Improving the Efficiency of Regulatory e-Submissions

is being presented by Donald Palmer, Associate Director, Regulatory Systems, with MedImmune and airs on Tuesday, November 16th, 2010. For more details or to register, please visit our site at www.fxconferences.com

As more companies work closely with partners, outsource partners, or CROs, the need to standardize processes and requirements for electronic submissions is becoming more pronounced. In addition, there is a need for these interactions to be efficient, from publishing processes and systems to document management, to the authoring process.

This audio conference presentation looks at the current types of processes and technology needed for electronic regulatory submissions, for companies both small and large. It also considers possible changes to these processes and technology, as a company grows and/or seeks to gain greater efficiencies. The speaker also looks at where tools might be developed and/or integrated for further efficiencies.

Effective Translation Process for Japan Regulatory Submissions

is being presented by Jason Heaton, Compliance Specialist, with ForeignExchange Translations, and airs on Wednesday, November 3rd, 2010. For more details or to register, please visit our site at www.fxconferences.com

Many companies doing business in Japan rely on their Japanese affiliates to handle the creation of regulatory documentation, due to language and cultural considerations and the complexities of Japanese regulations. A problem with this approach is that often the US-based companies then don't know exactly what was submitted to the government, which can have serious implications.

The Japan submission dossier preparation and translation process requires a unique approach. Cooperation among submission authors, the translators and the Japanese affiliate is essential to make it work. When it does, a company can be assured that its English and Japanese submissions stay consistent, and there are no questions about what is submitted. It has the side benefit of building cross-cultural teams, where both parties focus on their core competencies.

This audio conference discusses how regulatory documentation gets translated, looks at specific approaches companies take for their Japan dossier creation, identifies the problems with the usual approaches, and then presents best practices for creating consistent, accurate and timely submissions.

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, with Nancy Hoft Consulting, and is previously recorded. For more information, 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

Effective Translation Process for Japan Regulatory Submissions

Many companies that do business in Japan rely on their Japanese affiliates to handle the creation of regulatory documentation, due to language and cultural considerations and the complexities of Japanese regulations. A problem with this approach is that often the US-based companies then don't know exactly what was submitted to the government, which can have serious implications.

The Japan submission dossier preparation and translation process requires a unique approach. Cooperation among submission authors, the translators and the Japanese affiliate is essential to make it work. When it does, a company can be assured that its English and Japanese submissions stay consistent, and there are no questions about what is submitted. It has the side benefit of building cross-cultural teams, where both parties focus on their core competencies.

This audio conference discusses how regulatory documentation gets translated, looks at specific approaches companies take for their Japan dossier creation, identifies the problems with the usual approaches, and then presents best practices for creating consistent, accurate and timely submissions.

Effective Translation Process for Japan Regulatory Submissions is being presented by Jason Heaton, with ForeignExchange Translations, and airs on Wednesday, July 29, 2009. For more details, or to register for this audio conference please visit our site at www.fxconferences.com

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

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