Early inclusion of Asia in Clinical Development Plans: Opportunities, Challenges and Solutions
Sponsored by: Linical
- Clinical Development Plans
Date: 11 March
Time: 2PM London/ 9AM New York
• Due to unique regional features, conducting clinical trials in Asia can provide benefits such as a faster recruitment process, high quality equivalent data and an interesting cost scenario. It is also worth to mention that Asian trials can facilitate licensing deals and provide access to one of the fastest-growing pharmaceutical markets. Nevertheless, despite these opportunities, there are challenges related to diverse regulatory environments, infrastructure, legal issues, language and cultural hurdles.
• This webinar aims to provide awareness about opportunities related to clinical trials in Asia, but also to give insight into strategies to successfully plan and manage these trials. Through an overview of the current clinical development scenario in main Asian territories and a review of essential issues to take into account to run a clinical trial in Asia, the audience will have the opportunity to get an expert vision on how to properly plan the trials, avoid obstacles and maximize results. Our experts will also address how to access the Japanese market and the value of global project management in trials involving China.
• Join us and learn about opportunities and how to overcome hurdles in the development of clinical trials in key Asian countries
Director of Global Project Management – Linical HQ Japan
Susanne Kaiser is the Director of the Global Project Management (GPM) at Linical HQ in Japan. The GPM department manages all international clinical trials for Linical’s Japanese and Asian clients as well as studies in Japan and Asia for our European and US based clients. As a Project Manager and Project Director Susanne has successfully managed both large (2500+ patients) and small, phase I to IV full scope trials from study start-up through close out across the world (Europe, Asia, Australia, North & South America) and is fluent in Japanese as well as several European languages.
Toshiaki Nagafuji Ph.D.,R.Ph.,
Head of Innovative Drug Development Business – Linical HQ Japan
Mr. Nagafuji has a 25+ years’ experience in the Japanese pharma market at both clinical development and licensing/business development. Since 2016 he is the head of the Innovative Drug Development Business (IDDB Unit) at Linical HQ, providing biotech companies with consulting services; market analysis, regulatory/clinical development strategy, interaction with PMDA, medical writing, and strategic partnering/licensing.
Senior Project Manager, PMP – Linical Europe
Santiago Zas is Senior Project Manager at Linical. Santiago has a PhD in Pharmacy, and he is a certified Project Management Professional with more than 25 years’ experience in CRO industry. He has managed full service international studies at all stages, being focused in managing studies performed in China for clients in EU since 2018.
Guest Speaker for Introduction: Marc Scull – Vice President Business Development – Linical Europe
Key Learning Objectives
- Get to known opportunities linked with conducting clinical trials in Asia
- Gain insight about how to deal with the particularities associated with these studies to guarantee an optimal outcome
- Get familiar with the most important aspects to consider to plan the trials
- Understand how to overcome obstacles in the development of clinical trials in key Asian countries
- Project Management
- Clinical Operations
- Regulatory Specialist
- Clinical Innovation
- Global Development
- Medical Director
- Operational Director
- Chief Medical Officer (CMO)
- Chief Scientific Officer (CSO)
- Managing Director (MD)
- Vice President
- VP - Regulatory Affairs
- Head of Clinical Operations