Friday special - save 75% on "Device e-Labeling & Regulatory Compliance in the EU"

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. Currently, most Instructions for Use are provided in paper format, which can be very lengthy.

The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. This is especially the case with IVDs, since these are usually used by healthcare professionals in a clinical environment, with relatively common access to computers and Internet facilities.

However, the latest revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.

But hurry! If you purchase Device e-Labeling & Regulatory Compliance in the EU" by November 19, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

How to Mark & Label Devices Under IEC60601-1 3rd Edition

Get up to speed on the latest requirements incorporated into the 3rd Edition of IEC 60601-1 and take the guesswork out of marking and labeling your medical devices!

Marking and labeling is just one area to tackle in the complicated development of medical devices, but it is a critical one to understand. How do you make sense of all those regulations? It’s challenging enough preparing and testing the device; then you have to worry about the user manuals, screen prompts and packaging too.

In this audio conference, Leo Eisner guides you through each new, added or modified regulation incorporated into the most recent revision of IEC 60601-1. The third edition of this cornerstone standard for medical electrical devices sees major changes from the second edition, changes you need to know about for successful compliance. Ease your marking and labeling stress with detailed guidance from a leading expert.

How to Mark & Label Devices Under IEC60601-1 3rd Edition is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Wednesday, November 18, 2009. For more details or to register, please visit our site at www.fxconferences.com

The Art and Science of Drug Product Regulatory Submissions

Collectively, pharmaceutical drug products include a surprisingly wide variety of possible dosage forms and functions. No matter the dosage form, there are requirements that must be met in manufacturing and testing. A high-quality, organized CMC submission should be organized based on the CTD format, and contain information that will aid in a positive review and a quality drug product for patients. Fortunately, there are many similarities across this wide variety of dosage forms, including general product development principles which can be utilized throughout the life of any drug product.

This session provides an overview of the similarities -- and some unique differences -- of manufacturing, analysis and regulatory expectations. Our speaker explains how these similarities can fit together to produce a high-quality submission to the FDA for marketing approval, as well as regulatory maintenance after approval.

The Art and Science of Drug Product Regulatory Submissions is being presented by Dr. Andrew Trammel, Director, Executive Consultant, with Beckloff Associates and airs on Tuesday, December 8, 2009. For more details or to register, please visit our site at www.fxconferences.com

Stay in the Game: Leading Pharma and Biotech Teams in Tough Times

What do you want others to say of your leadership during these challenging times? When the going gets tough, thanks to conditions such as dropping revenues and profits, mergers and acquisitions, re-organizations or shrinking pipelines, there is an opportunity for leaders to step up and stand out. It is also a time to step back for a little self-reflection on just what are the leadership requirements for this “new normal” of organizational life.

Based on over 20 years of experience working with such companies as Pfizer, Sanofi-Aventis, Biogen Idec and Boehringer Ingelheim, in both research and commercial divisions around the world, Lynda McDermott provides attendees with “best practice” leadership learnings and tools to help you and your people “stay in the game."

Stay in the Game: Leading Pharma and Biotech Teams in Tough Times is being presented by Lynda McDermott, President, of EquiPro International and airs on Thursday, December 17, 2009. For more details or to register, please visit our site at www.fxconferences.com

Cost & Effectiveness: Healthcare Reform and its Implications for Pharma & Devices

With health care reform on the horizon, the business case for quality and efficiency in health care has never been clearer. The new system will encourage payers to reimburse only for consistent and efficient care. Increasing transparency will make it easier for patients, who will in turn demand care that meets their needs. Preparing for the future of health care is therefore critical to the survival of many organizations. This changing health care landscape will have implications for medical providers and suppliers alike.

This session provides an overview of health care reform by understanding Massachusetts reform as a likely model. Dr. John Freedman outlines how such changes are likely to impact clinicians, as well as medical suppliers. This includes outlining key macro trends related to performance measurement, improvement, efficiency and cost containment.

Cost & Effectiveness: Healthcare Reform and its Implications for Pharma & Devices is being presented by Dr. John Freedman, Principal, of Freedman HealthCare, LLC and airs on Thursday, December 3, 2009. For more details or to register, please visit our site at www.fxconferences.com