Overview of PMDA Clinical Trial Consultation
Topics Covered:
During the webinar, our presenter Hideyuki Takahashi (Senior Manager, Medicinal Product Regulatory Affairs – Japan) discussed the following topics:
- Pathway & timeline from Kick-off meeting to FSIV.
- Key Regulatory considerations and documentation requirements for clinical trial approvals.
- Question & Answers (Q&A).
As a continuous practice, Freyr is destined to organize more webinar sessions related to Regulatory aspects of Life Sciences. We hope you would like to participate in these future sessions. If yes, we will be happy to inform you in prior to the next session.
Shruti Dwivedi is an emerging Strategic Pharmaceutical Marketer with experience in International B2B Marketing Management for Medicinal Products. In her short yet impactful career, she has contributed to Brand Management and Global Marketing Plan Execution while honing her skills in both Qualitative and Quantitative Research. Shruti has demonstrated an aptitude for building relationships with Key Opinion Leaders and working closely with stakeholders. As the Team Lead for Marketing and Communications Strategy at Freyr, she supports Regulatory marketing initiatives across the Asia Pacific and Latin America regions, helping to drive brand visibility and contribute to successful campaigns.
With over forty (40+) years of experience in R&D and NDA/MAA for pharmaceuticals, including roles in Preclinical Research, Clinical Development, Biostatistics, and Regulatory Affairs. His expertise spans Clinical Development Strategy, Strategic Planning for Registration, and interactions with Japan's health authorities, including PMDA consultations. He also developed NDA/sNDA dossiers across various therapeutic areas.
Host
Shruti Dwivedi
Team Lead, MPR Marketing Strategy.
Presenter
Hideyuki Takahashi, Ph.D.
Senior Manager, MPR Regulatory Affairs Japan