DIA
Drug Information Association Logo

Improving Efficiency Within the Current Regulatory System: Results of the Escher project

Sep 18 2014 9:30AM - Sep 18 2014 5:00PM | Hotel Pullman Brussels Midi Place Victor Horta 1 1060 Brussels Belgium

« Back to Listing

Overview 

The European Medicines Regulatory system is well developed and has achieved many successes in bringing medicinal products to the market to the benefit of patients and their health.
However it has been receiving criticism for not supporting true innovation enough, for being bureaucratic, and full of redundancies and inefficiencies, which impact timelines and development costs.
What of this is true, what is not? What could be improved and what needs to be changed?
This workshop, organised jointly by DIA and TOPRA, will address these important questions and bring an important contribution to the debate improving the regulation for the benefit of all stakeholders.

Registration to the meeting is available on TOPRA website.
Register NOW!

Featured Topics 

The Escher Project: scientific evidence and dialogue on the development and regulation of medicines.
The Escher Project initiates research and policy debate on the development, marketing authorization, reimbursement and use of medicines. Our goal is to facilitate patient access to medicines and innovative technologies that address public health needs.
............................................................
Registration fees

To be booked via TOPRA

Industry fee - GBP665.50 = GBP550.00 + GBP115.50 (21% BE VAT)
Government fee - GBP332.75 = GBP275.00 + GBP57.75 (21% BE VAT)
Academic fee - GBP332.75 = GBP275.00 + GBP 7.75 (21% BE VAT)
Student fee - GBP114.95 = GBP95.00 + GBP19.95 (21% BE VAT)

Hotel & Travel 

TOPRA and DIA have blocked a limited number of rooms at the following hotel:

Hotel Pullman Brussels Midi
Place Victor Horta 1
1060 Brussels
Belgium

Tel.: (+32)25289800
Fax: (+32)25289801
Email: H7431-SB@accor.com
Reference Code (ESCHER14)

at the rate of:
EUR 169 per single room (inclusive of breakfast and VAT, excluding of city tax)
Important: The room rate is available until 15 August 2014 or until the group block is sold-out, whichever comes first

Contact Information 

Registration Questions
TOPRA
Phone.: +44 (0) 20 7510 2560
meetings@topra.org

Agenda and Event Logistics
DIA EMEA

Tamara Kohler, Team Leader
Phone: +41 61 225 51 57
Fax: +41 61 225 51 52
tamara.kohler@diaeurope.org

Program Committee 

Previous Next

Agenda  

Day 1 Thursday, Sep 18, 2014

  • 9:30AM - 10:30AM (Central Europe Standard Time)

    REGISTRATION AND WELCOME COFFEE
  • 10:30AM - 11:00AM (Central Europe Standard Time)

    WELCOME AND INTRODUCTION

    Speaker(s):

    • Welcome from TOPRA
      Lynda Wight
      TOPRA, United Kingdom
    • Welcome from Chairman and Background to the Escher Project initiated in 2008
      Andre W. Broekmans
      Director of Escher
      TI Pharma, Netherlands
    • The current Escher Project: Improving the EU system for marketing authorisation: Reviewing regulatory deficiencies and inefficiencies
      Jean Philippe de Jong, DrMed, MD, PhD, MA, MSc
      Project Leader, Exon Consultancy
      The Escher Project, Netherlands
    • Introduction by AESGP/EFPIA
      Pär Tellner, MSc
      EFPIA ICH Coordinator, Director Regulatory Affairs
      EFPIA, Belgium
    • Introduction by AESGP/EFPIA
      Christelle Anquez-Traxler, PharmD
      Regulatory and Scientific Affairs Manager
      AESGP, Belgium
  • 11:00AM - 11:40AM (Central Europe Standard Time)

    PAEDIATRICS

    Speaker(s):

    • The Results
      Jacoline Bouvy
      Postdoctoral Researcher
      Utrecht University, Netherlands
    • Reflection from Industry
      Angelika Joos, MPharm
      Executive Director, Global Regulatory Policy
      MSD (Europe) Inc., Belgium
    • The Regulatory View
      Jordi Llinares Garcia, DrMed, MSc
      Head of Product Development Scientific Support Department
      European Medicines Agency, European Union, United Kingdom
  • 11:40AM - 12:20PM (Central Europe Standard Time)

    CONDITIONAL MARKET APPROVAL

    Speaker(s):

    • The Results
      Jarno Hoekman
      Postdoctoral Researcher
      Utrecht University, Netherlands
    • Reflection from Industry
      Susan Forda, PhD, MBA
      Vice President, International Regulatory Affairs
      Eli Lilly & Company Ltd., United Kingdom
    • The Regulatory View
      Olga Solomon
      Deputy Head of Unit
      European Commission, Belgium
  • 12:20PM - 1:20PM (Central Europe Standard Time)

    LUNCH
  • 1:20PM - 2:00PM (Central Europe Standard Time)

    MUTUAL RECOGNITION PROCEDURE (MRP)/DECENTRALISED PROCEDURE (DCP)

    Speaker(s):

    • The Results
      Hans Ebbers, MSc
      Postdoctoral Researcher
      Utrecht University, Netherlands
    • Reflection from Industry
      Christine Eising
      Category Head New Growth Opportunities
      Novartis Consumer Health SA, Switzerland
    • The Regulatory View
      Peter Bachmann, DrSc
      Senior Expert, European Drug and Regulatory and International Affairs
      Federal Institute for Drugs and Medical Devices (BfArM), Germany
  • 2:00PM - 2:40PM (Central Europe Standard Time)

    PHARMACOVIGILANCE

    Speaker(s):

    • The Results
      Jacoline Bouvy
      Postdoctoral Researcher
      Utrecht University, Netherlands
    • Reflection from Industry
      David B. Jefferys, MD, FRCPC
      Senior Vice President
      EFPIA, Elsai Europe Limited, United Kingdom
    • The Regulatory View
      Fergus Sweeney, PhD
      Head of Inspections and Human Medicines Pharmacovigilance (Division)
      European Medicines Agency, European Union, United Kingdom
  • 2:40PM - 4:00PM (Central Europe Standard Time)

    WORKSHOP 1: PAEDIATRICS

    Speaker(s):

    • Angelika Joos, MPharm
      Executive Director, Global Regulatory Policy
      MSD (Europe) Inc., Belgium
    • Jarno Hoekman
      Postdoctoral Researcher
      Utrecht University, Netherlands
  • 2:40PM - 4:00PM (Central Europe Standard Time)

    WORKSHOP 2: CONDITIONAL MARKET APPROVAL

    Speaker(s):

    • Davina Elizabeth Stevenson, PhD
      Associate Director, Regulatory Affairs (Liver Disease)
      Gilead Sciences International Ltd, United Kingdom
    • Wouter Boon
      Assistant Professor
      Faculty of Geosciences, Utrecht University, Netherlands
  • 2:40PM - 4:00PM (Central Europe Standard Time)

    WORKSHOP 3: MUTUAL RECOGNITION PROCEDURE (MRP)/DECENTRALISED PROCEDURE (DCP)

    Speaker(s):

    • Peter Bachmann, DrSc
      Senior Expert, European Drug and Regulatory and International Affairs
      Federal Institute for Drugs and Medical Devices (BfArM), Germany
    • Hans Ebbers, MSc
      Postdoctoral Researcher
      Utrecht University, Netherlands
  • 2:40PM - 4:00PM (Central Europe Standard Time)

    WORKSHOP 4: PHARMACOVIGILANCE

    Speaker(s):

    • Susan M Sandler
      Senior Director, Regulatory Affairs, Clinical Research Services
      PAREXEL International, United Kingdom
    • Jacoline Bouvy
      Postdoctoral Researcher
      Utrecht University, Netherlands
  • 3:40PM - 4:00PM (Central Europe Standard Time)

    Tea and coffee break
  • 4:00PM - 4:40PM (Central Europe Standard Time)

    FEEDBACK FROM THE 4 WORKSHOPS WITH RECOMMENDATIONS FOR FUTURE ACTION
  • 4:40PM - 5:00PM (Central Europe Standard Time)

    REVIEW OF THE DAY

    Speaker(s):

    • Andre W. Broekmans
      Director of Escher
      TI Pharma, Netherlands
    • Jytte Lyngvig, PhD
      Senior Vice President and Managing Director, DIA EMEA
      DIA Europe, Middle East and Africa, Switzerland
  • 5:00PM - 5:00PM (Central Europe Standard Time)

    CLOSE OF THE WORKSHOP
« Back to Listing Back To Top