Ryoichi Tomioka Email & Phone Number | • 4 years RA (Regulatory Affairs) experience for making and maintaining J-PI (labelling in Japan) as follows. - As for J-PI draft filling for J-NDA, ➢ Worked with internal concerned departments, such as non-clinical, clinical, medical, pharmacovigilance, Marketing, CMC, industry affairs and so on. ➢ Prepared M1.8, M1.7, M1.6 and answers to inquiries for labelling part from Japan regulatory authority (PMDA). - As for J-PI draft filing for post-marketing revision consultations with PMDA, ➢ Managed schedule up to filing J-PI draft and the rationales for the revision. ➢ Worked with internal concerned department, such as pharmacovigilance, medical, marketing and industrial affairs. ➢ Prepared J-PI draft and the rationales for the revision. ➢ Served as a contact point for the company, such as filing consultation documents, preparing and filing answers to inquiries from PMDA. ➢ Made revised J-PI model and consultation J-PI draft based on the new instructions for package inserts of prescription drugs, which filed them with PMDA. • 5 years DM/data-management experience (3 years at CRO and 2 years at Pharmaceutical Industry as specified dispatched staff from CRO) concerning clinical trial and post-marketing surveillance as follows, - Executions of operations, such as data cleaning. - Drew up and implemented operational efficiency improvements.

Ryoichi Tomioka

• 4 years RA (Regulatory Affairs) experience for making and maintaining J-PI (labelling in Japan) as...
Greater Tokyo Area, Greater Tokyo Area, Japan

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Ryoichi Tomioka’s Location Greater Tokyo Area, Greater Tokyo Area, Japan

Ryoichi Tomioka’s Current Industry Abbvie

Ryoichi Tomioka’s Prior Industry Sanofi | イーピーエス株式会社

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Senior Associate

2021-08-01 00:00:00 - Present

Associate

2016-11-01 00:00:00 - 2019-09-01 00:00:00

Data Manager

2011-04-01 00:00:00 - 2016-10-01 00:00:00

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Ryoichi Tomioka is a • 4 years RA (Regulatory Affairs) experience for making and maintaining J-PI (labelling in Japan) as follows. - As for J-PI draft filling for J-NDA, ➢ Worked with internal concerned departments, such as non-clinical, clinical, medical, pharmacovigilance, Marketing, CMC, industry affairs and so on. ➢ Prepared M1.8, M1.7, M1.6 and answers to inquiries for labelling part from Japan regulatory authority (PMDA). - As for J-PI draft filing for post-marketing revision consultations with PMDA, ➢ Managed schedule up to filing J-PI draft and the rationales for the revision. ➢ Worked with internal concerned department, such as pharmacovigilance, medical, marketing and industrial affairs. ➢ Prepared J-PI draft and the rationales for the revision. ➢ Served as a contact point for the company, such as filing consultation documents, preparing and filing answers to inquiries from PMDA. ➢ Made revised J-PI model and consultation J-PI draft based on the new instructions for package inserts of prescription drugs, which filed them with PMDA. • 5 years DM/data-management experience (3 years at CRO and 2 years at Pharmaceutical Industry as specified dispatched staff from CRO) concerning clinical trial and post-marketing surveillance as follows, - Executions of operations, such as data cleaning. - Drew up and implemented operational efficiency improvements. - Reviewed the results for next steps.