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Biosimilars Conference

Dec 2 2014 9:00AM - Dec 3 2014 5:00PM | Maritim Hotel Berlin Stauffenbergstrasse 26 10785 Berlin Germany

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Overview 

One year further into the life of Biosimilars, this 1.5 days conference will provide an update on the current status for biosimilars in EU and globally. The conference will give an overview of the current regulatory, scientific and market access perspectives for biosimilars, including discussion on a number of Hot Topics in the field. Plenary lectures followed by panel discussions of sufficient length to provide participants an opportunity to bring forward their own experience and share their thoughts and ideas with the experts.

 

One of the highlight hot topics will be the new guidline on biosimilars just published by the European Medicines Agency (click here for details).

Featured Topics 

  • Current regulatory status of biosimilars in the EU
  • Stakeholders views and experiences with biosimilars
  • The importance of assessing immunogenicity in biosimilar development
  • Interchangeability and switching
  • Global development of biosimilars
  • Global regulatory challenges for biosimilars
  • Naming and labelling of biologicals including biosimilars
  • Market access and pricing of biosimilars in EU

Who Should Attend 

This conference is aimed at intermediate and experienced professionals from:

  • Regulatory agencies
  • The pharmaceutical industry and service providers including
  • Regulatory affairs personnel
  • Pharmacovigilance staff
  • Clinical and medical personnel
  • Academic institutions
  • Physicians
  • Patient organisations

Learning Objectives 

  • Deal with regulatory requirements
  • Scientific and operational challenges and opportunities
  • Exchange experiences and discuss Hot Topics with experts
  • Update the participant on the current knowledge including regulatory and scientific thinking

Hotel & Travel 

VENUE LOCATION

Maritim Hotel Berlin
Stauffenbergstraße 26
10785 Berlin
Germany

Phone +49 (0)30 2065-0
Web: http://www.maritim.com/en/hotels/germany/hotel-berlin

MAP AND TRAVEL INFORMATION

The Maritim Hotel Berlin occupies a prime, central spot on the city's Tiergarten park in the quiet diplomatic quarter, close to the "Kurfürstendamm" and the "Potsdamer Platz". Close by are the "Kulturforum" with the "Berlin Philharmonie", the New National Gallery, the Painting Gallery and various shopping possibilities.

Please download map here

Busses and trams:

from Tegel airport
Bus X9 to "Bahnhof Zoo", from there take bus 200 to stop "Philharmonie" (approx. 30-40 minutes)

from Schönefeld airport
by rail to stop main station, from there take bus M85 to stop "Kulturforum" (approx. 45-60 minutes)

from Berlin main station
Bus M85 direction "S Lichterfelde West" (Exit "Washingtonplatz") to stop "Kulturforum"

For details on public transportation please visit: http://www.bvg.de/en


 

Contact Information 

Registration Questions
Phone.: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 8:00-17:00 CET
diaeurope@diaeurope.org

Agenda and Event Logistics
Nicole Hintersatz, Event Manager
Phone: +41 61 225 51 51 Fax: +41 61 225 51 52
Nicole.Hintersatz@diaeurope.org

 

Program Committee 

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Agenda  

Day 1 Tuesday, Dec 02, 2014

  • 11:30AM - 12:30PM

    REGISTRATION AND LUNCH
  • 12:30PM - 12:40PM

    WELCOME AND INTRODUCTION

    Speaker(s):

    • Steffen Thirstrup, MD, PhD
      Medical Advisor & Advisory Board Member
      NDA Group, Denmark
  • 12:40PM - 2:30PM

    Session 1: BIOSIMILARS IN THE EUROPEAN UNION – WHERE WE ARE AND WHERE WE GO


    Session Chair(s):

    • Suzette Kox, MPharm
      Senior Director, Scientific Affairs
      EGA, Belgium
    • Steffen Thirstrup, MD, PhD
      Medical Advisor & Advisory Board Member
      NDA Group, Denmark

    Speaker(s):

    • The New European Commission - Perspective and initiatives
      Representative Invited
      Deputy Head of Unit
      European Commission
    • Biosimilar Medicinal Products Working Party (BMWP) – Impact of experiences on guidelines
      Christian Schneider, DrMed
      Medical Head of Division, Medicines Licensing and Availability
      Danish Health and Medicines Authority, Denmark
    • How do Biosimilars Evolve on the European Market
      Per Troein
      VP Strategic Partners
      IMS Health Inc, United Kingdom
  • 2:30PM - 3:00PM

    COFFEE BREAK
  • 3:00PM - 5:00PM

    Session 2: LISTENING TO THE USERS - PATIENTS AND PHYSICANS AND PHARMACISTS


    Session Chair(s):

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

    Speaker(s):

    • Health Care Professionals’ and Patients’ Perception, Understanding and Experience of the Biosimilar Concept

      Patient's Organisation Perspective
      Durhane Wong-Rieger, PhD, MA
      President and Chief Executive Officer
      Canadian Organization For Rare Disorders (CORD), Canada

    • Health Care Professionals’ and Patients’ Perception, Understanding and Experience of the Biosimilar Concept

      Physician's Perspective on Biosimilars
      Michael Reilly, JD
      Executive Director
      Alliance For Safe Biologic Medicines, United States

    • Health Care Professionals’ and Patients’ Perception, Understanding and Experience of the Biosimilar Concept

      Hospital Perspective
      Arnold Vulto
      Professor of Hospital Pharmacy & Practical Therapeutics
      Erasmus University Medical Center , Netherlands

  • 5:00PM - 6:00PM

    DRINKS RECEPTION

Day 2 Wednesday, Dec 03, 2014

  • 8:00AM - 8:30AM

    WELCOME COFFEE
  • 8:30AM - 10:00AM

    Session 3: EVALUATING IMMUNOGENICITY OF BIOSIMILARS: WHY IT MATTERS


    Session Chair(s):

    • Paul Chamberlain
      Advisory Board Member
      NDA Group, United Kingdom

    Speaker(s):

    • 10 Years’ Experience with Biosimilars – what are the learnings?
      Paul Chamberlain
      Advisory Board Member
      NDA Group, United Kingdom
    • Assessing Immunogenicity – a risk-based approach?
      Christian Schneider, DrMed
      Medical Head of Division, Medicines Licensing and Availability
      Danish Health and Medicines Authority, Denmark
    • Immunogenicity: Industry perspectives
      Patrick Liu, MD, PhD
      Senior Director
      Teva Pharmaceuticals, Inc. , United States
    • Immunogenicity: Industry perspectives
      Harald Weber, MD
      Group International Medical Director Biopharmaceuticals
      F. Hoffmann-La Roche AG, Switzerland
  • 10:00AM - 10:30AM

    COFFEE BREAK
  • 10:30AM - 12:00PM

    Session 4: INTERCHANGEABILITY & SWITCHING – WHERE DOES THE JOURNEY GO?


    Session Chair(s):

    • No-image Sabine Atzor, RPh
      Head of EU Regulatory Policies
      F. Hoffmann-La Roche Ltd., Switzerland
    • Elena Wolff-Holz
      Paul-Ehrlich-Institute, Germany

    Speaker(s):

    • Interchangeability - A fifth hurdle for access to US market?
      Paul Chamberlain
      Advisory Board Member
      NDA Group, United Kingdom
    • Experiences in Practice - Outcome and learnings of a switching study in Norway
      Guro Løvik Goll
      Diakonhjemmet Hospital, Norway
    • Current situation in the EU – Evaluation and perspectives
      Jaap Venema, PhD, PMP
      Therapeutic Area Lead Biotherapeutics, Global Medical Affairs
      Abbvie, United States
    • Current situation in the EU – Evaluation and perspectives
      Suzette Kox, MPharm
      Senior Director, Scientific Affairs
      EGA, Belgium
  • 12:00PM - 1:00PM

    LUNCH BREAK
  • 1:00PM - 2:30PM

    Session 5: LABELLING AND NAMING FOR BIOSIMILARS: THE DEBATE CONTINUES


    Session Chair(s):

    • Christian Schneider, DrMed
      Medical Head of Division, Medicines Licensing and Availability
      Danish Health and Medicines Authority, Denmark

    Speaker(s):

    • WHO Biological Qualifier – Recent developments and what will be the next steps?
      Raffaella Giovanna Balocco Mattavelli, PharmD, PhD
      Manager, International Nonproprietary Name Programme
      World Health Organization, Switzerland
    • Labelling & Naming – European Biosimilars Group (EBG) perspective
      Elke Grooten, MPharm
      Director Public Affairs
      Sandoz Europe, Belgium
    • Labelling & Naming – European Biopharmaceutical Enterprises (EBE) perspective
      Virginia Lee Acha, PhD, MSc
      Director, Regulatory Affairs
      Amgen International Inc, United Kingdom
  • 2:30PM - 4:00PM

    Session 6: LOOKING BEYOND THE EU - GLOBAL OUTLOOK AND EXPERIENCES


    Session Chair(s):

    • No-image Sabine Atzor, RPh
      Head of EU Regulatory Policies
      F. Hoffmann-La Roche Ltd., Switzerland
    • Elena Wolff-Holz
      Paul-Ehrlich-Institute, Germany

    Speaker(s):

    • Biosimilar Infliximab Case Study
      Approaches to extrapolation of indications
      Elena Wolff-Holz
      Paul-Ehrlich-Institute, Germany
    • Biosimilar Infliximab Case Study
      Canada view on Biosimilar Infliximab Marketing Authorization
      Jian Wang, MD, PhD
      Chief, Clinical Evaluation Division - Haematology/Oncology
      Health Canada, Canada
    • Biosimilar Infliximab Case Study
      Company Perspectives on Extrapolation and Indication – Biosimilar and industry view
      Paul K. Audhya
      Vice President, US Medical Affairs
      Hospira Inc., United States
    • Biosimilar Infliximab Case Study
      Company Perspectives on Extrapolation and Indication – Biosimilar and industry view
      Frederic Michel Ivanow, PharmD
      Senior Director, Global Regulatory Affairs
      Johnson & Johnson, United Kingdom

Registration Fees 

Member

Member Academia
€675.00
Member Government
€675.00
Member Standard
€1350.00

Non-Member

NonMember Academia
€805.00
NonMember Government
€805.00
NonMember Standard
€1480.00
Group Discounts

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

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

Register Online
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