Training Plan of Good Registration Management (GRM) in Asian Region

DOI Web Site

Bibliographic Information

Other Title
  • Good Registration Management (GRM : 医薬品・医療機器等の承認審査・申請のための管理原則) のアジアにおける人材育成トレーニング
  • Good Registration Management (GRM:イヤクヒン ・ イリョウ キキ トウ ノ ショウニン シンサ ・ シンセイ ノ タメ ノ カンリ ゲンソク)ノ アジア ニ オケル ジンザイ イクセイ トレーニング

Search this article

Description

<p>Good Registration Management (GRM) is the concept to promote Good Review Practice (GRevP) by review authorities and Good Submission Practice (GSubP) by applicants cooperatively. The purpose of GRM is to enhance quality and efficiency of medical product registration process from application submission throughout review and approval. The GRM was taken up as one of the official topics for regulatory convergence by APEC RHSC in 2015, and its training program has been developed under the APEC Training Center of Excellence (CoE) model by collaborations among the stakeholders from regulatory authorities, industry and academia. Summary of GSubP activities, as an essential element of GRM, will be described together with overall plan of the GRM training program.</p>

Journal

Keywords

Details 詳細情報について

Report a problem

Back to top