3-hr Virtual Seminar – Japan: Regulatory Compliance Requirements for Life Science Products
This 3 hour virtual seminar on Japan regulatory compliance requirements will explain the country’s regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan. Why Should You Attend: If your job responsibilities require you to have knowledge of Japan’s regulatory requirements, ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements or understand how best to consider Japan into your Global Business Strategy, then you will profit from attending our training. This 3 hour virtual seminar 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. The recent changes made by PMDA to be more sponsor and applicant-friendly will be reviewed. Real world experiences on actual interactions with the Agency since these changes were implemented, will also be discussed. Agenda: (All time in PST) 10:00 – 11:15 am (Powerpoint presentation; Session I) 11:15 – 11:30 am Break 11:30 – 12:50 pm (Powerpoint presentation; Session II) 12:50 – 1:00 pm (Q&A Session) Who will Benefit: -Clinical / Pharma & Device personnel -Clinical Trial Project Managers -Monitors / CRAs -QA / QC Personnel -Pharmacovigilance reporting personnel -Regulatory personnel whose responsibilities require knowledge of Japan’s Regulatory and Clinical Trial environment -Global Supply Chain personnel -Manufacturing personnel -Global Business Development personnel Instructor Profile: Mr. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Consumer Products and Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in Product Development, Global Business Development and Regulatory Compliance for pharmaceuticals, medical devices, consumer products, food and cosmetics manufacturers. The company has offices in Columbus, Ohio, Brussels, Belgium and Buenos Aires, Argentina and several satellite offices in the Asia / Pacific region where they interact with the global Ministries of Health and product Registration Agencies. Country establishment, product licensing and maintenance and license renewals are core competencies of our speaker. Mr. Russell has received a B.S. and M.S.in Chemistry. For Registartion: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702979?channel=limesfinder
