Perspectiva general

Complete this On-Demand Training Course to 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 recorded lectures, real-world examples, scenario-based activities, and self-paced online modules. This basic to intermediate level training course focuses on prescription drugs and well-characterized biological products.

This on-demand training course takes an average of 19 hours to complete. Learners have access to the course for one year from the date of purchase.

Interested in the live virtual offering of this course being held August 19-23, 2024? View details.

“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

Lo que aprenderá

- Fundamentals of the Investigational New Drug (IND) and New Drug Application (NDA) Processes
- What to expect at meetings and in other interactions with FDA
- Regulatory requirements of prescription drug labeling and promotion
- Post-marketing requirements
- Sources of regulatory intelligence information

¿Quiénes deben asistir?

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

Objetivos de aprendizaje

At the conclusion of this activity, participants should be able to:
- Recognize the importance of incorporating regulatory strategy into the drug development plan
- Identify content and format requirements for INDs and NDAs
- Outline the requirements for submitting INDs, NDAs, amendments, and NDA supplements
- Explain the FDA review processes for evaluating INDs and NDAs
- Define NDA post-approval responsibilities and requirements
- Identify regulatory programs and mechanisms that can facilitate and expedite new drug development
- Determine how to report adverse events in accordance with FDA pre-marketing and post-marketing regulations
- Apply sound meeting practices and productive dialogue principles when interacting with the FDA
- Outline the regulatory requirements for prescription drug labeling and promotion
- Identify resources for regulatory intelligence

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Regulatory Affairs: The IND, NDA, and Post-Marketing On-Demand Training

Perspectiva general

Lo que aprenderá

¿Quiénes deben asistir?

Objetivos de aprendizaje

Be informed and stay engaged.