Optimizing RFPs: Simple Steps to Better Responses

Is your organization in the process of putting together an RFP? Have the responses to your past RFPs fallen short of expectations? CRO teams respond to hundreds of RFPs each year. It is clear which sponsors have invested time to build internal consensus and to develop a document that clearly articulates their needs and project goals. The result is a guide that assists the CRO in assembling a higher quality response that directly addresses the needs of the sponsor.

This audio conference is the first in a three-part series designed to share best practices for optimal outsourcing.

Optimizing RFPs: Simple Steps to Better Responses was presented by Beth Mandel, Director of Strategic Solutions, with Covance. It aired on 2006-12-06 and is available to download at our site www.fxconferences.com

Optimizing Site Performance: Risk Planning vs. Remediation

What causes the widespread variance in site performance in clinical trials, declining data quality and missed timelines? What can drug development service providers and sponsors proactively do to optimize site performance?

A large percentage of clinical trial budgets is allocated to fixing problems after they occur, rather than towards proactive activities which could help predict and prevent errors. This audio conference discusses protocol violations as a consequence of stressed environmental conditions at investigative sites. The presentation looks at why these violations are so pervasive, and the inability of conventional measures to adequately detect and address them. The speaker then discusses how protocol violations are preventable within a risk management paradigm, and outlines a process for addressing them using Failure Mode and Effect Analysis (FMEA).

Optimizing Site Performance: Risk Planning vs. Remediation is being presented by Pam Atwell, Director, Operational Strategies and Planning, of Covance Clinical Development Services and airs Thursday, Dec. 4, 2008. For more details or to register, please visit our site www.fxconferences.com

Real-Time Adverse Event Analysis Using IVR

This audio conference provides an overview of practical considerations regarding the challenges of obtaining adverse event (AE) data, particularly in real-time. A fundamental challenge in the adverse event reporting arena is a lack of, or incorrect, information on patient exposure data and AE incident reporting.

This presentation suggests a strategy for utilizing your IVRS data stream to enhance understanding of patient exposure and enable real-time, proactive decision-making on the progress of the clinical trial. Data already captured in your IVR can provide significant insight into clinical trial performance and improve your understanding of adverse events in your trial. The strategy presented in this audio conference enables you to immediately improve your understanding of AEs without any additional capital expenditure.

Real-Time Adverse Event Analysis Using IVR was presented by Hal Ward, Executive Director Global Head of Drug Safety of Covance on 2007-08-15 and is available for download at www.fxconferences.com

Building Bridges: A Practical Guide to Leading Global Pharma and Biotech Teams

Today, whether the task is to develop a new drug, launch a product or work on a strategic project, much of our work is done through global teams. These teams are usually cross-functional, cross-geographic, cross-cultural and span multiple time zones. They may also cross company lines through strategic alliances. They face the challenges of having to work "virtually", with a balance of high tech and high touch.

Based on Lynda's experience working with over 1,000 global teams in over 25 countries, She will provide the participants with "best practice" learnings and tools relevant to developing and leading world class global teams.

Building Bridges: A Practical Guide to Leading Global Pharma and Biotech Teams is presented by Lynda McDermott, President, of EquiPro International and airs Wednesday, November 19, 2008. For more details or to register please visit our site www.fxconferences.com

Marketing Your Medical Device in Canada

Despite the downturn in the global economy, Canada remains an important and growing market for medical device manufacturers. However, differences between Health Canada and FDA regulations and device classifications have resulted in some confusion over the best approach to take when entering the Canadian marketplace.

This presentation covers the basic steps you will need to take to obtain the appropriate licences for your company and/or medical device (e.g. Medical Device Licence or Medical Device Establishment Licence). The presentation will include a discussion about the Canadian Medical Device Regulations, the role of ISO 13485:2003 CMDCAS, and issues related to language translation.

Marketing Your Medical Device in Canada is presented by Daryl Wisdahl, Director, of Wisdahl Consulting Group and airs on Thursday, Nov. 20, 2008. For more details or to register for this conference, please visit our site www.fxconferences.com

Managing Global Market Research for Consistency and Insight

Medical companies are increasingly sponsoring global research projects – but is this research effective? How can cultural and linguistic differences be managed to ensure the integrity of the result? Are differences between cultures just skin deep or do they extend to personality? How can we create research metrics that will have consistent meaning around the world? In this Webinar we will provide understanding of these issues and tools for managing global research projects.

Managing Global Market Research for Consistency and Insight is presented by Peter Simpson, President, of Segmedica and airs Wednesday, November 12, 2008. For more details or to register, please visit our site www.fxconferences.com

Brand Development and Enforcement Strategies

In uncertain economic times, it is especially important that companies develop strong, identifiable, unique and protectable trademarks and brands, and enforce against encroachment. In this presentation the speaker covers the entire range of brand development, from brand selection to trademark searching and counseling, international brand registration and brand expansion.

The presentation also covers enforcement strategies for brand owners, with discussion on improper importation of counterfeit or infringing merchandise and the steps that can be taken at the border to prevent it. Other enforcement targets to be discussed include: counterfeiters operating at the local level; distributors, exporters and manufacturers operating up the commercial line; and infringers who do not directly copy a brand, but use marks likely to cause confusion. The presentation also covers brand development and enforcement over the Internet.

Brand Development and Enforcement Strategies is presented by Anthony F. Lo Cicero, Intellectual Property Attorney of Amster Rothstein & Ebenstein LLP and airs Tuesday, Nov. 25, 2008. For more details or to register, please visit our site www.fxconferences.com

The New Europe: Overview for Device Manufacturers

The new 25-member European Union has its roots in World War II and the Cold War. It is a collection of 25 very different markets in terms of size and development.

Although European law and policy attempts to create a huge single market of more than 450 million people, in reality much of that market is still highly segmented. The legacy of Communism still weighs heavy in most of the new members that joined in 2004, affecting the ability of Western medical device manufacturers to do business and deal with regulatory issues in these countries.

The New Europe: Overview for Device Manufacturers was presented by Mika Reinikainen, VP, of Quintiles Consulting on 2004-09-16. For more information, or to download this product, please visit our site www.fxconferences.com

The Revised MDD: Practical Implications for Devices

The Medical Devices Directive (MDD), which sets down the rules and regulations for marketing medical devices in the EU, is in the final stages of a lengthy revision process. The general consensus is that the directive has been working well to date, but that certain aspects need to be tightened up. To this end, there are no radically new requirements, but there will be an increased demand for clinical data and post-market surveillance. What will this mean for medical device manufacturers?

In this audio conference, Dr. Helen Colquhoun summarizes the revisions and describe in detail those with the greatest potential impact. She discusses the implications of these revisions for medical device manufacturers, illustrating points with practical examples and using different scenarios to explain how best to approach the issues raised.

The Revised MDD: Practical Implications for Devices was recorded on 2006-02-23 and is available for download at www.fxconferences.com

Writing & Designing for an International Audience

Are you responsible for generating content for global markets? Are you worried that the meaning in your message might be lost or altered because of cultural differences? Culture, translation, writing, and design interweave in curious ways when preparing content for an international audience. These elements require important skills for creating global content, especially given the increasing pressure to standardize and comply with various international and internal standards.

This presentation highlights some key contradictions inherent in writing and designing for a multicultural and multilingual audience and discuss proven strategies for their resolution.

Writing & Designing for an International Audience was recorded on 2007-12-11 and it running again Oct 29th, 2008 by popular demand. For more details or to register, please visit our site www.fxconferences.com

What You Need to Know to Get Started in XML

So you've heard about XML, and now you are trying to decide whether or not to start using it at your company. Or, perhaps you are just curious about what XML is and whether it lives up to the hype. Maybe your boss has made noises about converting to XML, and you need a crash course on the subject.

This presentation is aimed at giving those with little or no knowledge of XML an overview of what exactly XML is, and what it is -- and is not -- good for.

What You Need to Know to Get Started in XML was presented by Kit Brown, Principal, of Comgenesis LLC, and is now available for download. For more details or to download this audio conference, please visit our site www.fxconferences.com

Workflow & Version Control: Taming the Documentation Tiger

Take a look at your email inbox. Chances are someone has sent you a working document as an attachment because they are finished with it and now it's your turn. It's also a good bet bet that the folder containing your current project has file names like Operation-v1.doc and Operation-v2.doc. Every document goes through some kind of workflow and version control. Many companies do this using email attachments and file naming conventions. A true document management environment will include workflow and version control, but these systems are usually too costly for the small documentation shop.

In this audio conference, Brian Travis discusses the shortcomings of current document management practices, and ways to streamline and improve the process.

Workflow & Version Control: Taming the Documentation Tiger was presented on 2007-05-10 and is available for download. For more details or to download this conference, please visit our site www.fxconferences.com

Writing for Translation: The 1% Solution

Why should you learn how to use Controlled English? Increasingly, documentation must be designed for two distinct but related types of audiences—-those reading the text in translation, and those for whom English is a second language.

While many businesses still have their documentation translated, English is quickly becoming the standard of our global village. But English is a complex language to read, write, and understand. Using Controlled English makes documents easier for non-native English speakers to understand, and the more consistent, less ambiguous language also makes for less expensive translations. It is critical that technical documentation and training manuals clearly convey meaning in fields with complex products and liability issues.

This audio conference explains how 1% of the English language is sufficient to communicate with customers in 181 countries. It will also cover the steps to implement Controlled English and its pitfalls and benefits for the translation of technical documentation.

Writing for Translation: The 1% Solution was presented by John Smart, SMART Communications, on 2005-06-21 and is now available for download. For more details or to purchase a recording, please visit our site 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 is being re-broadcast on Tuesday, October 21st, and is presented by Nancy Hoft, of Nancy Hoft Consulting. For more details or to register, please visit our site at www.fxconferences.com

Registering Device Trials on ClinicalTrials.gov

It has been a full year since Title VIII of the Food and Drug Administration Amendments Act of 2007 expanded the scope of information that must be registered in ClinicalTrials.gov and mandated the inclusion of medical device trials. Additional new requirements also included increasing the amount of trial information, requiring results, and setting penalties for noncompliance.

One year later, the medical device community still has a lot of questions about its requirements and responsibilities for compliance with Title VIII, and the FDA is still working on providing the answers and guidance. This audio conference looks at the latest information surrounding registration of medical device trials and what you need to do to be in compliance.

Registering Device Trials on ClinicalTrials.gov is presented by Amy Wise, Manager of Clinical Research, of PharmaNet and airs Thursday, Nov. 13, 2008. For more details or to register, please visit our site www.fxconferences.com

Search Marketing: What Healthcare Marketers Need to Know

With over 80% of consumers and business people starting their quests for information on the Web via the major search engines, search marketing has become a critical component of a successful marketing strategy. While an expertly executed search marketing campaign is a cost-effective and easily measured investment, there are many misconceptions about what search marketing is, how it works, and which practices (known as “black hat”) can cause your brand irreparable harm

Veronica “Niki” Fielding of Digital Brand Expressions will cover the basics of search marketing and what it means for the life sciences industry. Attendees will get an executive review of the four key components used to generate visibility on Google and the other major search engines. These are: - Search engine optimization - Search engine advertising - Search engine reputation management - Social media management.

Search Marketing: What Healthcare and Pharma Marketers Need to Know is presented by Niki Fielding, President, of Digital Brand Expressions and airs Wednesday, October 29th, 2008. For more details or to register, please visit our site 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 is presented by Rob Wagner, Executive Producer, of FXConferences.com and airs Wednesday, October 15th. For more details or to register please visit our site www.fxconferences.com

Integrating Data Streams for More Efficient Trials

Are you interested in faster clinical trials and improved data quality? For most sponsors and CROs, the answer would be an emphatic "Yes!". Managing a clinical trial effectively requires collaboration across multiple trial requirements. This presentation illustrates how IVR/IWR and lab data can be integrated and reconciled in real-time, improving the speed and overall quality of trial results. The presentation uses real-life case studies to demonstrate the trial efficiencies and benefits gained when combining labs and IVR/IWR data in real-time. The speaker also discusses technical considerations to enable an integrated data stream.

Integrating Data Streams for More Efficient Trials is presented by Vicky Czarnik, Senior Technical Strategy Manager, of Covance IVRS and airs Thursday, Nov. 6, 2008. For more details or to register, please visit our site www.fxconferences.com