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1st DIA Risk Management Workshop in Japan

Mar 13 2014 9:30AM - Mar 14 2014 5:00PM | UDX Gallery NEXT 4-14-1 Sotokanda Chiyoda-ku Tokyo 1010021 Japan

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Overview 

Simultaneous Translation Available

It has become common knowledge that risk management of pharmaceutical products is vitally important for safety management. The Safety Risk Management Plan (RMP) is understood as a core document for postmarketing safety management in the US and Europe and this document is utilized during daily safety management activity.

In Japan, the RMP system was introduced from April 1, 2013. The RMP document should be submitted as one of the CTD documents (M1.11) at JNDA and after approval the RMP will be disclosed on the PMDA website.

However, it has become clear that there is some difference in the understanding of RMPs between professionals in pharmaceutical companies and health authorities. This workshop will give professionals in these two fields the chance to come together and discuss RMP strategies, covering key topics including how to create a useful RMP for medical professionals.

The workshop will feature presentations introducing examples from the EU, which is a region that is advanced in the use of RMP. Participants will also practice how to create a virtual product through group work, and discuss the Virtual RMP. Please join us at this session.

Who Should Attend 

  • Main Player of RMP creation in a pharmaceutical company
  • Professionals who have general information for RMP
  • Reviewer of RMP in company and agency
  • RMP user for medical field

Hotel & Travel 

For accommodations at the Akihabara Washington Hotel, please visit the following URL to make reservation.

Attendees should make their airline and room reservations as soon as possible.
Nearest airport: Haneda Airport

Address: 1-8-3 Kanda Sakuma-Cho, Chiyoda-ku, Tokyo 101-0025, Japan
Telephone: +81 3 3255-3311 / Fax: +81 3 3255-7343
URL: http://akihabara.washington-hotels.jp/

Contact Information 

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-5575-2130
Fax: +81-3-3583-1200
DIAJapan@diajapan.org
www.diajapan.org

Program Committee 

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Agenda  

Day 1 Thursday, March 13, 2014

  • 9:30AM - 9:40AM

    Opening Remarks

    Speaker(s):

    • Ko Sekiguchi, MBA
      Director
      DIA JAPAN, Japan
    • Rei Maeda
      Eli Lilly Japan K.K., Japan
  • 9:40AM - 11:40AM

    Session 1: Lecture 1


    Session Chair(s):

    • No-image Rei Maeda
      Eli Lilly Japan K.K., Japan

    Speaker(s):

    • Risk Management Plan ~What are the Differences and Harmonization Points among Japan, US, and Europe?~
      Mamiko Kasho
      Global Pharmacovigilance, Corporate Medical Affairs
      Eisai Co., Ltd., Japan
    • Risk Management in the EU: Lessons from pioneers
      Panos Tsintis, DrMed,FFPM,FRCP
      Medical Advisor & Advisory Board Member
      NDA Group, United Kingdom
  • 1:00PM - 5:30PM

    Session 2: Group Work

    Speaker(s):

    • Kasumi Daidoji, MSc,RPh
      Manager, Safety Management Dept, Corporate Regulatory Compliance
      Eisai Co., Ltd., Japan

Day 2 Friday, March 14, 2014

  • 9:30AM - 11:30AM

    Session 3: Presentation of Group Discussion

    Speaker(s):

    • Koh Miyakawa
      Director
      Takeda Pharmaceutical Company Limited, Japan
  • 1:00PM - 3:00PM

    Session 4: Lecture 2


    Session Chair(s):

    • Shinichi Nishiuma, MD
      Senior Medical Advisor, Global Patient Safety
      Eli Lilly Japan K.K., Japan

    Speaker(s):

    • Overview of EU Risk Management and Regulations
      Panos Tsintis, DrMed,FFPM,FRCP
      Medical Advisor & Advisory Board Member
      NDA Group, United Kingdom
    • Current Situation of RMP Evaluation in PMDA
      Hiroyuki Murakami
      Reviewer, Office of New Drug I
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 3:30PM - 5:00PM

    Session 5: Panel Discussion


    Session Chair(s):

    • Akiko Hori, MD,PhD
      Risk Management Director, Office of Safety
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • No-image Rei Maeda
      Eli Lilly Japan K.K., Japan

    Speaker(s):

    • Mamiko Kasho
      Global Pharmacovigilance, Corporate Medical Affairs
      Eisai Co., Ltd., Japan
    • Labeling in the US, EU and Japan
      Rie Matsui, RPh
      Director, Regional Labeling Head for Asia International Labeling Group
      Pfizer Japan Inc., Japan
    • Hiroyuki Murakami
      Reviewer, Office of New Drug I
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Mitsuo Saito, PhD
      Associate Professor
      Teikyo Heisei University, Japan
    • Panos Tsintis, DrMed,FFPM,FRCP
      Medical Advisor & Advisory Board Member
      NDA Group, United Kingdom

Registration Fees 

Member

Member Academia
¥40000.00
Member Government
¥40000.00

Non-Member

NonMember Academia
¥40000.00
NonMember Government
¥55000.00
NonMember Standard
¥101000.00
Group Discounts

There are no group discounts for this event.


CANCELLATION POLICY: On or before March 6, 2014
Administrative fee that will be withheld from refund amount:
Industry (Member or Nonmember) = ¥20,000
Government/Academia/Nonprofit (Member or Nonmember) = ¥10,000

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.

Register Online
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