Conducting Exploratory Trials in Scandinavia

Debating where to take your trial? While emergent research settings like India and Asia have captured much of the media spotlight in recent years, there are few places in the world better-suited for phase 1 and phase 2 clinical trials than Scandinavia. Populations in the Nordic region are ethnically homogeneous with a majority of caucasians. Both governments and populations generally display a positive attitude toward clinical research, and trial participants have high compliance rates. All citizens have free and equal access to healthcare, preventing sampling bias due to differences in social status. Health care facilities in the region all have access to state-of-the-art medical equipment, and the infrastructure is of the highest standards. In this audio conference, the speaker discusses these and other factors that make the Scandinavian countries a leading choice for exploratory trials.

Conducting Exploratory Trials in Scandinavia is presented by Dr. Claes Strom, Partner and COO, of aCROnordic and airs Thursday, Oct. 30, 2008. For more details please visit our site www.fxconferences.com

How to Write for a Global Audience

In today's world, technical documentation must be designed for multiple audiences - both the users who read the text in translation, and those for whom English is a second language. By using Controlled English and authoring with an eye to translation, companies can make the entire process of product globalization faster, cheaper and less prone to errors.

This audio conference provides some basic guidelines on how to write for a global audience, enabling attendees to reduce the cost and improve the quality of translations, improve training and customer support, and protect their companies from litigation under the "failure to warn" principle.

How to Write for a Global Audience was presented by John Smart, President, SMART Communications on 2006-05-18 and is now available for download at www.fxconferences.com

Best Practices for Medical Device Design

Medical device design should not be the result of happenstance. Device development by happenstance might or might not be successful. However, there do exist within the process opportunities for improvement.

This presentation highlights brief case studies concerning the development of several novel medical devices. It will also examine the practical realities faced by the developers, and discuss their respective approaches. The presentation also looks at key factors leading to failures and successes of device design.

Best Practices for Medical Device Design was presented and recorded on 2005-03-16 and is now available for download at www.fxconferences.com

Changing Your Approach for Success in Post-Market Research

There is a growing industry awareness of post-marketing research, thanks to the many pressures surrounding this phase of drug development. The demands of new regulatory guidelines, decreased pipelines, challenges to extend life cycle management, and increases in drug and healthcare costs, have propelled pharmaceutical and biotech personnel into the world of post-marketing research. These changes have, in turn, made it necessary to understand the differences between pre-marketing and post-marketing environments.

In this audio conference, the speaker provides a fresh perspective and useful tools to help attendees strategically plan and execute post-marketing research.

Changing Your Approach for Success in Post-Market Research is presented by Maria Harrison, Vice President, Late Phase Development, of PRA International and airs Thursday, Oct. 16, 2008. For more information or to registration, please visit our site www.fxconferences.com

Partnering with the New e-Patient for Recruitment Success

The Internet has changed the way people approach their own health care, creating a new breed of engaged, empowered consumer known as the ‘e-patient’. They are taking charge of finding information about their diagnoses and treatment options, and they aren’t shy about interacting online with other patients to exchange experiences and learn more. The most active searchers, according to a groundbreaking white paper by Dr. Tom Ferguson and the e-Patients Scholars Working Group, are acute (newly diagnosed) and chronic patients – arguably, the optimal candidates for clinical trial participation.

This conference profiles the new e-patient, offers strategies for getting his/her attention, and assesses the benefits and challenges of partnering with this population to optimize clinical trial participation.

Partnering with the New e-Patient for Recruitment Success is presented by Linda Wolf & Yuriy Zhuk, of BBK Healthcare, and airs December 16th, 2008. For more details or to register, please visit our site www.fxconferences.com

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.

Takeaways include Tips for successful logistics planning in global clinical studies, Strategies for effective clinical supply shipping, and many more. Global Clinical Studies: Logistical Challenges from Supply to Assay is presented by Karen Oliver, Director Global Accounts, of World Courier, and runs Wednesday, October 8th, 2008. For more details or to register please visit our site www.fxconferences.com

Ensuring GCP-Compliant Trials with Clinical Quality Audits

In the race to start and complete clinical trials, securing investigator, CRO, and sponsor GCP compliance can be an overwhelming task. Clinical quality audits are an essential tool in ensuring that clinical research is conducted in accordance with GCP requirements. Given the pressures of executing efficient and expedited research, including audits in your overall clinical investigative plan increases the quality of research data and protects sponsor investment. Addressing compliance issues early and consistently, through corrective and preventative action, enhances data integrity and the quality of the overall clinical trial.

This audio conference provides attendees with tips for an efficient and effective clinical audit strategy, along with tools to assist in conducting GCP audits of clinical investigators, clinical research organizations and sponsors.

Ensuring GCP-Compliant Trials with Clinical Quality Audits is presented by Carol Houts, Director of Regulatory, Quality and Safety, with Pleiad on Thursday, Oct. 9, 2008. For more details or to register. please visit our site www.fxconferences.com

Setting Up and Managing a European Distribution Network

Lining up European distribution can be a daunting challenge. The European market is the largest consumer and industrial market in the world. The European Union (EU) has added 12 countries since May 2004, bringing the total population of the 27 EU countries to almost 500 million. The European medical technology market has 30% of the world market. With an aging population, this market has huge growth potential and is the recipient of almost half of all US medical technology exports.

To be successful in Europe, you need to set up distributors in each local market. After you determine which countries have the highest market potential, it is vital to conduct a thorough screening & selection process to find the best possible distribution partners in those countries. In addition to setting up distributors, you may also need to consider a European support structure to accommodate long term growth, including European warehousing, reverse logistics, and potentially European product support.

This presentation focuses on the challenges of doing business in Europe, with practical advice for handling key distribution and product support issues.

Setting Up and Managing a European Distribution Network runs Tuesday, Oct. 21, 2008 and is presented by Michael van der Woude, Partner, of EDM Services. For more information or to register, please visit our site www.fxconferences.com

Implementing GMP for Combination Products: What Applies When?

For 10 years now FDA has been progressively developing its regulation of the complex product area known as combination products, with very few formal guidance documents for industry. Combination product manufacturers are faced with the challenge of deciding how to implement a quality system that is compliant with applicable Good Manufacturing Practices and Quality System Requirements.

In this audio conference, our speaker discusses the applicable guidance and current thinking on meeting FDA expectations for combination products, sharing specific examples of accepted practices and how FDA regulations and guidance are currently being applied. The presentation also examines the recent history of combination product approvals in the US, as well as important trends and issues for the future.

Implementing GMP for Combination Products: What Applies When? is presented Thursday, Sept. 18, 2008 by Linda Alexander, CEO & Founder, of Alquest. For more information, please visit our site www.fxconferences.com

Using Mutual Recognition and Decentralized Procedure for EU Drug Registrations

Is your company preparing to market a new pharmaceutical product in Europe? Pharma companies intending to bring new products to market in the EU must follow one of three distinct processes – Centralized Procedure, Decentralized Procedure or Mutual Recognition. Previous presentations by Dr. Granzer have dealt with Centralized Procedure. This presentation focuses on the other two methods, Decentralized Procedure and Mutual Recogniton.

These procedures can be used for certain new drugs, generics and herbal medicinal products. In the case of the MRP there must be a national marketing authorization in place, whereas DCP can be used to seek approvals where none currently exist. This presentation provides an overview of DCP and MRP, including which procedure is appropriate for which products, the expected timeframe for each, and the kinds of submissions expected.

Using Mutual Recognition and Decentralized Procedure for EU Drug Registrations is presented by Dr. Ulrich Granzer, of Granzer Regulatory Consulting on 2008-10-02. You can register at our site www.fxconferences.com

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 uses real-life examples to highlight potential cultural problems, including inappropriate number and color references, and the confusing use of dates and numbers. Listeners will be able to put the conference material to immediate use in improving their technical literature.

21 Steps to Easier Globalization through Better Writing was recorded on 2005-09-27 and is now available for download at www.fxconferences.com

Introduction to ISO 13485:2003 and ISO 14969

ISO 13485:2003 has hit the street several years ago. Understanding the impact that these standards have on devices and diagnostics will help you to develop a forward-looking ISO strategy.

Drawing on her work with industry-leading device and diagnostic companies on ISO standards, Sue Spencer discusses the technical and strategic challenges being faced by those charged with maintain ISO. This audio conference walks you through the maze of updates to ISO 13485:2003 and provides insight to supporting guidance document ISO 14969.

Introduction to ISO 13485:2003 and ISO 14969 was recorded on 2003-07-16 and is now available for download at www.fxconferences.com

Industry Update: Revisions to the Medical Devices Directive

Due to the widely held view that certain aspects needed to be clarified, the EU Medical Devices Directive (MDD) is being revised. A number of proposed revisions have been under consideration for over a year now. Among the likely changes, there will be an increased demand for clinical data and post-market surveillance.

In this audio conference, Dr. Helen Colquhoun provides an update on the review progress, and describe the revisions, giving detail on those of greatest importance to device companies.

Industry Update: Revisions to the Medical Devices Directive was recorded on 2007-02-22 and is now available for download at www.fxconferences.com

CE Marking: 7 Steps to Getting Started in Europe

With a population approaching a half-billion people, the EU represents arguably the most lucrative market today. However, before any medical device company can sell in Europe, it must first obtain the CE Mark. The process of obtaining approval to affix the CE Mark to your product differs significantly from the US FDA system.

This presentation covers the basic steps companies need to follow in obtaining the CE Mark, including a discussion about ISO 13485:2003 and how it differs from FDA Good Manufacturing Practices (GMP), issues related to language translation and labeling, creation of a Technical File and how this differs from the FDA 510(k) application, dealing with Notified Bodies, selecting an Authorized Representative and an overview of the costs and timelines involved in achieving certification.

CE Marking: 7 Steps to Getting Started in Europe was recorded on 2007-04-03 and is now available for download at www.fxconferences.com

The EU Perspective on Risk Management

Does your company market its products in Europe, or are you planning to enter the EU market? Have you taken the requisite steps to address risk management? Risk management must be an integral part of global product development and commercialization.

In this audio conference Dr. Blesse will provide a detailed overview of EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use and its legislative background. He will also provide examples of why this new regulation should not be perceived as another threat to industry, and how it offers strategic options.

The EU Perspective on Risk Management was recorded on 2007-07-19 and will replay on September 16th, 2008 at 11:30 Eastern time. For more information on this audio conference, please visit our site www.fxconferences.com

Adaptive Trial Design: Streamlining the Clinical Supply Process

Adaptive trial design has generated intense press coverage and industry excitement as it represents a significant change from traditional study design. This type of trial uses real-time patient information to make critical trial decisions as the study is ongoing. While this design offers the pharmaceutical industry the opportunity to speed up the drug approval process, mid-trial changes to treatment arms and patient populations has a significant impact on drug supply management.

From a clinical supply perspective, the inventory implications of an adaptive trial design must be carefully analyzed. Cost vs. benefit analysis is paramount as well as identifying inventory strategies for all possible scenarios well before first patient in (FPI).

Adaptive Trial Design: Streamlining the Clinical Supply Process is presented by Geert Langendries, Covance IVRS Project Management Group. This audio conference was recorded on 2007-12-05 and is now available for download at www.fxconferences.com

Achieving Benefits Plan Buy-In from Spanish-Speaking Employees

Even when employee benefits material is well translated and presented in Spanish, many companies find that Spanish speakers are still reluctant to participate and instead opt out of very valuable opportunities for health coverage, retirement plans, etc. This tendency is frustrating to HR professionals, brokers and benefits providers who have invested putting together a Spanish presentation.

This discussion addresses misconceptions Spanish speakers commonly hold about insurance and finance in this country and present practical and cost-effective strategies for conducting effective enrollment meetings and maximizing participation among Spanish speakers in benefit plans.

Achieving Benefits Plan Buy-In from Spanish-Speaking Employees is presented by Melissa Burkhardt, President, of Futuro Sólido. This audio conference was recorded on 2008-05-28 and is now available for download at www.fxconferences.com

A Guide to Efficient Translation Management

Managing translation projects efficiently is all about choosing the right tool for the job. Translators use translation memory tools. Localizers use localization tools. What specialized tools exist for managing translation projects? When is automation and workflow management the answer?

This presentation, Angelika Zerfass provides an overview of the latest tools and technology available to the translation project manager, from small helpers to full-fledged workflow management tools. Learn how and when these tools can help them work faster and more efficiently, cutting costs and improving translation quality.

A Guide to Efficient Translation Management was previously recorded on 2005-12-15 and is now available for download at www.fxconferences.com