Prepare & Submit Investigational New Drug (IND) and Investigational Device Exemptions (IDE) Applications and Conducting Meetings with FDA

  • Speaker:Marina Malikova, Ph.D., MSci, MA, CCRA, RAC
  • Duration:80Min
  • Product Code:GRC-90493

Live Session - How it works

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  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
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  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 

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 in the Webinar Session:

  • 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:      

  • 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

Certifications: 

GRCTS Attendance Certificate. 

Instructor Profile:

Marina Malikova, Ph.D., MSci, MA, CCRA, RAC | Executive Director, Surgical Translational Research:Operations and Compliance.

Dr. Malikova has over fourteen 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 andInterventional 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.

Dr. Malikova has 10 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College.She has developed and taught several courses such as: Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine.

She also served as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine since Summer, 2012.

Dr. Malikova is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Association Professionals Society (RAPS) and European Society of Radiology(ESR). Currently, she is serving as an Editor for SAGE publishing group and National Institute of Health (NIH) reviewer for grants and clinical trial proposals.   

 

Available Options

Recording: 6 Months Access to the Training which can be accessed from any location

$425

CD-DVD: Shipped within 2 working days

$455

USB - Shipped within 2 working days

$485

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$2,745

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$4,875

Recording Access for 12 Months: Participant can access the training Recording for 12 months from any location

$1,215

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