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11 reviews for
Understanding US FDA Regulatory Affairs
28 May 2026 | 1-Day Live Online Course
Original price was: £595.£476Current price is: £476.
Develop effective regulatory strategies when working with the FDA
Learn more about the course by toggling through the tabs below.
Course Overview
To place your pharmaceutical, biotech of advanced therapy on the US market you must first gain FDA regulatory approval. Like all regulatory agencies, the FDA process requires skill and knowledge to navigate efficiently and to ensure fast approval.
This FDA regulatory training course examines the processes, terminology and best practices to ensure your interactions with the FDA are positive. Once completed, you will have the confidence to successfully submit Investigational New Drug Applications (IND) and New Drug Applications (NDA). You will learn the practical regulatory skills to get your pharmaceutical or biotech approved by FDA reviewers. You will also learn how best to gain approval for generics and biosimilars.
Key Learning Objectives
- Understand the FDA structure, history and terminology so you are better equipped to communicate and interact with reviewers
- Gain practical skills to manage the FDA Investigational New Drug (INDs) process and ensure submission efficiency
- Understand best practice to navigate the FDA Investigational New Drug Application (IND) process and ensure you have all the data needed
- Examine the FDA regulatory processes and requirements for pharmaceuticals, biologics and advanced therapies
- Gain top tips for interacting with the FDA to obtain information quickly and prevent submission delays
- Learn best practice for getting a generic product approved, including biosimilars.
Who Should Attend?
This course is aimed at professionals who work in regulatory affairs and are involved in the approval of therapeutics in the US. These include:
- Regulatory Affairs Professionals
- CMC Regulatory Professionals
- Product Registration Personnel
- Project Managers in Regulatory Affairs
- Compliance Managers
- Documentation Specialists
- Quality Professionals and QPs
Course Information
Course Information
- The course begins at the time stated at the top of the page
- The course is broken up into modules outlined below
- There will be breaks between modules
28 May 2026 | 26 November 2026
1-Day Live Online Training
Register at the top of the page.
Session 1
180 mins | 9:30 AM UK
Overview of the US Food and Drug Administration (FDA)
- Brief history of the FDA and Regulations and how we got to where we are  today
- Review the FDA’s organisation by division
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Examining the drug development regulations in the US
- The drug development process in the US
- Clinical trials and Investigational New Drug (INDs)
- Discover who is involved in development and the types of INDs
- Basic understanding of the IND content and timings
- Defining the regulatory requirements for submitting an IND
FDA Meetings
- Review the various FDA meetings (Type A, B and C)
- Discuss meetings on Biosimilars
- Office of Tissues and Advanced Therapies (OTAT) meetings
Session 2
180 mins | 1:30 PM UK
Evaluation of FDA review options
Understanding the following FDA review options:
- Fast track / Priority review / Accelerated review / Breakthrough status
- OTAT and RMAT Process / Interact
Reviewing the NDA process /BLA Process
- Defining full NDAs / BLA
- Examining the NDA categories
- Explaining abbreviated NDAs and 505 (b) (2)
- Learn the requirements and processes for biologics and advanced therapies (Cell and Gene)
ANDA (Generics) and 351K (Biosimilars)
- Review of key differences to EU
- Overview of regulatory positions
- US strategies for development
Additional Considerations
- Change Control
- Use of Agents
- Master Files
- OTC Monographs
Andrew Willis is a regulatory and Development consultant with 30 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.
Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Andrew’s experience covers multiple applications, scientific advice meetings and orphan drug applications. He has significant experience with novel drug delivery systems has been utilized in all the above type of applications.
Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. He currently delivers extensive training courses on the EU and US, specifically looking at QbD, CMC regs and lifecycle management. Andrew has delivered multiple courses on FDA regulatory affairs, supporting professionals with their FDA submissions. He has delivered FDA regulatory courses on a range of products such as pharmaceuticals, biotech, cell and gene, generics and biosimilars.
Format, Dates & Times
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
28 May 2026
1-Day Live Online Training
Register at the top of the page.
26 November 2026
1-Day Live Online Training
Register at the top of the page.
On-Demand Access
Can’t wait for the next course date?
Get instant access to the training materials by selecting ‘On-Demand’ from the drop-down menu above. Start learning at your convenience. You’ll also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
Course Times
For live online delivery, the course starts at 9:30 AM (UK time) and finishes at 4:30 PM (UK time).
Group Discount
If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.
For a quote, complete our contact form by following the link. Get in touch.
Customised Team Training
We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.
For more information, complete our contact form by following the link. Get in touch.
What is Included?
Certification
Download your official Educo Life Sciences Certificate of Attendance to showcase your achievement and professional development.
Access to Recordings for 2 Weeks
Enjoy unlimited access to all session recordings for up to two weeks after the final session — perfect for revision or catching up.
Learner Reference Guide
Attendees receive an overview packed with key concepts, examples, and references from your training to support you long after the course concludes.
On-Demand or Live Online
This course is delivered live or you can access on-demand materials immediately to begin learning straight away.
6 Hours of Learning
This course includes a total of 6 hours of learning.
Expert Trainer
Engage directly with leading trainers who bring real-world experience and insider knowledge to every session.
Additional Course Information
Free Online Module
Free Online Module
- Some of our courses include a free to attend module 1. Please check above to see if this applies to this course.
- If applicable, module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
- To register for module 1, please submit your details in the form located above.
- Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
Full Course Information and Pricing
Full Course Information and Pricing
- To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
- There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
- The full training course is delivered either online or in a classroom. Please check which course format you have booked.
- For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
- For live online courses – The dates and times of modules/sessions are subject to change.
- For live online courses – The module/session durations are approximate.
On-Demand Information and Pricing
On-Demand Information
- Most courses are available on-demand. If you select this option you will be able to begin training instantly.
- You will gain access to a previous live online session, slides and learner reference guide.
- You will also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
- Depending on the course length you will have access to the on-demand materials for 1 to 3 months.
11 reviews for Understanding US FDA Regulatory Affairs
28 May 2026 | 1-Day Live Online Course
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University of Nebraska Medical Center –
n/a
IASIS PHARMACEUTICALS HELLAS –
n/a
Individual Booking (verified owner) –
n/a
RaoufAzizi –
I want to travel can you give me a visa
Fresenius Kabi. –
A very informative, experienced presenter
Ipsen –
Detailed and pragmatic journey through FDA-driven processes, stakeholders and meetings.
Blue Pharma –
Great course to understand US FDA specific interactions with the Applicant/MAH from development to life cycle management.
Pfizer –
An interesting overview of FDA regulatory process, it was a small group which allowed for asking many questions
Individual Booking (verified owner) –
Very well organized. I found it very engaging and the speaker was very confident and knowledgeable.
Polifarma –
na
SGS (verified owner) –
Course content and delivery was excellent, lots of info provided which will require additional review to fully digest as this is not routinely part of my day-to-day activities. This course provided exactly what I needed to understand the terminology and landscape when working towards FDA IND or NDA submissions.