How to Successfully Select a Translation Vendor: Best Practices and Common Pitfalls

Selecting the wrong translation vendor can cripple your new product launch or upgrade, waste your precious time, drive up your overall project costs and potentially result in significant lost revenue. What you don't know CAN hurt you!

The selection of the right language partner directly affects the success of your translation project. Whether your text is promotional or technical in nature and whether you need to have it translated into one language or many, find out how to select the right translation vendor to fit your company's specific needs. So that you can minimize the hassles and unexpected surprises that can occur over the course of a translation project -- big or small!

Learn how to avoid common pitfalls when selecting linguistic specialists and how to dig beneath the surface to find out who can really get the job done.

How to Successfully Select a Translation Vendor: Best Practices and Common Pitfalls was presented by Eve Lindemuth Bodeux, Founder of Bodeux International LLC. This audio conference aired on 2003-04-29 and is available at www.fxconferences.com

How to Evaluate Your RiskMAP

A key element of any Risk Minimization Action Plan (RiskMAP) is the description of ways in which the Sponsor will determine if the risk minimization efforts are working.

In this audio conference, Dr. Stemhagen discusses strategies and approaches for evaluating RiskMAPs, in conjunction with the types of risk minimization "tools" that can be implemented. She also describes the range of evaluation methods that can be used to evaluate risk management interventions, such as use of existing databases, market research data, and ad hoc data collection through registries and large simple studies. Dr. Stemhagen provides attendees with examples of metrics developed from ongoing programs, and outline strategies for selecting the most appropriate evaluation tools for the circumstances.

How to Evaluate Your RiskMAP was presented by Dr. Annette Stemhagen, VP Epidemiology & Risk Management, with United BioSource Corporation and aired on 2006-10-12. For more details or to purchase a download of this conference, please visit our site www.fxconferences.com

Biologic vs. Non-biologic: Current FDA Thinking on IVDs

In the United States, in vitro diagnostic products are classified and reviewed under two separate FDA Centers, depending on whether the product is intended to be used to diagnose a condition, predict if a particular treatment will be effective or monitor the effect of a treatment, or if it is intended to be used in the testing of transfusable blood or cellular products.

In this audio conference we highlight the differences in the two product review processes between the Centers and provide insight into their expectations regarding information required in submissions and following product approval. Recent Guidance Documents issued by FDA are discussed.

Biologic vs. Non-biologic: Current FDA Thinking on IVDs was presented by Ann Quinlan-Smith & Pamela J. Vaughan, President & Senior Principal Consultant, with Alquest, Inc. and aired on 2008-02-28. For more details about purchasing a download, please visit our site www.fxconferences.com

Maximizing Results Through Your Workforce: Hire More People or Develop the People You Have?

In our current business climate it seems like everyone is trying to do more with less, and that includes people at your workplace, too. So how can you maximize results when people are overwhelmed and stressed out? Through strategic talent development - and engaging people to further develop their skills and enhance their desirability to their employer. What if you don't have time to develop people? Is this time to strategically add people to your team? You bet.

Through GAP Analysis and Case Studies you will discover how to evaluate your current team, maximize their production, and produce better results. In this session, we will go step by step through a skills inventory and GAP Analysis to help you clarify your team member’s strengths and areas of development to meet or exceed your corporate objectives, and help you determine whether or not you need to hire to supplement team strengths.

Maximizing Results Through Your Workforce: Hire More People or Develop the People You Have? is being presented by Laura Raynak, Managing Director, with Raynak Executive Search and airs on Wednesday, January 21, 2009. For more details, please visit our site www.fxconferences.com

Managing Long-Term Registries: Strategies for Successful Management of Long-Term Clinical Programs

Management of registries and other longitudinal studies creates unique challenges for sponsors, CROs, and other vendors. Programs of many years’ duration are faced with management and operational challenges. Management challenges include staff turnover at the sponsor as well as CROs and vendors. Proactive management of these staff changes that ensure successful ongoing team interactions is essential to program survival. Maintenance of project document history and documentation is another management challenge for long term programs. Ensuring that project decisions and documentation are well specified and accessible to all relevant stakeholders ensures common understanding and expectations across all stakeholder groups and assists project teams in addressing questions about decisions made by predecessor teams or team members.

Operational challenges for managing long term programs include changes in the marketplace and standards of care. Changes in these over time can significantly impact sponsor needs for data. Additionally data collection tools and strategies can also change significantly over time. Use of sequential adaptive methodology to anticipate potential changes at the program planning stage can facilitate changes as these are required over time.

Finally, challenges can be posed by turnover of site staff site, and long term involvement and enthusiasm of sites can be difficult to maintain. Strategies for successful engagement of sites for the study’s duration, and retraining of site staff over time require upfront planning and ongoing re-examination. Representatives from stakeholder groups including CROs, Other Vendors/Sponsors/Sites will discuss lessons learned from the management of long term programs including strategies that have contributed to successful management as well as pitfalls to avoid in managing future programs.

Managing Long-Term Registries: Strategies for Successful Management of Long-Term Clinical Programs is being presented by Eunice Franklin-Becker, Project Manager, Registries and Observational Studies, with Covance Periapproval Services and airs on Thursday, February 25, 2008. For more information or to register for the conference, please visit our site www.fxconferences.com

The Employee Free Choice Act: What it Means for Employers

If the Employee Free Choice Act passes, it may be the biggest shift in Federal Labor Law since the 1940s, and could severely affect your organization. Employers should understand and be prepared for the movement this Act will create toward a labor organization. This Act will amend the National Labor Relations Act and change the procedures in which employees choose to or not to join a union. Employers should be proactive in learning and creating a good offense to limit labor organizing.

Lisa Anne Friday, a leading expert in the Medical Human Resources field, will give a comprehensive overview of the act, and how it will impact the way you and your company do business. This presentation is set to arm you with a greater understanding of the Employee Free Choice Act and better understand the new climate your organization may be working under, should the Act pass in the first quarter of 2009.

The Employee Free Choice Act: What it Means for Employers is being presented by Lisa Anne Friday, Human Resource Division Director, with Community Health Systems and airs Wednesday, January 7th 2009. For more details or to register for this audio conference, please visit our site www.fxconferences.com

Electronic Submissions in Europe – eCTD and non-eCTD Submissions (NeeS)

December 31, 2009 is 385 days away. Why is this significant? European regulatory authorities are targeting January 1, 2010 for all national Competent Authorities(NCA) to accept eCTD-only submissions for marketing applications. In addition, for Sponsor organizations already filing eCTD submission in Europe, version 1.3 of the EU Module 1 specification for eCTD submissions is effective January 1, 2009. The EU Module 1 specification was revised in May 2008 to include section 1.10, Paediatric Information.

With the multiple filing procedures in Europe, the eCTD presents many interesting challenges. Which filing procedure is most appropriate? Should a Sponsor file individual submissions or combined submissions for the Reference Member State(RMS) and the Concerned Member States(CMS)? Which countries accept eCTD-only submissions, eCTD with a paper copy of one or more modules, or non-eCTD Submissions(NeeS)?

Now is the time for Sponsor organizations to recognize the true value of the eCTD for global regulatory submissions.

Electronic Submissions in Europe – eCTD and non-eCTD Submissions (NeeS)is being presented by Gina A. Ross, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates and airs Tuesday, January 20th 2009. For more details or to register, please visit our site www.fxconferences.com

The New Rules for Continuing Medical Education

Both industry supporters (pharmaceutical, biotech and medical devices companies) and Continuing Medical Education providers have been affected by changes in the rules governing commercial support of CME programs. Industry support of CME has been scrutinized by Congress. The ACCME has issued new guidance, as well as a “Call for Comment,” on the issue of industry funding. The new PhRMA Code specifically addresses CME funding, as do certain state laws, most notably the new Massachusetts law governing relationships between industry and physicians.

Life sciences companies need to keep abreast of these changes to make sure their internal policies are consistent with the latest law and guidance. CME providers need to be current as well, both to maintain their accreditation status and to be sure they are able to remain competitive in the current environment. In this audio conference, we take a look at the new rules and what sponsors and providers need to do to comply.

The New Rules for Continuing Medical Education is being presented by Maria D. Buckley, with Nutter McClennen & Fish LLP and airs on Thursday, January 8, 2009. For more details or to register for this conference, please visit our site www.fxconferences.com

Risk Management Best Practices for Medical Devices

Managing risk has always been an integral part of medical device development, but is now becoming more integrated with quality management systems. Previous experience with “risk assessment” had been the application of risk analysis to determine specific risks associated with a device. This is no longer the case with a quality management system such as ISO 13485 and the recently updated ISO 14971 standard defining and clarifying the risk management process.

This presentation helps organizations to better understand how risk management can reach its full potential as a management tool. When there are complaints or adverse events for a product family, have these been addressed in the risk analysis? When does the risk management file get updated or reviewed? How does an organization go about creating a system to assure that risk management fulfills that role within the product life cycle? These questions will be answered as the speaker walks attendees through the process of implementing a risk management system within a medical device company.

Risk Management Best Practices for Medical Devices is being presented by Richard Vincins, Senior Consultant, with Emergo Group and airs on Thursday, January 22, 2009. For more details, or to register for this audio conference, please visit our site www.fxconferences.com

Effective Licensing in the Wake of MedImmune v. Genentech

The licensing of life science technologies, especially oncology-related technologies, is becoming an essential part of doing business. With MedImmune v. Genentech, the United States Supreme Court transformed the relationship between patent licensors and licensees. Historically, licensees were prevented from challenging patents on invalidity grounds. Now, a licensee may challenge a patent's validity while paying royalties to the licensor.

Although framed as a procedural question of standing to bring suit, the application of this Supreme Court case has the potential to shift the decision making of licensors and licensees and to significantly change the volume and cost of patent licensing activities. In this audio conference Dr. Samardija explores the Supreme Court decision and the various decisions that have followed, and provides attendees with 10 drafting tips to decrease the risks associated with a licensee challenging the validity of a patent.

Effective Licensing in the Wake of MedImmune v. Genentech is being presented by Michael R. Samardzija, PhD, with Bracewell & Giuliani and airs on Thursday, January 29, 2009. For more details, or to register for this conference please visit our web site at www.fxconferences.com

Global Patent Standards

Is your patent adequately protected in all of the markets where you do business? Are you sure about that?

In many industries, patent protection in both the United States and abroad is critical, but the requirements for each country are not necessarily the same. Thus, in developing a patent strategy, the different requirements of countries where protection is desired must be considered prior to filing.

In this audio conference, we review the various global patent standards in countries where patent protection is typically sought. Particular emphasis will be placed on written description requirements, obviousness and inventive step standards in the United States and in Europe.

Global Patent Standards is being presented by Christopher Rhodes, PhD, JD, Intellectual Property Attorney, with Lowrie Lando & Anastasi LLP and airs on Thursday, January 15, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

Medical Device Research and Regulations in Israel

Israel represents the largest single medical device market in the Middle East, valued at roughly 885 million dollars and growing at an annual rate of almost 5%. There is an extensive medical network and high doctor-to-patient ratio, both reflected in a low infant mortality rate and high life expectancy. Distribution of medical conditions and trauma is comparable to the EU and USA.

Israeli schools provide medical professionals with Western-level training, and as a result the country operates on the frontier of medical technology development. With its experienced doctors and high-tech medical facilities, Israel offers medical device companies a regulated, accepting environment in which to conduct clinical studies of the highest quality. Study enrolment is high, as is data quality.

This audio conference provides attendees with information on the regulations governing Israeli clinical studies, and the requirements for placing your medical device on the market in Israel.

Medical Device Research and Regulations in Israel is being presented by Efraim Roe Kozorovitsky, Executive Director - Medical Devices, with Premier Research Group and airs on Thursday, February 5, 2008. For more details or to register for the audio conference, please visit our site www.fxconferences.com

Device Advertising and the First Amendment: Your Rights

Within recent years the effect of the First Amendment on FDA-controlled speech has drastically changed. Courts have stated standards for what FDA can do in controlling speech in advertisements. The difficult question is predicting the practical impact of these court decisions. FDA still has enormous authority to control speech and labeling. This presentation discusses the balance between FDA control of indications versus court restrictions on FDA control of speech.

Device Advertising and the First Amendment: Your Rights was presented by Robert J. Klepinski, of Fredrikson & Byron and aired 2007-08-23. This audio conference will be replayed on Wednesday, December 17, 2008 by popular demand. For more details or to register for this conference please visit our site 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, of Fredrikson & Byron and aired 2007-01-18. For more details or to purchase a download of this event, please visit our site www.fxconferences.com