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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V8-S2] The Latest Regulatory Trend and Counter Measures for Data Integrity

Session Chair(s)

Shuji  Sumida, MSc, RPh

Shuji Sumida, MSc, RPh

Senior Director, Quality & Regulatory Compliance Unit

Chugai Pharmaceutical Co., Ltd., Japan

The integrity of required scientific data and process records in ensuring the quality, efficacy, and safety of drugs has come under the spotlight. One major reason for this trend is instances of the alteration and falsification of data and records at a number of drug manufacturing sites. Steps such as access controls and review of audit trails are thus needed to stop intentional fraud, and the FDA has issued some warning letters in the last few years because of insufficient measures to ensure data integrity. Such factors have led to data integrity coming under closer scrutiny, with guidances issued for all GxP areas, not only GMP. In this session, we will discuss the main issues and what we can do to resolve them, taking a look at the latest regulations and recent inspection findings.


Hiroyuki  Kawakita

Data Integrity:Regulatory expectation and findings on GMP Inspection

Hiroyuki Kawakita

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Specialist (for Inspection)

Satoshi  Morino

The Latest Global Regulatory Trends on Data Integrity and Issues to be Addressed by the Pharmaceutical Industries

Satoshi Morino

Eisai Co., Ltd., Japan

Kashima Quality Assurance, Japan Regional Quality, Global Quality HQs

Atsuto  Kobe

Data Integrity Remediation Activities for Inspection Readiness and Outcome of FDA Inspection

Atsuto Kobe

Chugai Pharmaceutical Co., Ltd., Japan

Pharmaceutical Technology Quality Dept