1. Paya Serai Coffee House
1st National Bio-Therapeutics Congress - Putting Patient First 22 November 2014 at PJ Hilton General Agenda
Start
End
Topic
Speaker
Venue
0830
0900
Registration of delegates NA
Ballroom Foyer
0910
Welcome address
Mr Yew Wei Tarng
President, PhAMA
Ballroom
0930
Opening Remarks
Y. Bhg. Dato Eisah A Rahman
Senior Director of Pharmacy Services
Ministry of Health
1015
Evolving Regulatory Landscape & Challenges in Evaluating Biosimilars
Pn. Arpah Abas
Deputy Director/ Head of Biotechnology Section,
National Pharmaceutical Control Bureau
1030
Coffee Break
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.
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
1315
Lunch
Paya Serai Coffee House
1415
Case presentation
Indication extrapolation
Interchangeability and substitution
Biologic Qualifier – An INN proposal
By:
Dr. Paul Cornes, Consultant Clinical Oncologist, UK
1435
Launch of PhAMA Biosimilars Position paper
Ms Leah Goodman
1st Vice-President of PhAMA
1450
1620
Breakout session & Panel Discussion
See overleaf for sessions
Anggerik 1 & Anggerik 2
(Second Floor)
1635
Wrap up of full day MC
1650
Closing
Mr. Muru Annamalai
2nd Vice-President of PhAMA

2. Anggerik 1 & Anggerik 2 (Second Floor)
Workshop sessions
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
Anggerik 1 & Anggerik 2 (Second Floor)
Workshop 2
Speaker 1: Dr. Paul Cornes
Consultant Clinical Oncologist, UK
Speaker 2: Dr. Paul Cornes
Speaker 3: Dr. Thomas Schreitmueller
Head, Regulatory Policy
Biologics, Roche
20 mins: Globalization of Biosimilars
20 mins: The rising costs in healthcare - can Biosimilars help?
20 mins: The needs and challenges of Innovation in healthcare
30 mins: Q&A and comments
Ballroom
(First Floor)