Technical and Regulatory Writing for FDA-Regulated Industry

In the field of regulatory affairs, professionals often encounter the task of writing complex documents for diverse audiences. These documents encompass a wide range, including reports, protocols, clinical trial and marketing approval applications, technical reports on studies, and various communication documents. The purpose of this exclusive technical writing workshop is to provide regulatory professionals with valuable insights into best practices and regulatory strategies for crafting effective documents. The workshop will cover a spectrum of writing needs, from simple issues like minutes of meetings and correspondence notes to more intricate tasks such as producing comprehensive nonclinical and clinical study reports, as well as regulatory submissions to regulatory bodies such as FDA, EMA, Health Canada, and others. During the workshop, the trainer Dr. Mukesh Kumar will share practical tips and utilize examples to demonstrate effective methods of organizing and conveying information in clear and readable documents. They will cover essential aspects such as editing, formatting, presenting, and publishing technical regulatory documents to ensure they are well-received by regulatory agencies. Additionally, the workshop will explore the guidelines for writing documents intended for electronic submission to FDA and other regulatory authorities. This unique workshop is designed to equip regulatory writers of all skill levels with technical, practical, logical, and logistical tips to enhance their abilities.

Topics: Technical Writing, Regulatory Writing, Clinical Trials, Clinical Research, Clinical Development, Clinical Studies, Electronic Submission, FDA Regulations, FDA Compliance