Date(s) And Time(s):
Mar 14 2012 8:30AM - Mar 16 2012 5:30PM
Location:
Holiday Inn Temple of Heaven Beijing
No.1 AnDing DongLi, South third ring, Fengtai District
100075 Beijing
China
http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr...
Overview:
The course is designed to introduce requirements, process, and techniques for preparing successful and high quality registration dossiers for regulatory submissions.
The Modules provide a comprehensive description on the Common Technical Dossier structure — completely updated to reflect the latest changes in pharmaceutical regulatory affairs. The course will focus on the specific regional requirements for Module 1 including discussion of the relevant legislation in EU and China. The requirements for the Quality documentation (Module 3) will be presented in detail based on the recent ICH-Q guidelines.
The course is for new developments as well as for generics.
Featured Topics
• CTD, eCTD
• Module 1
• Cover Letter
• Application Forms
• Product Information
• Environmental Risk Assessment
• Information relating to Orphan Market Exclusivity
• Risk-management System
• Paediatric Information
• Module 3
• Pharmaceutical Development and Quality Risk Management
• Quality of Active Substance including Purity Issues
• Impurity Testing
• Stability Testing
• Setting Specifications
• Marketing Authorisation Procedures
• Variation Procedures
Learning Objectives:
At the conclusion of this course, participants should be able to:
• Identify the recent requirements for developing drug substance and drug products and setting up a registration dossier
• Define the requirements for developing a product and discuss how to prepare the regional Module 1 and the Quality documentation
• Discuss the legal background of the dossier requirements and identify the relevant guidelines
• Demonstrate optimal presentation of information and justifications
Target Audience:
• Governmental institutions
• Pharmaceutical industry professionals
• Development managers and experts
• QA and new manufacturing managers
Event Code:
12983
DIA CHINA OFFICE
Contact : XIE Fei
Gateway Plaza, Tower A, Room 1155, 18 XiaGuangLi, North Road, East Third Ring, Chaoyang District, Beijing, 100027, China
Tel: +86 10 5923 1222 Fax: +86 10 5923 1180
Email: fei.xie@diachina.org; dia@diachina.org