Video Production and Localization for eLearning

is being presented by Xavier Marchand, COO, with JBI Studios and airs on Tuesday, April 6, 2010. For more details or to register, please visit our site at www.fxconferences.com

Narrators on green screen, real-life scenarios, interview simulations… Video content can transform the learner experience. Thanks to plummeting costs of production and distribution, video is becoming a common component of eLearning courses. However, in order to optimize the video budget, it is important to understand the different solutions and how they impact the production process, the production crew needed, the editing effort, and production timeframes.

This audio conference presentation stops short of delving into all of the technical details of video production, but helps decision makers and content developers understand the main quantitative and qualitative aspects of video production, and also discusses the wide range of possibilities available for using video content in multilingual deployments.

Good Auditing Practices for EU Notified Body Audits

is being presented by Theo Nusselder, Founder & Director, of cePartner4u and airs on Tuesday, March 30, 2010. For more details or to register, please visit our site at www.fxconferences.com

Are you ready for a Notified Body audit? The European Medical Devices Directive requires that manufacturers of medium- and high-risk devices apply for an assessment of the manufacturing process and the technical documentation. The manufacturer is responsible for the design, manufacture, packaging and labeling of a device before it is placed on the market, regardless of whether these operations are carried out by the manufacturer or outsourced to a third party. The quality system must ensure that the products conform to the requirements of the Directive at every stage, from design to final inspection.

The Notified Body must audit the quality system to determine whether it meets the requirements, and the auditors have thorough knowledge of the rules on the inspections. Such rules are given in ISO requirements for audit and certification of management systems (ISO 19011:2002) and GHTF guidelines for Regulatory Auditing of Medical Device Manufacturers (GHTF/SG4/N28R4:2008). In this audio conference presentation attendees learn how to use these rules as a guide to Good Auditing Practice for the Notified Body assessment and CE-certification procedures.

Comparative Costs of Clinical Development in CEE and Other Regions

is being presented by Dr. Malgorzata Szerszeniewska, CEO, of Easthorn Clinical Services in CEE and airs on Wednesday, March 24, 2010. For more details or to register, please visit our site at www.fxconferences.com

It has recently been shown that the cost of clinical trials may play a crucial role in the drug development process. A lot of the most innovative biotech companies struggled financially last year and many programs have been put on hold or cancelled due to cash flow problems. A lot of companies have had difficulties in finding partners to help them financially to complete even very promising programs. That is why the cost of conducting clinical trials has become one of the major factors for pharma companies’ drug development strategies, their pipelines, and their CRO selection criteria. As market volume shrank CROs had to compete for fewer studies and price has become an important selection criterion.

This presentation provides a comparison of clinical trial costs in central and eastern europe and other representative regions. Our speaker addresses a variety of factors influencing the costs and discusses the dynamics and directions of recent changes. This information is of use in future budget planning, strategic country selection for specific clinical trials and minimizing financial surprises while running trials in CEE.

Is Your Product Development Cycle Ready for IEC 60601-1 3rd Edition?

is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Thursday, March 4, 2010. For more details or to register, please visit our site at www.fxconferences.com

Development and adoption of the IEC 60601-1 standard has been a long and complicated process. Four years after the standard was published, there remains much confusion. This audio conference takes a look at the ever-changing international and regulatory requirements impacted by the 3rd edition of IEC 60601-1. What is the best strategy for your company when it comes to designing your product to IEC 60601-1? Should you design and test to 2nd or 3rd edition, or both? That depends on when and where you plan to market your medical electrical product, whether you will be selling legacy products, and if there are significant changes expected in the future that may require retesting or resubmission to a national regulatory authority.

In this audio conference, 60601 expert Leo Eisner discusses the current status of IEC 60601-1 3rd edition, scheduled changes and important regulatory dates, and how the collateral and particular standards are aligned to 3rd edition. The presentation also covers points to consider when setting up a company transition strategy.

The third edition of this cornerstone standard for medical electrical devices has gone through major changes since 2nd edition. Ease your 60601-1 regulatory compliance strategy stress with detailed guidance from a leading expert.

QA Oversight of Vendor Management

is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Wednesday, March 17, 2010. For more details or to register, please visit our site at www.fxconferences.com

Managing vendors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.

This conference discusses what a quality agreement is and how to use it as a tool in managing your vendors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.

Quality Testing for Complex Medical Devices

is being presented by Lura Wolfe, Technical Quality Engineer & Consultant and airs on Wednesday, March 3, 2010. For more details or to register, please visit our site at www.fxconferences.com

Testing in complex software and hardware environments presents unique challenges in product development, and it is vital that your QA team be being able to meet these challenges and ensure quality. Agile development methodologies were implemented for quick creation and delivery of software, but they introduce new challenges when deliverables keep changing, timetables are shortened, and development complexity rapidly increases.

This audio conference presentation examines the testing methods typically used with complex medical devices. The speaker draws on first-hand experience and provides examples of test plans, test cases, and test lists, and discusses how to use documentation to create, track, and report testing results.

An Integrated Approach to Managing Supply Chain Risk

Supply chain integrity has never been a bigger or more complex challenge for today's global businesses. Increased pressure for improved financial performance, combined with the need to optimize assets and resources, has resulted in a growing reliance on outsourcing and offshoring, often to developing countries. However, with the benefit of reduced costs comes the increased and more complex threat of supply chain interruption. Efficient supply chains are by definition lean, stretched and fragile, resulting in an ever-present threat of breakdown. While most organizations prepare themselves for the more obvious areas of weakness, breakdown can come from unanticipated causes and all too often, traditional insurance products fail to provide any, or sufficient, financial help.

Many companies fail to appraise the full extent of supply chain vulnerabilities, and as a result, are not totally confident that risks are managed within acceptable financial targets. In this session our experts explain how an integrated model for the identification, treatment and acceptance of risk can address these concerns.

An Integrated Approach to Managing Supply Chain Risk is being presented by James Bird & Andrew Tait, Partner, Jardine Lloyd Thompson & Principal, Core Risks Ltd. and airs on Tuesday, March 2, 2010. For more details or to register, please visit our site at www.fxconferences.com

Establishing Value for Diagnostics & Biomarkers in a Real-Life Setting

While considered a relatively novel term in research, biomarkers and diagnostics have been extensively used in the pre-clinical and clinical research and diagnosis arena for many years. Their magnitude in positively influencing the medical community’s ability to accurately diagnose and treat human conditions, although still undefined, seems limitless. Currently, a renewed focus is being placed on healthcare outcomes, and the containment of medical cost, diagnostics, biomarkers and personalized medicine are fostering better outcomes and savings.

In this Webinar, our speakers discuss how the need for more clinical applications for diagnostic biomarker testing is expected to have an explosive growth among several disease categories in the five years. They also explain how the operational execution of biomarker and diagnostic research varies greatly from traditional clinical research, while looking at the unique requirements and challenges.

Establishing Value for Diagnostics & Biomarkers in a Real-Life Setting is being presented by Dr. Jerome Wilson & Kathleen Kushner, Sr. Scientific Affairs Director & Scientific Affairs Director, Late Phase Services, with PRA International and airs on Tuesday, February 23, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

EU Centralized Procedure for Generics

Since its inception in 1995, the centralized procedure has been used for new and biological drugs. Now that the data protection period for the first approvals at EMA is over, generics can be approved in the European Economic Area using the centralized procedure. But does this make sense? What are the alternatives? What is the decision matrix to be used to decide upon the “right procedure”?

This presentation gives answers to these and several more questions on the EMA, the CP and its role in generics approval.

EU Centralized Procedure for Generics is being presented by Dr. Ulrich Granzer, Principal Consultant, Granzer Regulatory Consulting and airs on Tuesday, March 9, 2010. For more details or to register, please visit our site at www.fxconferences.com

Generating High Performance: Beyond Technical Abilities

In today’s competitive environment, reliance on strong technical ability is critical for organizational success – but that isn't enough! In order to drive innovation, technical breakthrough, process improvement and efficiency, experts within an organization must also work collaboratively and cohesively across technical domains and organizational levels. Most technical experts and teams face greater constraints in “soft skill” competencies than in their technical abilities.

Successful organizational performance, team deliverables and individual advancement are often inhibited by ineffective leadership, influence, communication, teamwork and presentation skills. This presentation provides participants with 'best practice' learnings and tools for selecting, engaging and developing well-rounded employees that drive organizational success.

Generating High Performance: Beyond Technical Abilities is being presented by Diane Brown, Founder, of The Talent Journey and airs on Tuesday, March 16, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

Considering Human Factors in Designing Medical Device Trials

Increasingly, 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 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 was presented by Annette Valles-Sukkar, Senior Manager, Clinical Operations, with Pleiad Devices and aired on 2009-05-07. For more details or to download this event, please visit our site at www.fxconferences.com

Outsourcing and Offshoring in a New Era of FDA Enforcement

The increasing use of outsourcing and offshoring by FDA-regulated companies for strategic and cost purposes has greatly improved business outcomes and efficiencies. Unfortunately, despite the clear benefits, there are many significant challenges to structuring and managing these relationships to minimize the risk of FDA enforcement, particularly in the new, more aggressive FDA enforcement climate.

In this audio conference, our speaker provides some business context regarding the use of offshoring and outsourcing, and discusses issues and considerations in structuring relationships, as well as considerations in planning for FDA review and inspection of oversight programs.

Outsourcing and Offshoring in a New Era of FDA Enforcement is being presented by John Garvey, Principal, with Compliance Architects, LLC and airs on Thursday, March 11, 2010. For more details or to register, please visit our site at www.fxconferences.com

Electronic Informed Consent: Putting the Pieces Together for Implementation

As clinical trials have moved toward electronic methods for patient recruitment, trial management and data collection, the provision of candidate informed consent has remained a paper-based document that is increasingly outside the trial management process. More and more, the possibility of using electronic formats to enhance the consenting process is being considered. This audio conference examines the FDA guidelines for consent and their relationship to electronic consenting and inspection, as well as the importance of making connections to e-trial management and data capture.

In this presentation, our speaker outlines the steps to using electronic consent and gives examples of how electronic presentation of an informed consent document can increase candidate understanding and access to information. Dr. Brink also provides insight into making the e-consent decision, how to use e-consent to manage trial risk, and FDA guidance regarding e-consenting and its integration into the clinical trial process.

Electronic Informed Consent: Putting the Pieces Together for Implementation is being presented by Dr. Susan Brink, CEO, with ConsentSolutions, Inc. and airs on Thursday, March 18, 2010. For more details or to register, please visit our site at www.fxconferences.com