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Web Seminar Agenda: 1:00 – 1:20 Login & Setup
1:20 – 1:30 Introduction
1:30 – 2:30 "Presentation" 2:30 – 2:45 Final Thoughts
2:45 – 3:00 Break
3:00 – 3:30 Q&A
For a complete pricing structure, please click here Early Bird Deadline: Friday, October 3, 2008
Registration Deadline: Monday, October 13, 2008
Who Can Benefit: Personnel in pharmaceutical or biotech areas responsible for regulatory filing, and/or set up and conduction of stability studies, including: - Stability Directors, Managers & Supervisors
- Stability Group Personnel
- Regulatory Group Personnel
- QA/QC Management
- Internal Auditors
- Education/Training Managers & Personnel
- Laboratory Directors, Managers, Supervisors & Scientists
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Speaker: Nanda Subbarao, PhD
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In light of harmonization efforts in collaboration with ICH, the global guidelines for Stability Conditions were recently revised and modified, in particular the splitting of global stability regions earlier designated as Zone IV into Zone IVa and IVb. The regulatory authorities of the ASEAN countries, all considered hot and humid areas, have defined the harmonized requirements for stability testing on products intended to reach the ASEAN common market. This live and comprehensive web seminar will cover the impact of these guidance revisions on global expectations for new and existing pharmaceutical ingredients, as well as address information to be submitted in original and subsequent applications for marketing authorization of their related pharmaceutical products for human use. In addition, a comparison of the regulatory expectations for different global regions will be presented, along with a model stability study that will span the requirements for all global areas. Learning Benefits: Gain a better understanding of the Stability Study Guidance applicable to different global areas Understand the climatic conditions which have lead to the revision of the stability conditions Designing a stability study which will adequately cover requirements in all global regions
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Areas of Expertise
Speaker Bio Dr. Subbarao received her PhD in Bio-organic Chemistry from the Indian Institute of Technology in Bombay, India, and possesses more than 13 years of hands-on industrial experience in stability and laboratory cGMP systems. More>>>
Sponsorship During each webinar, a 15-minute break period will be allotted for companies to promote new products and technologies in today's fast paced environment. More>>>
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