Understanding Key Factors When Working with the U.S. FDA - 1-Day Online Training Course (July 12th, 2024)

Dublin, Jan. 31, 2024 (GLOBE NEWSWIRE) -- The "US FDA Training Course - Understanding Key Factors When Working with the FDA (Food and Drug Administration)" conference has been added to ResearchAndMarkets.com's offering.

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.

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


  • CPD: 6 hours for your records
  • Certificate of completion

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


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 Amendments)

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

For more information about this conference visit https://www.researchandmarkets.com/r/j1bs3a

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