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Estatuto
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Associados
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Notícias
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Mapa do Local
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Links
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Pergunte à ACBIO
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Analysts, monitors, supervisors and managers from the bioequivalence and
bioavailability industries, pharmaceutical equivalence,
regulatory, quality assurance and related indutries.
June 07th 2010
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TIME |
SUBJECT |
SPEAKER |
MODERATOR |
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08:00–08:45h |
Check In and
Breakfast |
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08:45–09:00h |
Introduction |
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09:00–09:15h |
Regulated
sector: Overview and challenges for conducting BE studies |
Prof.
Dr. Eduardo Abib Júnior (ACBIO) |
Dr. Eduardo Abib Júnior (ACBIO) |
|
09:15–09:30h |
Regulated
sector: Overview and challenges for conducting Equifar
studies |
Prof. Dr. Luis Carlos B. Moura (REQBIO |
|
|
09:30–10:00h |
Health in
Brazil |
Dra. Luiza
Gonçalves Barcellos
(Ministry of Health ) |
|
|
10:00 – 10:30 |
A regulatory
overview for BA/BE studies in Brazil |
Dr. Dirceu Raposo de Mello
(to be confirmed) |
|
|
10:30–10:45h |
Coffee Break |
|
|
|
10:45–12:00h |
Sponsor overview on BE studies |
Dr. Lauro D. Moretto (SINDUSFARMA)
Dr. Luciano Maurício Lobo (PRÓ-GENÉRICOS) |
Prof. Dr. Luis Carlos B. Moura (REQBIO) |
|
12:00–14:00h |
LUNCH |
|
|
|
14:00–15:30h |
BE studies with non-chromatographic analytical
methodologies (ligand binding assays)
BE studies with non-chromatographic analytical
methodologies (ICP-AES)
Brazilian regulatory issues for non-chromatographic
methods |
Dr. Luciano Miranda (Laboratory Abbott)
Dr. Flávio Leite (T&E Analítica)
Dr. João
Tavares Neto (Anvisa) |
Dr. Maria Franscesca Riccio (ACBIO) |
|
15:30–15:45h |
Coffee Break |
|
|
|
15:45-17:30h |
BE perspectives in Latin America.
Global Harmonization of Bioanalytical Method Validation
Guidelines (BMV) and Sample Analysis
Good Practices in BE – Management of QAU |
Dr. Maria Nellia Gai (Universidad de Chile – facultad de
Ciencias Quimicas Y Farmaceutica)
Dr. Fábio Garofolo (Bionalytical Services, Algoruthme Pharma
Inic., Montreal – Canada)
Dr. Ticiana Moura (Sandoz do Brasil) |
Prof. Dr. Rafael Barrientos Astigarraga(ACBIO) |
|
17:30h |
WELCOME COCKTAIL |
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June 8th - 2010
|
TIME |
SUBJECT |
SPEAKER |
MODERATOR |
|
08:00–10:30h |
How to deal with highly variable drugs in BE
Ethical issues on BE studies
Clinical and biochemical parameters for inclusion
criteria for healthy volunteers |
Dr. Antonio Amarante (MEDIANA CONSULTORIA)
Prof. Dr. Carmem Bertuzzo (COMITÊ DE ÉTICA – UNICAMP)
Dr. Gustavo Amaral Campana (FORMATO CLÍNICO) |
Prof. Dr. José Pedrazolli Júnior (ACBIO) |
|
10:30–10:45h |
Coffee Break |
|
|
|
10:45–12:30h |
BE studies design for oncological products
Statistical analysis for specific design in BE studies (variable
doses, patients, groups, parallel studies)
PK and PD studies for medicines registration and renewal
in Brazil |
Dr. Ariadna Barra (ANVISA)
Dr. Paula G. Strassmann (PGS/MEDICAL STATISTICS)
Dr. Simoni Buranello (GC2 Pesquisa e Desenvolvimentos de
produtos na Área de Saúde e Laboratório Central para Estudos
Clínicos) |
Prof. Dr. Paulo Pizzão(HOSPITAL IGESP) |
|
12:30–14:00h |
LUNCH |
|
|
|
14:00–15:30h |
Biowaiver and in-vitro BE
|
Dr. Luka Peternel (LEK–Slovenia)
Dr. Ariadna Barra (ANVISA) |
Prof. Dr. José Carlos Saraiva (REQBIO) |
|
15:30–15:45h |
Coffee Break |
|
|
|
15:45-16:45h |
Dissolution tests for in-vitro BE – Protocol design |
Prof. Dr. Clarice Madagleno Bueno Rolim (REQBIO)
Dr. Raquel Lima e Silva (ANVISA) |
Dr. Leonardo Teixeira (ACBIO) |
|
16:45-17:30h |
CLOSING
REMARKS |
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Date, Location and
Accommodations |
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Date: June 07th
and 08th, 2010
Time: 8
am to 5 pm
Location: Novotel
São Paulo Center Norte (www.centernorte.com.br)
Address:
Av. Zaki Narchi, 500 - Vila Guilherme - São Paulo – SP
Accomodations: Reservations can be made by calling
Edna, +55 (11) 2855-4667 or
e-mail:
edna@businesshall.com.br
Parking:
valet available at the location
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Interactive Map - Click to Zoom in and Out
*No refund in case of withdrawal.
** Registration substitutions will be accepted 10 days
before the event.
*** Registrations will not be held at the venue.
Dra
Joseane Pozzebon (Scentryphar Pesquisa Clínica Ltda)
Dra
Mineko Tominaga (NUBEC-Núcleo de Bioequivalência e Ensaios Clínicos)
Dr Rafael E. Barrientos Astigarraga (MAGABI
Pesquisa Clínica Farmacêutica. Ltda)
Dra Silvana Aparecida Calafatti (UNIFAG- Centro de Bioequivalência)
ACBIO-BR -
Associação Brasileira de Centros de Biodisponibilidade e
Bioequivalência
(Brazilian Association of Bioequivalence and Bioavailability Centers)
DR. EDUARDO ABIB JÚNIOR
President
Support:
Sponsors:
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