2-day In-person Seminar (March 22-23, 2018)

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.   
Who Will Benefit:
  • 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

    For more info, fill the box below. We will contact you within 24 hrs.

For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com