Professional Training
4.4 (20 Reviews)

The FDA Drug Approval Process

Length
2 days
Price
1,299 GBP 1,099 GBP
Next course start
2 December, 2024 (+4 start dates)
Course delivery
Virtual Classroom
Length
2 days
Price
1,299 GBP 1,099 GBP
Next course start
2 December, 2024 (+4 start dates)
Course delivery
Virtual Classroom
Leave your details so the provider can get in touch

The FDA Drug Approval Process

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

Upcoming start dates

Choose between 4 start dates

2 December, 2024

  • Virtual Classroom
  • Online
  • English

24 February, 2025

  • Virtual Classroom
  • Online
  • English

11 June, 2025

  • Virtual Classroom
  • Online
  • English

7 October, 2025

  • Virtual Classroom
  • Online
  • English

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Reviews by course attendees

Average rating 4.4

Based on 20 reviews.
Reviews are published according to our review policy.
Write a review!
4/5
Richa D
02 Oct 2023

A good, detailed process of FDA drug approval process

4/5
Magdalena O
14 Jun 2023

Very good webinar I am glad I was able to attend.

4/5
Jillian G
10 Oct 2022

Good webinar focused on various stages of the FDA drug/device approval process.

International Professional & Industry Academy
10-12 Rivington Street
EC2A 3DU London

About IPI Academy

International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...

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