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2nd DIA Labeling Workshop in Japan

  February 17, 2012  
Nomura Conference Plaza Nihonbashi , Tokyo, Japan
Apr 21 2012 7:00AM - 3:00PM

How Pharmaceutical Labeling Staffs, PMDA, and Package Labeling Users Can Ensure Appropriate Labeling Revisions

The contents of a pharmaceutical package label are drafted from the clinical trial and post marketing data obtained by applicants in foreign countries, who participate in new drug applications. During the review process, package labeling is then discussed with applicants and regulators (Pharmaceutical and Medical Device Agency; PMDA). Once the final package label is approved, the information is then used in the medical field. When new drug safety information is found and/or serious adverse affects arise, pharmaceutical companies need to consider revising their package label. However, there is some diff erentiation between revision logic and timing between each company. For this reason, global companies should consider harmonization with foreign countries’ labeling practices and/or CCDS. Due to the fact that there are variations between PMDA logic and theory, package labeling is a major focus for many pharmaceutical companies.

The 2nd Labeling Workshop will focus on labeling revision, same as the 1st workshop, as well as revision ideas of pharmaceutical companies and the PMDA, to help facilitate future effective labeling revisions.

• Participants will use sample data to create revised package labeling and PMDA will resolve concerns and unclear points on labeling revision activities.
• Features representatives from industry, PMDA, and medical pharmacists.

Event Code:
Organized by: DIA Japan
Invited Speakers:
Akiyoshi Uchiyama, MD, PhD
President, Artage Inc.
Teiki Iwaoka, PhD
Executive Consultant,
Director of Drug Safety Outsourcing Planning,
Medical & Pharmaceutical Business Transformation
Outsourcing Unit, CAC Corporation
Toshinobu Iwasaki, PhD
General Manager, Product Development Regulatory
Aff airs Dept., Pharmaceutical Development Div.,
Shionogi & Co., Ltd..
Kana Maruyama
Labelling Control Group,
Regulatory Aff airs Department 3,
Development and Medical Aff airs Division,
GlaxoSmithKline K.K
Rie Matsui, RPh
Senior Manager,
Post Marketing Regulatory Strategy
Pfi zer Japan Inc.
Tomoko Matsukawa
Clinical Safety & Pharmacovigilance Dept.
Development & Medical Aff airs Division,
GlaxoSmithKline K.K.
Ken Nakajima
Associate Manager, Evaluation Management,
Pharmacovigilance Dept., Headquarters for Product
Safety and Quality Assurance,
Otsuka Pharmaceutical Co., Ltd.
Yuji Ohne
Director, Pharmacovigilance,
SymBio Pharmaceuticals Limited
Junko Sato, PhD
Director for Risk Management, Offi ce of Safety II
Pharmaceuticals and Medical Devices Agency
Katsumi Tanaka
Offi ce of Safety II & Offi ce of Safety I
Pharmaceuticals and Medical Devices Agency
Deadline for Abstracts: Call contact
Register online or forward to
DIA Japan, Nisso 22 Building, 7F, 1-11-10 Azabudai, Minato-ku,
Tokyo 106-0041 Japan
tel +81-3-5575-2130 • fax +81-3-3583-1200
E-mail: keiko.cambridge@diajapan.org
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