16th International Conference of Drug Regulatory Authorities

Rio de Janeiro, Brazil - August 24 . 29, 2014

PRE-ICDRA | 24 - 25 August 2014 (OPEN) |

Sunday / 24 August Monday / 25 August
08:00 - 09:00 Registration
09:00 - 10:30 Plenary 1
Regulatory challenges of
biotechnological products
Workshop 5
Ensure the quality of
SBPs throughout
standardization
Workshop 6
WHO Guidelines on SBPs
Coffee
11:00 - 12:30 Plenary 2
Regulatory framework for similar biotherapeutic
products (SBPs): challenges and way forward
Workshop 7
Immunogenecity in
biotherapeutics/SBPs
Workshop 8
EU Regulatory framework
and experience
Lunch
14:00 - 15:30 Workshop 1
Regulatory experience:
China
Workshop 2
Pharmacovigilance for
biotherapeutic products
Workshop 9
Clinical
comparability
Workshop 10
Regulatory experience:
Republic of Korea
Coffee
16:00 - 17:30 Workshop 3
Nommenclature
Workshop 4
Regulatory experiences:
Brazilian experience
Plenary 3
Access to medicines and the impact of
biosimilars on markets
18:00 - 20:00 Pre-ICDRA Welcome Reception