Best Practices for Building Global eLearning Programs

e-learning: One day you love it, the next you hate it. Where would you be without it, yet you curse it.

In order to reach and teach an increasingly diverse employee population, companies are adapting their e-learning programs. Designing, building, and deploying e-learning programs is hard enough for one culture - it becomes much harder when the audience doesn't all speak English or isn't all located in one country.

In this audio conference, we present how to apply good program design principles. Not only will you be able to maximize your e-learning investment, but by following best practices in conceptualizing and building your programs, you guarantee efficient training for today’s diverse employee population.

Best Practices for Building Global eLearning Programs is previously recorded and was presented by Eoghan O'Maolain, Director of eLearning Development, with Rendition Digital. For more details on 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

Indications: The Next Battleground in FDA Advertising Enforcement

Recent Supreme Court decisions have provided new protection to commercial speech, challenging the manner in which FDA regulates industry. In response, FDA takes great care to not mention advertising and has shifted its enforcement focus to indications.

The Food, Drug, and Cosmetic Act (FDCA) does not give FDA broad control over advertising, yet it does give FDA explicit control over the approval/clearance process and the resulting indications. FDA is tightening up on statements in ads by closely interpreting indications. This makes it even more critical to plan and write accurate PMA and 510(k) scopes to prevent FDA enforcement.

This audio conference discusses the best way to work within the new reality of FDA advertising enforcement.

Indications: The Next Battleground in FDA Advertising Enforcement was presented by Robert J. Klepinski, Fredrikson & Byron and aired on 2007-01-18. For more details, or to register please visit our site at 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 was presented by Nancy Hoft, with Nancy Hoft Consulting, and is previously recorded. For more information, or to download this conference please visit our site at www.fxconferences.com

EU Device Labeling: Issues and Requirements

For many companies, achieving ISO 13485 certification, applying the CE mark and finally exporting to Europe is a great victory. However, many companies forget that the EU is made up of 27 separate countries (Bulgaria and Romania being the newest members) and underestimate the complexity of dealing with language requirements and the use of symbols for each country. Will Germany allow English labeling for devices used only by a professional? Does Belgium require Dutch, French or German -- or all three?

In this presentation, we discuss these issues and also cover the use of symbols in packaging, instructions for use (IFU) and device labels.

EU Device Labeling: Issues and Requirements was presented by Dr. Jaap Laufer, .P. Public & Regulatory Affairs, with Emergo Group Inc. and aired on 2007-09-06. For more details, or to download this audio conference please visit our site at www.fxconferences.com

505(b)(2) Submissions: Eligibility, Strategies & Preparation

There are a variety of scenarios under which information that is not generated by an applicant could be useful to support a submission for drug approval under Section 505(b)(2) of the FDC Act. In developing a strategy, one must consider the quickest route to approval, the best labeling and the broadest use supported by the data. Depending on the products to be submitted for approval (changes to an approved drug, a marketed unapproved drug, or a new chemical entity with previously published information), the scope and the extent of the available information will have an impact on the bridging (nonclinical, clinical) studies to be performed and submitted.

In this conference, the speaker describes the drugs that can and cannot be submitted under Section 505(b)(2), strategies for different products, the role of patents and marketing exclusivity, and types of bridging studies. He also shares insights into search strategies to obtain and select appropriate published literature references, preparation of summaries, use of previous agency findings of safety and effectiveness, and the potential pitfalls in using published literature findings and agency findings.

505(b)(2) Submissions: Eligibility, Strategies & Preparation is being presented by Dr. Howard Hubbell, President, of Hubbell Consulting, LLC and airs on Tuesday, October 27, 2009. For more details, or to register please visit our site at www.fxconferences.com

Drug Establishment Registrations, Drug Listings and the FDA Electronic Submissions Gateway

The new FDA requirements cover both the format (SPL Release 4 files) and the submission modality (via the FDA Electronic Submissions Gateway – ESG) for electronic drug establishment registrations and drug listings, imposing a double electronic challenge upon all firms who must register and list. As of June 1, 2009, paper forms FDA 2656 and FDA 2657 are no longer acceptable. Many firms have been surprised by the challenge and complexity of electronic drug establishment registrations and drug listings. Headaches and frustrations with the tools, the process and the content are increasing as the end of 2009 approaches.

To meet an end-of-year deadline, firms must have a solution for ESG connectivity in place, as well as a means to prepare and validate their SPL R4 files. Most importantly, they must have a solid grasp of the content necessary to produce compliant drug registrations and listings. In this session, the speaker provides practical advice regarding SPL-R4 file content, submissions and validation.

Drug Establishment Registrations, Drug Listings and the FDA Electronic Submissions Gateway is being presented by Dr. Greg Onyszchuk, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates, Inc. and airs on Thursday, October 22, 2009. For more information about this audio conference, or to register please visit our site at www.fxconferences.com

Managing the Shift to Electronic Submissions

The electronic common technical document (eCTD) presents many challenges to a Sponsor organization, but may also yield significant benefits through increased efficiencies and improved reviews by regulatory agencies. Sponsor organizations that have decided to adopt the eCTD now have the challenging task of managing and implementing the paradigm shift from paper to electronic regulatory submissions.

The first of many challenges is to evaluate and modify existing document preparation processes to accommodate differences between paper and eCTD. Once these changes have been identified, the next step is to convince upper management the changes are necessary to move the organization forward to preparing electronic submissions. Another challenge is working with vendors to receive electronically-compliant documents. The eCTD requires sponsor organizations to rethink their business and those with whom they do business.

Managing the Shift to Electronic Submissions was presented by Gina Ross, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates a Cardinal Health and aired on 2008-04-17. For more information, or to download this audio conference please visit our site at www.fxconferences.com

Using SharePoint in an FDA-Regulated Environment

Pharmaceutical and biotech companies have been facing increasing demands to improve their organizational effectiveness through information sharing and collaboration. At the same time, there is an important need for a controlled document management system that is compliant with FDA regulations. In this conference, our speakers look at the steps necessary to design and implement Microsoft SharePoint within the confines of a regulated environment. The presentation discusses various solutions, with a special focus on regulatory needs at various stages of the drug development lifecyle.

Speakers John Postle and Cary Cyr explain how to achieve ongoing compliance through the use of SharePoint as a validated application in a qualified environment. They also present a real-life case study from Tufts Medical Center, which illustrates how research laboratories are using SharePoint for collaboration.

Using SharePoint in an FDA-Regulated Environment is being presented by John Postle & Cary Cyr, Vice President, Life Science Enterprise & Senior SharePoint Specialist, with Court Square Group and airs on Thursday, October 22, 2009. For more details or to register, please visit our site at www.fxconferences.com

Clinical Data Requirements under the New MDD & AIMDD

The Medical Device Directive (MDD 93/42/EEC) and the Active Implantable Medical Device Directive (AIMDD 90/385/EEC) have been significantly changed by the European Amended Device Directive (2007/47/EC), and many of these changes are expected to become active in March 2010. Clinical evaluations must follow a well-defined and methodologically sound procedure. In this audio conference, the speaker describes these expectations for clinical evaluations and provides suggested templates for clinical evaluation reports (literature reviews and clinical studies).

This session provides valuable information to Class I and Class IIa medical device manufacturers, who may now be expected to add clinical evaluations to their current technical documentation in the EU. It also provides important insights for regulatory, clinical and quality departments within device manufacturing companies, as well as to CROs and consultants who are assisting these companies with their 2010 compliance preparations.

Clinical Data Requirements under the New MDD & AIMDD is being presented by Dr. Joy Frestedt, President/CEO, of Frestedt Incorporated and airs on Wednesday, October 21, 2009. For more details, or to register please visit our site at www.fxconferences.com

Creating New Domains in CDASH

This is the third in a series of three audio conferences focusing on the CDASH (Clinical Data Acquisition Standards Harmonization) standard. The first two discussed the 16 existing CDASH core data domains and how to map CRFs to those domains. Most studies will also include data that are not part of CDASH, and making these data CDASH consistent will greatly increase the efficiency of data capture and submission. This session examines how to develop CDASH-consistent CRFs and data structures for these non-core domains.

Using the principles and assumptions underlying CDASH, the speaker walks through how to identify the correct CDASH data model, defines the CRF questions and associated data structures, addresses controlled terminology and determines compatibility with SDTM, the electronic regulatory submission data standards. The appropriate information sources are discussed and the results are captured in a useful online tool. This audio conference assumes the attendee has some familiarity with basic CDASH terms and concepts, and/or has attended previous sessions in this series.

Creating New Domains in CDASH is being presented by Kit Howard, Principal and Owner, with Kestrel Consultants and airs on Tuesday, October 20, 2009. For more details or to register, please visit our site at www.fxconferences.com

Outsourced Data Management: How to Align Performance Expectations

When it comes to clinical development outsourcing, it is not uncommon to see that data management has not been included in the process until it is well underway or nearly complete. Unfortunately, this tactical approach to data management outsourcing opens the door for performance expectations to diverge once the trial is underway, as initial expectations were never made transparent and fully aligned.

This session explores the challenges and strategies involved in successful data management outsourcing between sponsor companies and CROs. The speaker shares his insights and offers actionable, pragmatic approaches to consider, and reviews case studies which measure the impact of these approaches on a sponsor’s business success.

Outsourced Data Management: How to Align Performance Expectations is being presented by Mark Anderson, Senior Director, Clinical Data Management, with Covance and airs on Wednesday, October 28, 2009. For more details or to register, please visit our site at 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 includes 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 was presented by Daryl Wisdahl, Director, with Wisdahl Consulting Group and aired on 2008-11-20. For more details, or to download this conference please visit our site at www.fxconferences.com

Good Engineering Practices: Achieving Excellence with ASTM E2500-07

ASTM E2500-07 provides a framework for any engineering or project organization to establish a project approach that, when implemented with the proper engineering quality management system framework, streamlines engineering activities and redundancies. This session examines how Good Engineering Practices (GEP), combined with a corresponding engineering quality management system, are the keys to project success, project delivery excellence and compliance.

In this conference, the speaker also reveals the importance of utilizing communication tools and engineering document templates to achieve consistency from project engineer to project engineer, and project to project -- ultimately resulting in better project outcomes as measured by cost, quality and schedule.

Good Engineering Practices: Achieving Excellence with ASTM E2500-07 is being presented by Sam DeMarco, President, of Compliance Team Inc. and airs on Wednesday, September 30, 2009. For more details, or to register please visit our site at www.fxconferences.com

Preparing for Increased European Clinical Data and Evaluation Requirements

The newly revised European Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) come into effect on March 21, 2010. There is no transition period, which means that medical devices placed on the market or put into service as of that date will be expected to comply with the revised directives. Some of the most important revisions concern clinical data and clinical evaluation, and the types of adverse events that must be reported if they occur during the clinical study.

In this audio conference, the speaker reviews these changes to the directives, their relationship to ISO 14155, and explores effective ways to prepare for compliance.

Preparing for Increased European Clinical Data and Evaluation Requirements is being presented by Dr. Maria Donawa, President, of Donawa Lifescience Consulting and airs on Thursday, October 8, 2009. For more details, or to register for this audio conference, please visit our site at www.fxconferences.com

Current Trends in Clinical Neuroscience: A Focus on Multiple Sclerosis

Recent advances in the treatment of multiple sclerosis represent the most significant therapeutic success in neurology since the introduction of L-dopa for Parkinsonism 40 years ago. Traditional clinical trials in MS have required large numbers of subjects for a period of six months or longer. However, due to the intense competition for MS subjects, as well as technological advances and understanding of imaging techniques, MS clinical trial design is evolving. Efficient and focused subject recruitment approaches, combined with state-of-the-art trial design, are required to assess the large number of potential therapeutics in the clinical development pipeline.

In this audio conference, Dr. Peroutka discusses recent successes in MS treatment and provides attendees with practical knowledge concerning CNS clinical research, the competitive MS landscape and the analytic approach to MS subject recruitment. He also shares his insights on the conduct of MS studies, including how to leverage global experience locally.

Current Trends in Clinical Neuroscience: A Focus on Multiple Sclerosis is being presented by Dr. Stephen Peroutka, Vice President, Neurosciences, Scientific Affairs, with PRA International and airs on Thursday, October 1, 2009. For more details or to register, please visit our site at www.fxconferences.com

Life Cycle Management for Medical Diagnostics

Experience has shown that effective life cycle management (LCM) is critical to maintaining customer satisfaction, while minimizing waste and expense. This audio conference guides attendees through the critical moments of the diagnostic life cycle, beginning with the introduction of a new product, the "maintenance" of the product during its core lifetime, and finally, the obsolescence and likely replacement of the product in the field.

In this presentation our speaker, a 30-year veteran of the diagnostics industry, discusses the various aspects of effective life cycle management in the area of medical diagnostics and IVDs, while identifying key departments and their role in the life cycle management process.

Life Cycle Management for Medical Diagnostics is being presented by Anthony Eistetter, Senior Consulting Partner, with SciMed Parnters, Inc. and airs on Wednesday, October 7, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com

Proactively Manage Project Financials: Scope of Work, Cost to Complete & Scope Change

Effective management of project financials is absolutely integral to successful project management. It is essential to to establish a baseline budget, construct billing guides and calculate the Earned Value Analysis (EVA) with detailed projections of spend rates. In this session, the speaker discusses the change order process, including how to identify an out-of-scope item and/or scope creep, plus proactive approaches to manage your project financials.

This conference explores best practices on how to build a budget, analyze spend, proactively identify change orders and identify strategies to work within the budget. The speaker also reviews options for effectively controlling the budget.

Proactively Manage Project Financials: Scope of Work, Cost to Complete & Scope Change is being presented by Dr. Ann Flandermeyer, Senior Director, Project Management & Clinical Operations, with Covance and airs on Wednesday, October 14, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com

The 2010 MDD Revisions and What They Mean for Translation

Companies are scrambling to meet the new requirements of the 2010 European Medical Device Directive (MDD). One of the most challenging components of the new directive is the increased focus on language translation for software and labeling. The updated MDD states that software that is integral to the operation of a medical device must be translated into the languages of the countries in which the device will be sold. In the past, companies have been able to avoid software translation by stating that the great majority of professional device users can read English.

Software translation is no small feat. It can be expensive, time-consuming and a minefield for errors. But it doesn't have to be this way. Through implementing some best practices and avoiding common pitfalls, software translations can go smoothly. Notified bodies are now placing particular emphasis on the risks presented by inaccurate labeling and translations. Inaccuracies in labeling and IFUs can lead to incorrect use of a device, resulting in injury, death, notified body action, lawsuits and bad publicity. The root causes of inaccurate translations are many, but fortunately, these can be sidestepped through careful preparation, translator screening and efficient processes.

This presentation focuses on the implications of the 2010 MDD for translation. It also covers specific best practices and common pitfalls in software translation and labeling translation, and looks at some of the most common root causes of inaccurate labeling and how to avoid them.

The 2010 MDD Revisions and What They Mean for Translation is being presented by Jason Heaton, with ForeignExchange Translations and airs on Tuesday, October 6, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com

Building & Managing Cross-Cultural Teams

Members of clinical and research teams often come from a wide range of cultural backgrounds and countries. Each culture has unique communication and interaction customs. How can you most effectively encourage people from many diverse backgrounds to join your team, and most importantly, invite them to contribute to your organization's innovation and efficacy?

This audio conference reveals how best to recruit team members from all communities and encourage increased participation from each of them, regardless of their background. The speaker shares her insights on how to increase cultural competency, improve cross-cultural communication techniques and develop team members into leaders -- ensuring that succession planning is proactive, not reactive.

Building & Managing Cross-Cultural Teams is being presented by Wendy Willow Wark, Founder, of Inclusion Strategies and airs on Tuesday, October 6, 2009. For more details or to register, please visit our site at 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 was presented by Carol Houts, Director of Regulatory, Quality and Safety, with Pleiad Inc. and aired on 2008-10-09. For more details or to download this conference, please visit our site at www.fxconferences.com