Preparation of FDA Submissions and Communicating with the FDA

Course Agenda

First Day

Legal Basis for FDA’s Authority to Regulate Chemical Drugs, Biologics and Biopharmaceuticals

• Overview of human medicine regulation by the FDA
• Drug regulatory pathways granted to the FDA by U.S. Congressional laws
• Human medicine distinctions: chemical drugs vs. biologics, CDER vs. CBER, generics vs. biosimilars

FDA Regulatory Drug Development Review and Approval Process

• FDA's requirements/expectations for CMC, Nonclinical, Clinical content from Phase 1 through market approval
• Differences in the FDA regulatory review and approval pathways for NDAs, BLAs, ANDAs and biosimilars
• Accelerated and fast track FDA review opportunities

Meeting with the FDA

• PDUFA, BsUFA, GDUFA meetings with the FDA - justified not entitled
• Risk assessment – when should you have a meeting with the FDA
• Lessons learned of what to do/not to do

Critical Importance of FDA Submissions and Communication during the IND Stage

• What the FDA is looking for in IND submissions/amendments – avoiding the 'clinical hold'
• Forms, format and content required during the clinical stages
• Strategic value of the End-of-Phase 2 (EOP2) meeting with the FDA

Second Day

Critical Importance of the FDA NDA/BLA/ANDA Dossier Preparation

• Need to avoid the Refusal to File
• What the FDA is looking for in the market application dossier – forms, format, content
• Strategic value of the Pre-NDA/BLA submission meeting with the FDA

FDA Review and Approval of the NDA/BLA/ANDA Submission

• First milestone – avoiding the 'Refusal to File'
• Intense interactions with the FDA covering CMC, Nonclinical and Clinical
• Race to meet the time clock – avoiding the Complete Response Letter

Post-market Approval Submissions and Interactions with the FDA

• Supplements for changes in CMC and Clinical, and required FDA reporting/updating
• Problem reporting: Field Alert Reports (FAR), Biologic Product Deviation Report (BPDR), and ORA inspections
• Honoring post-market approval commitments and ongoing adverse event reporting

Navigating the Rich FDA Website Resources

• On-line resources for Drugs
• On-line resources for Biologics
• Insights into the FDA NDA/BLA review process

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

Testimonials

"This was a well-balanced and complete course and very well structured. The tips and lessons learned were very useful." Olivier B., Senior Regulatory Affairs Associate, Ablynx NV

"I was very impressed with the breadth and depth of knowledge the course director had!" Jennifer, Regulatory Affairs Specialist, Liebel-Flarsheim Company LLC

"My expectations were exceeded with this course. I definitely recommend this for all pharma professionals who are keen to develop their skills in contacting the FDA and to learn how his communication process works." Carlos V., Early Development Manager, Ache Laboratorios Farmaceuticos

"This was an excellent course even for seasoned professionals. This course offers a great overview of the current regulatory environment while also promoting interactions between industry professionals. A great course for professional development." Rachael G., Regulatory Associate, USWorldMeds

"Very good course, interactive and very useful for regulatory professionals. It covered all points from agenda and complied with the objectives. This course helped me to better understand FDA regulations." Maria R., Regulatory Affairs Manager, Probiomed S.A. de C.V.

"I liked the course organization and the material. The communication with the Course Director was very easy." Erica L., Regulatory Affairs Specialist, Probiomed S.A. de C.V.

"The Course Director did a great job in keeping us engaged. I most enjoyed the specific examples that were presented within the different topics covered throughout the course. The course content was very thorough, as well as current (updated). This is very important in this field. After attending the course, I have a better understanding on how to prepare/ communicate for FDA interactions. I enjoyed the course very much. He is a great, very knowledgeable instructor!" Daphne, Scientist, Janssen R&D

"This course was pretty intuitive with very good, real-life examples. I like the global perspective incorporated into the presentation slides." Lara N., Director, Regulatory Affairs, Nexgen Pharm

"Very thorough. We covered a large amount of information and the Director was knowledgeable and willing to answer a wide range of questions." Vincent A., Regulatory Affairs Manager, Prestige Brands

"Thoroughly enjoyed the course. Course Director presented and spoke at a good pace to keep your interest peaked. Now have a much better understanding of the submissions process. Knowledge gained in this course will help in my day-to-day work life." Joanne A., Sr. Medical Affairs Coordinator, Bayer

"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

"This course was a great overview of the submission process. Has been very informative, as my company is preparing for an IND filing." Caitlin C., QA Document Control Specialist, Celtaxsys

"The Course Director was an excellent trainer and presenter. The course was fabulous, and I have a very good understanding of the material. The materials, media, internet references will all be put to good use. Thank you for the great experience - I am ready to apply my knowledge!" Stacey H., Sr. QA Associate Regulatory Affairs, Gallus BioPharmaceuticals

"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 INDs and how much with NDAs/BLAs?

The course covers all aspects of FDA submissions and communicating with the FDA; all the way from submission of the original IND, through IND amendments, FDA meetings during clinical development, preparation and submission of the market approval dossier (NDA, BLA, ANDA) and maintenance of the market approval.

Does the course cover CMC, Nonclinical and Clinical concerns?

The course covers FDA concerns and expectations for Chemistry, Manufacturing & Control (CMC), Nonclincal (i.e., animal studies) and Clinical (i.e., human studies).

I am new to regulatory issues. Will I understand what is being presented?

The course systematically covers all aspects of FDA submissions and communications in three layers. The first layer is a broad overview, and the remaining two layers each dig deeper into understanding the FDA concerns.