Industry Update on Centralized Procedure in the EU

The revised EU pharma legislation has seen some major changes since coming into force, changes that have now been implemented and, more importantly, interpreted. New and additional guidelines have been issued, a system of scientific advisory groups (SAG) has been established, and the procedure to obtain a marketing authorization is being performed in a more stringent way.

In this audio conference we discuss how the paediatric regulation has created the necessity for a more extensive planning process and in particular, how line extensions of existing products are concerned.

Industry Update on Centralized Procedure in the EU is being presented by Dr. Ulrich Granzer, with Granzer Regulatory Consulting and airs on Thursday, April 30, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

Taking the Literature Route for Clinical Evaluations

Evaluation of clinical data is a necessary part of the European technical file or design dossier for CE marking medical devices. The purpose of the evaluation is to demonstrate conformity with the essential requirements concerning performance and safety of the device under normal conditions of use. The data may come from published literature, a clinical trial or a combination of the two.

This audio conference focuses on the literature route for providing clinical data, which, if done well, may preclude the need for a de novo clinical trial. The presentation highlights pitfalls and best practices, and describe Medical Device Directive (MDD) requirements concerning clinical evaluations. This presentation also discusses use of the clinical literature review as a tool for post-market surveillance and as an input into risk management processes.

Taking the Literature Route for Clinical Evaluations was presented by Carol Houts, Director of Regulatory, Quality and Safety Concerns, with Pleiad and aired on 2008-07-24. This audio conference is available for download at www.fxconferences.com

Considering Human Factors in Designing Medical Device Trials

Increasingly, the FDA is requiring that clinical evaluations take into account human factors and their effects on device design. It is becoming more important to address how these affect the safety, performance and reliability of medical device use to ensure appropriate device design. Evaluating the human interface in the user environment produces critical data for pre-market applications to the FDA. However, medical device trials intending to collect these unique data must be carefully designed to bring the most valuable data to light.

In this audio conference the speaker looks at various human factors which must be taken into consideration when designing a medical device clinical trial, and uses a series of real-life examples to illustrate how best to incorporate them into the design process. In addition, all attendees will receive a copy of Pleiad's Human Factors Considerations checklist.

Considering Human Factors in Designing Medical Device Trials is being presented by Annette Valles-Sukkar, Senior Manager, Clinical Operations, with Pleiad Devices and airs on Thursday, May 7, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

Effective Strategies for Successful Medical Device-CRO Partnerships in Post-Approval Studies

Outsourcing in the life sciences industry is an established business practice that saves time and money. Medical device post-approval studies differ in both subtle and considerable ways from that of drugs or biologics, including how to approach and conduct mandated post-marketing studies. Successful partners in this realm require a firm understanding not only of the regulations, but also how to nurture seamless, high-functioning project teams.

This conference provides insights into building successful CRO partnerships that focus on medical device manufacturer needs, including risk analyses, communication plans, safety considerations (adjudications and DSMBs), effective team building and setting milestones and metrics to track success.

Effective Strategies for Successful Medical Device-CRO Partnerships in Post-Approval Studies is being presented by Yvonne Albright and Barbara Vargas, Project Managers, with Covance Periapproval Services and airs on Thursday, April 16, 2009. For more details or to register, please visit our site at www.fxconferences.com

20 Tips for Better Telephone Presentations

We live in an age when even the smallest of companies routinely operate on a global scale. Meanwhile, the cost of travel continues to spiral ever higher. As a result, many businesses are cutting back on face-to-face meetings, relying instead on teleconferences, webinars and other communications vehicles to make the connection with clients and prospects. However, while it is comparatively cheap and convenient to give presentations and conduct meetings using the telephone or web-based technology, it is not without its drawbacks. This presentation discusses the most common pitfalls, and provides actionable tips for more professional and effective long-distance business relations.

20 Tips for Better Telephone Presentations was presented by Rob Wagner, Executive Producer, with ForeignExchange Translations, and is available for download at www.fxconferences.com

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 was presented by Eric Henning, Senior Project Manager, with KEMA. To purchase a download of this event or 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

Minimizing Distraction, Maximizing Productivity and Finding Flow

It can be exceedingly difficult, in challenging economic times, to stay focused. However, when things are bleak and rumors of job losses figure prominently in water cooler discussions, we are still required to perform at our best. If anything, it becomes more important than ever to be productive and maximize our value. However, with so many external and internal distractions and pressures, how does anyone stay on top of their game? It’s quite simple really -- focus! But what exactly should we focus on? In this audio conference, Dr. Bruce Jackson looks at how to find your flow, to get and stay "in the zone" and achieve peak performance.

Minimizing Distraction, Maximizing Productivity and Finding Flow is being presented by Dr. Bruce Jackson, Director, with Center for the Advancement of Leadership and airs on Wednesday, May 6, 2009. For more details or to register, please visit our site at www.fxconferences.com

Harnessing the Marketing Potential of Social Networking Sites

You’ve heard of social networking through popular sites like Twitter, Facebook and LinkedIn. But how can you make these and other sites work to your professional advantage? From recruiting top talent to targeted marketing touches, social networking is an extremely valuable tool that is making the business world think outside the box. Even top level executives at major corporations are ‘tweeting’ their way closer to their customers and employees.

If you are new to the world of online social networking, this audio conference teaches you where to go and how to construct a network that is a powerful relationship builder, not a time waster. If you’ve explored social networking with little results, this presentation provides some great tips and resources to help you focus on what is important and what will help grow your business.

Harnessing the Marketing Potential of Social Networking Sites is being presented by Michelle Burns, with The Word Zone, LLC and airs on Tuesday, April 28, 2009. For more details or to register, please visit our site at www.fxconferences.com

Ensuring Translation Quality with ASTM F 2575-06

After many years lacking industry-specific standards, translation providers and users now have a few to choose from. The two that have created the most buzz are the European standard, EN 15038:2006, and the American standard, ASTM F 2575-06. Translation providers are clamoring to declare themselves compliant with both of these. While the EN standard is focused more on establishing a baseline for providers, the ASTM standard serves as a better real-world guide for providers and clients.

The overriding theme of ASTM F 2575-06 (Standard Guide for Quality Assurance in Translation) is one of cooperation between client and provider. The writers of the standard understand that quality in translation is a collaborative process. The document is filled with explanations and definitions of industry-specific terms and practices, as well as practical tips for working together with a vendor to build a foundation of quality.

This audio conference provides an overview of ASTM F 2575-06, dissecting its different sections, determining its applicability to certifications and testing, pointing out ways clients can use the standard to work with their vendors to achieve the highest level of quality and discussing the differences between ASTM F 2575-06 and EN 15038:2006.

Ensuring Translation Quality with ASTM F 2575-06 is being presented by Jason Heaton, with ForeignExchange Translations, and airs on Wednesday, April 29, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

IEC 60601 3rd Edition: Overview and Adoption Update

The IEC 60601 3rd Edition represents a major change in the way medical devices are evaluated and approved. This audio conference will provide an overview of the major differences between the 2nd and 3rd Editions of the standard, including process changes for assessing acceptable risk, in addition to the electrical and mechanical changes.

Because the changes have a major impact on the way certification is viewed, there is still a lot of discussion among the major medical markets on how to interpret the standard, what national differences to include, and what requirements will be required to assess conformity. We also provide an update on the adoption status in the major medical device markets.

IEC 60601 3rd Edition: Overview and Adoption Update aired on 2007-09-13 and is available for download at www.fxconferences.com

Global Patent Standards

Is your patent adequately protected in all of the markets where you do business? Are you sure about that?

In many industries, patent protection in both the United States and abroad is critical, but the requirements for each country are not necessarily the same. Thus, in developing a patent strategy, the different requirements of countries where protection is desired must be considered prior to filing.

In this audio conference, we review the various global patent standards in countries where patent protection is typically sought. Particular emphasis will be placed on written description requirements, obviousness and inventive step standards in the United States and in Europe.

Global Patent Standards is being presented by Christopher Rhodes, PhD, Intellectual Property Attorney, with JD - Lowrie Lando & Anastasi LLP and airs on Tuesday, March 24, 2009. For more details or to register for this conference, please visit our site www.fxconferences.com

Preserving Relationships in the Face of Divergent Project Expectations

Managing divergent project expectations is a challenge that is often faced by project managers at CROs and sponsor companies. If a relationship becomes compromised, which strategies can address misunderstandings and improve relationships among shakeholders?

In this audio conference we discuss best practices for project planning to help ensure consistent expectations, and strategies for addressing divergent expectations and improving working relationships. We also talk about the importance of up-front planning to ensure consistent project expectations among stakeholders, and identify processes available to clearly define expectations and open channels of communication.

Preserving Relationships in the Face of Divergent Project Expectations is being presented by Michael Hill, Project Manager, Registries and Observational Studies, with Covance Periapproval Services and airs on Wednesday, April 8th, 2009. For more details or to register for this conference, please visit our site www.fxconferences.com

Retaining Employees and Making Training Stick

Retaining quality, high-producing employees is a critical goal of any company. However, while investing in employees is arguably the smartest investment a company can make, it frequently seems to be the lowest of priorities during times of economic challenge. Traditionally, investing in employees takes the form of training. But if training is not structured properly, it results in little to no behavioral or attitude change, wasting time and precious resources.

So how do you make sure training will "stick"? Designing interactive experiences increases retention and ensures behavioral change to increase productivity and your bottom line. This audio conference explores five key steps that will not only ensure training retention, but also help you reduce staff turnover.

Retaining Employees and Making Training Stick is being presented by David Piltz, Managing Partner, with The Learning Key, Inc. and airs on Thursday, May 14, 2009. For more details, or to register for this conference, please visit our site www.fxconferences.com

Building a Global CMS: Challenges & Lessons Learned

Developing and implementing a global information management system is a daunting process, and the challenges are magnified for any company working within a regulated industry. With production facilities in the US and Europe and products sold in 92 markets, CaridianBCT is a world leader in blood collection and processing technology. This audio conference provides a first-hand account of how the CaridianBCT technical communications team implemented a scalable, flexible and measurable global information management system – from source content development through localization..

This case study looks at how CaridianBCT is implementing the Astoria content management system and integrating it with the Idiom WorldServer translation management system, improving the throughput, efficiency and traceability of the localization process. The speakers also discuss the drivers for change, how standards helped, and time, cost and resource considerations.

Building a Global CMS: Challenges & Lessons Learned is being presented by Jason Arnsparger & Jennifer Linton, Localization Project Manager & XML and CMS Project Manager, with CaridianBCT and airs on Tuesday, April 7, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

Building Better Business Relationships

Relationships are fundamentally critical to business success. However, most individuals and organizations lack the number, quality and level of relationships to achieve their goals and have no effective way to address this critical problem. With the right mindset, process, skills and best practices, individuals and organizations can dramatically improve the productivity and speed at which they build business relationships and achieve critical business outcomes. In this high-energy session, you learn to apply proven techniques that will help you rapidly develop, deepen and manage the relationships that are most important to your success.

Building Better Business Relationships is being presented by Dr. Jeff Kaplan, Director of Leadership Development & Training, with Ferrazzi Greenlight and airs on Thursday, April 2, 2009. For more details, please visit our site www.fxconferences.com

Best Practices for Back Translation as a QA Tool

Back translation is the translation of an already-translated text back into its original language. The use of back translation as a QA tool is becoming more prevalent in the life sciences industries, as often required by regulatory industries. These translated materials include product information, labels, informed consent forms, websites, software strings and a variety of other written content.

The issues presented by this growing trend in back translation are complex and often misunderstood by those removed from the localization process. Back translation as a QA tool can be successfully accomplished when these issues are fully understood and the process properly applied.

Best Practices for Back Translation as a QA Tool was presented on 2008-08-06 and is available for download at www.fxconferences.com

Optimizing CRA Deployment in Global Clinical Trials

This audio conference will provide insight into how to drive ROI by optimizing CRA deployment and data management staff planning. Specifically, the presentation will detail the critical patient data that should be captured in your IVR system in order to maximize the efficiency and organization of CRA site visits. This data can then be linked with your clinical trial management system to project the data workload accumulated at investigator sites.

The speaker will provide practical examples of how this information has been used to optimize deployment of CRAs to investigator sites and to drive efficiencies in those site visits. Furthermore, the presentation will examine how the IVRS data stream can also be used to determine the amount of data management staff that will be required in the trial. More effective utilization of an IVRS data stream can enhance visibility into trial performance and drive cost-saving efficiencies.

Optimizing CRA Deployment in Global Clinical Trials was presented on 2007-11-15 by Marie Snell, with Covance and is available for download at www.fxconferences.com

IEC 60601-1 3rd Edition: Setting the Standard for Electromedical Devices

The third edition of IEC 60601-1 is now a year old; however, this standard is so different from the second edition that manufacturers and certifiers alike have yet to get their act together. One of the major reasons for this is the explicit introduction of risk management as a part of IEC 60601-1.

Risk management is inextricably woven into the fabric of this standard. Not only is there a general requirement for manufacturers to establish a risk management process that conforms to ISO 14971 (clause 4.2), but there are also more than one hundred times where the standard directs manufacturers to determine risk acceptability in applying a particular clause.

This audio conference examines how risk management is used in the third edition, as well as the implication both for manufacturers and for third party certifiers.

IEC 60601-1 3rd Edition: Setting the Standard for Electromedical Devices was presented on 2007-02-15 and is available for download at www.fxconferences.com

Beyond Global Feasibility: An Evidence-Based Approach to Creating Realistic Development Timelines

One of the greatest risks to successful drug development today is delayed clinical development timelines. Detailed planning and appropriate site and country selection is the most critical factor in meeting target patient accrual goals within the planned timeline. Historically, site and country selections have been made primarily utilizing survey-based prospective feasibility. Unfortunately, survey-based feasibility alone is no longer sufficient to provide the detail necessary to select countries and sites to maximize patient accrual and minimize development timelines. An evidence-based methodology approach coupled with survey-based feasibility provides the most accurate forecast for patient accrual and the selection of sites and countries with the highest likelihood of being productive.

In this audio conference we will discuss the key items of an evidence-based approach to feasibility and ultimately, site and country selection.

Beyond Global Feasibility: An Evidence-Based Approach to Creating Realistic Development Timelines is being presented by Kent Thoelke, Sr. Vice President of Therapeutic Expertise, Scientific & Medical Affairs, with PRA International and airs on Wednesday, March 25, 2009. For more details or to register, please visit our site www.fxconferences.com

Hazard Analysis for Medical Devices Under IEC60601 and ISO14971

If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.

This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It will discuss documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.

Hazard Analysis for Medical Devices Under IEC60601 and ISO14971 is being presented by Markus Weber, Principal Consultant, with System Safety Inc. and airs on Thursday, March 19th, 2009. For more details or to register please visit our site www.fxconferences.com

This audio conference has been pre-approved by RAPS as eligible for one (1)credit toward a participant's RAC recertification upon completion.

21 Steps to Easier Globalization through Better Writing

Going global? Many of the problems encountered during the globalization process can be traced back to the earliest stages of developing product documentation. The good news is most of these problems can be avoided by following a few basic rules.

John Smart has spent over two decades helping companies market to 218 countries. In this presentation, he will describe the 21 most common problems encountered in writing for a global audience, identifying each type of error, describing the problem and showing how to make corrections. The presentation will use real-life examples to highlight potential cultural problems, including inappropriate number and color references, and the confusing use of dates and numbers. Attendees will be able to put the conference material to immediate use in improving their technical literature.

21 Steps to Easier Globalization through Better Writing is previously recorded, and available for download at www.fxconferences.com