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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.

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 

A limited number of rooms are available a special rate at the event hotel:
Maritim Hotel Berlin
Address: Stauffenbergstrasse 26, 10785 Berlin, Germany
Tel:  +49 (0) 30 2065-0
Web: http://www.maritim.com/en/hotels/germany/hotel-berlin

Single room EUR 139.00 incl. breakfast and VAT
Double room EUR 179.00 incl. breakfast and VAT
Please note those guests travelling on business are exempt from additional Berlin city council tax of 5 %.

To book your room click here

Attendees should make reservations as soon as possible using the promotional code DIA14115. DIA rate is guaranteed until 1 November 2014, or until room block is filled. After this rooms are subject to availability and prices may vary.

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 

Previous Next

Agenda  

Day 1 Tuesday, Dec 02, 2014

  • 11:30AM - 12:30PM

    REGISTRATION AND REFRESHMENTS
  • 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
      Senior Medical Officer
      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 DOCTORS (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

      Doctors Perspective on Biosimilars
      Representative Invited
      Chief medical officer at Childhood
      Childhood Obesity Unit Region Skane

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

      Hospital Perspective
      Representative Invited
      Hospital Medisch Spectrum Twente

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

      Doctors Perspective on Biosimilars
      Representative Invited
      Professor
      Karolinska University Hospital

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

      Patient's Organisation Perspective
      Representative Invited
      Director
      European Patients Forum

  • 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):

    • Assessing Immunogenicity – a risk-based approach?
      Representative Invited
      Head, Unit on Diabetes/Cardiology, German CHMP Alernate
      Bfarm
    • 10 Years’ Experience with Biosimilars – what are the learnings?
      Paul Chamberlain
      Advisory Board Member
      NDA Group, United Kingdom
    • Immunogenicity: Industry perspectives
      Patrick Liu, MD, PhD
      Sr Director
      Teva Pharmaceuticals, 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
    • 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):

    • Representative Invited
      Research Professor
      Finnish Medicines Agency

    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 – Biosimilar and originator industry perspective
      Representative Invited
      Director Pharmaceutical Policy
      EGA
    • Labelling & Naming – Biosimilar and originator industry perspective
      Representative Invited
      Director, Regulatory Affairs
      Amgen International Inc
  • 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
      Representative Invited
      Research Professor
      Finnish Medicines Agency
    • Biosimilar Infliximab Case Study
      Representative Invited
      Chief, Clinical Evaluation Division - Haematology/Oncology
      Health Canada
    • Biosimilar Infliximab Case Study
      Alex Kudrin
      VP Celltrion
      Celltrion, Korea, Republic of
    • Biosimilar Infliximab Case Study
      Representative Invited
      Senior Director, Global Regulatory Affairs
      Johnson & Johnson

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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