The EU Paediatric Rule: Threats, Issues & Lessons Learned

The European Union’s paediatric regulation, which came into force two years ago, requires all applicants submitting a marketing authorization application for a new molecular entity to also provide a paediatric investigation plan (PIP). The objective of the new legislation is to develop "better medicines for children" within the EU. This mandatory PIP is being evaluated by the Paediatric Committee of the EMEA. There are obvious consequences for the pharmaceutical industry, as the PIP must be made available during submission, and paediatric trials will have to be performed.

In this audio conference we provide the latest information on various aspects of the legislation and how it is affecting drug manufacturers, including real-life experiences to date and lessons learned from those who have been through the process.

The EU Paediatric Rule: Threats, Issues & Lessons Learned is being presented by Dr. Ulrich Granzer, Owner, Granzer Regulatory Consulting and airs on Thursday, September 10, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

An HPI Approach to Capturing Critical Performance Factors

In this audio conference, our speaker provides attendees with a proven process for improving overall workplace performance for any job in any functional area of an organization. Unlocking the "Performance DNA" in your organization by finding out "what is right to fix what is wrong" is a powerful process that takes a positive spin on what is historically a negative process.

This "Performance DNA" process provides a foundation for improving job performance appraisals and measures, HR selection processes (to ensure you get the right person for the right job), and training and development (to build results-based curriculums tied to job outcomes). It also positively impacts manager coaching and development processes (that impact behavior change), employee satisfaction, and the overall quality of the products and services that you deliver to your clients.

Attendees receive practical ideas, simple tools and a validated process that works to capture the critical performance factors for ANY job -- a process that has been taught to over 6,000 performance analysts in over 28 countries.

An HPI Approach to Capturing Critical Performance Factors is being presented by Mason Holloway, Principal Consultant, with Beacon Performance Group and airs on Tuesday, August 25, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Using Learning Styles to Successfully Engage All Learners

Ever wonder why some learners evaluate a training session as "excellent" while others find it incredibly lacking? Your learning style describes how you like to take in and process new information. Your learning style determines the types of activities you find enjoyable and those that you find painful. As a trainer, it is important to recognize these differences and address the different needs of every learner. How do you address every learning style's needs in the same learning session?

In this session, you will learn to identify the four primary learning styles, including your own. You will see how your learning style impacts the way that you design and deliver training. You will leave with a simple, four-step model for designing and delivering training that you can use to address every learner's needs. We will apply this brain-based learning model to activities that you are using right now and learn where you design and delivery could improve by adding activities that appeal to the learners you might be missing.

Using Learning Styles to Successfully Engage All Learners is being presented by Jeanine O'Neill-Blackwell, President & CEO, of 4MAT 4Business and airs on Thursday, August 27, 2009. For more details or to register, please visit our site at www.fxconferences.com

Regulatory and Scientific Considerations for API Drug Development

The establishment of a robust Active Pharmaceutical Ingredient (API) development program is an integral part of drug development. A well-planned API development program that is properly integrated with the drug product, clinical, non-clinical and marketing programs is essential to prevent delays that can result in lost time, revenues and market life cycle.

This audio conference provides an overview of the scientific, regulatory and compliance requirements of API development at the various phases of development. The speaker also discusses special considerations associated with API development such as APIs manufactured from biological sources, the use of DMFs, and the management of manufacturing contractors.

Regulatory and Scientific Considerations for API Drug Development is being presented by Dr. William Putnam, Director, Executive Consultant, Scientific Consulting, with Beckloff Associates, Inc. (a Cardinal Health company) and airs on Wednesday, August 26, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

Regulatory and Practical Implications of e-Labeling for IVDs in Europe

With more than 20 official languages in the European Union, manufacturers often encounter challenges when providing paper instructions for use by traditional means. In MEDDEV 2.14/3, the European Commission gives guidance to manufacturers of in vitro diagnostic devices regarding the supply of instructions for use, which can now be provided by alternative means such as a dedicated website. However, there are strict conditions which apply to such websites, including the requirement that the manufacturer also provide a toll-free telephone number for customer support.

In this conference, our speaker details the IVD e-labeling requirements as defined in the MEDDEV guidance, and explains the challenges posed by the implementation of e-labeling solutions that comply with those requirements.

Regulatory and Practical Implications of e-Labeling for IVDs in Europe is being presented by Dr. Dirk Stynen, Founder & Principal Consultant, Qarad and airs on Tuesday, September 8, 2009. For more details, please visit our site at www.fxconferences.com

Off-Label Information: Regulation & Dissemination

Off-label promotion is a perennial hot topic within the life sciences. The rules can appear ambiguous at times, but the consequences of running afoul of FDA are serious indeed. In this audio conference, our speakers provide background information and examine the current regulatory status of off-label promotion of drugs and medical devices. The presentation also looks at the "how-tos" for dissemination of off-label information; the role of sales representatives and medical science liaisons (MSLs), and the practical application of the FDA's January 2009 guidance on reprints.

This session also examines the consequences of off-label promotion, reviews some actual enforcement actions taken against life sciences companies by FDA, and the roles of the Office of the Inspector General, U.S. Attorney's Office and state governments.

Off-Label Information: Regulation & Dissemination is being presented by Caryn Silverman & Soo Kim, Partner & Senior Associate, with Sedgwick, Detert, Moran & Arnold LLP and airs on Thursday, September 3, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Bringing Your IVD Product to the European Market

The European IVD market is widely considered lucrative for its steady growth and strong potential. As such, revenue generation from the EU marketplace is a key factor in the business plans for most new IVD products. One of the major challenges for any IVD product manufacturer is to achieve rapid European market penetration and establish a sustained market presence. However, in most cases a one-size-fits-all approach will not be successful.

In this audio conference, our speakers draw upon their experience in the European IVD marketplace to give attendees an overview of the key European markets to consider when developing a strategy, and provide expert advice on how to tailor your approach accordingly. The presentation focuses on the challenges that need to be addressed by any IVD product manufacturer when preparing to enter the milieu that is the European market.

Bringing Your IVD Product to the European Market is being presented by Paul Kenny & Janine Kukula, Founders, of KKPD, and airs on Tuesday, September 1, 2009. For more details or to register, please visit our site at www.fxconferences.com

Clinical Trial Insurance: Managing Common Problems and Pitfalls

Proof of clinical trial insurance is often a requirement in order to initiate clinical trials. However, obtaining such proof - normally in the form of an insurance certificate - is not always a straightforward process. This presentation explores the reasons behind that, and examines why there is no consistent approach across territories for the same trial/protocol. It also examines the implementation of the European Clinical Trials Directive and the resulting frustrations felt by purchasers of insurance in terms of delay, administration and cost.

In this audio conference, the speaker looks at how the law/regulations, practical requirements, information requirements and insurer approaches can differ by territory, and draws upon extensive experience to put forth some methods of managing this and avoiding pitfalls along the way.

Clinical Trial Insurance: Managing Common Problems and Pitfalls is being presented by James Bird, Partner, with Jardine Lloyd Thompson and airs on Tuesday, September 29, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Using Simulation to Train Medical Device Users and Marketers

Simulation can be a powerful tool for educating your marketing staff and customers on the proper use of medical devices, creating better trained users and in turn, improving patient safety. It is also a technology tool that can be leveraged by both medical device and pharmaceutical manufacturers to benefit physicians and patients, while creating positive returns for sales and marketing.

This audio conference explores the advantages of using simulation for training, marketing and sales to improve the rollout of devices to a user community. It also includes an overview of adult learning strategies and how simulation addresses the needs of the adult learner.

Using Simulation to Train Medical Device Users and Marketers is being presented by Lura Wolfe, Technical Quality Engineer, with Medical Simulation Corporation and airs on Thursday, August 20, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Terminology Management with SDL Trados MultiTerm - Webinar

Working with SDL Trados Translator's Workbench to save and reuse whole sentences is only one part of the translation process. Dictionaries, glossaries, or term bases are also a very fundamental part of translation. SDL MultiTerm offers an automatic lookup during translation with Workbench. In order to be able to work with MultiTerm term recognition, you have to set up your very own term base and fill it with the company- and subject matter-specific terminology of your area of expertise.

During this session, attendees learn how to set up their own term base in MultiTerm, and how to set up an Excel list that can be converted into the MultiTerm import format.

Terminology Management with SDL Trados MultiTerm - Webinar is being presented by Angelika Zerfass, Translation Tools Consultant and airs on Monday, July 27, 2009. For more details please visit our site at www.fxconferences.com

Avoiding the Top 20 Global Documentation Errors

The biggest single hurdle to a smooth globalization effort is written documentation. However, with careful planning, companies can remove communications obstacles before they arise. The technique described in this presentation is called "PokaYoke," a Japanese term for any device or software that can prevent process errors. Learn how you can build quality into your documentation and translation. The presentation covers the top 20 errors that a linguistic "PokaYoke" can find, monitor and correct.

John Smart has spent over two decades helping companies write technical documentation for readers in 218 countries. This presentation uses real-life examples to highlight terms, words and phrases guaranteed to fail any quality control. Attendees will be encouraged to adopt a "PokaYoke" approach to their localization and technical documentation.

Avoiding the Top 20 Global Documentation Errors was presented by John Smart, President, of SMART Communications, and is previously recorded. For more details or to download this event, please visit our site at www.fxconferences.com

Medical Device and IVD Registration in China

China represents an attractive market for many mutinational companies due to two key elements: the dense population and huge consumer base; and the country's rapid economic growth. Due to the government policy of economic regeneration and the urbanization reshaping most regions, Chinese people are gradually becoming more affluent. As a result, there has been exponential growth in the medical device and IVD market in recent years. This phenomenon is similar to the drug industry in the early 90's.

The market potential for these two sectors is simply tremendous. Although there are different predictions and calculations from various experts regarding the market size of the medical device industry, a conservative estimate is over five billion US dollars. China is already the number two player in the Asia market and is just behind Japan in terms of volume. But while the potential is attractive, the registration process for medical devices and IVDs in China is quite lengthy, and the regulatory hurdles significant.

This presentation provides an introduction to the regulatory environment in China, and the requirements and process for registering medical device and IVD products.

Medical Device and IVD Registration in China was presented by Janice Ma, Operations Director & Co-founder, of ChinaGate Ltd. and aired on 2007-08-09. For more details or to download this conference, please visit our site at www.fxconferences.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

How to Mark & Label Devices Under IEC60601-1 3rd Edition

Get up to speed on the latest requirements incorporated into the 3rd Edition of IEC 60601-1 and take the guesswork out of marking and labeling your medical devices.

Marking and labeling is just one area to tackle in the complicated development of medical devices, but it is a critical one to understand. How do you make sense of all those regulations? It’s challenging enough preparing and testing the device; then you have to worry about the user manuals, screen prompts and packaging too!

In this audio seminar, Leo Eisner guides you through each new, added or modified regulation incorporated into the most recent revision of IEC 60601-1. The third edition of this cornerstone standard for medical electrical devices sees major changes from version two you need to know for successful compliance. Ease your marking and labeling stress with detailed guidance from a leading expert.

How to Mark & Label Devices Under IEC60601-1 3rd Edition was presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and aired on 2007-10-23. For more details or to download this conference, please visit our site at www.fxconferences.com

Optimizing RFPs: Simple Steps to Better Responses

Is your organization in the process of putting together an RFP? Have the responses to your past RFPs fallen short of expectations? CRO teams respond to hundreds of RFPs each year. It is clear which sponsors have invested time to build internal consensus and to develop a document that clearly articulates their needs and project goals. The result is a guide that assists the CRO in assembling a higher quality response that directly addresses the needs of the sponsor.

This audio conference is the first in a three-part series designed to share best practices for optimal outsourcing.

Optimizing RFPs: Simple Steps to Better Responses was presented by Beth Mandel, Director of Strategic Solutions, with Covance, and is previously recorded. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Getting Your Money’s Worth from Training and Development

In the current economic climate, companies must maximize the return on investment from every training and development program if those programs are to deliver on the promise of enhanced organizational and individual performance.

In this presentation, Andrew Jefferson, co-author of The Six Disciplines of Breakthrough Learning and Getting Your Money’s Worth from Training and Development explains the keys to optimizing the business impact of training and development, and how to get your money's worth from every dollar you spend. He also explains the Six Disciplines of Breakthrough Learning that dramatically increase the value of any investment in training and development, and discusses a process approach that includes the learner’s complete experience, from the invitation to the new finish line of learning: improved results.

This conference looks at the criticality of getting managers involved and practical steps to increase their participation. It also explores the single greatest opportunity to improve outcomes: the post-course application period and driving learning transfer. The focus throughout is on maximizing the value delivered by any training and development initiative.

Getting Your Money’s Worth from Training and Development is being presented by Andrew Jefferson, CEO, with Fort Hill Company and airs on Wednesday, August 12, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com

How to Select a CRO: Best Practices

The outsourcing and procurement divisions of pharmaceutical and biotech companies are charged with identifying and selecting external vendors most suited to assist them with delivering success for their organizations. Today, with the broad selection of companies available, offering a variety of services, a streamlined, straightforward selection process presents a challenge.

As a whole, the selection process represents a significant time investment from Sponsor organizations. One method for streamlining the selection process is to develop a set of standard criteria to evaluate and judge the respondents. However, the underlying complexity of the multiple variables involved raises questions as to the effectiveness of a standardized approach.

This audio conference is the second in a three-part series designed to share observations on best practices. This presentation discusses the components of CRO selection and will focus on comparing and contrasting a standardized approach versus customized approach.

How to Select a CRO: Best Practices was presented by Teresa Ptaszynska, BSc., PhD, Director, Proposal Development, with Covance and is previously recorded. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Best Practices for Managing In-Country Translation Reviews

It's challenging enough for manufacturers to deal with evolving EU regulations, never mind that your head is spinning from coordinating the reviews of multiple translated components in numerous countries!

Internal politics, miscommunication across time zones, and vacation schedules can make translation reviews an expensive and time-consuming process. Rather than shifting responsibility overseas or skipping reviews altogether, attend this advanced audio conference.

You learn that with proper planning, open communication, and strong vendor relationships, it is possible to reduce turnaround time, keep translation costs manageable and even avoid a few headaches.

Best Practices for Managing In-Country Translation Reviews was presented by Andres Heuberger, President, of ForeignExchange Translations, Inc. and is previously recorded. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Ensuring Compliance in Global Clinical Trials

An increasingly intense competitive environment and the shrinking pools of treatment populations in traditional markets has forced drug companies to ‘go global’ and approach emerging markets to place research and secure enrollment. But how do you ‘go global’ without sacrificing consistency and quality in clinical trials?

This audio conference discusses the unique challenges posed by international clinical trials, and provide a regulatory expert view of how to overcome these challenges and ensure compliance across various countries and geographic regions.

Ensuring Compliance in Global Clinical Trials was presented by Bruce Wagman, Vice President Regulatory & QA Services, with Covance, Inc. and aired on 2008-04-24. For more details or to download this conference, please visit our site at www.fxconferences.com

Recruiting Research Participants Using Web-Based Software

Could the Internet be the key to driving participation in your clinical research? More and more institutions and organizations are successfully using web-based software to recruit larger numbers of research participants for clinical trials and studies. Internet technology can increase recruitment numbers and enrollment, and increase the revenue to the institution when studies are filling with subjects. Anyone with Internet access can get the information they need, register, provide consent, answer a series of questions, and join a pool of potential research participants online.

In this audio conference, our speakers examine how web-based software can make patient recruitment faster and more efficient, and provide real-life examples of the positive results achieved at two leading health care institutions.

Recruiting Research Participants Using Web-Based Software was presented by Geoff Ott, mdlogix & Charles Rathmann, Washington University and aired on 2008-12-11. For more details or to download this conference, please visit our site at www.fxconferences.com

Writing and Responding to RFPs & RFQs

Knowing how to properly write and respond to Requests for Proposal (RFP) or Requests for Quotation (RFQ) are essential business skills. This session explores the key elements that should be included in every RFP, and reviews the components of a complete and sensible work plan that should be included in all proposals.

In this audio conference buyers learn how to craft better RFPs to ensure all responding vendors fully understand your project and can provide complete, apples-to-apples responses. Vendors learn how to write a winning RFP response, regardless of the quality of the RFP, including a work plan that will convince the buyer you have the right team for the job – and ensure that you can do it on time and on budget.

Writing and Responding to RFPs & RFQs is being presented by Chris Willis, CEO, of Media 1 and airs on Thursday, August 13, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com

Implementing QA Automation in an FDA-Controlled Software Environment

With major changes expected at the FDA, including increased scrutiny of complex medical devices, automating your QA process is more important than ever. This presentation provides medical device software engineering and QA professionals with practical guidelines on how to successfully implement QA automation. The speaker discusses how to select and implement the correct tools, how to validate those tools and how to work with technical teams to develop the cost justification.

This audio conference also looks at why the CDRH Software Forensics Lab recently acquired 5 different static analysis tools, and what this means to medical device makers.

Implementing QA Automation in an FDA-Controlled Software Environment is being presented by Ken Carson, Senior Vice President, Client Services, with Full Spectrum Software, Inc. and airs on Tuesday, August 11, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com