START FREE TRIAL

Preparing and Submitted Investigational New Drug (IND) and Pre-Market New Drug (NDA) Applications and Conducting Meetings with FDA

Summary

  • 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

Overview

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.

Why should you attend?

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.

Marina Malikova

Expert

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.

FAQ

With a FREE membership you can get one Exclusive Video every 30 days!

With a free memebrship account, you can browse the entire library, buy credits & attend live webinars and read expert posts. Join and explore the coolest complaince platform ever. Feel free to upgrade anytime to view all Exclusive content and get additional benefits for your account.

Do I have to pay to join?

For FREE signups there is no payment required. No Credit Card needed. We also offer EDGE & PRO, paid memberships.

What are the different formats?

There are Live and Recorded, Expert led webinars. Durations vary from 30min to 6hrs. Standards & checklists are in pdf form

What if I am interested in more than one exclusive?

You can upgrade to EDGE memebrship at any time and enjoy unlimited Exclusive viewing. All our memebrships are annual plans.

How many videos can I watch?

As a FREE memebr you get 1 free exclusive video every 30days. You can buy additional videos.

Who are the Experts?

All Experts on our platform are handpicked or referred by other Experts based on years of experience & proven expertise in providing learning & consulting advice.

What if I have questions after watching a video?

We provide first of its kind, Expert on Call service, where you can directly schedule one on one call with the Expert of your choice & discuss.

Free Content

Choose this content or anyone of 100s of Exclusive contents. Get one free exclusive every 30days

Paid Content

Choose from 100s of live and recorded content uploaded by Experts every day

Ready to get started?

Get in touch, or create an account