Regulatory Affairs Part II: The NDA Phase

Oct 17 2011 8:30AM - Oct 19 2011 3:45PM

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

Basics of NDA Submission and Post-marketing Regulatory Requirements

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 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:
• Prepare NDA/BLA using the Common Technical Document format
• Define FDA 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
• Biostatisticians
• Quality professionals
• Medical writers
• Basic researchers
• Business and marketing professionals

Event Code:
11435

Contact Information:

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

Basics of NDA Submission and Post-marketing Regulatory Requirements

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 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:
• Prepare NDA/BLA using the Common Technical Document format
• Define FDA 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
• Biostatisticians
• Quality professionals
• Medical writers
• Basic researchers
• Business and marketing professionals

Event Code:
11435

Contact Information:

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

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