Management Forum Logo

Presented by
Management Forum

US FDA Training Course - Understanding Key Factors When Working with the FDA (Food and Drug Administration)

An Essential Overview

This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration). For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.

27 November 2024
+ 13 March 2025, 11 July 2025, 26 November 2025 »
from £549

Need help? Enrol or reserve

Format: Live online
CPD: 6 hours for your records
Certificate of completion

Download Print Enrol or reserve

Overview

This course has been designed to provide an essential overview of the key factors when working with the FDA. It will equip senior managers and project managers with pivotal information to enable them to interact with their teams and ask critical questions to ensure the best outcomes when making applications to the FDA.

The programme will provide an overview of the US FDA’s organisational divisions and examine the drug development regulations. It will provide a valuable guide through the review options and discuss the New Drug Application (NDA) process and how the FDA deals with Generics and Biosimilars.

For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.

This course is part of our Biopharma training courses series which aims to provide up-to-date knowledge on industry best practices and regulations surrounding biopharmaceuticals.

Benefits of Attending

Learn the critical factors involved when embarking on product development for the US market
Understand how to communicate effectively about US activities throughout the organisation
Know the structure of the FDA and how it works
Understand how to comply with the regulations and requirements
Discover the best review process for your application
Learn the requirements and processes for biologics and advanced therapies
Review the key differences between the EU and FDA applications for Generics (ANDA) and Biosimilars (315k)
Get the opportunity to understand the complexities and discuss best approaches with an expert in this area

Who Should Attend

Pharmaceutical and Biopharmaceutical Starts-ups
Pharmaceutical Executives
Senior Management
Business Development Managers
Regulatory Strategists
Project Managers
All those who wish to broaden their knowledge on working with the FDA

Enrol or reserve

This course will cover:

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

Examining the Drug Development Regulations 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

FDA Meetings

Review the various FDA meetings in accordance with PDUFA VII (Prescription Drug User Fee Admendments)

Evaluation of FDA Review Options

Understanding the following FDA review options:

Fast track / Priority review / Accelerated review / Breakthrough status
Understand the importance of Cell and Gene Therapy in FDA and Regenerative Medicine Advanced Therapies (RMAT) Process / Interact

Reviewing the New Drug Application (NDA) process / Biologics Licensing Application (BLA) Process

Defining full NDAs / BLA
Examining the NDA categories
Explaining abbreviated NDAs and 505 (b) (2)

Understand ANDA (Generics) and 351K (Biosimilars) Applications

Review of key differences to EU
Overview of regulatory positions
US strategies for development

Review the Importance of Lifecycle Management in the US

Annual reports
Change being Effective
Prior Approval Supplements
Comparison to EU variation regulation

Enrol or reserve

Andrew Willis
San Salvatore Training Ltd

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.

He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

27 November 2024

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 13982

GBP 549 649
EUR 789 929
USD 893 1,049

Until 23 Oct

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

13 March 2025

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
05:00-13:00 New York (UTC-04)
Course code 14586

GBP 549 649
EUR 789 929
USD 893 1,049

Until 06 Feb

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

11 July 2025

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 14831

GBP 549 649
EUR 789 929
USD 893 1,049

Until 06 Jun

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

26 November 2025

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 15098

GBP 549 649
EUR 789 929
USD 893 1,049

Until 22 Oct

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.