients are also being utilized with these materials. This article examines the opportunities realized when using polymers for orthopedic implants.
Breast Implants
Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase breast size (augmentation) or to rebuild breast tissue after mastectomy or other damage to the breast (reconstruction). They are also used in revision surgeries, which correct or improve the result of an original surgery.
Medical Device Development: Regulation and Law – Jonathan S. Kahan (Author)
Medical Device Development: Regulation and Law, 2nd Edition, is the must-have resource for the novice or veteran medical device regulatory affairs professional. This practical reference provides the most comprehensive and updated analysis of US medical device and diagnostics development and approval requirements anywhere. This book also features in-depth analysis on how emerging developments and trends are reshaping medical device and combination product regulations in the US.
Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices – John J. Tobin, Gary Walsh (Authors)
This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing.
The Citizens Guide to the FDAs Office of Regulatory Affairs (ORA) – Mark Fennell (Author)
This book discusses FDA’s Office of Regulatory Affairs (ORA). The Office of Regulatory Affairs manages the FDA field offices throughout the nation. The field offices ensure the safety of food, drugs, and medical products. The offices do this through analyzing samples, inspecting manufacturing facilities, and enforcing the regulations as necessary.
TOPRA Symposium 2011
This important annual Symposium is now recognised as a key event in the European calendar of all those working in the healthcare regulatory affairs arena.
This Symposium is for all those involved in regulatory affairs and brings together representatives of industry, the regulatory agencies and the European Commission to discuss and understand today’s regulatory issues and debate the future plans for regulation. This is the key annual European regulatory forum for all those involved in the pharmaceutical sector and aims to bring you all the latest information and, importantly, what is coming over the horizon. There will also be ample time to network in the breaks and view services from exhibitors in the industry and the regulatory bodies.
