Building the eCTD for FDA Submission

Who Should Attend
This course is intended for Professionals in the Pharmaceutical, Biotech and related fields who are responsible for compilation and submission of electronic applications to FDA. It will be especially valuable to:

  • Regulatory Affairs Professionals
  • Documentation Specialists
  • Managers and Supervisors
  • Professionals managing clinical data

Description
Electronic Submission is an extremely efficient tool for managing submissions of complex technical documentation to regulatory authorities involved in the drug approval process. The use of electronic submissions allows for effective life cycle management of series of documents that are submitted to the FDA during their review process. The electronic submission process also provides an user friendly document for the FDA reviewers. All required information is readily available for the FDA’s review process. Upon completion of this course, you will be a master at compiling and submitting complex technical applications through FDA’s electronic gateway.