Best Practices for Building Global eLearning Programs

e-learning: One day you love it, the next you hate it. Where would you be without it, yet you curse it.

In order to reach and teach an increasingly diverse employee population, companies are adapting their e-learning programs. Designing, building, and deploying e-learning programs is hard enough for one culture - it becomes much harder when the audience doesn't all speak English or isn't all located in one country.

In this audio conference, we present how to apply good program design principles. Not only will you be able to maximize your e-learning investment, but by following best practices in conceptualizing and building your programs, you guarantee efficient training for today’s diverse employee population.

Best Practices for Building Global eLearning Programs is previously recorded and was presented by Eoghan O'Maolain, Director of eLearning Development, with Rendition Digital. For more details on this audio conference, please visit our site at www.fxconferences.com

Optimizing Country Selection for Clinical Research

A number of elements can influence decision-making when developing a global footprint within the clinical research environment. These elements include: knowledge of the regulatory framework and timelines, suitability of the healthcare setting, compatibility of standard of care, interest within the physician community, internal resource availability to train sites and monitor high quality data, and the competitive landscape.

In this presentation, Dr. Stansfield discusses these elements, with a primary focus on the ways that patient access can influence the successful outcome of clinical research for a new product. She also highlights the pros and cons of different approaches.

Optimizing Country Selection for Clinical Research was presented by Susan Stansfield, PhD, Executive Vice President Product Registration Europe, Africa & Asia Pacific, with PRA International and aired on 2008-02-14. For more details, or to download this conference please visit our site at www.fxconferences.com

Indications: The Next Battleground in FDA Advertising Enforcement

Recent Supreme Court decisions have provided new protection to commercial speech, challenging the manner in which FDA regulates industry. In response, FDA takes great care to not mention advertising and has shifted its enforcement focus to indications.

The Food, Drug, and Cosmetic Act (FDCA) does not give FDA broad control over advertising, yet it does give FDA explicit control over the approval/clearance process and the resulting indications. FDA is tightening up on statements in ads by closely interpreting indications. This makes it even more critical to plan and write accurate PMA and 510(k) scopes to prevent FDA enforcement.

This audio conference discusses the best way to work within the new reality of FDA advertising enforcement.

Indications: The Next Battleground in FDA Advertising Enforcement was presented by Robert J. Klepinski, Fredrikson & Byron and aired on 2007-01-18. For more details, or to register please visit our site at www.fxconferences.com

An Introduction to Regulatory Writing: Creating an Effective Message

Did you ever wonder what reviewers look for in your regulatory submissions? This audio conference combines the results of two in-depth interviews regarding effective writing in regulatory submissions and with known effective writing techniques and practices. The interviews were with a previous FDA reviewer and a current reviewer for a large Notified Body. Both interviewees shared their reactions to the quality and effectiveness of the writing in the hundreds of submissions they have each reviewed.

Topics include: analyzing the audience, identifying topics, organizing the topics in a logical way, applying document design principles, establishing document management conventions, writing, and assessing the effectiveness of your writing.

An Introduction to Regulatory Writing: Creating an Effective Message was presented by Nancy Hoft, with Nancy Hoft Consulting, and is previously recorded. For more information, or to download this conference please visit our site at www.fxconferences.com

EU Device Labeling: Issues and Requirements

For many companies, achieving ISO 13485 certification, applying the CE mark and finally exporting to Europe is a great victory. However, many companies forget that the EU is made up of 27 separate countries (Bulgaria and Romania being the newest members) and underestimate the complexity of dealing with language requirements and the use of symbols for each country. Will Germany allow English labeling for devices used only by a professional? Does Belgium require Dutch, French or German -- or all three?

In this presentation, we discuss these issues and also cover the use of symbols in packaging, instructions for use (IFU) and device labels.

EU Device Labeling: Issues and Requirements was presented by Dr. Jaap Laufer, .P. Public & Regulatory Affairs, with Emergo Group Inc. and aired on 2007-09-06. For more details, or to download this audio conference please visit our site at www.fxconferences.com