Readability Testing for Patient Information in Europe

is being presented by Simon Andriesen, CEO, of MediLingua BV and airs on Tuesday, November 2nd, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

Readability testing of patient information leaflets has been the law in Europe since 2005. One on the language versions – English or any of the other EU languages – must be tested for readability. During a readability test a leaflet is discussed with 25 participants, who have to answer a range of questions using the information they find in the leaflet. This way most if not all errors or shortcomings will surface and can be corrected.

This audio conference presentation will provide an overview and best practices concerning readability testing. The speaker will discuss how to set up a test environment, how to recruit the right people for testing, and how to formulate strong, effective questions.

Global Clinical Studies: Logistical Challenges from Supply to Assay

As the nature of clinical trials becomes more complex, the focus and expertise of personnel involved has become more specialized. To manage a successful study, awareness of all aspects in this process is critical.

In this audio conference, Ms. Oliver reveals all of the logistical challenges involved in clinical studies and effectively illustrates them through two scenarios: 1) drug distribution through delivery and 2) specimen transport from patient to assay.

The topics covered will include successful strategies for the transport of cold chain including regulatory and import considerations. Also discussed will be aspects of clinical sample logistics including site and lab selection, and customs.

Global Clinical Studies: Logistical Challenges from Supply to Assay was presented by Karen Oliver, Director Global Accounts, with World Courier and aired on 2008-10-08. For more details or to download 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

Regulatory and Practical Implications of e-Labeling for IVDs in Europe

With more than 20 official languages in the European Union, manufacturers often encounter challenges when providing paper instructions for use by traditional means. In MEDDEV 2.14/3, the European Commission gives guidance to manufacturers of in vitro diagnostic devices regarding the supply of instructions for use, which can now be provided by alternative means such as a dedicated website. However, there are strict conditions which apply to such websites, including the requirement that the manufacturer also provide a toll-free telephone number for customer support.

In this conference, our speaker details the IVD e-labeling requirements as defined in the MEDDEV guidance, and explains the challenges posed by the implementation of e-labeling solutions that comply with those requirements.

Regulatory and Practical Implications of e-Labeling for IVDs in Europe is being presented by Dr. Dirk Stynen, Founder & Principal Consultant, Qarad and airs on Tuesday, September 8, 2009. For more details, please visit our site at www.fxconferences.com

Improving the Readability of Your Patient Information

Updated

Life sciences companies go to great lengths to provide patients and users with all the information they need to use products safely and effectively. But how do you ensure those patients understand what you are telling them? According to the Institute of Medicine, nearly half of the adult population in the United States may lack the skills needed to function within the healthcare system. The FDA says patient materials should be written at a 6th to 8th grade reading level, while recently revised European Commission guidelines call for "well designed and clearly worded" package inserts.

In this presentation, the speaker provides attendees with the tools to overcome some of the challenges encountered when communicating written health care information. The presentation includes a brief overview of health literacy in the U.S., and discusses how plain language, organization and format can all be used to create PPIs, medication guides, marketing collateral and patient education materials that conform to current regulatory guidelines.

Improving the Readability of Your Patient Information is being presented by Michael Aldridge, Faculty, with University of Texas at Austin School of Nursing and airs on Thursday, March 26, 2009. For more details or to register, please visit our site at www.fxconferences.com