An Introduction to Regulatory Writing: Creating an Effective Message

Did you ever wonder what reviewers look for in your regulatory submissions? This audio conference combines the results of two in-depth interviews regarding effective writing in regulatory submissions and with known effective writing techniques and practices. The interviews were with a previous FDA reviewer and a current reviewer for a large Notified Body. Both interviewees shared their reactions to the quality and effectiveness of the writing in the hundreds of submissions they have each reviewed.

Topics include: analyzing the audience, identifying topics, organizing the topics in a logical way, applying document design principles, establishing document management conventions, writing, and assessing the effectiveness of your writing.

An Introduction to Regulatory Writing: Creating an Effective Message was presented by Nancy Hoft, of Nancy Hoft Consulting and aired 2008-07-16. For more information or to purchase a download of this event, please visit our site www.fxconferences.com

Conducting Drug Trials in Asia Pacific

With constant pressure to reduce the cost of drug development and to find eligible subjects for clinical trials, developing areas of the world are of increasing interest to trial sponsors. But how does the quality of data compare with traditional sites? And what about the rate of recruitment? Do these alternative sites really offer a substantial benefit in terms of time and cost savings?

This presentation, the second in a series featuring speakers from Covance addressing alternative site selection, focuses on the opportunities and the reality of performing clinical trials in the Asia Pacific market.

Conducting Drug Trials in Asia Pacific was presented by Dr. Helen Ormandy, Director, Centres of Excellence, with Covance Asia Pacific and aired on 2006-05-04. For more details or to purchase a download, please visit our site www.fxconferences.com

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