概要

Fundamentals of IND/NDA submissions and Postmarketing Regulatory Requirements

Learn about FDA regulations and expectations for the content, submission, and review of INDs/NDAs and the importance of regulatory strategy. This comprehensive course employs a blend of real-world and interactive lectures, workshops and online precourse modules. This basic to intermediate level training course focuses on prescription drugs and well characterized biological products. The requirements specific to generic drugs, biosimilars, devices, and OTC monograph products are not covered in detail.

何を学ぶか

Fundamentals of the Investigational New Drug (IND) and New Drug Application (NDA) Processes

Preparation
Content
Maintenance and updates
Strategy

What to expect at meetings and in other interactions with FDA
Regulatory Requirements of Prescription Drug Labeling and Advertising
Postmarketing Requirements

参加対象

Regulatory affairs professionals new to the IND/NDA processes
Clinical research and development professionals
Biostatisticians
Basic researchers
Quality and manufacturing professionals
Medical writers
Business professionals
Project managers

学習目的

At the conclusion of this activity, participants should be able to:

Explain the importance of incorporating regulatory strategy into the drug development plan
Recognize content and format requirements for INDs/NDAs in the Common Technical Document (CTD) Format
Communicate the requirements for submitting INDs/NDAs and amendments and supplements
Describe the FDA review processes for evaluating INDs/NDAs
Define NDA post-approval responsibilities and requirements
Identify regulatory mechanisms to facilitate and expedite new development
State how to report adverse events in accordance with current FDA regulations
Apply formal meeting principles and practices when interacting with the FDA
Outline the regulatory requirements for prescription drug labeling and advertising

Regulatory Affairs: The IND, NDA, and Post-Marketing

概要

何を学ぶか

参加対象

学習目的

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