Medical Device Research and Regulations in Israel

Israel represents the largest single medical device market in the Middle East, valued at roughly 885 million dollars and growing at an annual rate of almost 5%. There is an extensive medical network and high doctor-to-patient ratio, both reflected in a low infant mortality rate and high life expectancy. Distribution of medical conditions and trauma is comparable to the EU and USA.

Israeli schools provide medical professionals with Western-level training, and as a result the country operates on the frontier of medical technology development. With its experienced doctors and high-tech medical facilities, Israel offers medical device companies a regulated, accepting environment in which to conduct clinical studies of the highest quality. Study enrolment is high, as is data quality.

This audio conference provides attendees with information on the regulations governing Israeli clinical studies, and the requirements for placing your medical device on the market in Israel.

Medical Device Research and Regulations in Israel was presented by Efraim Roe Kozorovitsky, Executive Director, Medical Devices, with Premier Research Group. This conference aired on 2009-02-05 and is available at www.fxconferences.com

Predicting and Preventing Protocol Violations

Often, a large percentage of sponsor clinical trial budgets are allocated to remediation, focused towards fixing problems after they occur, rather than towards proactive activities which could help predict and prevent errors.

This presentation discusses clinical trial protocol violations as a consequence of stressed "environmental" conditions at investigative sites, the potential risk for patient safety and the overall impact on the success of clinical trials. The speaker examines why protocol violations are so pervasive, as well as conventional measures to handle them and their inability to adequately detect and address them. The presentation also looks at Failure Mode and Effect Analysis (FMEA) as a proactive approach to predict and prevent protocol deviations/violations. The presentation will also discuss how clinical trial protocol violations are preventable within a risk management paradigm, and will outline a process for addressing protocol violations using the FMEA approach.

Finally, the presentation addresses the implications to the sponsor's clinical trial budget of the proactive, predictive, prevention approach embodied by FMEA and how additional investment up-front can lead to improved clinical trial performance.

Predicting and Preventing Protocol Violations was presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, with Covance and aired on 2007-06-14. This conference is available for download 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

Benefits & Risks Throughout the Product Lifecycle: How to Strike a Balance in a Post-FDAAA World

One of the provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) is that the FDA requires manufacturers to submit a Risk Evaluation and Mitigation Strategy (REMS) when a drug or biologic first comes on the market, or later if they become aware of new safety data about the drug. What risk signals should be looked for early in the development process?

In this audio conference we present case studies of various levels of REMS requirements and focus on how to use post-market surveillance requirements to support your product safety profile. Meeting the challenges raised by FDAAA through optimal risk management and utilizing integrated actvities that begin with early clinical testing are key, and must continue throughout the product lifecycle.

Benefits & Risks Throughout the Product Lifecycle: How to Strike a Balance in a Post-FDAAA World is being presented by Dr. Edgar Adams & Robin Carter, Executive Director, Epidemiology & Senior Director, Risk Management Operations, with Covance, and airs on Tuesday, May 5, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

Good Reprint Practices: What the FDA Says Now

After years of arguing about the legality of distributing medical journal articles concerning unapproved uses for approved drugs and devices, the FDA has finally released a draft guidance recognizing such distribution as a normal activity. The guidance on Good Reprint Practices outlines the type of articles suitable for dissemination to healthcare professionals, the types of articles which should not be disseminated, and acceptable methods of distribution. However, in some ways this new guidance may be even more rigorous than past programs. It could even be argued that some of the provisions are unconstitutional.

In this audio conference, our speaker discusses the scope of the draft guidance on Good Reprint Practices and provide expert advice on implementing a program to ensure compliance for drug and device companies.

Good Reprint Practices: What the FDA Says Now was presented by Robert J. Klepinski, with Fredrikson & Byron and aired on 2008-09-04, and is available at www.fxconferences.com