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Starting 5 - 6 April 2022
Live Online Training Course | 9am - 5pm CEST
Starting 5 - 6 April 2022

Live Online Training Course | 9am - 5pm CEST

Informa Connect Certification Program

Develop key skills to support growth in the medical device industry with Informa Connect

About the Certification Program

Informa Connect develops and delivers learning programs, both online and classroom-based to provide professionals in the pharmaceutical industry with the knowledge necessary for their business growth. That's why we provide the Informa Connect Certification Program, giving you the opportunity to demonstrate how you're expanding your credentials while you develop your skillset. Earners of these certificates can demonstrate, to partners and peers, their ability to develop alongside regulatory and technological advancements in the industry.

What are the benefits of the certification program?

A printable certificate

Skill recognition by the industry

Elevate your knowledge and professional status

US FDA Drug Submission Procedures Certificate

Requirements

Earners of this badge will gain a comprehensive understanding of the US regulatory processes such as Investigational New Drug Applications (IND) and New Drug Applications (NDA). In addition they will gain an insight into the workings of the FDA review process and best practice for requesting information from the FDA Regulators. On completion of the course, they will have a practical insight into the FDA’s requirements for new drug development and drug registration dossiers, and understand how to prepare a generic drug submission for fast approval.


  • Complete all modules within the agenda

Skills Obtained

Obtaining the US FDA Drug Submission Procedures certificate will demonstrate that attendees have taken part in the full course, developing the following knowledge and skills:


  • Understanding of the legal and regulatory requirements for registration of prescription drugs in the US
  • Submit complete dossiers by understanding the critical elements of US INDs and NDAs
  • Define the best strategy for your submission pathway
  • Data requirements for INDs, NDAs and ANDAs (generics)
  • How to communicate with the FDA
  • Submit and follow post-approval activities