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The FDA (Food and Drug Administration) Drug Approval Process Training Course

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

12-13 June 2024
+ 2-3 December 2024 »
from £1099

Need help? Enrol or reserve

Format: Live online
CPD: 12 hours for your records
Certificate of completion

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Course overview

The US is the largest market globally for pharmaceutical sales, so having a good understanding of FDA procedures is vital for those submitting in this challenging region. This course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments.

The comprehensive programme will cover procedures for submission of INDs, NDAs, ANDAs and 505(b)(2), provide a useful insight into the organisation and structure of the FDA and its review processes, and highlight recent changes. The course will emphasise areas of interest to innovative manufacturers, but will also deal with issues relating to generic and over-the-counter drugs.

There will be ample opportunity for discussion with our expert trainer as well as other delegates and a practical workshop session to optimise learning.

Benefits of attending:

Review the latest FDA regulatory requirements for drug development
Understand FDA regulatory strategic needs
Ensure that you comply with FDA requirements for NDAs, ANDAs and 505(b)(2)
Discuss recent changes and developments with an industry expert and Improve your communication and interactions with the FDA

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Who should attend?

This programme will be especially beneficial to those responsible for preparing US registration documents (INDs, NDAs, Biologics License Applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market.

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The The FDA Drug Approval Process course will cover:

Day 1
Day 2

Pharmaceutical Medicine and Documents

The role of regulatory affairs
The purpose of the Common Technical Document (CTD)

FDA History and Organisation

Review of FDA centers
Organization of the CDER and CBER
Differences between CDER and CBER

Legal Basis (Patent Exclusivity PDUFA, GDUFA, BsUFA)

21^st century cure act
Patent and exclusivity
PDUFA
GDUFA
BsUFA

Legal Basis Continued

Application and Submissions Types

Investigational new drugs (IND)
New drug applications (NDA)
Abbreviated new drug applications (ANDA)
Over the counter drugs (OTC)
Biologics license applications (BLA)
Orphan drug designations

Refusal to File

Reasons for refusal
The regulatory process

Investigational New Drug (IND) Applications

Review of the content of an IND

Getting Products to the Market Faster

Review of expedited programs in the US
- Fast Track designation
- Breakthrough Therapy designation
- Accelerated Approval
- Priority Review designation

FDA Meetings and Documentation

FDA communication philosophy
Different meeting types
- Scope
- Format
- Procedure

CTD Content - Setting the Scene

Lean authoring to ensure possible document re-use for multiple purposes
A review of the different modules

CTD Content - M1

CTD Content - M3 and Corresponding M2

CTD Content - M4 and Corresponding M2

CTD Content - M5 and Corresponding M2

Submission Format and Methods

Study tagging files
Datasets
- Case report forms
- Bioresearch monitoring (BIMO) clinical data

US Amendment Procedures

A review of US amendment procedures (incl. annual reports, minor/major changes)

High Level Comparison US vs EU

A review of the main differences in terms of dossier content and procedures

Case Study

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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

12-13 June 2024

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 13707

GBP 1,299
EUR 1,869
USD 2,129

Limited places remaining

2 days 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

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Not ready to book yet?

for 7 days, no obligation

2-3 December 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 13917

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 28 Oct

2 days 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.