The followings has been featured at seminars or published
- Common Technical Documents for generic medicine
2017/02/17 - Regulatory considerations on decision making in early phase.
2016/08/23 - Regulatory Strategy Management in the development
process from POC to NDA
2016/07/15 - Product Development Plan driven by regulatory strategy
2016/05/23 - NDA Dossier and Scenario Development
2015/03/16 - Working Knowledge for R&D Due Diligence
2014/04/22 - Practicalities of R&D Due Diligence for Research Acquisition
2014/02/20 - Basic Knowledge on Regulatory Strategy Development for
Project Manager in Global Product Development
2013/10/25 - Making the most of Interview Meeting with PMDA & Points to
be considered for desirable outcomes.
2013/06/25 - Unmet medical needs & Orphan drug designation in the context
of Regulatory Strategy
2013/01/24 - Regulatory Strategy & Project Management of Global
Pharmaceutical Development Process and Sourcing – Gap &
Optimization between HQs and affiliates on strategic agenda
2012/12/21 - Clinical Trial Consultation in the context of enabling
Registration Dossier
2012/11/28 - Regulatory Strategy Development in Global Pharmaceutical
Development Process & Regulatory Souring
2012/08/31 - Registration Package & Communication with Regulator
2012/06 - Regulatory Strategy Development for Orphan Drug
Designation & Application
2012/05/24 - Basic Knowledge and Skills for Regulatory Scientists in
Pharmaceutical company
2012/04/13 - Briefing Documents & inquiries from PMDA
2012/02/27 - Roles of Regulatory Scientist for Business Opportunity
Assessment & Portfolio Management
2011/10/25 - Business Tools & Working Knowledge for Regulatory
Scientist
2011/07/21