Best Practices for Successfully Implementing a Global Content Management System

is being presented by Jason Arnsparger, Solutions Development Consultant, with ForeignExchange Translations, Inc. and airs on Thursday, January 12th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Thinking about implementing a content management system? As the demand for technical, training, marketing documentation and product labeling increases, so too does the need to deliver this content more quickly and in more languages. To meet these requirements, many regulated companies are migrating towards structured authoring and content management systems that enable the re-use and re-purposing of existing content.

In this presentation, our speaker draws upon first-hand experience, first with a medical device company and more recently with a localization provider, and discusses tips, challenges, best practices and lessons learned with CMS implementations. Attendees receive valuable insight and hear first-hand how to reap the CMS benefits while minimizing implementation headaches.

Increased FDA/CMS Coordination: What it Means for Industry

is being presented by Dr. Edward E. Berger, Principal and Founder, with Larchmont Strategic Advisors and airs on Tuesday, April 12th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Efforts to improve communications and coordination between FDA and CMS, including an initiative to implement a formal program for parallel review of new products by the two agencies, have sparked industry concern over the potential blurring of the heretofore bright line between the FDA’s market clearance function and CMS’ responsibility for Medicare coverage and payment determinations. This concern is compounded by the absence of established mechanisms at CMS for the safeguarding of company confidential information contained in regulatory submissions.

This audio conference presentation looks at the present status and likely outcomes of FDA/CMS interagency coordination efforts, and evaluates the opportunities as well as the threats posed by those efforts to developers of new therapeutics, devices and diagnostics.

Building a Global CMS: Challenges & Lessons Learned

Developing and implementing a global information management system is a daunting process, and the challenges are magnified for any company working within a regulated industry. With production facilities in the US and Europe and products sold in 92 markets, CaridianBCT is a world leader in blood collection and processing technology. This audio conference provides a first-hand account of how the CaridianBCT technical communications team implemented a scalable, flexible and measurable global information management system – from source content development through localization..

This case study looks at how CaridianBCT is implementing the Astoria content management system and integrating it with the Idiom WorldServer translation management system, improving the throughput, efficiency and traceability of the localization process. The speakers also discuss the drivers for change, how standards helped, and time, cost and resource considerations.

Building a Global CMS: Challenges & Lessons Learned is being presented by Jason Arnsparger & Jennifer Linton, Localization Project Manager & XML and CMS Project Manager, with CaridianBCT and airs on Tuesday, April 7, 2009. For more details or to register for this event, 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