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US-FDA Drug Submission Procedures

17 - 18 September 2018

Radisson Blu Edwardian Grafton, London

Tougher regulatory approval processes pose potential set-backs for pharmaceutical companies registering drugs in the USA . . . can you afford to waste your R&D investment by delaying your product launch? In the challenging environment of US drug registrations procedures, you and your colleagues need to understand all the current procedures. To help you do this, PTI has developed this course that will clarify the US regulatory process. By attending this extensive two day course, you will gain a practical insight into the FDA’s requirements for new drug development and how to prepare your new drug registration dossier according to US guidelines.

  • Work your way through the laws and regulations governing the registration of prescription drugs in the US
  • Submit complete dossiers by understanding the critical elements of US INDs and NDAs
  • Meet the data requirements for INDs and NDAs
  • Communicate better with the FDA by knowing its structure and the interactions within the agency
  • Know how to obtain information from the FDA
  • Understand the logistics of sponsor-FDA interactions

Andrew Willis has over 28 years' of experience in regulatory affairs and pharmaceutical development with specific knowledge in EU and US registrations, CMC regulatory requirements and multiple clinical aspects related to successful registration of drug products.

Previously Vice President of Regulatory Affairs and Consulting Services at Catalent Pharma Solutions, Andrew now works as an independent Regulatory Affairs and Pharmaceutical Development Consultant.

This course has been specifically designed to address the training needs of executives who are or will be involved in the preparation of development plans and/or registration dossiers.

  • Compliance Managers
  • Documentation Managers
  • Product Registration Personnel
  • Project Managers in Regulatory Affairs
  • Marketing Managers
  • Clinical Research Personnel
  • Key contributors to the submission
    package for the US market

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