CMC WRITING AND SUBMISSION STRATEGIES: A GLOBAL REGULATORY APPROACH Quality Section of Regulatory Applications
Lunedì 19 Agosto 2013 13:29
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Course Offered by:

The Center for Professional Advancement
www.cfpa.com

In Collaboration with:

SiTec PharmaBio

www.sitec-pharmabio.com


Course Description

This course will provide in-depth instruction on Chemistry, Manufacturing and Controls (CMC) requirements and reviewprocesses for clinical trial, registration and post approval drugapplications in the US, Europe and Japan. Additionalconsiderations and integrative approaches for submissions inemerging markets ("Most of the World" countries/regions)will be discussed.

Emphasis will be placed on current national and ICH guidelines, and special considerations for biologics will be discussed.

Development, manufacturing, analytical testing, controls and stability issues will be presented for solids, parenterals and other dosage forms.

Overviews of Quality By Design (QbD) submissions and Drug Master Files will be presented. Successful regulatory filing strategies and best practices will be illustrated with examples and case studies.


Who Should Attend

This course is intended for individuals responsible for R&D/technical writing/quality management/original and postapproval submissions in pharmaceutical companies, especially those in:

• Regulatory Affairs

• QA/QC

• Process Chemistry

• Analytical Chemistry

• Preformulation and Formulation Development

• Scale-up and Technology Transfer

Experience of one year or more in one of the above areas is recommended to fully benefit from this course.

 

Learning Objectives

Upon completion of this course, you will be able to:

• Describe the regulatory review processes and health authority expectations through product lifecycle.

• Analyze and compile CMC data to support CTD clinical trial applications, registration files and post approval submissions in the US and Europe.

• Explain special writing strategies for Quality By Design marketing applications, Drug Master Files and "Most of the World" registration dossiers.

• Identify regulatory compliance issues in agency inspections.

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