Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, Biosimilars, Post-Approval Supplements)™

Course Description

This course will give participants the necessary overview of the US Food and Drug Administration's (FDA) current responsibilities, procedures, guidances and regulatory pathways that affect the review and approval of chemical drugs, biologicals, biopharmaceuticals, biosimilars and chemical generics.  Using the ICH Common Technical Document (CTD) module format outline, significant Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be analyzed and discussed, as a basis for strategic planning for both submitting INDs, NDAs, BLAs, ANDAs, and post-approval supplements, as well as for holding key meetings with the FDA.

Similarities and differences between clinical INDs and market approval dossiers, and between the various market approval dossiers (NDAs, BLAs, and ANDAs) will be discussed.  Other topics to be discussed include Fast Track pathway, comparison of chemical generics with biosimilars, FDA's commitments under the User Fee Acts (PDUFA, BsUFA, GDUFA) and FDA's evaluation of industry's performance in meeting its requirements and expectations for review of drug products.

Who Should Attend

Personnel in the pharmaceutical, biopharmaceutical, biologics and generic drug industry who are involved in preparing FDA submissions (INDs, NDAs, BLAs, ANDAs, post-approval supplements) will find this course to be of particular benefit. Those who need to interact with FDA staff, including Project Managers, Regulatory Affairs, Clinical, Nonclinical, Manufacturing, and Quality personnel, will also find this course extremely useful.

Learning Objectives

By the end of this course, attendees will:

• Understand the importance and underlying principles of the FDA regulatory review process for chemical drugs, biologics and biopharmaceuticals from Phase 1 IND through market approval
• Learn how to prepare appropriate and necessary FDA regulatory submissions throughout the drug development process covering the CMC, Nonclinical and Clinical areas
• Learn how to more effectively communicate with the FDA through submissions and meetings
• Fully understand the seriousness with which the FDA carries out its responsibilities and the ramifications of either not filing or filing incomplete submissions

Past Participants' Comments

"Course Director's time management was excellent! Well-tailored course material/presentation slides. Very good presentation skills/delivery of course content by the Course Director. Very friendly, and well-organized CfPIE administrator. Another top class training course from CfPIE. Well-tailored, well-delivered, well done!" Jane M. Senior Clinical Project Leader, Bavarian Nordic

"This was a very well organized course. The pace was perfect and it provided a wealth of information to enhance my ability to file INDs and NDAs. This course was well worth the cost and time away from work." Dr. Sandra W., Research Fellow, Merck

"The content of the course was exactly what I was looking for – comprehensive review with practical applications through real-life examples. The knowledge base and personal experience of the instructor and ability to make the course interactive provided an optimal learning environment on a somewhat heavy topic." Jim C., Director, Medical Research, Pfizer

"The course director was incredible and thoroughly versed in the subject matter. Top notch trainer!" Yvonne S., QA Document Manager, Inst. For One World Health

"Very personable Course Director. Held the attention of the class. Very well-organizaed and prepared. Course Notes were well organized. Able to handle questions well and present ‘real-life’ experiences." Angela S., Medical Writer, Abbott Laboratories

"Always nice to see actual or mock documents of how things look eCTD, CTD, slides of pre IND meeting examples. Thank you so much, the course was very well done!" Tammy L., Regulatory Affairs Senior Manager, Ultradent Products

"This course gave a great overview and insight into requirements for submissions and working with the FDA. The Course Director’s experience provided additional insight that was appreciated!" Amy H., Regulatory Affairs Manager, Cardinal Health

"Very comprehensive and easy to understand!" Carl D., Team Leader of Regulatory Affairs, The Dial Corp.

"The speaker was superior. Seldom do I go to a course where the speaker does not read the overheads word for word. Super, Super, Super!" Chandler W., Manager, Analytical Services, Stability Group

"The Course Director articulated his ideas and the course content in a manner that was concise and interesting. This was the best course and instructor that I have been exposed to thus far. Excellent speaker…great job!" Lynn C., Regulatory Affairs Associate, Biomira

"Great balance of overview of a high amount of material, but also a lot of specific, practical advice." Sean O., QA/Regulatory Compliance, MD Andersen

Frequently Asked Questions

How much of the course deals with NDAs and how much with INDs?

The course discusses all the ICH requirements for the CMC section of NDAs, i.e., Module 3 and the Quality Section of Module 2. This provides participants who are working on NDAs with a detailed outline from which to construct an NDA. For participants who are working on INDs, the course provides the scope of studies that will be needed to prepare an NDA and a discussion of the reduced requirements for each Module 3 section for INDs in Phase 1, 2 and 3.

Does the course cover biologics and ANDAs?

The course does not cover the information and data required for filing a biologically produced active ingredient to be filed with CBER nor specific requirements for ANDAs.

Does the course cover post-approval changes?

The course addresses submission of Comparability Protocols for post-approval changes but not other guidances related to post-approval changes.

I am new to CMC and regulatory affairs. Will I understand what is being presented?

The course covers the requirements for NDAs and INDs in a very systematic way and provides a complete overview so it is a good introduction to this field.

I have filed several NDAs already. Will I get anything out of the class?

Participants with experience filing NDAs have found the course valuable in assessing whether they are filing too much or too little information and data.