Preparing and Submitted Investigational New Drug (IND) and Pre-Market New Drug (NDA) Applications and Conducting Meetings with FDA
Contents of IND and NDA
Overview of current regulatory guidelines for IND and NDA submissions
Regulatory requirements for IND and NDA application process
Submissions to IND or NDA to the FDA
Establishing communications with FDA
Type of FDA meetings
Amendments to IND and NDA applications
Progress reports for IND and NDA
Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. In this session new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce IND and NDA submissions that comply with the requirements and are clear to the reviewers.
Fear, uncertainty and doubt (FUD) liner for the marketing purpose
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 pre-market New Drug Applications (NDA). Participants also will gain experience with tools that help manage timelines and sections needed from contributors.
Dr. Malikova has over 15 years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices, biologics and combination products. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.
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