The Regulatory Department is the key contact with regulatory agencies. Regulatory must prepare documents that inform the agency about the proposed development plan, keep the agency up to date and answer any questions the agency has about an on-going investigation, request and prepare for meetings with the agency to discuss development plans, construct and write the marketing application and submit any updates to the marketing application in a concise and informative manner.

Submissions to a regulatory agency involve more than just writing. They also encompass strategy, editing, publishing and systematic tracking of key information. Through lectures, case studies, and hands-on exercises, new and experienced regulatory professionals learn how to work with the regulations, guidance documents and style guides to produce submissions that comply with the requirements and are clear to the reviewers.

In this practical workshop, approved drug labels and summary basis of approvals are used to help students acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including pre-marketing and marketing applications. Participants also gain experience with tools that help manage timelines and sections needed from contributors.

Learning Objectives

• Find the required regulations and guidance documents for drug and biologic submissions.
• Use regulations and guidance documents to outline and construct a variety of drug and biologic submissions.
• Formulate a working knowledge of regulatory submissions, publishing, and style guides.
• Create checklists that encompass timelines and sections needed from contributors.

Course Outline

Food and Drug Adminstration (FDA) Division Information

• Submission basics - outlining the submission, creating the Table of Contents, timing of submission/timelines, contributions from other departments, editing, style guides, templates, supportive documents, Quality-Assuring (QAing) the submission

Publishing the Submission

• Submission publishing basics
• Copies (how many to make and keep)
• Introduction to electronic publishing requirements

Tracking the Submissions

• Creating the index history
• Creating an issues log
• Common Technical Document (CTD) format

Pre-Market

• FDA meetings (Type A, B and C): phase I, phase II, end of phase II, requesting the meeting, preparing the meeting package, meeting minutes
• Additional submissions: fast track, orphan drug, special protocol assessment
• The submission
• Routine submissions: clinical submissions, non-clinical submissions, annual reports, investigator brochure updates, protocol amendments, investigators

Marketing Application

• Non-Disclosure Agreements (NDAs) in a CTD format