Clinical Evaluation of Medical Devices in the EU

is being presented by Anthony L. Fitzhugh, M.D., Project Manager/Lead Auditor, with TUV SUD America Inc and airs on Thursday, December 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com

Annex X of the Medical Device Directive (EC Directive 93/42/EEC) requires that a manufacturer who seeks to place a medical device on the market in the EU first conduct and document in the technical file/design dossier a clinical evaluation that fully evaluates the safety and efficacy of the device. An amendment (2007/47/EEC) to the Medical Device Directive—published in 2007— has made this requirement even more stringent than in the recent past. The clinical evaluation must now be documented in such a manner that this section of the file comprises a standalone document. Moreover, all manufacturers must actively maintain their compliance with the aforementioned clinical requirements as well as post-market clinical follow-up—unless it can be shown to be not necessary.

As a result of these changes, those working in regulatory affairs must ensure that they have the proper expertise and strategy in place to allow their company to comply with these requirements prior to and after placement of their medical device on the EU market. This audio conference presentation covers the EU regulatory framework for meeting the revised clinical requirements, as well as strategies for maintaining the clinical data section of the technical file or design dossier.

Usability and Clinical Testing for Home-use Medical Devices

is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, August 3rd, 2011. For more details or to register, please visit our site at www.fxconferences.com

There are many devices and diagnostics that are or could be used by patients in their own homes: in-vitro diagnostics with complex software algorithms and connections to computer databases and websites; haemodialysis machines; ventilators; artificial hearts; intravenous infusion pumps; and various types of wound-care devices. Home-based use of complex devices to treat liver disease, depression, and heart disease are in development. In fact, any complex device that delivers therapy over a prolonged period of time needs to accommodate in-home use because payers will not pay for and patients will not comply with prolonged hospital or clinic-based treatment regimens.

In order to obtain labelling that allows use of a complex device or a diagnostic by the patients themselves, the medical device first needs to be designed in a way that minimizes potential use errors. This involves usability testing, which takes into account different characteristics of the patients who will use the device such as age, education, professional background, and different physical abilities (the so-called human factors). If clinical data are required for approval, these are usually obtained by testing the device in the intended setting such as patients using the devices at home. Setting up and managing clinical trials to accommodate these requirements can be challenging.

This audio conference presentation discusses the process of designing and testing medical devices intended for use in the home, and provides case studies and insight on how best to obtain the requisite clinical data in a home setting.

MEDDEV 2.7/3: Best Practices for Clinical Evaluation Reports

is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, May 4th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Evaluation of clinical data is a necessary part of the European technical file or design dossier for CE marking of medical devices. The purpose of the evaluation is to demonstrate conformity with the essential requirements concerning performance and safety of the device under normal conditions of use. The data may come from published literature, clinical trials, or a combination of the two.

This audio conference will focus on the literature route for providing clinical data, which, if done well, may preclude the need for a de novo clinical trial. The presentation will highlight best practices, describe the Medical Device Directive (MDD) requirements concerning clinical evaluation, and describe the most recent changes in the regulatory guidance, MEDDEV 2.7/3, which was issued in December 2010.

Best Practices for Preparing Clinical Evaluation Reports

is being presented by Phil Triolo, President, of Phil Triolo and Associates LC and airs on Tuesday, March 22nd, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com

Clinical Evaluation Reports (CERs) document the assessment and analysis of clinical data (literature, results of clinical investigations, complaints) and preclinical data to establish conformity of a medical device with the pertinent requirements of the Medical Devices Directive.

Recent publication of ISO 14155:2011 introduces new requirements that supplement the requirements and recommendations for CERs that appear in MEDDEV 2.7.1 Rev 3 and GHTF document SG5/N2R8:2007.

This audio conference presentation outlines these new requirements and provides helpful hints and examples of how to meet, efficiently and effectively, new and existing CER requirements.

Drivers and Risks of Off-shoring Clinical Data Management

is being presented by Dr. Johann Proeve, Head of Global Data Management, with Bayer Healthcare and airs on Thursday, March 24th, 2011. For more details or to register, please visit our site at www.fxconferences.com

Off-shoring of certain activities related to the management of clinical trials has become commonplace in the pharmaceutical and biotechnology industry, and one of the functions most affected has been clinical data management (CDM). The main contributors for off-shoring CDM are the fixed costs, lower salaries in low-cost countries and CDM being viewed as a non-core competency in the industry.

But is off-shoring really the easy solution it might appear to be when faced with the rising cost of conducting clinical research? Certainly, off-shoring of CDM is associated with certain risks, including high staff turnover, required overhead for the management of the processes, availability of knowledgeable staff for health authority inspections and the eventual erosion of the cost advantage compared to Western countries.

This audio conference addresses the main drivers and risks associated with the off-shoring of CDM, and looks at the various ways in which CDM can contribute and thereby justify its existence.

Academic Medical Centers and Clinical Research Productivity: How to Choose The Best Sites

is being presented by Anita S. Kablinger, Physician, Carilion Clinic
, Virginia Tech Carilion School of Medicine and airs on Tuesday, November 23rd, 2010. For more details or to register, please visit our site at www.fxconferences.com

Fulfilling enrollment numbers for clinical trials and providing the required data is of utmost concern to industry. Subject selection must be accurate and swift to meet deadlines. Recruitment remains one of the most difficult aspects of clinical research and choosing sites that will produce good clinical data of truly ill patients is always hard. Literature suggests that, although private research sites often achieve enrollment numbers in a timely fashion, academic center subject selection frequently represents sicker patients with a subsequent lower placebo response. How then does industry and its partners determine the appropriate sites for a multi-center trial to achieve success?

This presentation reviews the important aspects of site selection with respect to academic medical centers, with the goal of maximizing efficiency and productivity of all those involved and increasing the probability of study success.

EDC Front to Back: Integrating Clinical Trial Data for Operational Benefit

Successfully implementing EDC depends on having processes in place that take advantage of the technology. Although it is generally possible to use EDC with processes that were designed for paper case report forms, there are many ways EDC can be integrated into the clinical trial process to make it more efficient, and depending on the goals for EDC, there are many metrics that can be captured to help establish benefits. Among these are cycle time for resolving queries, use of standards, quality of data, cost per form or datapoint, time between last patient visit and database lock.

This conference explores how processes related to EDC can be integrated into clinical trial processes for creating and deploying case report forms, as well as monitoring and managing trials. Our speaker shares insights on how to use lean concepts to look at the processes you have, identify opportunities for improvement and show measurable progress.

EDC Front to Back: Integrating Clinical Trial Data for Operational Benefit is being presented by Ross Rothmeier, Senior Director, EDC Portfolio, Clinical Development Services, with Covance and airs on Tuesday, November 17, 2009. For more details or to register, please visit our site at www.fxconferences.com

Medical Device Clinical Evaluations: EU vs. US

In this presentation, Dr. Colquhoun explains the circumstances in which medical device manufacturers need to generate de novo clinical data. The audio conference also looks at the different types of clinical evaluations and the importance of conducting them in the EU (and USA).

The speaker presents an overview of the regulatory and quality controls of evaluations being conducted in the EU, and then highlights specific requirements in the four most popular European countries for medical device evaluations. These requirements are then compared and contrasted to those of the USA. Finally, the presentation also addresses general topics such as vigilance requirements, language and the operational process of conducting trials in the EU and USA.

Medical Device Clinical Evaluations: EU vs. US was presented by Helen Colquhoun, MD, CEO, with Pleiad Devices. For more details, or to download this event please visit our site at www.fxconferences.com

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

Clinical Data Capture Standards for Regulatory Submission Trials

The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that develops data standards for clinical studies, and Clinical Data Acquisition Standards Harmonization (CDASH) defines the standards for case report forms. CDASH is designed to help investigative sites capture data more easily and to facilitate submitting data to regulators, while reducing confusion between investigators, sponsors and research sites.

This audio conference offers an overview of the structure, content and terminology of the CDISC CDASH standard and how it fits into the research process. It also provides an understanding of CDASH, and insight into how implementation may impact each organization. Attendance benefits those who define, collect, store or analyze clinical data.

Clinical Data Capture Standards for Regulatory Submission Trials is being presented by Kit Howard, Principal and Owner, Kestrel Consultants and airs on Tuesday, August 18, 2009. For more details, or to register for this event please visit our site at www.fxconferences.com

State of Readiness? XML in the Life Sciences

The life sciences industry is being thrust into the world of XML. FDA's recently mandated Structured Product Labeling (SPL) initiative as well as private initiatives with Standard Response Letters, Clinical Data, and Product Information Management (PIM) for EMEA labeling have made it clear that the use of XML is on the upswing. But how do you benchmark your organization with your peers? What are the biggest problems in working with documentation?

ForeignExchange Translations, RWD Technologies, and Data Conversion Laboratory asked these questions to a broad cross-section of the life sciences industry through a comprehensive survey. In this presentation we unveil the results, looking at where the industry stands on XML initiatives, and where it needs to be. You learn how your peers are tackling the issues associated with SPL, Standard Response Letters, and Clinical Data Reports. You hear what they report as the biggest problems, and what they are doing to solve them.

State of Readiness? XML in the Life Sciences was presented by Don Bridges, Commercial Technical Documents Manager, of Data Conversion Laboratory (DCL) & Joe Jenkins, Life Sciences Market Director, of RWD Technologies and aired 2006-11-30. For more details or to purchase a download, please visit our site www.fxconferences.com

Biomarker Data Interpretation and Challenges of Biological Variation

With the emphasis on biomarkers to improve drug development the question arises as how to interpret the data.

The traditional clinical laboratory methodology for interpreting data involves the identification of the expected values (the normal range) and from this range defining the probably of disease or no disease (sensitivity and specificity). The challenge in drug development is in monitoring the patient over time while identifying if important changes have occurred in the biomarker values that indicate inappropriate toxicity or demonstrate appropriate efficacy.

The use of the reference interval as a means of identifying toxicity or efficacy will be challenged and an alternative approached based embracing biological variation will be proposed.

Biomarker Data Interpretation and Challenges of Biological Variation is being presented by Gordon F Kapke Ph.D., Sr. Director Biomarker Services, Covance Central Laboratory Services and airs Wednesday, January 28th 2009. For more details or to register for this audio conference, 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

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

Handle With Care: Clinical Data Cleaning

Clinical trials are becoming more challenging, time-consuming and resource intensive. In addition to the pressure for timeliness which face the sites at the front lines of clinical trials, today's standard data cleaning methods cater to approaches that are at high risk of inadvertently introducing bias into the data, thus skewing the trial results.


This presentation explores the premise that the very process of data cleaning has the potential to in fact do more harm than good in more detail. The presentation also introduces predictive, proactive, and preventative real-life measures that can be deployed to manage the level of errors and the need for data cleaning, thus improving the overall data quality.

Handle With Care: Clinical Data Cleaning is presented by Elaine Job, Executive Director, Data Management Late Stage Development Services, of Covance, Inc. For more information on this audio conference, please visit our site www.fxconferences.com