Software as a Device: What You Need to Know About the New MDD

The current landscape of device regulations, as directed by the MDD, has undergone some substantial changes. The directive, published in April 2007, becomes a requirement in March of 2010. MDD: 93/42/EEC defines new regulatory challenges for device manufacturers groups and notified bodies, specifically in post market surveillance and vigilance.

It is time to start planning for the new requirements of the new MDD. Classification rules have been modified with some former devices now falling into higher class ratings, essential requirements have been changed, stricter definitions relating to medical devise, and more controls on software are jut some of the major changes.

Software as a Device: What You Need to Know About the New MDD is presented by Eric Henning, Sr. Project Manager, of KEMA. For more details on this audio conference, please visit our site www.fxconferences.com

Maximizing Productivity Among Spanish-Speaking Employees

On occasion, even when material and instructions are translated well, employers do not get the response that they need from Spanish-speaking employees. This happens not because of a lack of desire to be a valuable employee, but because of Spanish speakers’ misconceptions about what it takes to be a valuable employee in the United States.

In this audio conference we will address common challenges for employers---apart from the language barrier---and will offer various strategies for improving morale and encouraging desired behavior like compliance with training and regulation and participation in benefit plans.

This event is presented by Melissa Burkhardt of Futuro Sólido. To learn more, please visit www.fxconferences.com.

Writing & Designing for an International Audience

Are you responsible for generating content for global markets? Are you worried that the meaning in your message might be lost or altered because of cultural differences? Culture, translation, writing, and design interweave in curious ways when preparing content for an international audience. These elements require important skills for creating global content, especially given the increasing pressure to standardize and comply with various international and internal standards.

This presentation will highlight some key contradictions inherent in writing and designing for a multicultural and multilingual audience and discuss proven strategies for their resolution.

This event is presented by Nancy Hoft of Nancy Hoft Consulting. To learn more, please visit www.fxconferences.com.

Meeting the Challenges of Global Oncology Trials

Successful global oncology trials require careful planning, starting with looking at the strategic elements that span people, process and technology. Challenges in clinical research in oncology today include multiple new agents for multiple new targets combined with an increase in the number of patients needed to demonstrate that a therapy provides a significant benefit for patients. There is also a need to minimize the time it takes to go from basic science discoveries into clinical studies. The risk posed by delays in study start-up and patient recruitment can be mitigated by proactively planning for the study.

Planning needs to reflect the traditional and nontraditional considerations of feasibility and study design and incorporate trends and best practices. Patient recruitment is a key strategic consideration, along with epidemiological and genetic factors. Facilities, expertise and other resources along with technology play a key role in global trial planning.

Area-specific regulatory requirements vary in terms of standards of care, and differences among healthcare systems influence trial planning, as do local and cultural considerations.

This presentation will focus on the central challenges in global oncology trials today and make recommendations about how they might be addressed to mitigate risks in terms of timelines and costs.

This event is presented by Ute Berger of PRA International. To learn more, please visit 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