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.

Studies in Special Patient Populations: More than Just a Regulatory Requirement

In global drug development, supportive trials -- such as those in special patient populations -- are required to complement the regulatory submission package. Studies in hepatically or renally impaired patient populations are therefore often performed in parallel to Phase III trials in order to have them completed when the NDA is filed. However, in aging populations with reduced organ function, these studies can provide valuable information on interpretation of clinical data generated in Phases II and III.

In this audio conference, the speaker discusses the strategic and organizational aspects of these trials, while providing a deeper understanding of their value in special patient populations.

Studies in Special Patient Populations: More than Just a Regulatory Requirement is being presented by Dr. Christian Reh, Vice President, Clinical Affairs, Early Development Services, with PRA International and airs on Thursday, October 29, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

The Pre-IND Program: 12 Steps to a Successful IND Filing

The Pre-IND phase of drug development is the foundation upon which all subsequent IND research depends, in order to obtain FDA market approval (NDA) after completion of required Phase 1-3 trials. Therefore, it is essential to give proper forethought and attention to these first, all-important steps. This audio conference looks at the 12 essential steps to complete during the Pre-IND phase of development leading to the filing of an original IND with the goal of obtaining FDA approval for initial Phase 1 clinical trials.

Our speaker, veteran industry expert Dr. Larry Hofmann, will give expert guidance on the optimum background and make-up of your pre-IND development team. He will also discuss strategic planning for and preparation of the FDA meeting information package -- provided to the FDA reviewing division 30 days prior to the pre-IND meeting -- which must include available pharmacology and toxicology summaries, as well as a summary of CMC data on the IND clinical formulation to support the proposed Phase 1 and Phase 2a study protocols.

The Pre-IND Program: 12 Steps to a Successful IND Filing is being presented by Dr. Larry Hofmann, President, with LMH Associates, Inc. and airs on Tuesday, March 31th, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

This audio conference has been pre-approved by RAPS as eligible for one (1) credit toward a participant's RAC recertification upon completion.