CPSA BRASIL 2017

The Sanitary Regulation as a Strategy for the Development of Products and Services in the Pharmaceutical Chain

Preliminary Program Agenda

Updated 15 June, 2017

Tuesday 1 August

8:00 am - 9:30 am

Registration & Continental Breakfast

9:00 am - 5:00 pm

Poster Session Open

9:30 am - 10:00 am

Welcome & Opening Remarks

Opening Remarks – Together We Progress!

Mike Lee

Welcome
Mike S. Lee
Milestone Development Services

Natália Bellan

Format, Objectives, Opening Remarks
Natália Bellan
Inteligência Sanitária

10:30 am - 11:15 am

Plenary Lecture

Kyriakie Sarafoglou

Waht is Regulatory Convergence?
Aileen Baldwin
Unites States Drug Testing Laboratories

11:15 am - 12:45 am

Symposium Session

Regulatory Convergence
Chair: Gustavo Mendes Lima Santos, ANVISA

12:45 pm - 2:00 pm

Sponsored Lunch & Roundtables

2:00 pm - 3:30 pm

Parallel Sessions

Symposium Session 2
Good Regulatory Practices
Chairs: Natália Bellan and Agnaldo Simonetti, Inteligência Sanitária

Pharmacopeias and their Impact on Sanitary Regulation
Gérson Antônio Pianetti, Universidade Federal de Minas Gerais

Jabuticaba 1A
Clinical Research: Challenges from Designing to Interacting with Regulatory Agencies
Chair: Carlos Kiffer, UNIFESP

Challenges in Trial Design and Implementation
Sonia Dainesi, Recepta Biopharma

Challenges in Patient Recruitment and Electronic Solutions
Bruno de Souza Oliveira, CIO IHealth Group

Challenges in New Tests Development and Validation
To be Announced

Jabuticaba 1B
To be Announced
Chair: To be Announced

4:00 pm - 5:30 pm

Parallel Sessions

Symposium Session 3
Quality Management and Assurance System
Chair: Osvaldo Cirilo, Universidade de São Paulo

Good Manufacturing Practices: National and International Inspections
Marcelo Vogler, ANVISA

Jabuticaba 2A
Medical Devices - Trends
Chair: Alexandre Hamparian, UNIFESP

Jabuticaba 2B
Medicines-Trends in the Studies About Bioequivalents
Chair: Suellen Cristina Renno Silva, Aspen Farmacêutica

Wednesday 2 August

8:00 am - 9:30 am

Registration & Continental Breakfast

9:30 am - 10:15 am

Symposium Session 4

Opportunites for Technological Innovations vs. the University
Chair: To be Announced

10:15 am - 11:30 am

Symposium Session 5

Technology: The Connection to the Success of the Pharmaceutical Chain
Chair: Daniel Temponi Lebre, CEMSA

11:30 am - 12:45 am

Symposium Session 6

Quality Control:
Analytical, Biological, and Microbiological

Chair: Rafael Barrientos, Eurofarma

12:45 pm - 2:00 pm

Sponsored Lunch & Roundtables

2:00 pm - 3:30 pm

Parallel Sessions

Symposium Session 7

What are the Main Points to Launch a New product on the Market?
Chair: Natália Bellan, Inteligência Sanitária

Jabuticaba 3A
Nanotechnology
Chair: Rogério Sassonia, Centro de Ciências Integradas - Química UFT-Araguaína

Jabuticaba 3B
Pos Registration:
Tecnovigilância and Farmacovigilância

To be Announced

3:45 PM - 4:45 PM

Closing Remarks

Mike Lee, Milestone Development Services
Natália Bellan, Inteligência Sanitária

4:45 PM - 6:00 PM

CLOSING Social EVENT

Cocktails and Music