Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on arcane scientific and technical arguments. Because regulations are legally binding requirements predicated upon statutory laws and judicial opinions, it is essential that professionals in the pharmaceutical and medical device companies clearly understand and effectively employ legal writing techniques to frame persuasive argument when negotiating with FDA. The success or failure of many new drugs, biologic or medical device projects hinge on presenting essential information

Date : 3rd August 2017 to 4th August 2017

Place : United States, Raliegh

Website :https://www.eventbrite.com/e/fda-legal-writing-skills-that-result-in-effective-regulatory-quality-submissions-ntz-tickets-33687707841?aff=NDT

Contact Person:Paula Edwards

Description:

Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on arcane scientific and technical arguments. Because regulations are legally binding requirements predicated upon statutory laws and judicial opinions, it is essential that professionals in the pharmaceutical and medical device companies clearly understand and effectively employ legal writing techniques to frame persuasive argument when negotiating with FDA. The success or failure of many new drugs, biologic or medical device projects hinge on presenting essential information

Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on arcane scientific and technical arguments. Because regulations are legally binding requirements predicated upon statutory laws and judicial opinions, it is essential that professionals in the pharmaceutical and medical device companies clearly understand and effectively employ legal writing techniques to frame persuasive argument when negotiating with FDA. The success or failure of many new drugs, biologic or medical device projects hinge on presenting essential information will be held in Raliegh,United States on date 2017-08-04

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Deadline for abstracts/proposals : 1st August 2017

Keynote Speakers : Robert J Michalik, J.D.., RAC, is a Massachusetts regulatory attorney and founder of RegulatoryPro.com, a consulting firm providing general and specialized services to the biopharmaceutical and medical device industries. Mr. Michalik has over 25 years' experience working in the biopharmaceutical and medical device industries. Starting with a bachelor's degree in science (biochemistry), Bob has held a wide variety of technical, quality and regulatory positions that literally span the

Conference Highlights :The seminar will be valuable to any person working in Regulatory Affairs or Quality Management who are responsible for summarizing data and technical results, obtaining regulatory clearance or approval of a product, and selling or marketing regulated products. Regulatory Affairs professionals Quality Assurance professionals Marketing professionals Scientific and Engineering / Product Development Managers Consultants to any regulated industry

Venue :Raleigh, NC, United States

Check the event website for more details.