About Zenosis
Benefits of Zenosis
Zenosis Regulatory Affairs & Compliance
SUB01: Orphan Drug Applications in the EU and USA
SUB02: The European Centralised Procedure (CP)
SUB03: The Mutual Recognition Procedure (MRP)
SUB04: Preparing Submissions in the Common Technical Document (CTD) Format
SUB05: Electronic Common Technical Document (eCTD)
SUB06: Variations to Marketing Authorisations in Europe
SUB07: Registration of Monoclonal Antibodies
SUB08: The ANDA: Requirements for Obtaining Approval for a Generic Product in the USA
SUB09: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA
SUB11: The Decentralised Procedure (DCP)
ESS01: Essentials of EU and US Regulatory Affairs for Human Medicinal Products
CT01: How to Obtain Approval to Conduct Clinical Trials in the EU
CT10: The IND: How to Gain Approval for Clinical Trials in the USA
Zenosis Clinical Trials
CT03: An Introduction to ICH Good Clinical Practice (ICHJ-GCP)
CT04: An Introduction to Clinical Trial Preparation and Design
CT05: An Introduction to Clinical Trials in India
CT06: Clinical Trial Monitoring: Site Evaluation and Setup
CT07: Introduction to Clinical Trials and Drug Development
CT08: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure
CT09: Preparing for a GCP Audit or Inspection
SC01: Pharmacokinetics and Pharmacodynamics in Drug Registration
CT01: How to Obtain Approval to Conduct Clinical Trials in the EU
CT10: The IND: How to Gain Approval for Clinical Trials in the USA
GMP/CMC
Drug Safety & Pharmacovigilance
Request a Zenosis Trial
Zenosis Terms & Conditions
Pathways Summary
CT10The IND: How to Gain Approval for Clinical Trials in the USA
The Investigational New Drug (IND) application is a submission to the Food and Drug Administration (FDA) through which the sponsor seeks approval to conduct clinical studies with an investigational drug.
The IND application is the crucial stepping stone from non-clinical to clinical testing. The IND must contain information on a number of areas including animal pharmacology, drug distribution, toxicology, manufacturing, and the clinical protocol.
This module will provide regulatory professionals with the background and necessary detail needed to complete and submit an IND application for FDA approval.
Approximate Course Time: 3 hours
Level: Intermediate
Audience: Regulatory, Compliance, Manager, Other
Category: Clinical, Regulatory, Submissions
Region: USA
Who will benefit from this module?
This module is primarily aimed at Regulatory professionals who are new to the IND application process. Professionals in clinical research, data processing, project management and marketing, and those whose role involves interaction with the FDA will also benefit from this module. Individuals, within the pharmaceutical and biotechnology industries, who desire a greater understanding of writing regulatory submissions for the approval of products, will also find this module valuable.
Learning objectives
- Describe what an IND is, and why it is needed.
- Access the key regulatory documents surrounding INDs.
- Describe the content and format of an IND application.
- Describe the IND review and approval process.
- Describe the IND reporting requirements, and the types of amendments that can be made to an IND.
Course Outline
Orientation – Designed as an introduction to using the Zenosis modules, this session guides you through the different functions of the module interface - such as how to navigate and interact with the content material. Also provided are five short tips on how to get the most from your e-learning experience.
Overview – This session briefly describes the legislative guidelines that apply to obtaining FDA approval to conduct clinical trials in the USA.
An introduction to Investigational New Drug Applications – This session provides a brief overview of the IND and of the submission process.
IND content and format requirements – Explore the specific format and content requirements of an IND application as specified by the Center for Drug Evaluation and Research (CDER).
The FDA review – This session discusses the FDA review principles for IND applications, with a view to improving your application.
Maintenance of an IND – This session outlines the different types of IND amendments, when they are required, and the regulations that govern them.
Summary – Key point summary for all topics covered in this module. Ideal for review, a refresher or a consolidation of learning points.
Assessment – Multiple-choice mastery assessment.