Workshop on Drug Regulatory Affairs
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Workshop on Drug Regulatory Affairs with focus on Electronic Common Technical Document (eCTD) submission to give an overview of regulatory affairs concepts which Pharma companies must comply to sell their drugs both domestic and in the international market. These issues are very critical to Clinical Research Organizations, Bio Tech companies also.
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Workshop on Drug Regulatory Affairs
- 1. Workshop on Drug Regulatory Affairs www.ixora-group.com
- 2. ©2015 Ixora Tech Consulting-All Rights reserved www.ixora-group.com Intro • Workshop on Drug Regulatory Affairs to give an overview of regulatory affairs concepts which Pharma companies must comply to sell their drugs both domestic and in international markets. • These issues are very critical to Clinical Research Organizations, Bio Tech companies also.
- 3. ©2015 Ixora Tech Consulting-All Rights reserved www.ixora-group.com Workshop Objectives • To create a thorough understanding of important regulatory concepts • To create experts in the field of Regulatory Affairs documentation and research • To create an entry platform in the field of Regulatory Affairs for fresh graduates • To help students build their career in Regulatory Affairs and become Regulatory Affairs professionals • To provide students with a global knowledge of Regulatory Affairs
- 4. ©2015 Ixora Tech Consulting-All Rights reserved www.ixora-group.com Workshop Content • Basic Fundamentals of Regulatory Affairs • Introduction to Regulatory Bodies • Introduction to Quality Standards for Regulatory Compliance • Common Technical Documents - CTD (API & Formulation) • CTD Fundamentals ( Module 1 - 5) • eCTD Fundamentals & Details • Best Practice in Preparing eCTD • Submission using eCTD Format • Life Cycle Management for eCTD • eCTD Software for Compilation & Validation • Key Point for Successful eCTD Submission • ASEAN Common Technical Dossier (ACTD) • Marketing Authorization Procedures in USA • Marketing Authorization Procedures/ Channels in Europe • Marketing Authorization Procedures in India • Marketing Authorization Procedures in ROW markets • Maintenance and Annual updates for Marketing authorizations