CPSA BRASIL 2017

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

Preliminary Program Agenda

Updated 26 July, 2017

Monday 31 July


Thermo

8:30 am - 5:00 pm

LOCATION
CRQ 4–Oscar Freire St, 2039
Pinheiros, São Paulo
SP, 03178-200

Limited seats available!

REGISTER NOW

PRE-CONFERENCE WORKSHOP

Thermo Fisher Scientific Workshop:
Analytical and Regulatory Challenges in Pharmaceutical Industry

On July 31st at CRQ-SP you will have the chance to talk with our experts and invited speakers about some exciting topics in Pharmaceutical Industry. Please register and reserve your seat!

Main Topics: Residual Solvents, Elemental Impurities, Charged Aerosol Detection, Extractables and Leachables and Thermo Scientific Informatics Systems.

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8:30 am – 9:00 am
Opening Lecturer
Mike Lee, CPSA Founder and President
Milestone Development Services

9:00 AM - 9:20 AM
Institucional Presentation Thermo Fisher
Daniela Queiroz, Senior Manager, Marketing
Thermo Fisher Scientific – Brazil

9:20 AM - 10:00 AM
Residual Solvent USP 40, NF 35 General Chapter ‹467› Pedro López García, Scientist
USP Pharmacopeia

10:00 AM - 10:30 AM
Advances in Gas Chromatography to improve your routine in residual solvents analysis
Monica Piovani, Product Applications Specialist
Thermo Fisher - Brazil

10:30 AM - 11:00 AM
Coffee Break

11:00 AM - 11:40 AM
Use of coupled plasma techniques for elemental impurities determination according USP 232 and 233 new chapters
Mariana Ortega, Product Specialist
Nova Analítica

11:40 am – 12:00 pm
Charged Aerosol Detection – A valuable tool for pharmaceutical analysis
Tibor Muellner, Product Specialist
Thermo Fisher Scientific – Germany

12:10 pm – 12:40 am
Corona CAD: Application and Solutions
Lucas Sponton, Researcher
Libbs Farmacêutica

12:40 pm - 2:00 pm
Lunch

2:00 pm - 2:30 pm
How to reprocess Diode Array Detector Data for HPLC and UHPLC while maintaining data integrity into Chromeleon CDS Software
Marc Chalom, Application Manager
Thermo Fisher Scientific – Brazil

2:30 pm - 2:40 pm
How to increase productivity, regulatory compliance, and reliability of laboratory information through the Thermo Scientific Informatics System
Roberto Novak, Sales Manager
Thermo Fisher Scientific – Brazil

2:40 pm - 3:20 pm2
Mini Course: Introduction to Extractables and Leachables
Kyle D´Silva, Pharma & Biopharma Marketing Manager
Thermo Fisher Scientific – England

3:20 pm - 3:40 pm
Coffee Break

3:40 pm - 4:20 pm
Mini Course: Extractable and Leachable Workflows and Case Studies
Kyle D´Silva: Pharma & Biopharma Marketing Manager
Thermo Fisher Scientific – England

4:20 pm - 4:40 pm
Introduction to Compound Discoverer and mzCloud Viviane Nascimento, Product Applications Specialist
Monica Piovani, Product Applications Specialist
Thermo Fisher Scientific – Brazil

4:40 pm - 5:00 pm
Wrap up with coffee



CEMSA

and

Inovatie

8:30 am - 12:15 pm

LOCATION
Anfiteatro Luiz Trabulsi
no ICB3
Instituto de Ciências Biológicas
USP
Av. Prof. Lineu Prestes, 2415
Cidade Universitária
Butantã, São Paulo - SP

PRE-CONFERENCE WORKSHOP

PLANNING INNOVATIVE AND INCREMENTAL PRODUCTS WITH A VIEW TO FUTURE OPPORTUNITIES IN THE PHARMACEUTICAL MARKET

8:30 am
Reception and Delivery of Credentials

9:00 am
Opening Remarks
Camille R. Silva, Clinical Research & Medical Affairs

9:20 am - 10:00 am
Innovation in the Pharmaceutical Market:
How Do You Foresee Winning Products?
Nilva Bortoleto – Pharma Business Management

10:00 am - 10:40 am
Developing Innovative Products in Practice-
The Experience of Ache Laboratory
Eduardo Motti, Medical Director at Ache Laboratories

10:40 am - 11:00 am
Coffee Break & Networking

11:00 am - 11:40 am
Butantan and GSK Product Development Partnership Experience: Accumulated Learning and Evolution
Ana Marisa Chudzinski-Tavassi, Director of the Laboratory of Biochemistry and Biophysics at Butantan Institute

11:40 am - 12:15 pm
Discussion of Speakers and Guests:
Learning Pathway for Success in the Development of New Products

12:15 pm
Closing Remarks




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

Aileen Baldwin

Applications of Biomarkers of Drug and Alcohol Exposure
Aileen Baldwin
Unites States Drug Testing Laboratories

11:00 am - 2:00 pm

Vendor Expo & Poster Session
Meet with our participating vendors and review posters presentations with authors.

11:15 am - 12:45 am

Symposium Session

Regulatory Convergence
Chair: Gustavo Mendes Lima Santos, ANVISA

12:45 pm - 2:00 pm

Sponsored Lunch & Roundtable

2:00 pm - 3:30 pm

Parallel Sessions

Symposium Session 2
The Importance of Pharmaceutical Compendia:
A Regulatory Strategy

Chairs: Rafael Finocchiaro Maranho, United States Pharmacopeia; Gerson Pianetti, Universidade Federal de Minas Gerais

What are Pharmaceutical Compendium?
Gerson Pianetti, Universidade Federal de Minas Gerais

Reference Standard and its Characterization
Rafael Finocchiaro Maranho, United States Pharmacopeia

Jabuticaba 1A
Clinical Trials: Challenges from Designing to Interacting with Regulatory Agencies
Chair: Carlos Kiffer, GC2 / 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 Test Development and Validation
Rodrigo Viera Rodrigues, Groupo Investiga

Jabuticaba 1B
Quality Management and Assurance System
Chair: Osvaldo Cirilo, Universidade de São Paulo

Good Manufacturing Practices
Osvaldo Cirilo, Universidade de São Paulo

EHS and its Importance within the Good Manufacturing Practices
Victor Neubern, VNGC

4:00 pm - 5:30 pm

Parallel Sessions

Symposium Session 3
What is Compliance
Chair: Natália Bellan, Inteligência Sanitária; Agnaldo Simonetti, Inteligência Sanitária

Compliance in the Private Sector
Jaime César de M. Oliveira, Bayer

Compliance in the Public Sector
Beto Vasconcelos, FGV / RJ

Jabuticaba 2A
Drug Discovery and Development
Chair: Rogério Côrte Sassonia,Universidade Federal do Tocantins

Molecular Modeling and Design of Bioactive Ligands
SpDaniela Gonçalves Galasse Rando, Universidade Federal de São Paulo (UNIFESP)

Molecular Modifications as a Strategy to rational Drug Discovery
João Paulo dos Santos Fernandes, Universidade Federal de São Paulo (UNIFESP)

Calorimetry in Drug Design: The Energetic Fingerprint of a Good Candidate for a New Medicine
Rogério Côrte Sassonia, Universidade Federal do Tocantins (UFT)

Jabuticaba 2B
Trends in Bioequivalence Studies
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

Plenary Lecture

Carlos Kiffer

Opportunites for Technological Innovations: University and Pharma Company Interactions
Carlos Kiffer
GC2 / UNIFSEP

10:15 am - 11:30 am

Symposium Session 1

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

Computerized System Validation in a GxP Environment: Risk Management and GAMP5 Approach
Caroline Ferraz, Five Consultoria

Adding Digital Wisdom to Your Business
Carlos Giannecchini, Ito1 Serviços em TI

11:00 am - 2:00 pm

Vendor Expo & Poster Session
Meet with our participating vendors and review posters presentations with authors.

11:30 am - 12:45 am

Symposium Session 2

Quality Control:
Analytical, Biological, and Microbiological

Chair: Rafael Barrientos, Eurofarma

Validation of Analytical/Biologicals Methodologies
TBA

Validation of Rapid Methods in Microbiology:
A New Trend
Wesley de Oliveira, USP

12:45 pm - 2:00 pm

Sponsored Lunch & Roundtable

QC Multi-Attribute Monitoring of Biopharmaceuticals using Chromeleon and High Resolution Orbitrap MS
Kyle D’Silva, Thermo Fisher Scientific

2:00 pm - 3:30 pm

Parallel Sessions

Symposium Session 3

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

Flow of Registration and Launch of a Product in Brazil
Natália Bellan, Inteligência Sanitária

Case study: Challenges of the Pharmaceutical Market for Biological Products
Danilo Vitor Kabata, Biotest Farmacêutica

Jabuticaba 1A
Other Perspectives for the Pharmaceutical Market
Chair: Agnaldo Simonetti, Inteligência Sanitária

Trends in Medical Devices
Ana Maria Targa, AMT Consulting

Jabuticaba 1B
Post Registration
Chair: Thiago Mares Guia, Bionovis

Techno-surveillance and Pharmacovigilace
Fernando Pereira, Allergan

Product Change History
Priscilla Furlan, Laboratórios Baldacci

Interchangeability of Biologics and Biosimilars
Thiago Mares Guia, Bionovis

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