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CMC Forum Latin America 2016: Scientific Program (Agenda)
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To view the final program, click here.                          




 

Program Overview

Monday, 5 September 2016

07:30 – 17:00   Registration 

07:30 – 09:00   Continental Breakfast 

08:30 – 08:45   CASSS Welcome and Introductory Comments

08:45 – 09:15   CMC Strategy Forum Latin America 2016 Welcome and Introductory Comments                    

09:15 – 12: 15  Plenary Session: Regulatory Convergence: Recent Trends in the Regulations of Biotherapeutic Products in Latin America                         
                           
Adriana Hern
ández Trejo, COFEPRIS, Federal Commission for the Protection from Sanitary Risks, Mexico (invited)
                           
Bernardo Luiz Moraes Moreira, ANVISA, Brasilian Health Surveillance Agency, Brasil  (confirmed)
                            Yanira Maldonado Malpica, DIGEMID, General Directorate of Medicines, Supplies and Drugs, Peru (invited
                            Margarida Menezes Ferreira, INFARMED, National Authority of Medicines and Health Products, Portugal (invited
                            Leslie Rivera Rosado, CDER, FDA, USA (confirmed)

12:15 – 13:30  
Buffet Lunch 

13:30 – 15:00   Panel Discussion 

15:00 – 15:30   PM Break 

15:30 – 18:15   Workshop Session: FIFARMA

18:15 – 19:45   Networking Reception

19:45                  Adjourn Day One

Tuesday, 6 September 2016

07:30 – 17:00   Registration

07:30 – 09:00   Continental Breakfast 

09:00 – 10:50   Workshop Session: Lifecycle Management Part One: Control Strategy and Setting Specifications 
                            Patrick Swann, Biogen, USA (talk will focus on control strategies) - (confirmed)
                            Athena Nagi, Merck & Co., Inc., USA (talk will focus on setting specifications) - (confirmed)

11:00 – 11:30   AM Break 

11:30 – 12:45   Panel Discussion 

12:45 – 14:00   Buffet Lunch

14:00 – 16:15   Workshop Session: Lifecycle Management Part Two: Risk Management and Established Conditions  
                            Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland (talk will focus on established conditions) - (confirmed)     

16:15 – 16:45   PM Break 

16:45 – 18:00   Panel Discussion 

18:00 – 18:30   Recap of Program Summary Slide Presentation

18:30 – 18:45   Closing Remarks

18:45                  Adjournment

 



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