Date: 11 July 2018
Time: 12noon - 1pm (BST)
Note: this webinar will not be available for on-demand access post-event.
Overview
During this webinar you will learn about the regulatory requirements for Japan focusing on the key elements which are very different from the EU regulatory practices, including clinical trials and preparing for PMDA scientific advice. This will provide you with the essential updated tools for forming your Japan and Global Regulatory strategies and discuss the cultural differences when working with Japanese companies.
Learning objectives
- Strategic considerations for the Japanese market
- General regulatory requirements for clinical trials in Japan
- Preparation for PMDA scientific advice
- Cultural considerations
Target audience
This webinar will be suitable for all individuals as it will start with the basic introduction of the Japanese regulatory framework.
Presenter
Dr Mohamed Oubihi is an expert in the Japanese pharmaceutical market with over 20 years' experience in Regulatory, Drug Development and Business Development for Japan and other global markets. He is the CEO of Yakumed Ltd, a niche consultancy specialising in the Japanese market and composed of a hand-picked team of Japanese experts and business leaders.
Mohamed and his colleagues at Yakumed have experience in guiding more than 20 European and American companies in introducing their drugs to Japan through successful interactions and submissions with Japan's PMDA and key opinion leaders. Yakumed have also supported several companies in establishing their own operations in Japan's pharmaceutical market or in partnering with local companies.
Mohamed is well connected in the Japanese market and academia. He is former Vice Chairman of the Enzyme Division of the Japanese Association of Food Additives.
CPD
This course offers 1 CPD hour for successful completion, to learn about why CPD is important visit the Lifelong Learning page.
Please note, this webinar will not be recorded.
How do I apply?
Simply login or create an account and register below.
Course fees:
| Type |
Member |
Non-member |
| Standard |
£75+VAT |
£95+VAT |
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Terms and conditions
Please read the training terms and conditions before purchasing this webinar. By purchasing this webinar, you are agreeing to the terms and conditions.