Investigational New Drug Application in the Pharmaceutical Industry
Description
Welcome to Pharmastate Academy’s comprehensive course on Investigational New Drug (IND) application in the pharmaceutical industry. Unravel the significance of IND Applications in the pharmaceutical realm, exploring its pivotal role within regulatory frameworks.
Through this course, delve into the crucial elements of IND Applications, from preclinical data assessment to the meticulous drafting of clinical trial protocols.
Understand the ethical considerations and patient safety protocols integral to the drug development process. Gain insights into the responsibilities of stakeholders, including sponsors, investigators, institutional review boards (IRBs), and regulatory agencies.
Explore the diverse classifications of IND Applications, from Commercial to Research or Non-commercial categories.
Join us on this insightful journey to grasp the essence of IND Applications, navigating through regulatory requirements, submission procedures, timelines, and FDA review processes. Enroll now for a comprehensive learning experience that will empower you in the world of pharmaceutical quality.
Course Curriculum
1. Investigational New Drug Application in the Pharmaceutical Industry
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1.1 Objectives
05:15 -
Quiz: Introduction
2. IND Classification
3. Regulatory Framework
4. Key Stages
5. Stakeholders Responsibility
6. IND Application Process
7. Investigational Plan
8. Safety Monitoring & Reporting
9. Final Assessment
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