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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
Details
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
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.
Programme
Module 1 – History and Review of the organisation of the US Food and Drug Administration (FDA) and future vision
- The History of the FDA and Regulations
- The FDA today
- FDA’s reorganisation by Division
- The Future Direction of FDA – FDA perspective
Module 2 – The drug development regulations in the US and implications for the industry
- The Drug Development Process in the US
- Clinical Trials and INDs – Discover the parties involved in development and the Types of INDs
- Basic Understanding of the IND Content:
- Analysing the manufacture of Drug Substance and Drug Product
- Preclinical testing requirements
- Clinical testing requirements
Module 3 - Analysing the Investigational New Drug Application (IND) and defining the regulatory requirements
- Requirements for submitting an IND
- Understand the FDA review process for INDs
Maintaining active INDs successfully
- Clarifying the obligations of the Sponsor
- Explaining the procedures for reporting Adverse Events (AEs)
- Defining other IND amendments
- Preparing Annual Reports
Module 4 - Evaluation of review options
Understanding the options:
- Fast track
- Breakthrough status
- Accelerated review
- Priority review
- OTAT and RMAT Process / Interact
Module 5 - Identifying the various categories of NDAs
- Defining full NDAs
- Explaining abbreviated NDAs and 505 (b) (2)
- How to mage Biological and Biosimilars
- The Content Overview
Module 6 - Generic Submissions
- Examine the legislative history and key regulations for ANDAs
- Patent and exclusivity – Understand Paragraph 1-IV, and Biosimilars
- Generic Drug User Fee Amendments (GDUFAs)
- Opportunities for improvement and challenges
- Managing launch activities including PLAIR
Module 7 - How does the FDA review and maintain an NDA?
- Clarifying the procedure from the receipt to the filing of the NDA
- Assessing when there will be a refusal to file
- Sponsor - reviewer interactions
- Maintaining NDAs successfully
- When and how to do NDA amendments
- Scale-up and post approval changes
- Annual reports
Module 8 – Interacting with the FDA and Obtaining information from the FDA
- FDA Meetings Type A, B and C
- Meetings on Biosimilars
- OTAT Meetings
- The Summary Basis of Approval
- Advisory Meetings
- Best Practice for Meetings
Book now
Book now
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21-22 Mar 2022 Live webinar |
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21-22 Mar 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 14 Feb 22* |
Enrol now
to attend Live webinar |
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20-21 Jun 2022 Face-to-face, (venue not yet confirmed) |
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20-21 Jun 2022 Face-to-face (venue not yet confirmed) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 16 May 22* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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19-20 Sep 2022 Live webinar |
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19-20 Sep 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 15 Aug 22* |
Enrol now
to attend Live webinar |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code