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Who should attend Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings
Project Managers, Clinical Research Associates, Data Managers, Project Team Leaders with limited direct regulatory experience, Grant Administrators, Regulatory Associates
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Project Managers, Clinical Research Associates, Data Managers, Project Team Leaders with limited direct regulatory experience, Grant Administrators, Regulatory Associates

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Seminar Summary:

In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors. (see full course description)

 
 
 

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Training Course Syllabus:


Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and are clear to the reviewers.

In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors.

Learning Objectives:

Identify the required regulations and guidance documents for drug and device submissions
Use regulations and guidance documents to outline and construct drug and device submissions
Formulate a working knowledge of regulatory submissions, publishing, and style guides
Create checklists that encompass timelines and sections needed from contributors
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar
DOWNLOAD BROCHURE

Seminar Summary:

In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors. (see full course description)

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