Bridging the Linguistic Quality Gap: How to Measurably Improve Translation Quality

A cornerstone of the translation industry is the quality of the linguistic work completed, yet linguistic quality remains nebulous for many end clients and translation suppliers. Linguistic quality means different things to different organizations and for different types of projects. With lack of measurable quality systems comes the need to add steps to the process to “ensure” quality. This perceived increase in quality (more people looking at the text) results in slower time-to-market and increased costs.

This audio conference looks at how to move from an uncertain quality outcome to measurable, predictable quality, while presenting an approach to defining, measuring and improving linguistic quality within an organization. The speaker also discusses how to utilize these measurements to meet the organization’s business objectives on a broader scale, spanning improvements in cost and time-to-market.

Bridging the Linguistic Quality Gap: How to Measurably Improve Translation Quality is being presented by Sonia Monahan, Executive Vice President, Quality Systems, with ForeignExchange Translations, and airs on Tuesday, November 10, 2009. For more details or to register, please visit our website at www.fxconferences.com

FDA End-of-Phase 2 IND Meeting: Finalizing the IND Clinical Plan

The End-of-Phase 2 FDA meeting is the optimum time to obtain FDA input at a single Type B meeting on the remaining pharmacology and toxicology studies, chemistry manufacturing and controls (CMC) of the clinical formulation, and the overall IND clinical plan to support an NDA submission for market approval. Therefore, it is essential to give proper forethought and attention to the all-important steps in preparing for the EOP-2 FDA meeting.

In this conference our speaker, veteran industry expert Dr. Larry Hofmann, gives expert guidance on the optimum background and makeup of your EOP-2 FDA meeting team. He also discusses strategic planning for and preparation of the FDA meeting information package, which must include available pharmacology and toxicology, Phase 1 and Phase 2 study summaries, as well as a summary of CMC data on the previous IND clinical formulations and proposed Phase 3 formulation to support the proposed Phase 3 and remaining Phase 1 study protocols.

FDA End-of-Phase 2 IND Meeting: Finalizing the IND Clinical Plan is being presented by Dr. Larry Hofmann, President, of LMH Associates, Inc. and airs on Tuesday, November 3, 2009. For more information, or to register for this event please visit our site at www.fxconferences.com

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

A Systematic Approach to Japanese Medical Device Submissions

Planning to take your products to Japan? Japan represents an 18-billion-dollar market for medical device manufacturers, and 40% of that is imports. However, entering the Japanese marketplace requires careful forethought and planning.

In this audio conference we provide an overview of the regulatory process in Japan including detailed timelines, cost estimates, and common mistakes made during market entry. The first part of the presentation will focus on the time and cost associated with a Japanese device submission, as well as outlining the steps needed to prepare for a submission. In the second part, our speaker discusses the initial steps of any Japanese submission and explains the difference in device classifications and approval categories. From there, we move on to common pitfalls and shortcomings of most foreign device submissions. This will include a detailed look at the different data and analysis needed, as well as a cultural section on dealing with Japanese reviewers, market authorization holders (MAH) and distributors.

A Systematic Approach to Japanese Medical Device Submissions is being presented by Michael Halper, President, of Small World Medical and airs on Tuesday, November 10, 2009. For more details or to register for this event, please visit our website at www.fxconferences.com

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

Achieving Compliance and Beyond with Simplified Technical English

Even the best product is only as good as its documentation and technical data, which allow the customer to use it safely and effectively. Simplified Technical English (STE) can help you meet documentation compliance requirements, and can also increase the efficiency and productivity of your employees. Formerly known as AECMA Simplified English, STE is an international standard (ASD-STE100) that helps to make technical documentation easy to understand and easier to translate for global customers. Simplified Technical English standardizes vocabulary, grammar and style, while letting users control their specific terminology.

In this session, Dr. Frans Wijma highlights some of the key benefits and rules of STE that can help to address 99% of the main challenges behind documentation processes, such as high cost, ease of translation, damage to product, delayed time-to-market and inadequate customer support.

Achieving Compliance and Beyond with Simplified Technical English is being presented by Dr. Frans Wijma, Managing Director, with Shufra and airs on Tuesday, November 3, 2009. For more details, or to register please visit our site at www.fxconferences.com