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Session 6 / Venue 2: Global Simultaneous Submission - Lessons Learned and Overcoming Next Challenges
Session Chair(s)
Satomi Ando, MSc
Manager, Clinical Research & Medical Development Center
Japanese Foundation For Cancer Research, Cancer Institute Hospital , Japan
The session in the last year was a good and first opportunity to share information on this theme, where medical writers from domestic and foreignaffiliated pharmaceutical companies spoke about experiences and issues relevant to simultaneous NDA filing in global development. Since then, experiences of global simultaneous filing have been steadily increasing. Some are successful in simultaneous approval or the first approval in Japan ahead of other regions, but others failed to achieve a goal despite development strategy. Some faced challenges specific to simultaneous filing in NDA review process, resulting in longer time to approvals, or giving-up approval in the worst case. This year’s session will take up issues to address toward success (earlier approval); what is a key to success of global simultaneous filing, and what are roles of medical writers to contribute to earlier approval. We will have presentations from Medical Writers with many experiences of simultaneous filing, and also presentation from standpoint of NDA reviews from PMDA reviewer. Panel discussion will follow to deepen discussions.
Speaker(s)
Aim for Simultaneous Approval Beyond Simultaneous NDA from CTD Author’s Perspective
Yoko Hirano, MSc
Pfizer Japan Inc., Japan
Through Experience of Global Simultaneous Submission, Review, and Approval - Changing and Expanding Possibility of Medical Writer’s Role
Ayako Sato, MA
Novartis Pharma K.K., Japan
RA Functions Department
Reviewer Perspective for Global Simultaneous Submission and Approval
Aki Nakai
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director for Personnel Coordination, General Affairs
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