3rd DIA Labeling Workshop in Japan

Overview

A package labeling of pharmaceutical drug is most essential material and it is recognized that package labeling is very important communication tool between pharmaceutical company and medical professionals.

A package labeling is drafted based on clinical trial data and post marketing data of foreign countries at new drug application by applicant. During review process, this package labeling is discussed with applicant and regulator, and it is used on actual medical field after approval as fi nal package labeling with pharmaceutical drug.

DIA Japan Labeling Workshop had provided some useful information such as Pharmaceutical industry’s points of view, PMDA and actual medical institute’s point of view through the previous two workshops. On the other hand, it becomes very important to provide the safety information directory to patients and patient’s families for safety medication. This information providing process and creating safety materials are a little bit different from Labeling creation and revision process and it will be needed to new idea and understanding actual medical institute’s processes and so on. Furthermore it is very important to understand prescriber’s point of view.

At 3rd Labeling workshop, it should be focused on direct safety information providing to patients, we will share some information of pharmaceutical company experience of direct safety information providing to patients and medical institute’s Pharmacist’s and Prescriber’s point of view on morning lecture’s session. And on the afternoon session, we will discuss and conduct debate for the direct safety information providing to patents based on some concrete example data.

This workshop will be very useful opportunity for labeling work.

Contact Information

Questions?
Keiko Cambridge, Program Manager
Phone +81 3.5575.2130
Fax +81 3.3583.1200
keiko.cambridge@diajapan.org

Program Committee

Previous Next

Program Committee 1-3 of 11

Akiyoshi Uchiyama

President
Artage Inc., Japan

Teiki Iwaoka, PhD,MS

Executive Consultant, Director of Drug Safety Outsourcing Planning
CAC EXICARE Corporation, Japan

Kana Maruyama

Labelling Department, Development and Medical Affairs Division
GlaxoSmithKline K.K., Japan

Program Committee 4-6 of 11

Rie Matsui, RPh

Director, Regional Labeling Head for Asia Medical Documentation and Labeling
Pfizer Japan Inc., Japan

Tomoko Matsukawa

GlaxoSmithKline K.K., Japan

Ken Nakajima

Associate Manager, Evaluation Management, Pharmacovigilance Dept.
Otsuka Pharmaceutical Co., Ltd., Japan

Program Committee 7-9 of 11

Yuji Ohne

Director, Pharmacovigilance
SymBio Pharmaceuticals Limited, Japan

Junko Onaka

Group Manager, Labeling Group, Regulatory Compliance Dept, RA Div.
Janssen Pharmaceutical K.K., Japan

Junko Sato, PhD

International Liason Officer
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Program Committee 10-11 of 11

Shoji Takamatsu, PhD

Office Director, Office of Safety II
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Katsumi Tanaka

Showa University Hospital, Japan

Agenda

Day 1 Saturday, March 16, 2013

9:30AM - 9:40AM
Opening Remarks

Session Chair(s):
- Akiyoshi Uchiyama
  President
  Artage Inc., Japan
9:40AM - 10:20AM
Effectiveness of Early post marketing phamacovigilance

Session Chair(s):
- Tatsuo Kishi
  Director, Office of Safety II
  Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Effectiveness of Early post marketing phamacovigilance
10:30AM - 12:00PM
Session 1
Speaker(s):
- Pharmaceutical Industry’s Point of View on Safety Information Distribution for Patients
  Takashi Yamada
  Head of Phamacovigilance
  Bayer Yakuhin, Ltd., Japan
- Actual Medical Fields Situation of Direct Safety Information Providing for Patients
  Koichi Mizuno
  Sub-Director of Pharmaceutical Department
  National Center for Global Health and Medicine, Japan
- Considerations and Sufferings of Physicians for Safety Providing for Patients
  Seiji Hori
  Department of Pharmacology
  Jikei University School of Medicine, Japan
1:00PM - 2:15PM
Session 2

Registration Fees

Other Fees

Medical/Paramedical: ¥5000.00

Member

Charitable Nonprofit/Academia Member: ¥15000.00
Member Government: ¥15000.00
Member Standard: ¥32000.00

Non-Member

Charitable Nonprofit/Academia Nonmember: ¥22500.00
NonMember Government: ¥22500.00
NonMember Standard: ¥39500.00

Group Discounts

There are no Group Discounts for this event.

CANCELLATION POLICY:
On or before March 8, 2013 Administrative fee that will be withheld from refund amount:
Industry (Member or Nonmember) = 21,400 JPY
Government/Academia/Nonprofit (Member or Nonmember) = 10,700 JPY
Medical/Paramedical (Member or Nonmember) = 3,000 JPY

Cancellations must be in writing and be received by the cancellation date above. Registrants who do not cancel by that date and do not attend will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of any such substitutions as soon as possible. Substitute registrants will be responsible for nonmember fee, if applicable.

DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

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