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  PhAMA Biosimilar Summit (22 November 2014)

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Media Engagement

 

Start End Topic Speaker Venue
0830 0900 Registration of delegates NA Ballroom Foyer
0900 0910 Welcome address Mr Yew Wei Tarng
President, PhAMA
Ballroom
0910 0930 Opening Remarks Y. Bhg. Dato Eisah A Rahman
Senior Director of Pharmacy Services
Ministry of Health
Ballroom
0930 1015 Evolving Regulatory Landscape & Challenges in Evaluating Biosimilars Pn. Arpah Abas
Deputy Director/ Head of Biotechnology Section,
National Pharmaceutical Control Bureau
Ballroom
1015 1030 Coffee Break   Ballroom Foyer
1030

1130

Size does Matter? Professor João Eurico da Fonseca
Head of the Rheumatology Research Unit at the Instituto de Medicina Molecular and Professor of Rheumatology and Biomedical Engineering, both part of the Faculty of Medicine, University of Lisbon, Portugal.
Ballroom

1130

1215

Regulating the development and approval of biosimilar monoclonal antibodies – Considerations on some Regulatory and Clinical Topics Dr. Thomas Schreitmueller
Head, Regulatory Policy, Biologics, Roche
Ballroom
1215 1315 Lunch   Paya Serai Coffee  House
1315 1415 Case presentation
  1. Indication extrapolation
  2. Interchangeability and substitution
  3. Biologic Qualifier - An INN proposal
By:
  1. Professor João Eurico da Fonseca
  2. Dr. Paul Cornes, Consultant Clinical Oncologist, UK
  3. Dr. Thomas Schreitmueller
Ballroom
1415 1435 Launch of PhAMA Biosimilars Position paper [DOC] [PPTX] Ms Leah Goodman
1st Vice-President of PhAMA
Ballroom
1435 1450 Coffee Break   Ballroom Foyer
1450 1620 Breakout session & Panel Discussion See overleaf for sessions Anggerik 1 & Anggerik 2
(Second Floor)
1620 1635 Wrap up of full day MC Ballroom
1635 1650 Closing Mr. Muru Annamalai
2nd Vice-President of PhAMA
Ballroom

 

Session

Speaker

Topic Venue
Workshop 1 Professor João Eurico da Fonseca

Head of the Rheumatology Research Unit at the Instituto de Medicina Molecular and Professor of Rheumatology and Biomedical Engineering, both part of the Faculty of Medicine, University of Lisbon, Portugal.
A Physician's Consideration towards  Bio similars (Rheumatologist, Gastroenterologist and Dermatologist)

An interactive 1 - 1 session with physicians across the discipline to understand the common challenges ,unmet needs and factors that influence a physicians mind when deciding between an innovator biologic and a bio similar compound

JAPAC Advisory Board Biosimilars Meeting Report
Anggerik 1 & Anggerik 2 (Second Floor)
Workshop 2 Speaker 1: Dr. Paul Cornes
Consultant Clinical Oncologist, UK

Speaker 2: Dr. Paul Cornes
Consultant Clinical Oncologist, UK

Speaker 3: Dr. Thomas Schreitmueller
Head, Regulatory Policy
Biologics, Roche

 

Ballroom
(First Floor)