Course Description

The Regulatory Department is the key contact with regulatory agencies. Regulatory must prepare documents that inform the Agency about the proposed development plan, keep the Agency up to date and answer any questions the Agency has about an on-going investigation, request and prepare for meetings with the Agency to discuss development plans, construct and write the marketing application and submit any updates to the marketing application in a concise and informative manner. 

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

In this practical course, approved drug labels and summary basis of approvals are used to help students acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including pre-marketing (IND), and marketing (NDA/CTD) applications. Participants also gain experience with tools that help manage timelines and sections needed from contributors.

Learning Objectives

• Find the required regulations and guidance documents for drug and biologic submissions
• Use regulations and guidance documents to outline and construct a variety of drug and biologic submissions
• Formulate a working knowledge of regulatory submissions, publishing, and style guides
• Create checklists that encompass timelines and sections needed from contributors
• Produce a mock IND

Who Should Attend

Any part of the drug development team who wishes to know more about the IND submission process such as: regulatory associates, quality assurance, manufacturing, clinical, project management, and pre-clinical personnel will benefit from this course.

Instructor

Meredith Brown-Tuttle, RAC

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Course Outline

Day 1: 8:30 a.m. – 5:30 p.m.

• FDA Division Information
• Submission Basics
• Outlining the submission
• Applicable regulations and guidance documents
• Information available for submission
• Building the information pyramid
• Creating the Table of Contents
• Timing of submission/timelines
• Contributions from other departments
• Editing
• Style Guides
• Templates
• Supportive documents
• QAing the submission
• Cover Letter
• Publishing the Submission
• Submission publishing basics
• Pagination
• Volumization
• Table of Contents
• Binder Covers
• Tabs
• Labels
• Copies (how many to make and keep)
• Copies to the Agency
• Archive copy
• Review copy
• Introduction to electronic publishing requirements
• Tracking the Submissions
• Creating the index history
• Creating an issues log

Day 2: 8:30 a.m. – 5:30 p.m.

• Common Technical Document Format
• Pre-Market
• FDA Meetings (Type A, B and C)
• Pre-IND
• Phase I
• Phase II
• End of Phase II
• Requesting the meeting
• Preparing the meeting package
• Meeting minutes
• The IND Submission
• Routine IND Submissions
• Clinical
• Non-Clinical
• CMC
• Annual Reports
• Investigator Brochure Updates
• Protocol /Protocol Amendments
• Investigators
• Additional IND Submissions
• Fast Track
• Orphan Drug
• Special Protocol Assessment
• Marketing Application
• NDA in a CTD Format
• Type of NDAs
• 505 (b)(1)
• 505 (b)(2)
• 505 (j)
• Organizing the NDA
• Publishing the NDA

There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day.

Course Dates and Locations

June 10-11, 2009

Philadelphia, PA

Course # SPDA0609

Philadelphia Airport Marriott

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Registration Fees

Register Early and Save!

$1,595 by May 1

$1,795 after May 1

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

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Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE# 778-000-08-007-L01-P. Released 11/08.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.