Date: 10 November 2021
Time: 12noon - 1pm
Note: this webinar will not be available for on-demand access post-event.
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. You will get the opportunity to hear about recent updates and regulatory pathways, but also understand what cultural considerations to take into account when working with the Japanese market.
- Strategic considerations for the Japanese market
- General regulatory requirements for clinical trials in Japan
- Preparation for PMDA scientific advice
- Cultural considerations
This webinar will be suitable for all individuals as it will start with the basic introduction of the Japanese regulatory framework.
Dr. Mohamed Oubihi is a well-known expert in the Pharmaceutical Industry with unique expertise in the Japanese Market. He has over 20 years professional experience in the bio and pharmaceutical industry working for companies such as Biogen, Novo, Abbvie and Amicus. He has been involved in the areas of Regulatory Affairs, Drug Development and Business Development. Mohamed with his entrepreneurial streak, command of the Japanese language and wide connections in Japan, has successfully led over 40 small and medium pharmaceutical companies to break into the Japanese market.
Mohamed is the President and CEO of YAKUMED, a company that is specialized in the Japanese pharmaceutical and cell/gene therapy market. YAKUMED provides a wide range of strategic and operational services spanning commercial, regulatory affairs, pricing, safety, drug development and business development areas. YAKUMED has a multidisciplinary team of highly respected Japanese experts and Business Leaders.
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.
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