TIME

PROGRAM

LECTURER

MEDIATOR

8:00 to 8:45

REGISTRATION

 Eduardo Abib Junior (President of ACBIO)

8:45 to 9:15

OPENING SESSION
 

The importance of support in the exchange of national and international experience for  quality , efficacy and safety in the use of drugs

Eduardo Abib Junior
(President  of  ACBIO)

Kellen Santos Rezende (Departamento do Complexo Industrial e Inovação em Saúde - DECIIS/SCTIE/MS)

Laura Castanheira                 (Gerência de Avaliação de Segurança e Eficácia – GESEF/ANVISA)
 

9:15 to 10:15

Certification of Clinical Research / Bioavailability Professionals

 Honório Silva
(Inter American Foundation for Clinical Research) 

Stephen Sonstein
(Eastern Michigan University)

10:15 to  10:30

Coffee break

10:30 to 11:15

 Impact of Excipients on Drug Absorption

 Dr. Vinod Shah                               (Pharmaceutical Consultant)

 José Pedrazzoli Junior (UNIFAG/CORE)

11:15 to 12:00

 Potential impact of excipients, size and form of dosage, on the gastrointestinal transit 

 Werner Weitschies 
(University of Greifswald)

12:00 to 12:30

Discussion on topics presented

12:30  to 2:00

Lunch break - no included

2:00 to  2:30

 Biological-  Peptides and Proteins Characterization and Stability

 Roberto de Araújo
(Clinical Research Director RDO R&D)

 Raquel Marcolongo (Pharmagenix)

2:30 to  3:00

Biosimilars- Are they really Generic Drugs ?

Lynda Cedar                           
(Pharm D., DESS., M.Sc., Tox., PhD)

3:00 to 3:30

 Studies for Registration of Biologic Drugs

 Laura Castanheira (Gerência de Avaliação de Segurança e Eficácia – GESEF/ANVISA)

3:30 to 4:00

Discussion on topics presented

4:00 to 4:15

Coffee break

4:15  to 5:30

Clinical and Bioavailability Studies for the Registration of New Drugs

 Clarice Alegre Petramale
Clinical Research  and Essay Coordination- COPEM)

Ariadna Cristina Gomes Barra
(Bioequivalence Coordination - COBIO/ANVISA)

 Ricardo de Lima Zollner (Unicamp)

5:30 to 6:00

Discussion on topics presented

TIME

PROGRAM

LECTURER

MEDIATOR

9:00 to 9:30

The benefits of including REQBIO in the Latin American Network of Bioavailability and Bioequivalence

( RLABB)
 

Luis Carlos Moura (REQBIO)

 
Dr. Norberto Rech (ANVISA)

Luciana Fernandes Duarte (SCENTRYPHAR)

 9:30 to 10:15

Latin American Network of Bioavailability and Bioequivalence (RLABB) as support in Pharmaceutical Attention.
 

Aldo Alvarez (Red Sudamericana de Atención Farmacéutica  - REDSAF)

10:15 to 10:30

Coffee break

10:30 to 11:15

 Evolution in the Validation of Bioanalytical Methods

 Richard W Abbott
(Department of Biosciences, Shire Pharmaceuticals,Hampshire International)

 
Rafael Barrientos
(Vice presidente da ACBIO)

11:15 to 12:00

Recent Aspects in Validation of Bioanalytical Methods- RE 899

 Ariadna Cristina Gomes Barra
(Coordenação de Bioequivalência - COBIO/ANVISA)

João Tavares Neto
(Coordenação de Bioequivalência - COBIO/ANVISA)

12:00  to  12:30

Discussion on topics presented

12:30 to 2:00

Lunch Break - no included

2:00 to 3:30

 Global Harmonization in  Bioanalysis

  CT Viswanathan
(Associate Director, USA FDA)

 Philip Timmernan
(GBC)

Rafael Barrientos (Vice presidente da ACBIO)

3:30 to 4:00

Discussion on topics presented

4:00 to 4:15

Coffee Break

4:15 to  5:00

Main Questions:

RDC 31/2010

Regulations for Pharmaceutical Bioequivalence and Dissolution Profile

 Raquel Lima e Silva
(Equivalence Coordination -ANVISA)

 
Luis Carlos Moura (REQBIO)

5:00 to 5:30

New Quality System Structure

Jair Calixto
(SINDUSFARMA)

5:30 to 6:00

Discussion on topics presented