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.
- 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
- 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
Dr. Marina Malikova
Ph.D., MSci, MA, CCRA, RAC
Dr. Marina Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.
Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.
In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.
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