Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings

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.
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

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

Who will Benefit:

Project Managers
Clinical Research Associates
Data Managers
Project Team Leaders with limited direct regulatory experience
Grant Administrators
Regulatory Associates
Quality Assurance specialists
Manufacturing, Clinical, and Pre-Clinical Personnel which will be contributing to the IND/IDE or want to learn more about IND/IDE applications process

Speker:

Marina Malikova,Ph.D, MSci, MA, CCRA, RACExecutive Director at Boston University School of Medicine

Dr. 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.
For More Details:https://www.complianceonline.com/fda-meetings-ind-ide-applications-preparation-and-submission-seminar-training-80576SEM-prdsm?channel=eventbrite