Topic ID: 000000199-web
Start Date: Oct 23, 2015
Start Time: 10 AM PST | 1 PM EST
Name of Event: Japan: Regulatory Compliance Requirements for Life Science Products
Details:This webinar will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements, Marketing Authorization Procedures, Variations Processing, License Renewals and cultural working aspects within the Regulatory Environment in Japan. It will prepare you for regulatory approval processes, Agency meetings, the complexities of running studies in Japan, the importance of partner selection and will also add the cultural knowledge needed for success.
Areas Covered In The Session:
Part I: Japan Regulatory Compliance
Part II: Marketing Authorization Processes – Product Registrations / Licensing
This training program would be benificial in understanding of Clinical Trial Requirements, Marketing Authorization Procedures, Regulatory Structure, Variations Processing, License Renewals and cultural working aspects within the Regulatory Environment in Japan.
Speaker: Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.
For more details call Complystream at: (+1) 844 498 6361
Topic ID: 000000199-web
Start Date: Oct 23, 2015
Start Time: 10 AM PST | 1 PM EST
Name of Event: Japan: Regulatory Compliance Requirements for Life Science Products
Details:This webinar will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements, Marketing Authorization Procedures, Variations Processing, License Renewals and cultural working aspects within the Regulatory Environment in Japan. It will prepare you for regulatory approval processes, Agency meetings, the complexities of running studies in Japan, the importance of partner selection and will also add the cultural knowledge needed for success.
Areas Covered In The Session:
Part I: Japan Regulatory Compliance
Part II: Marketing Authorization Processes – Product Registrations / Licensing
This training program would be benificial in understanding of Clinical Trial Requirements, Marketing Authorization Procedures, Regulatory Structure, Variations Processing, License Renewals and cultural working aspects within the Regulatory Environment in Japan.
Speaker: Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.
For more details call Complystream at: (+1) 844 498 6361
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