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Technical and Regulatory Writing for FDA-Regulated Industry
Regulatory professionals have to write highly technical documents for a variety of audience. These documents include reports, protocols, clinical trial and marketing approval applications, technical reports on studies, and communication documents. This workshop will address best practices, and regulatory strategies on how to write effective documents covering anywhere from simple issues such as minutes of meetings and correspondence notes, to highly sophisticated nonclinical and clinical study reports, and regulatory submissions to FDA, EMA, Health Canada, and other regulators.
The trainers will provide practical tips using examples on how to organize and deliver information into clear and readable documents, and how to edit, format, present and publish technical regulatory documents for most favorable reception by the regulatory agencies. The workshop will also discuss rules for writing documents intended for electronic submission to regulatory agencies. This one-of-a-kind workshop will provide technical, practical, logical and logistical tips for regulatory writers of all levels of skills.
Don't wait to register for the Technical and Regulatory Writing for FDA-Regulated Industry. You'll meet influential people and maximize your opportunities for success. Start now by accessing the information below.
|Conference/Event Dates:||12/08/2016 - 12/09/2016|
|Conference/Event Hours:||8am-4pm EST|
|Primary Industry:||Other / Miscellaneous|
|Other Industries:||Business, Other / Miscellaneous|
|Cost to Attend:||http://www.fdamap.com/registration_technical-writing-workshop.html|
|Audience:||Regulatory affairs professionals preparing IND, DMFs, NDAs and other submissions
Medical and Technical writers
Project Managers, Directors
Supervisors, and lead workers in Regulatory Affairs
Quality Assurance and Quality Control
IT professionals looking to make eCTD submissions
|Venue:||Sheraton Boston Hotel|
|Venue Phone:||(410) 501-5777|
|Venue Type:||Indoor - Hotel|
|Official Conference Hotel:||Sheraton Boston Hotel|
|Conference Hotel URL:||www.sheratonbostonhotel.com|
|Booth Size||Booth Cost||Available Amenities|
|Marketing Vehicles Allowed:||n/a|
|Other Booth Sizes Available: n/a|
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