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Biosimilars Workshop

Nov 21 2013 11:30AM - Nov 22 2013 3:00PM | DoubleTree by Hilton (formerly The Burlington Hotel) Upper Leeson Street Dublin 4 IRELAND

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Overview 

This 1.5 day workshop will focus on the European experience with biosimilar medicinal products. The workshop will give an overview of the current regulatory as well as market-access situation for these products. Moreover, the lessons learned and the challenges faced by two classes of products, Erythropoietin (EPO) and Granulocyte-Colony Stimulation Factor (G-CSF), which were among the first classes of biosimilars approved in the EU, will be addressed and put into perspective for the most recently approved biosimilar monoclonal antibodies.

The workshop is being chaired by Steffen Thirstrup, who was the co-chair for the project group on Market Access for Biosimilars under EC’s Platform on Access to Medicines in Europe.

Key Topics
The workshop will provide
• An update on the current regulatory framework and market-access situation for biosimilars in the EU
• An overview of the regulatory, scientific and market access situation for biosimilars in the EU

PRESENTATION ACCESS INFORMATION
As a benefit of registration, presentations will be made available on the DIA website 1-3 days before the event start date. Please log in to MyDIA and choose My Presentation Downloads, where you will be able to download all presentations that have been submitted by speakers.
Note: You will need to enter your DIA User ID and password to verify your status. If you have forgotten your DIA User ID and password, use our Login Reminder.

Failté Ireland    Failté Ireland

Who Should Attend 

This conference is aimed at intermediate and experienced professionals from

  • Regulatory agencies
  • The pharmaceutical industry and service providers
  • Academic institutions

including

  • Regulatory affairs personnel
  • Pharmacovigilance staff
  • Clinical and medical personnel
  • Project managers and development

Learning Objectives 

• To provide insight into the regulatory requirements, scientific and operational situation, including challenges associated with biosimilars in the EU
• Attendance will offer opportunities to exchange experiences and engage in discussions with a range of stakeholders in the field of biosimilars

Special Offers 

Group Discounts Available – Send 3 participants and the 4th is free!

Conditions apply. Online registration not available for this offer. Call DIA in Europe on +41 61 225 51 51 or email for further information.

Hotel & Travel 

DIA has blocked a limited number of rooms at the following hotel:

DoubleTree by Hilton Dublin (formerly The Burlington Hotel)
Upper Leeson Street
Dublin 4, Ireland
Tel: +353 (0)1 618 5600
Fax: +353 (0)1 6185693

at the rate of:

EUR 105.00 per room/night inclusive of breakfast and VAT, plus city tax

To book your accommodation, fill out the Hotel Booking Form. Details of the hotel can be found on the Hotel website.

Important: Please complete your reservation by 5 November 2013. Reservations received after this date will be subject to hotel availability and room rate may vary.

In case of cancellation:

To avoid cancellation charges please cancel accommodation directly with hotel and acquire a cancellation number. If room is cancelled within seven days of arrival date, the hotel will endeavour to resell the space, if unable to resell the space a charge equal to the amount of the first night stay will apply.

 

Contact Information 

DIA Europe

KUECHENGASSE 16

4002 BASEL

SWITZERLAND

 

TEL.: +41 61 225 51 51

FAX: +41 61 225 51 52

E-MAIL: DIAEUROPE@DIAEUROPE.ORG

Program Committee 

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Agenda  

Day 1 Thursday, November 21, 2013

  • 12:30PM - 12:40PM

    WELCOME AND INTRODUCTION


    Session Chair(s):

    • Steffen Thirstrup, MD,PhD
      Medical Advisor & Advisory Board Member
      NDA Group, Denmark
  • 12:40PM - 2:20PM

    CURRENT CLIMATE FOR BIOSIMILARS IN THE EU


    Session Chair(s):

    • Steffen Thirstrup, MD,PhD
      Medical Advisor & Advisory Board Member
      NDA Group, Denmark

    Speaker(s):

    • Regulatory Perspective
      Christian Schneider, DrMed
      Senior Medical Officer
      Danish Health and Medicines Authority, Denmark
    • Tajani Initiative -- Access to medicines in Europe / Biosimilar medicinal products – Outcome of a multi-stakeholder project
      Hilda Juhász
      Policy Officer
      European Commission, Belgium
    • Pharmacovigilance and Safety Aspects – PRAC perspective
      Almath Spooner, PhD,RPh
      Pharmacovigilance and Risk Management Lead, IMB and Vice Chair, PRAC
      Irish Medicines Board, Ireland
  • 3:00PM - 5:00PM

    INTERCHANGEABILITY


    Session Chair(s):

    • Suzette Kox, MPharm
      Senior Director, Scientific Affairs
      EGA, Belgium

    Speaker(s):

    • Interchangeability – Regulatory perspective
      Pekka T Kurki, MD,PhD
      Research Professor
      Finnish Medicines Agency, Finland
    • Interchangeability – Physician’s perspective
      Julia S. Johansen
      University of Copenhagen, Denmark
    • Experiences gained – First Biosimilars to market
      Paul Greenland
      Vice President - Biologics
      Hospira UK Ltd, United Kingdom
    • Automatic Substitution Policies in Europe; what’s the rationale behind it?
      Fernando De Mora
      Professor
      Universitat Autonoma de Barcelona, Spain
    • Innovative Industry
      Jaap Venema, PhD,PMP
      Therapeutic Area Lead Biotherapeutics, Global Medical Affairs
      Abbvie, United States

Day 2 Friday, November 22, 2013

  • 8:30AM - 10:15AM

    EXTRAPOLATION


    Session Chair(s):

    • Sabine Atzor, RPh
      Head of EU Regulatory Policies
      F. Hoffmann-La Roche Ltd., Switzerland

    Speaker(s):

    • Extrapolation: Benefit-risk and compliance
      Elena Wolff-Holz
      Paul-Ehrlich-Institute, Germany
    • Quality Considerations of Biosimilars
      Virginia Lee Acha, PhD,MSc
      Director, Regulatory Affairs
      Amgen International Inc, United Kingdom
    • Experience with Physician's Perspective on Biosimilars
      Michael Reilly, JD
      Executive Director
      Alliance For Safe Biologic Medicines, United States
    • Traceability of biosimilars and INN Debate
      Lisette Vromans
      Ass Director Regulatory Liaison Regulatory policy EU & MOW
      Merck Sharp & Dohme, Netherlands
  • 10:45AM - 12:20PM

    MONOCLONAL ANTIBODIES


    Session Chair(s):

    • Christian Schneider, DrMed
      Senior Medical Officer
      Danish Health and Medicines Authority, Denmark

    Speaker(s):

    • Experience with First mAB Biosimilar Assessments – Regulator’s view
      Pekka T Kurki, MD,PhD
      Research Professor
      Finnish Medicines Agency, Finland
    • Physicochemical and Functional Comparability between the Proposed Biosimilar Rituximab GP2013 and Originator Rituximab
      Hansjoerg Toll
      Head Analyt. Characterization
      Sandoz GmbH, Austria
    • Extrapolation of Indications – Innovator industry perspective
      Fermin Ruiz De Erenchun, MD,PhD
      Global Regulatory Affairs, Pharmaceutical Division
      F. Hoffmann-La Roche Ltd, Switzerland
    • Immunogenicity
      Paul D. Chamberlain
      Principal
      bioLOGICA Consulting, France
  • 1:30PM - 3:00PM

    MARKET ACCESS/PRICING


    Session Chair(s):

    • Christian Schneider, DrMed
      Senior Medical Officer
      Danish Health and Medicines Authority, Denmark

    Speaker(s):

    • Biosimilars versus Generics: From regulation to market
      Fernando De Mora
      Professor
      Universitat Autonoma de Barcelona, Spain
    • Biosimilar Accessible Market: Size and outlook
      Per Troein
      VP Strategic Partners
      IMS Health Inc, United Kingdom
    • Role of HTA for Biosimilars
      Jorge Mestre-Ferrandiz, PhD
      Director of Consulting
      Office of Health Economics, United Kingdom

Exhibits  

DIA is not offering exhibition for this meeting. For more information on exhibition opportunities in 2013 please contact: Roxann Schumacher, DIA Exhibits Manager on +41 61 225 51 38 or email:roxann.schumacher@diaeurope.org

Registration Fees 

Member

Member Academia
€550.00
Member Government
€550.00
Member Standard
€1100.00

Non-Member

NonMember Academia
€665.00
NonMember Government
€665.00
NonMember Standard
€1215.00
Register Online
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