Overview of PMDA Clinical Trial Consultation
October 15, 2024
30 Minutes
Join the Webinar at your Convenient Time
For AMR & EU
3:00 PM GMT | 4:00 PM CET | 10:00 AM EDT | 9:00 AM CDT | 3:00 PM BST
For RoW
11:30 AM IST
What is it all about?
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is a key Regulatory body overseeing clinical trials. Engaging in clinical trial consultations with the PMDA requires thorough preparation, comprehensive documentation, and an understanding of the agency’s Regulatory expectations. Efficient consultation management is critical to expediting approvals and ensuring clinical trial success.
Are you looking for support in managing clinical trial consultations with the PMDA or seeking to navigate this process more effectively? Attend our webinar to learn strategic approaches for ensuring a smooth consultation experience with the PMDA.
The webinar will be hosted by Shruti Dwivedi and will be presented by Hideyuki Takahashi, Senior Manager, Medicinal Product Regulatory Affairs - Japan. You will receive an overview of PMDA Clinical Trial Consultation. The topics to be discussed during the webinar include:
- Pathway & timeline from Kick off meeting to FSIV.
- Key Regulatory considerations and documentation requirements for clinical trial approvals.
- Question & Answers (Q&A).
We value your time and look forward to having you in the webinar.
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