As a physician, researcher, educator and dynamic communicator, regulatory submission preparation training is second-nature to Dr. Jalal Al Zawahri. With hands-on experience in phase II-IV, clinical trial implementation, and new drug development, he brings expertise and “hands-on” workshop challenges to course participants. Success in regulatory affairs, medical writing, and FDA submissions provides Dr. AL Zawahri real-life, practical examples that he conveys to the audience most effectively. Experiences as a sub-investigator and medical writer allow him to share applicable Good Clinical Practices, FDA and ICH regulations, adverse events (AE & SAE) evaluation and reporting, compliance, and quality assurance emphasizing “on-the-job” relevancy.