EN 15038:2006 - A Tool for Assessing Translation Providers

Do you wish there were objective criteria for assessing your current or prospective translation providers? With so many agencies vying for your business, wouldn't it be nice if you had a checklist you could use for your RFP process or annual vendor reviews? Well, there is help: European standard EN 15038:2006, "Translation Services - Service Requirements." Forget the dry title. This is exciting news to those in the life sciences industry, where metrics and standards are vital. The European Committee for Standardization has done the hard work of creating a way for companies to objectively rate their translation providers.

EN 15038 provides guidance on such topics as human resources, linguist competency, technical resources, project management, client relationships and quality management. In short, it covers all the important areas that will determine the level of service and quality you can expect from your translation provider.

EN 15038:2006 - A Tool for Assessing Translation Providers was presented by Jason Heaton, with ForeignExchange Translations, and is previously recorded. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Data Management for Medical Device Trials: Best Practices

There are no regulations in the USA or EU that specifically govern case report form development or data management practices. There are some guidelines produced by professional bodies of data managers. This presentation covers the range of data management tasks from CRF design to data entry to raising and resolving queries to tracking all aspects of data management.

There will be a short discussion of importation of data as well as safety management as it pertains to data management. Throughout the presentation, general guidance on best practice will be given.

Data Management for Medical Device Trials: Best Practices was presented by Helen Colquhoun, MD, CEO, of Pleiad Devices and aired on 2007-11-01. For more details or to download this audio conference, please visit our site at www.fxconferences.com

An Overview of EMEA & Centralized Procedure

Learn about the EMEA, centralized procedure, Directive 2001/83, and how major changes with the EU could affect you.

European legislation, responsible for governing pharmaceutical regulations, has seen major changes in recent years. In 1999, an initiative of the EU Commission culminated in the implementation of a new regulation concerning the structure and name of the European Medicines Agency (EMEA).

Also affected by these sweeping changes was the centralized procedure. Major revisions were invoked concerning fast track, conditional approval and approval under exceptional circumstances. In addition, the basic EU pharma legislation, Directive 2001/83, has been modified to adapt to the needs of the enlarged European Union including 25 full members plus Iceland, Norway, and Liechtenstein.

In this audio conference, Dr. Granzer discusses the changes impacting pharmaceuticals in the EU and how to navigate the maze to get your products to market.

An Overview of EMEA & Centralized Procedure was presented by Dr. Ulrich Granzer, Granzer Regulatory Consulting and aired on 2008-04-03. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Multilingual Labels for Medical Devices - Best Practices

The device industry faces a dilemma: How can companies provide the required information in multiple languages, while making the information on their product labels readable on a variety of sizes of labels? Given the limited amount of space that's available on your labels, how can you best deal with the EU requirements for multilingual labeling?

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 device companies are struggling with the issues that surround multilingual label design and international symbology. This specialized audio conference helps labeling practitioners learn about best practices in the industry.

Multilingual Labels for Medical Devices - Best Practices was presented by Andres Heuberger, President, of ForeignExchange Translations and was previously recorded. For more details or to download this conference, please visit our site www.fxconferences.com

Effective Risk Management: The Cost of Prevention?

Managing the risk in clinical trials is a hot topic today, but how should it be done, how effective is it, and how do we demonstrate value for our investment?

This presentation outlines the current or transitional approach to risk management and where this could mislead. It moves on to consider the variability inherent within clinical trials and the importance of understanding this in risk management. The final section covers risk mitigation and some of the benefits which can accrue from employing an effective risk management strategy in clinical study delivery.

Effective Risk Management: The Cost of Prevention? was previously presented by Rob Davie, PhD, Vice President, Clinical Service Delivery & Clinical Development Services, Europe, with Covance. For more details or to download this conference, please visit our site at www.fxconferences.com

QA Oversight of Vendor Management

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.

QA Oversight of Vendor Management is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Tuesday, October 13, 2009. For more details or to register, please visit our site at www.fxconferences.com

Implementing a Quality Management System: ISO 13485

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer and regulatory requirements. One of the main objectives of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. It includes many of the elements of ISO 9001 but excludes some aspects not appropriate as regulatory requirements. ISO 13485:2003 is applicable to all medical device manufacturers, regardless of the type or size of the organization.

If regulatory requirements permit exclusions of design and development controls, or if “product realization” (Clause 7) is not applicable, these can be excluded from the quality management system. However, organizations claiming conformity with ISO 13485:2003 must reflect these exclusions. The processes required by ISO 13485:2003, which are applicable to the medical device(s) but are outsourced, must be accounted for in the organization's quality management system. ISO 13485:2003 is used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.

This conference looks at the requirements of ISO 13485:2003 and some practical aspects of setting up a quality system for medical device manufacturers.

Implementing a Quality Management System: ISO 13485 is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Thursday, October 15, 2009. For more details or to register, please visit our site at www.fxconferences.com

Mapping Your Case Report Forms to CDASH

This is the second in a series of three audio conferences focusing on the CDASH standard, and in this session the speaker provides practical knowledge for initiating the transition from sponsor-specific CRFs to CDASH-conforming data structures. CDASH, the CDISC data capture standards, defines CRF content for sixteen of the most commonly used data domains, and allows data to flow from the CRF smoothly into SDTM, the CDISC electronic regulatory submission standards. Each sponsor will eventually have to decide whether to adopt CDASH, and this session provides the tools to do both the impact analysis and the CRF mapping necessary to make that decision.

Mapping Your Case Report Forms to CDASH is being presented by Kit Howard, Principal and Owner, of Kestrel Consultants and airs on Tuesday, September 15, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Site Activation: How to Get Beyond the Classic Pitfalls

Efficient site activation is critical to set the tone for a successful clinical trial. Given the number of activities that are involved during site activation, there are several challenges that are faced -- many of which are encountered time and time again. Therefore, knowing what these challenges are, being able to work through them and even being able to prevent them when possible, is imperative to timely site activation.

This session reviews the processes and reports currently utilized to manage site activation issues, as well as practical tools and lessons learned. The speaker shares firsthand experiences and explains how to implement best practices that address the classic challenges of this dynamic process, while avoiding the pitfalls.

Site Activation: How to Get Beyond the Classic Pitfalls is being presented by Heather Almonte, Senior Manager, Site Activation Services, with Covance and airs on Wednesday, September 23, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Implementing Quality Systems to Enhance Profitability

Quality is a perennial buzzword, both within the life sciences and in other industries. But how does a company go about determining exactly what sort of system is needed, and making sure it is effective? In this audio conference, our speakers provide insight into the use of quality systems to improve profitability in both FDA-regulated and non-regulated industries. The presentation looks at the key points to consider, starting with what is a quality system and how can it improve performance?

The presentation also looks at the design and implementation of quality systems, and the return you can realistically expect to gain from putting a properly designed system in place.

Implementing Quality Systems to Enhance Profitability is being presented by Ralph W. Donnelly & Frank Mark, President, R. Donnelly & Associates / President, The Polmarc Group LLC and airs on Thursday, September 17, 2009. For more details or to register, please visit our site at www.fxconferences.com

Creating Policies and Procedures That Work

If you are a scientist, researcher, QA/QC, or product development expert, sooner or later you have to address critical quality and regulatory issues. And there is no more important component of sound quality and regulatory practices than well-thought-out and well-written policies and procedures.

Sub-optimal policies and procedures can have a significant deleterious effect on an organization -- not just in regulatory compliance but also in overall productivity. And even the most knowledgeable subject matter experts can struggle when creating policies and procedures.

Of course, this is not surprising – after all, framing policies and establishing procedures present significant challenges. What processes should have policies? Why? What procedures should be documented? And how extensively should they be documented? And what are the best approaches to drafting policies and procedures that will make them clear, easy to understand, easy to follow, and – perhaps most important of all – acceptable to regulatory authorities? In this audio conference, attendees learn important strategies to meet these challenges.

Creating Policies and Procedures That Work is being presented by Karl Keller, Principal, with Communication Partners and airs on Wednesday, Sept. 16, 2009. For more details or to register, please visit our site at www.fxconferences.com

Audio, Video & Subtitles: Localizing Multimedia Content

Multimedia files using audio and video (A/V) have become an important part of training material and corporate communications for companies wanting to effectively address a global audience. However, this enriched content presents new challenges during the localization process: the multimedia component adds dramatically to the impact of communications, but can also prove costly if not handled properly.

This audio conference presents an overview of A/V localization, including a review of the various options for localizing A/V content, and the associated cost implications. Our speaker also discusses content development with an eye to streamlining localization, and provides strategies for organizing your assets to reduce localization costs and turnaround time. Attendees also learn the common pitfalls to avoid during the multimedia localization process.

Audio, Video & Subtitles: Localizing Multimedia Content is being presented by Xavier Marchand, COO, with JBI Studios and airs Thursday, September 17, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Using Mutual Recognition and Decentralized Procedure for EU Drug Registrations

Is your company preparing to market a new pharmaceutical product in Europe? Pharma companies intending to bring new products to market in the EU must follow one of three distinct processes – Centralized Procedure, Decentralized Procedure or Mutual Recognition. Previous presentations by Dr. Granzer have dealt with Centralized Procedure. This presentation focuses on the other two methods, Decentralized Procedure and Mutual Recogniton.

These procedures can be used for certain new drugs, generics and herbal medicinal products. In the case of the MRP there must be a national marketing authorization in place, whereas DCP can be used to seek approvals where none currently exist. This presentation provides an overview of DCP and MRP, including which procedure is appropriate for which products, the expected timeframe for each, and the kinds of submissions expected.

Using Mutual Recognition and Decentralized Procedure for EU Drug Registrations was presented by Dr. Ulrich Granzer, Granzer Regulatory Consulting and aired on 2008-10-09. For more details, or to download this conference please visit our site at www.fxconferences.com

Medical Device Vigilance in the EU: Reporting Requirements & Event Trending

The revised MEDDEV 2.12-1 Rev 5 guidance regarding medical device vigilance was issued in April 2007, and came into effect on January 1, 2008. Whilst not legally binding, this guidance does reflect EU competent authority expectations, and companies are advised to build their vigilance system around the guidance, which needs to be fully understood. For example, a patient with worsening osteoporosis presents with severe ankle pain twelve months after surgical fixation of the ankle with bone graft and hardware (screws and plate). Examination of the patient reveals movement in the joint, demonstrating lack of fusion. Is this a reportable event?

In this session the speaker reviews the guidance, explains some key definitions and responsibilities, provides a vigilance process map and examines the criteria for reporting, using several examples. Event trending is also discussed, and how to make sense of the information that is delivered via the vigilance system.

Medical Device Vigilance in the EU: Reporting Requirements & Event Trending is being presented by Helen Colquhoun, MD, CEO, with Pleiad Devices and airs on Tuesday, September 22, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Preparing the Clinical and Regulatory Master Plan

Developing an accurate clinical and regulatory master plan is the key to getting any new drug or device product to the global marketplace quickly and in a cost-efficient manner. The master plan provides an invaluable roadmap of what needs to be done, and will also be used as a business plan in dealings with your notified body and potential investors. In this audio conference, our speakers discuss not just planning for CE marking, but incorporating the overall global market access into one plan. Attendees learn how key parameters and claims are defined, which is an important starting point.

The presentation also covers how to ensure compliance throughout the regulatory pathway to the global market, and how to ensure there is sufficient data available for immediate success of your products in global markets.

Preparing the Clinical and Regulatory Master Plan is being presented by Efraim Roe Kozorovitsky & Dr. Sunita Ahir, Executive Director, Medical Devices & Manager, Regulatory Affairs, with Premier Research and airs on Thursday, September 24, 2009. For more details or to register, please visit our site at www.fxconferences.com

From Emerging to Emerged: Clinical Development in Asia Pacific

Although in the past Asia Pacific was deemed an emerging region for clinical research, it has now evolved and emerged, catching the interest of global pharmaceutical and biotech companies. Good Clinical Practice (GCP) was adopted as a local regulatory requirement in most of these counties in the late 1990s. Since then, industry-funded clinical research has grown rapidly in the eleven countries that are routinely considered for global IND studies.

The reasons for this growth are simple: Asia Pacific provides sponsors with several advantages, including streamlined regulatory and IRB processes, highly educated investigators and study personnel, well-equipped qualified study institutions, strengthened clinical research infrastructure, and internationally recognized standard treatments.

This presentation reviews the major factors that have made Asia Pacific such an attractive region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing clinical trials in the Asia Pacific region. Attendees also receive practical advice on critical points to take into account when conducting trials in Asia Pacific.

From Emerging to Emerged: Clinical Development in Asia Pacific is being presented by Edward C. Ian, Senior Director of Clinical Operations, Asia Pacific, with PRA International and airs on Wednesday, September 2, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

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

Leveraging Vendor Relationships to Achieve EDC Objectives

With all the choices and differences between electronic data capture (EDC) vendors and the claims that they make, it can be a daunting task to find one that meets your organization’s objectives. Many companies are using EDC as a replacement for paper, but they may not have a strategy or measurable objectives to ensure that organizational goals are benefiting from the introduction of this technology. By clarifying organizational goals and objectives, organizations can both target the best vendors and service providers, as well as tailor their request for information and pricing to simplify the selection process and quantify the decision.

In this conference, the speaker shares important strategies to help reduce cycle time, lower the cost of operations and improve data collection quality. Attendees discover techniques to effectively communicate their decisions and make the most of their vendor relationships.

Leveraging Vendor Relationships to Achieve EDC Objectives is being presented by Ross Rothmeier, Senior Director, EDC Portfolio, Clinical Development Services, with Covance and airs on Wednesday, September 9, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

CE Marking: Pitfalls and Best Practices for IVD Directive Language Requirements

The $9 billion U.S. in vitro diagnostics (IVD) industry is ill prepared to meet the strict new regulations contained in the European Union's new IVD Directive. With only four business quarters left before the December 2003 deadline, IVD companies are realizing that translation is critical to earning the CE mark.

Manufacturers that lack effective plans for complying with the language requirements of the directive risk losing revenue and market share. Translation quality control, global labeling strategies and in-country reviews present new challenges for the majority of diagnostics manufacturers who are dealing with non-English texts for the first time.

CE Marking: Pitfalls and Best Practices for IVD Directive Language Requirements was presented by Andres Heuberger, President, with ForeignExchange Translations, Inc. and was previously recorded. For more details, or to download this conference please visit our site at www.fxconferences.com

Alternative Site Selection: China

This is one of two Covance audio conferences dealing with alternative site selection (the other event covers Latin America), and focuses on opportunities for the conduct of clinical research in China. This presentation provides an overview of the current clinical research environment in China and explores reasons why China should be considered as part of global drug development strategies.

Alternative Site Selection: China was presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, with Covance and is previously recorded. For more details or to download this conference, please visit our site at www.fxconferences.com

Optimizing Site Performance: Risk Planning vs. Remediation

A large percentage of clinical trial budgets is allocated to fix problems after they occur instead of proactive activities to predict and prevent errors. There are several factors causing the widespread variance in site performance in clinical trials, declining data quality and missed timelines. What can drug development service providers and sponsors do to proactively optimize site performance?

Protocol violations are a consequence of stressed environmental conditions at investigative sites and are extremely pervasive. Conventional measures won’t adequately detect or address them. This audio conference discusses and details 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 was presented by Pam Atwell, Director, Operational Strategies and Planning, with Covance Clinical Development Services and aired on 2008-12-04. For more details, or to download this audio conference, please visit our site at www.fxconferences.com

The New Rules for CME Sponsors and Providers

There are new rules governing commercial support of Continuing Medical Education (CME) programs which affect both CME providers and industry supporters, such as pharmaceutical, biotech and medical device companies. With Congress scrutinizing industry support of CME, the ACCME has issued new guidance, as well as a “Call for Comment” on the issue of industry funding. The new PhRMA Code (effective January 2009), along with independent state laws, has been adjusted to govern relationships between industry and physicians. Life sciences organizations, as well as CME providers, must keep abreast of these changes to maintain their accreditation status and ensure their internal policies are consistent with the latest laws and guidance.

This audio conference addresses how the new rules affect sponsors and providers and the best practices needed to comply.

The New Rules for CME Sponsors and Providers was presented by Maria D. Buckley, Nutter McClennen & Fish LLP and aired on 2009-01-08. For more details or to download this audio conference, please visit our site at www.fxconferences.com