$1,200 – $1,500

IND & IDE Applications Preparation and Submission, and Conducting FDA Meeti...

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(Venue to be announced shortly)

Boston, MA 02114

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Description

Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and are clear to the reviewers.

In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors.

Areas Covered:

  • Contents of IND and IDE
  • Regulatory requirements for IND and IDE application process
  • Submissions to IND or IDE to the FDA
  • Establishing communications with FDA
  • Type of FDA meetings
  • Amendments to IND and IDE applications
  • Progress reports for IND and IDE

Learning Objectives:

  • Identify the required regulations and guidance documents for drug and device submissions
  • Use regulations and guidance documents to outline and construct drug and device submissions
  • Formulate a working knowledge of regulatory submissions, publishing, and style guides
  • Create checklists that encompass timelines and sections needed from contributors

Who Should Attend:

  • Regulatory Affairs Management and Staff
  • Quality Assurance Management and Staff
  • Manufacturing Management and Staff
  • Project Managers
  • Clinical Research Associates
  • Data Managers
  • Project Team Leaders
  • Grant Administrators
  • Clinical and Pre-Clinical Personnel which will be contributing to the IND/IDE or want to learn more about IND/IDE applications process
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Date and Time

Location

(Venue to be announced shortly)

Boston, MA 02114

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