Microcycle Testing: Better eLearning QA in One-Fourth the Time

Conducting quality assurance testing is an important part of developing online courses. A new methodology called "microcycle testing," combined with online technologies, can help you achieve dramatic improvements in productivity during this important, but often overlooked, course development phase.

This audio conference explores how to dramatically compress the time it takes to conduct e-learning quality assurance testing, while at the same time, getting better results.

Microcycle Testing: Better eLearning QA in One-Fourth the Time is being presented by Garin Hess, CEO, with Rapid Intake and airs on Thursday, August 6, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Best Practices for Software Internationalization - Webinar

There's more to globalizing software than just translating the interface. But underestimating or enduring development surprises mean expensive halts and delays to global release plans. This webinar focuses on helping managers, localization professionals and engineers in understanding and planning for software engineering for the world. Learn the basics of engineering Locale support requirements to an overview of Unicode and how to implement it to support complex character sets like Chinese and Japanese.

You'll learn a Return on Investment approach to optimizing globalized software development for world-market requirements.

Best Practices for Software Internationalization - Webinar was presented by Adam Asnes, Founder, of Lingoport and aired on 2008-06-04. For more details or to download this webinar, please visit our site at www.fxconferences.com

Device Advertising and the First Amendment: Your Rights

Within recent years the effect of the First Amendment on FDA-controlled speech has drastically changed. Courts have stated standards for what FDA can do in controlling speech in advertisements. The difficult question is predicting the practical impact of these court decisions. FDA still has enormous authority to control speech and labeling. In this presentation we discuss the balance between FDA control of indications versus court restrictions on FDA control of speech.

Device Advertising and the First Amendment: Your Rights was presented by Robert J. Klepinski, with Fredrikson & Byron, and aired on 2007-08-23. For more details or to download this audio conference, please visit our site at 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 was presented by Vicky Czarnik, Senior Technical Strategy Manager, with Covance IVRS and aired on 2008-11-06. For more details or to download this event, please visit our site at www.fxconferences.com

Adapting Patient Recruitment to Global Cultures

Patient recruitment is often mistakenly equated with advertising, when in actuality it is a considered collection of practices in response to a problem or a set of risks. The discipline is still new to many world regions outside of North America, presenting challenges both in acceptance and in practice among study professionals globally.

This audio conference focuses on overcoming those challenges in order to successfully conduct patient recruitment globally using the most appropriate, effective, and ethically acceptable tactics. In addition, it will also illustrate methods for culturally adapting patient recruitment practices - particularly creating patient communications (including advertising) - to resonate with target populations in each country.

Adapting Patient Recruitment to Global Cultures was presented by Rob Laurens & Matt Stumm, Leader, Creative Services & Senior Art Director, with BBK Healthcare and aired on 2008-01-23. For more details, or to download this conference, please visit our site at www.fxconferences.com

The "Why" and "How" of eCTD Conversions

Effective January 1, 2008, all electronic submissions submitted to FDA in the United States must be in eCTD format. This deadline is forcing organizations within the pharmaceutical industry to evaluate the transition from submitting paper documents to submitting electronic documents to global regulatory agencies.

The transition from paper documents to electronic documents encompasses many areas within an organization and integrates technology with regulatory requirements for submission and regulatory document preparation. This presentation highlights the things sponsors, CROs, testing facilities, and medical writers need to know about the impact of the eCTD on the industry and on their businesses.

The "Why" and "How" of eCTD Conversions was presented by Gina Ross, Director, Managing Consultant Regulatory Publishing Services, with Beckloff Associates a Cardinal Health Company and aired on 2008-01-31. For more details or to download this conference, please visit our site at www.fxconferences.com

Effective Translation Process for Japan Regulatory Submissions

Many companies that do business in Japan rely on their Japanese affiliates to handle the creation of regulatory documentation, due to language and cultural considerations and the complexities of Japanese regulations. A problem with this approach is that often the US-based companies then don't know exactly what was submitted to the government, which can have serious implications.

The Japan submission dossier preparation and translation process requires a unique approach. Cooperation among submission authors, the translators and the Japanese affiliate is essential to make it work. When it does, a company can be assured that its English and Japanese submissions stay consistent, and there are no questions about what is submitted. It has the side benefit of building cross-cultural teams, where both parties focus on their core competencies.

This audio conference discusses how regulatory documentation gets translated, looks at specific approaches companies take for their Japan dossier creation, identifies the problems with the usual approaches, and then presents best practices for creating consistent, accurate and timely submissions.

Effective Translation Process for Japan Regulatory Submissions is being presented by Jason Heaton, with ForeignExchange Translations, and airs on Wednesday, July 29, 2009. For more details, or to register for this audio conference please visit our site at www.fxconferences.com

To learn more about Japanese Translations, please visit ForeignExchange Translations website at www.fxtrans.com

Customer Support In the Era of Social Media

As William Gibson has said: "The future is already here, it's just not evenly distributed." Are you leveraging the new capabilities technology is bringing? Companies need to create richer customer experiences, decrease costs, and speed innovation, and it's time to get on board with social media. Companies are finding gains in engaging social media not only internally, but externally as well. So how do you take advantage?

Focusing on customer support, this audio conference covers the principles, case studies and opportunities to be found. Leverage the power of ‘we’ for your organization.

Customer Support In the Era of Social Media is being presented by Dr. Clark Quinn, Founder, of Quinnovation and airs on Thursday, July 23, 2009. For more details or to register, please visit our site at www.fxconferences.com

The Influence of Reimbursement on Medical Technology: Completing Your Due Diligence

Reimbursement continues to play a major role in product adoption and commercialization. Whether evaluating coding solutions, payments, product pricing, coverage or compliance, having a good understanding of reimbursement has now become a necessity.

In this audio conference, speaker Charles Schneider, a leading expert in the field, discusses key reimbursement value drivers likely to play a critical role in the valuation of your technology. He describes core elements of his Reimbursement Due Diligence program, provides real-world examples and offers valuable practical experience to conference participants.

The Influence of Reimbursement on Medical Technology: Completing Your Due Diligence is being presented by Charles Schneider, Vice President, Reimbursement, with Musculoskeletal Clinical Regulatory Advisors, LLC and airs on Thursday, July 30, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

EN 1394:2007 - A New Dawn for Human Tissue in Europe

The previous 18 months has seen a huge leap forward in the regulation of human tissue products, through the publication of the Advanced Therapy Medicinal Product Regulations (ATMP). In parallel, the European Commission has expanded the directive 2004/23/EC into two technical directives, which detail requirements for ensuring public health when using human tissue from donation to distribution.

No longer will Europe be faced with a fragmented regulatory approach to human tissue products, it will have a unified system based on the free movement of human tissue across European borders.

EN 1394:2007 - A New Dawn for Human Tissue in Europe was presented by Phil Brown, Director of Regulatory Affairs, with Wright Medical and aired on 2008-07-02. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Improving Patient Recruitment Through Better CRA Training

The clinical trial industry's single greatest challenge continues to be timely patient recruitment and retention. One major obstacle is trial drift -- the gradual reduction in study knowledge as a clinical trial ages, resulting largely from inadequate staff training about the protocol and good clinical practices (GCP). The problem is further compounded by high turnover among site staff, with industry data suggesting an average CRA tenure of only 18 months to 2 years -- shorter than many studies.

At the same time, regulatory agencies are increasingly demanding proof that global clinical study staff are appropriately trained and assessed in a standardized manner and, depending on the therapeutic area, that ongoing "recalibrations" in staff education and training are performed during the term of a study in order to minimize trial drift. What's more, there is a growing movement in the industry to require site managers and CRAs to earn GCP certification, further underscoring why effective training is a business imperative.

This presentation focuses on how a well-planned, consistent training program can help sponsors and CROs meet or even exceed enrollment deadlines, and thereby speed drug development.

Improving Patient Recruitment Through Better CRA Training was presented by Linda Wolf, with BBK Worldwide Alliance and aired on 2008-05-22. For more details, or to download this conference please visit our site at www.fxconferences.com

Developing Software for Global Markets

Software application development is rarely designed, built and tested with wide-ranging locale requirements in mind. As a result, there is often an expensive surprise waiting when it comes time to translate or simply support user data like complex character sets, sorting, and variable formatting. Cultural differences in expressing things like dates, numerical units, postal addresses, phone numbers, and currencies represent a whole new level of difficulty. However, when internationalization is performed effectively, software can be quickly leveraged for any worldwide market opportunity.

This presentation provides an overview of how software internationalization issues can ripple through an application, but more importantly how they can be systematically diagnosed and efficiently addressed.

Developing Software for Global Markets was presented by Adam Asnes, President, of LingoPort and aired on 2006-02-16. For more details or to download this event, please visit our site at www.fxconferences.com

Using SPL for Electronic Drug Establishment Registration & Drug Listing Submissions

As of June 1, 2009, the FDA requires establishment registration and drug-listing data in a fully electronic format known as structured product labeling (SPL). This guidance applies to all prescription pharmaceutical, biological, OTC, and veterinary medicine producers and distributors. The implementation of SPL will eliminate the creation of paper forms, which duplicated information already contained in product labeling.

As industry continues to provide more electronic labeling information, the FDA is able to decrease the amount of proofreading of paper submissions, thereby decreasing the chances of human error. This audio conference explores how SPL allows for electronic technology to capture this information, decreasing the potential for human error in transcription and increasing efficiencies.

Using SPL for Electronic Drug Establishment Registration & Drug Listing Submissions is being presented by Craig Trautman, CEO, with Intagras and airs on Tuesday, July 14, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

Medicare Coverage of Clinical Trials: Opportunities & Obstacles

Medicare can help companies defray the cost of drug and device clinical trials by paying for some services delivered to program beneficiaries enrolled in “qualified” trials. In considering whether to seek Medicare coverage, trial sponsors and clinical sites need to be aware of the administrative obstacles introduced by the need to comply with fraud and abuse regulations and the Secondary Payer Statute.

This conference provides a detailed review of Medicare’s clinical trial coverage policies, the different rules that apply to device (IDE) and pharmaceutical (IND) trials, and the compliance issues that complicate the decision to seek Medicare funding.

Medicare Coverage of Clinical Trials: Opportunities & Obstacles is being presented by Dr. Edward Berger, Principal, with Larchmont Strategic Advisors and airs on Tuesday, July 21, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com

Medical Device Vigilance: An Input to Risk Management

Risk management is the process by which medical device manufacturers ensure that their devices are used with the minimum of risk. The risk management process involves assessing all theoretical, potential and actual risks for a product (the inputs), assessing the impact of those risks on the user of the device, and putting in place strategies to mitigate those risks (the outputs). Early in the device development process, most of the risks are theoretical. However, as the device moves into clinical use, safety data are generated and real risks are identified or confirmed.

This audio conference presents information about how vigilance (the collection and appraisal of human safety information), supplemented by non-clinical and bench data, feeds into the risk management process, and how the outputs are managed. This sounds like a fairly simple process, but interpreting vigilance data is not always easy. There may be internal corporate resistance to ideal modes of risk mitigation, and it is difficult to deal with risks that arise from misuse of the device. All of these issues are dealt with and illustrated by case studies presented in the audio conference.

Medical Device Vigilance: An Input to Risk Management is being presented by Helen Colquhoun, MD, CEO, with Pleiad Devices and airs on Thursday, July 9, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Effective Licensing in the Wake of MedImmune v. Genentech

The licensing of life science technologies, especially oncology-related technologies, is becoming an essential part of doing business. With MedImmune v. Genentech, the United States Supreme Court transformed the relationship between patent licensors and licensees. Historically, licensees were prevented from challenging patents on invalidity grounds. Now, a licensee may challenge a patent's validity while paying royalties to the licensor.

Although framed as a procedural question of standing to bring suit, the application of this Supreme Court case has the potential to shift the decision making of licensors and licensees and to significantly change the volume and cost of patent licensing activities. In this audio conference Dr. Samardija explores the Supreme Court decision and the various decisions that have followed, and provides attendees with 10 drafting tips to decrease the risks associated with a licensee challenging the validity of a patent.

Effective Licensing in the Wake of MedImmune v. Genentech was presented by Michael R. Samardzija, PhD, with Bracewell & Giuliani and aired on 2009-01-29. For more details or to download this conference, please visit our site at www.fxconferences.com

21 CFR Part 11: Gap Analysis, Remediation & Adding Value to Validation

In 1991 the pharmaceutical industry met with FDA to determine how best to accommodate paperless record systems under CGMP regulations. The final result, published in 1997, was 21 Code of Federal Regulations Part 11. It provides industry with quantitative information for electronic records and signatures that can be used to add value to the validation of automated systems. Part 11 regulations can be used to accomplish three tasks: create new requirement specifications that comply with Part 11 regulations, assess existing automated systems for Part 11 compliance, and remediate Part 11 compliance gaps in existing automated systems.

In this audio conference, attendees learn how they can quickly and easily assess and remediate their current systems for Part 11 compliance, and how to add value by incorporating Part 11 into the validation effort.

21 CFR Part 11: Gap Analysis, Remediation & Adding Value to Validation is being presented by Jeffrey Gassman, President & Founder, of Validation Plus, Inc. and airs on Thursday, July 16, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

Oncology Trials in 2009: Challenges & Innovative Approaches

One of the greatest risks for oncology trials today is the delay in clinical development timelines. The main reason for the timeline delay is patient recruitment. Due to the increase in the number of ongoing clinical trials in recent years, and subsequently decreased enrollment in the developed countries, innovative approaches are necessary to mitigate the risk of delay.

To meet clinical development timelines, proactive planning and comprehensive data analysis are necessary to mitigate the risk. Detailed planning and appropriate site and country selection are the most critical factors in meeting target patient accrual goals. This audio conference provides practical guidelines and innovative ideas which are useful when conducting oncology trials in the current environment.

Oncology Trials in 2009: Challenges & Innovative Approaches is being presented by Dr. Ute Berger, Vice President & Head of Medical Affairs - Europe, Africa & Asia-Pacific, with PRA International and airs on Tuesday, July 28, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Labeling for Diagnostic Devices: Best Practices

Since Dec. 7, 2003 in-vitro diagnostic (IVD) products must feature the CE mark to be sold in the European Union. With an ever-growing list of languages to be supported, IVD industry faces a dilemma: How can companies provide the required information in multiple languages, while making the information readable on a variety of sizes of labels?

The use of internationally recognized symbols as a substitute for text has been actively promoted to provide users with a uniform method of obtaining product information. Yet many diagnostics companies are struggling with the issues that surround multilingual label design and international symbology.

Labeling for Diagnostic Devices: Best Practices was presented by Andres Heuberger, President, with ForeignExchange Translations. For more details or to download this event, please visit our site at 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, with Covance and aired on 2007-08-15. For more details, or to download this conference, please visit our site at www.fxconferences.com

Conducting Exploratory Trials in Scandinavia

Debating where to take your clinical 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 being caucasian. Governments and populations both display a positive attitude toward clinical research, with high compliance rates by trial participants. All citizens have free and equal access to healthcare, preventing sampling bias due to differences in social status. Health care facilities in the region have first-rate infrastructures and access to state-of-the-art medical equipment. In comparison to other countries, trial costs can also be cut in half..

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 was presented by Dr. Claes Strom, Partner and COO, with aCROnordic and aired on 2008-10-30. For more information or to purchase a download of this conference, please visit our site at www.fxconferences.com

Website Access: Ensuring Compliance with Section 508 and the ADA

People with disabilities are one of the largest and fastest growing minority groups, with over $220 billion in discretionary income in the US alone. But beyond the business case, access to electronic and information technology by persons with disabilities is protected by law, including Section 508 of the U.S. Rehabilitation Act. Section 508 requires that electronic and information technology developed or purchased by the federal government is accessible by people with disabilities, and government procurement officers are strictly prohibited from doing business with any company that is not Section 508 compliant.

Currently, there are major changes underway in accessibility legislation that all companies must be aware of and prepared to address. Section 508 is under revision, there have been recent amendments to the Americans with Disabilities Act, and the UN is expected to soon ratify the Convention on the Rights of Persons with Disabilities, which includes IT accessibility mandates. This audio conference highlights the changes that will impact your company, and provides important information on compliance.

Website Access: Ensuring Compliance with Section 508 and the ADA is being presented by Debra Ruh, Founder & CEO, with TecAccess and airs on Wednesday, July 8, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com