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I deal with all questions and consultation about Safety Assurance ( including Pharmacovigilance ) from development to post-marketing of Drugs / Medical Devices. [Establishment & Maintenance of Safety Assurance System for GVP which is a Permission Matter, Making plans of Post Marketing Surveys as an Approval Condition based on GPSP and/or GCP]

When this forum cannot cope, I refr you to an appropriate respondent.

In addition, please utilize the "Q & A Box" because I archive all answer to questions received by people (except an item according to a unit) in it.

                                                       ¡¡¡¡¡¡¡¡¡¡¡¡¡¡PMS FORUM  Leader¡¡Shokichi Kusama

Focus of PMS Forum

For the Patient

What can we do?

Is risk evasion good enough?

How is risk evalluation possible?

For the company

Whether

  development / marketing

     is necessary and possible?

How is supply / sale

          contingency possible?

  

PMS FORUM¡¡

Address¢©194-0044

9 naruse 2090 Machida-city, Tokyo, Japan

TEL/FAX  050-1076-9343

Mobile       090-6152-1589

Mail: pms_forum21@yahoo.co.jp

Introduction of the Leader

                     (Shokichi Kusama)

I have been engaged in safety measure duties of Drugs from incunabula of GCP, GPSMP to the present, and made an effort to be a specialist of safety assurance from development to ao-called approval rearranging.

Addition, in industry activities, I was involved in the making of scheme of the whole industry, mainly, in Drug Safety Update (as DSU) for supplying revised information, and in the education of the safety administrative task.

 

 

On the trial run