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Sheraton Boston Hotel

2017 年 08 月 14 日 7:30 上午 - 2017 年 08 月 17 日 5:00 下午

39 Dalton Street, , Boston, MA 02119 , USA

Regulatory Affairs: The IND, NDA, and Postmarketing

概览

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.

Join us at the co-located Boston DIA Member Appreciation Reception and Kickoff for DIA 2018 on August 14, 5:30-7:45PM!

“The course is replete with information that has swirled around me since starting work in RA but that had remained elusive due to the narrow nature of my day-to-day. The course provided structure for this swirling information, which gave me a clear picture of how the pieces fit together. I'd definitely recommend it to anybody who has worked in regulatory affairs for a few years and/or has experience in only one area of RA but desires to understand the whole picture.”

-Previous Participant

内容纲要

  • 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 for Prescription Drug Labeling and Advertising
  • Postmarketing Requirements

谁应该参加？

  • 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

学习目标

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 drug 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

Digital Learning Catalog

DIA Learning: eLearning Soultions
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