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US-FDA Drug Submission Procedures

23 - 24 March 2020

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

Regulatory and Development consultant with 30 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.

Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of the above type of applications.

Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. He currently delivers extensive training courses available in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.

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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