Two Day FDA (Food and Drug Administration) Drug Approval Process Training Course: Procedures for Submission of INDs, NDAs, ANDAs and 505(b)(2) (October 10-11, 2022)

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Dublin, Sept. 28, 2022 (GLOBE NEWSWIRE) -- The "The FDA (Food and Drug Administration) Drug Approval Process Training Course" conference has been added to ResearchAndMarkets.com's offering.

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.

Key Topics Covered:

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 the 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

Speakers

Hans van Bruggen
Qdossier

Hans van Bruggen is CEO of and Senior Regulatory Affairs Scientist at Qdossier. He holds an MSc. in Pharmaceutical Medicine from the University of Surrey (UK) and has worked in the pharmaceutical industry for more than 35 years, primarily at global or European headquarters sites. He has gained a wealth of experience and a comprehensive view on what information is needed to evaluate the benefit/risk ratio of drugs for patients and healthy volunteers. He approaches interdisciplinary and international processes using that scientific background. He applies new technologies and Artificial Intelligence to facilitate the business and let people focus on what they can do best.

Marloes van der Geer
Senior Regulatory Affairs Scientist
Qdossier

Marloes van der Geer works as senior regulatory affairs scientist at Qdossier.Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Marloes has been actively involved in several industry associations like EFPIA and IFPMA. Also, she contributed to the ongoing IMI PREFER project in Europe, focused on the generation and use of patient preference data. In 2019, Marloes joined Qdossier.

Marloes' areas of expertise are: eCTD, lean authoring, publishing, biopharmaceuticals (incl. biosimilars), clinical development, regulatory convergence & harmonization and facilitated registration pathways (incl. orphan drugs), local RA activities (e.g. product information management).

For more information about this conference visit https://www.researchandmarkets.com/r/106uho

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