Medical Device Reimbursement in China

is being presented by Seth J. Goldenberg, President, of Asia Pacific Bio Intelligence and airs on Tuesday, April 24th, 2012. For more details, or to register please visit our site at www.fxconferences.com

Medical device and pharmaceutical manufacturers have been facing increasing downward pressure on their products because of pricing regulations in China. It has become increasingly important to not only understand how to get your product through the regulatory approval process in China, but also how to get the price you want in China's rapidly evolving healthcare landscape.

This audio conference presentation provides attendees with an overview of the healthcare system in China, and how imported medical devices are viewed and treated under the Chinese insurance system. Our speaker discusses device reimbursement policies at the local and national levels, and reviews some recent developments in that regard.

Navigating China's Medical Device Regulations

is being presented by Chang-Hong Whitney, MBA, RAC, President, Whitney Consulting Ltd. and airs on Thursday, June 16th, 2011. For more details, or to register please visit our site at www.fxconferences.com

China's medical device regulations have evolved greatly over the past twenty years. However, navigating the Chinese regulatory system is still a daunting task for many western companies. This audio conference provides essential information on the Chinese regulatory requirements for medical devices. Our speaker provides attendees with first-hand insight and guidance, drawing upon the experience and knowledge gleaned from daily dealings with SFDA officials and through managing numerous registration projects in China. Attendees learn the essential requirements for getting their medical products approved for the Chinese market, the time and costs involved, issues to watch for and obstacles down the road.

Clinical Investigations in Asia

Managing clinical studies in Asia can be both rewarding and challenging, as researchers face such issues as language, regulatory requirements and logistics. However, delays and frustrations can also arise if local practices -- such as standard treatments, insurance and reimbursement, indemnification of sites and investigators, and administration of study grants -- are not considered and anticipated. In addition to a well-structured feasibility study which provides meaningful information and data, the unique considerations of "locality" and corresponding solutions would be of value.

Whether or not a sponsor engages a CRO for Asian studies, it is important that they thoroughly understand the differences, the uniqueness (what and why things are done the way they are in Asia), and the latest on the local regulatory fronts, in order to assemble a solid and achievable clinical management plan.

Focused on China, Taiwan, Hong Kong, South Korea, Japan, Thailand and Singapore, this presentation draws on the benefits and challenges of managing clinical trials in Asia, based on recent experiences. The speaker also addresses critical points to ensure successful project start-up and conduct.

Clinical Investigations in Asia was presented by Edward C. Ian, Director of Operations in Asia, with PRA International and is previously recorded. For more details or to download this event, please visit our site at www.fxconferences.com

ForeignExchange Translations provides specialized Korean, Japanese, and Chinese translation services to medical device and pharmaceutical companies.

Clinical Trial Supply Challenges in China, Russia, Brazil & the Ukraine

In the ever-expanding market of clinical trial supply, the challenges are becoming more and more complex. This is particularly true of the increasingly popular, but still developing, emerging market countries. This session focuses on four emerging market locations -- China, Brazil, Russia and the Ukraine -- that can pose many obstacles for logistics professionals. Our speakers share insights into country regulations, potential pitfalls during the importation process, and the potential effects on the cold chain that these mistakes may cause.

In this audio conference, our speakers also identify the most common denominators that can impede clinical supply chain distribution, while sharing their experiences and the actions taken to find solutions in this complex arena.

Clinical Trial Supply Challenges in China, Russia, Brazil & the Ukraine is being presented by Karen Oliver & Tracci Gilchrist, Director, Global Accounts & Manager, International Issue Resolution, with World Courier and airs on Thursday, November 12, 2009. For more details or to register, please visit our site at www.fxconferences.com

To learn more about Brazilian Portuguese translations, please visit ForeignExchange Translations website by clicking here

Alternative Site Selection: China

This is one of two Covance audio conferences dealing with alternative site selection (the other event covers Latin America), and focuses on opportunities for the conduct of clinical research in China. This presentation provides an overview of the current clinical research environment in China and explores reasons why China should be considered as part of global drug development strategies.

Alternative Site Selection: China was presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, with Covance and is previously recorded. For more details or to download this conference, please visit our site at www.fxconferences.com

Medical Device and IVD Registration in China

China represents an attractive market for many mutinational companies due to two key elements: the dense population and huge consumer base; and the country's rapid economic growth. Due to the government policy of economic regeneration and the urbanization reshaping most regions, Chinese people are gradually becoming more affluent. As a result, there has been exponential growth in the medical device and IVD market in recent years. This phenomenon is similar to the drug industry in the early 90's.

The market potential for these two sectors is simply tremendous. Although there are different predictions and calculations from various experts regarding the market size of the medical device industry, a conservative estimate is over five billion US dollars. China is already the number two player in the Asia market and is just behind Japan in terms of volume. But while the potential is attractive, the registration process for medical devices and IVDs in China is quite lengthy, and the regulatory hurdles significant.

This presentation provides an introduction to the regulatory environment in China, and the requirements and process for registering medical device and IVD products.

Medical Device and IVD Registration in China was presented by Janice Ma, Operations Director & Co-founder, of ChinaGate Ltd. and aired on 2007-08-09. For more details or to download this conference, please visit our site at www.fxconferences.com

Securing Regulatory Approval for IVDs in China

With a population of 1.2 billion people and growing, China has emerged as a major consumer of healthcare products and one of the most lucrative markets for medical devices and IVD products. Following several years of double-digit growth, recent estimates put the value of the Chinese IVD market in the range of 1.5 billion dollars. However, entering the Chinese market requires no small amount of forethought and planning.

This audio conference discusses the latest organizational chart for the key departments in the SFDA, as announced September 2008, and give insight into hot topics and trends affecting the Chinese healthcare system.

Securing Regulatory Approval for IVDs in China was presented by Janice Ma, Managing Director, ChinaGate and aired on 2009-02-19. This conference is available for download at www.fxconferences.com

Clinical Investigations in Asia

Managing clinical studies in Asia can be both rewarding and challenging, as researchers face such issues as language, regulatory requirements and logistics. However, delays and frustrations can also arise if local practices -- such as standard treatments, insurance and reimbursement, indemnification of sites and investigators, and administration of study grants -- are not considered and anticipated. In addition to a well-structured feasibility study which provides meaningful information and data, the unique considerations of "locality" and corresponding solutions would be of value.

Whether or not a sponsor engages a CRO for Asian studies, it is important that they thoroughly understand the differences, the uniqueness (what and why things are done the way they are in Asia), and the latest on the local regulatory fronts, in order to assemble a solid and achievable clinical management plan.

Focused on China, Taiwan, Hong Kong, South Korea, Japan, Thailand and Singapore, this presentation draws on the benefits and challenges of managing clinical trials in Asia, based on recent experiences. The speaker also addresses critical points to ensure successful project start-up and conduct.

Clinical Investigations in Asia was presented on 2007-06-28 and is available for download at www.fxconferences.com

To learn more about Korean translations, please visit ForeignExchange Translations website at www.fxtrans.com

Securing Regulatory Approval for IVDs in China

With a population of 1.2 billion people and growing, China has emerged as a major consumer of healthcare products and one of the most lucrative markets for medical devices and IVD products. Following several years of double-digit growth, recent estimates put the value of the Chinese IVD market in the range of 1.5 billion dollars. However, entering the Chinese market requires no small amount of forethought and planning.

This audio conference will discuss the latest organizational chart for the key departments in the SFDA, as announced September 2008, and give insight into hot topics and trends affecting the Chinese healthcare system.

Securing Regulatory Approval for IVDs in China is being presented by Janice Ma, Managing Director, with ChinaGate and airs on Thursday, February 19th, 2009. For more details or to register for this conference, please visit our site www.fxconferences.com

This audio conference has been pre-approved by RAPS as eligible for one (1) credit toward a participant's RAC recertification upon completion.

Successful Medical Device Approvals in China

With over 1.4 billion people and an emerging public healthcare system, China is one of the most attractive secondary markets for medical device manufacturers worldwide. The regulatory requirements mandated by the State Food and Drug Administration (SFDA) have been evolving. In this audio conference, our speaker discusses the background of SFDA regulatory requirements and explain the process of registering your product in China, including specific information on how the SFDA defines and classifies a medical device, the registration dossier required by SFDA, regulatory criteria for testing and clinical trials. The presentation also provides examples of what has helped companies succeed in achieving approvals, and discuss the latest trends in the China regulatory environment.

Successful Medical Device Approvals in China was presented by Janice Ma, Managing Director, with ChinaGate and aired June 19th, 2008. For more details, or to listen to a sample clip, please visit our site www.fxconferences.com

Alternative Site Selection: China

This will be the second of two Covance audio conferences dealing with alternative site selection, and will focus on opportunities for the conduct of clinical research in China. This presentation will provide an overview of the current clinical research environment in China and explore reasons why China should be considered as part of global drug development strategies.

Alternative Site Selection: China is presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, of Covance. For more details please visit our site www.fxconferences.com

Medical Device and IVD Registration in China

China represents an attractive market for many mutinational companies due to two key elements: the dense population and huge consumer base; and the country's rapid economic growth. Due to the government policy of economic regeneration and the urbanization reshaping most regions, Chinese people are gradually becoming more affluent. As a result, there has been exponential growth in the medical device and IVD market in recent years. This phenomenon is similar to the drug industry in the early 90's.

The market potential for these two sectors is simply tremendous. Although there are different predictions and calculations from various experts regarding the market size of the medical device industry, a conservative estimate is over five billion US dollars. China is already the number two player in the Asia market and is just behind Japan in terms of volume. But while the potential is attractive, the registration process for medical devices and IVDs in China is quite lengthy, and the regulatory hurdles significant.

This presentation will provide an introduction to the regulatory environment in China, and the requirements and process for registering medical device and IVD products.

Medical Device and IVD Registration in China is presented by Janice Ma, Operations Director & Co-founder, of ChinaGate Ltd. For more details on this conference, please visit our site www.fxconferences.com

Successful Medical Device Approvals in China

With over 1.4 billion people and an emerging public healthcare system, China is one of the most attractive secondary markets for medical device manufacturers worldwide. The regulatory requirements mandated by the State Food and Drug Administration (SFDA) have been evolving.

In this audio conference, our speaker will discuss the background of SFDA regulatory requirements and explain the process of registering your product in China, including specific information on how the SFDA defines and classifies a medical device, the registration dossier required by SFDA, regulatory criteria for testing and clinical trials. The presentation will also provide examples of what has helped companies succeed in achieving approvals, and discuss the latest trends in the China regulatory environment.

This audio conference is presented by Janice Ma of ChinaGate. Learn more at www.fxconferences.com.