Technical and Regulatory Writing for FDA Regulated Industries

Course Description:

Regulatory professionals have to write highly technical documents for a wide 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 spanning everything 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.

Some of the key takeaways from this seminar will include:

• Practical tips using examples on how to organize and deliver information in clear and readable documents.
• How to edit, format, present and publish technical regulatory documents for most favorable reception by regulatory agencies.
• Rules for writing documents intended for electronic submission to regulatory agencies.
• Technical, practical, logical and logistical tips for all regulatory writers.

Who will Benefit:

• Regulatory affairs professionals preparing IND, DMFs, NDAs and other submissions
• Medical and technical writers
• Project managers and directors
• Supervisors and lead workers in regulatory affairs
• Quality assurance and quality control
• IT professionals looking to make eCTD submissions

For Registration -   http://www.complianceonline.com/technical-regulatory-report-writing-for-e-submission-sops-protocols-clinical-trial-and-marketing-approval-applications-seminar-training-80237SEM-prdsm?channel=pickevent

Note: Use coupon code 232082 and get 10% off on registration.