Intro to Writing Clinical Study Reports

is being presented by Michael Attella, Senior Regulatory Medical & Scientific Writer, Medical Composition Resources, LLC and airs on Tuesday, May 18th, 2010. For more details or to register, please visit our site at www.fxconferences.com

In an NDA, CTD or BLA, the Clinical Study Report (CSR) can be viewed as a building block for other more integrative and larger-scope regulatory-formatted documents (RFD) like the Integrated Summaries of Safety and Efficacy and even Investigator Brochures. It makes sense then, to train your quantitative writing skills (non-Protocol-oriented, and Results-based) on this most important process.

However, the majority of Regulatory Medical Writers (RMWs) will agree that this skill transcends the ability to write structurally correct grammatical sentences. Unfortunately, the available “how-to” sources for writing RFDs such as CSRs merely reiterate what the FDA sets out in very general descriptive paragraphs in such Guidances as the key E3 [1996] Structure and Content of Clinical Study Reports. There is a method to employ, which, until recently, has only come with experience. This audio conference will detail three of the several facets entailed when writing (and then routing for review) a Phase I, First-in-Humans safety report.

The Art and Science of Drug Product Regulatory Submissions

Collectively, pharmaceutical drug products include a surprisingly wide variety of possible dosage forms and functions. No matter the dosage form, there are requirements that must be met in manufacturing and testing. A high-quality, organized CMC submission should be organized based on the CTD format, and contain information that will aid in a positive review and a quality drug product for patients. Fortunately, there are many similarities across this wide variety of dosage forms, including general product development principles which can be utilized throughout the life of any drug product.

This session provides an overview of the similarities -- and some unique differences -- of manufacturing, analysis and regulatory expectations. Our speaker explains how these similarities can fit together to produce a high-quality submission to the FDA for marketing approval, as well as regulatory maintenance after approval.

The Art and Science of Drug Product Regulatory Submissions is being presented by Dr. Andrew Trammel, Director, Executive Consultant, with Beckloff Associates and airs on Tuesday, December 8, 2009. For more details or to register, please visit our site at www.fxconferences.com

The "Why" and "How" of eCTD Conversions

Effective January 1, 2008, all electronic submissions submitted to FDA in the United States must be in eCTD format. This deadline is forcing organizations within the pharmaceutical industry to evaluate the transition from submitting paper documents to submitting electronic documents to global regulatory agencies.

The transition from paper documents to electronic documents encompasses many areas within an organization and integrates technology with regulatory requirements for submission and regulatory document preparation. This presentation highlights the things sponsors, CROs, testing facilities, and medical writers need to know about the impact of the eCTD on the industry and on their businesses.

The "Why" and "How" of eCTD Conversions was presented by Gina Ross, Director, Managing Consultant Regulatory Publishing Services, with Beckloff Associates a Cardinal Health Company and aired on 2008-01-31. For more details or to download this conference, please visit our site at www.fxconferences.com