Regulatory Affairs Part 1: The IND Phase and Part II: The NDA Phase

http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr... Course

Date(s) And Time(s):
Mar 14 2011 8:00AM - Mar 17 2011 4:30PM

Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

Overview:

Learn how to apply regulatory concepts to ensure compliant IND submissions to the FDA. Gain insight into the regulatory background of the NDA, preparing an NDA, and postapproval activities. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.

What you will learn
• Overview of the drug development process
• The IND process
• Quality assurance in drug development (GXPs)
• FDA’s actions on the original IND and amendments
• Activities and submissions after the original IND
• Procedures for reporting adverse events (AEs)
• Overview and roles and responsibilities of FDA
• NDA in CTD format
• Regulatory compliance and FDA inspections
• Post-approval regulatory requirements for NDAs
• Regulatory requirements for prescription drug/biologics labeling
• Regulatory requirements for prescription drug/biologics advertising
• How to interact with the FDA

Learning Objectives:
At the conclusion of this course, participants should be able to:
• Apply the role of regulatory affairs and the impact on the drug development process
• Discuss the role of FDA and composition of FDA’s review teams
• Effectively plan and submit an IND
• Report adverse events accurately and correctly to the FDA
• Prepare NDA/BLA using the Common Technical Document format
• Define postapproval requirements
• Explain the regulatory requirements for prescription drug labeling and advertising/promotion
• Apply common meeting etiquette in dealing with the FDA during the IND/NDA phases

Target Audience:
• New regulatory affairs professionals
• Clinical researchers
• Quality professionals
• Biostatisticians
• Medical writers
• Basic researchers
• Business and marketing professionals

Event Code:
11436

Contact Information:

For detailed program information including faculty and topics, please contact:
Susan Mazak
Tel. +1-215-442-6183
Email Susan.Mazak@diahome.org