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UPCOMING LIVE SEMINARS
 
Clinical Project Management: Advanced
September 10-11, 2014
San Diego, CA






Preparing IND Submissions: How to Organize, Write, Submit, and Track Submissions

Upcoming Courses

Course #: SPDA1014
October 23-24, 2014
The Hub Meeting Center - CityView
Philadelphia, PA
Take advantage of our $1,595.00 price by registering early!
* After September 23, costs are $1,795.00.

Course #: SPDF1214
December 11-12, 2014
Hilton San Francisco
San Francisco, CA
Take advantage of our $1,595.00 price by registering early!
* After November 11, costs are $1,795.00.

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 
Who Should Attend

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

Meredith Brown-Tuttle, R.A.C. 

Click here for complete trainer biographies 

Course Outline 

Day 1: 8:30 a.m. – 5:00 p.m. 

FDA Division Information 

  • Submission Basics
    • Outlining the submission, creating the Table of Contents, timing of submission/timelines, contributions from other departments, editing, style guides, templates, supportive documents, QAing the submission 
     

Publishing the Submission 

  • Submission publishing basics 
  • Copies (how many to make and keep) 
  • Introduction to electronic publishing requirements 

Tracking the Submissions 

  • Creating the index history 
  • Creating an issues log 

Day 2: 8:30 a.m. – 5:00 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 

A copy of the book, "IND Submissions: A Primer" will be provided for all participants. 

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

Registration Fees

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. 

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings. 

Click here for our seminar cancellation policy 

Accreditation Information

ACPE LogoBarnett 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# 0778-0000-11-058-L01-P. Released: 8/11. 

Hold this course at your company! 

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