regulatory innovations · regulatory innovations: fda & anvisa complinace trends sept. 9th,...
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REGULATORY INNOVATIONS
FDA AND ANVISA COMPLIANCE TRENDS
AGENDA, OBJECTIVES AND ACKNOWLEDGEMENTS
AGENDA, OBJETIVOS E RECONHECIMENTOS
Sept. 9th, 2016
WELCOME
Boas Vindas Dr. Nelson dos Santos Júnior, SINDUSFARMA
REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 2
Sept. 9th, 2016 REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 3
PROUDLY SPONSORED BY:
Sept. 9th, 2016
PROUDLY ORGANIZED & SUPPORTED BY:
REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 4
Sept. 9th, 2016
AGENDA AND OBJECTIVES
REGULATORY TRACK
Single Audits Program for Medical Devices and Expectations for API’s (Pre-Recorded Presentation)
Drug Products ANVISA Approach
FDA Overseas: Current Issues Regarding FDA’s Evolving Approach to Global Regulation
INDUSTRY TRACK
Design of Facilities to comply with Global Health Authorities
Lunch Break
Trends on FDA Compliance: Registrations, ICH Q11 and ICH Q12
Trends on FDA Compliance: Quality Metrics and Continued Process Verification (CPV)
Inspection Trends and Industry Experience with FDA and ANVISA
The Benefits of Single Audits and Rational New Challenges
The Role of INCQS in the Quality Control of Biologics and Biotechnological Medicines
JOINT PANEL
Panel Discussion: FDA, ANVISA, Industry Speakers and Q & A’s
Networking
REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 5
Sept. 9th, 2016 REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 6
ACKNOWLEDGEMENTS BY ORDER OF PRESENTATION:
Dr. Nelson dos Santos Júnior, Vice President, Sindusfarma
Dr. Lauro D. Moretto, President, Academia Nacional de Farmácia
Kimberly A. Trautman, Executive Vice President, Medical Device International Services at NSF Int.
Sept. 9th, 2016 REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 7
ACKNOWLEDGEMENTS BY ORDER OF PRESENTATION:
Dr. José Carlos Magalhães da Silva Moutinho, Dir. of Board of Control & Monitoring Health, ANVISA
Scott Gottlieb, MD, Former FDA Deputy Commissioner for Medical and Scientific Affairs
Eng. Luis Merle, Partner at CMA Architects and Engineers LLP
Dr. Fabio Pereira Quintino, Manager Medical Device, Cosmetics & Sanitary Products Inspections,
ANVISA
Sept. 9th, 2016 REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 8
ACKNOWLEDGEMENTS BY ORDER OF PRESENTATION:
Magaly Aham, US RAC, Vice President of Compliance, Pharma-Bio Serv
Elizabeth Plaza, Founder & Chairwoman, Pharma-Bio Serv
Dr. Fernando Otero, Executive Director Operations Management, MSD, SP Brazil
Sept. 9th, 2016 REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 9
ACKNOWLEDGEMENTS BY ORDER OF PRESENTATION:
Dhalia Gutemberg, M. Sc., Technical Consultant, Camara Brasileira de Diagnostico Laboratorial
Eduardo Chaves Leal, Director of Fiocruz, Oswaldo Cruz Foundation,
National Institute for Quality Control in Health
Marina Costa Xavier de Oliveira, Regulatory Affairs Manager, and Quality Assurance
Abbott Vascular, Abbot Laboratórios do Brasil Ltda.
Sept. 9th, 2016
OPENING REMARKS ON INNOVATION AND COMPLIANCE
Abertura e comentários sobre Inovação e compliance
Dr. Lauro D. Moretto, President, Academia Nacional de Farmácia
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Sept. 9th, 2016
SINGLE AUDITS PROGRAM FOR MEDICAL DEVICES AND EXPECTATIONS FOR API’S
Programa de Auditoria Única para Dispositivos Médicos e Expectativas para IFAs
Kimberly A. Trautman, Executive Vice President, Medical Device International Services at NSF International
REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 11
Sept. 9th, 2016
DRUG PRODUCTS ANVISA APPROACH
Medicamentos Abordagem da Anvisa
Dr. José Carlos Magalhães da Silva Moutinho, Director of Board of Control and Monitoring Health, ANVISA
REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 12
BREAK – 15 mins.
We are taking a short break.
Please enjoy some coffee and refreshments while networking with fellow participants.
Sept. 9th, 2016
FDA OVERSEAS: CURRENT ISSUES REGARDING FDA’S EVOLVING APPROACH TO GLOBAL REGULATION
FDA Overseas: questões atuais sobre a evolução da abordagem da
FDA para a regulação global
Scott Gottlieb, MD, Former FDA Deputy Commissioner for Medical and Scientific Affairs
Current Resident Fellow, The American Enterprise Institute
REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 14
Sept. 9th, 2016
DESIGN OF FACILITIES TO COMPLY WITH GLOBAL HEALTH AUTHORITIES
Projeto de Instalações de acordo com Autoridades Globais de Saúde
Eng. Luis Merle, Partner with CMA Architects & Engineers LLP
REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 15
Lunch Recess – 1.5 hr.
Intervalo para Almoço – 1.5 hr.
Sept. 9th, 2016
TRENDS ON FDA COMPLIANCE: REGISTRATIONS, ICH Q11 AND ICH Q12
Tendências de Compliance da FDA: Registros, ICH Q11 e ICH Q12
Magaly Aham, US RAC, VP of Compliance, Pharma-Bio Serv
REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 17
Sept. 9th, 2016
TRENDS ON FDA COMPLIANCE: QUALITY METRICS AND CONTINUED PROCESS VERIFICATION (CPV)
Tendências de Compliance da FDA:
Métricas de Qualidade e Verificação de processo contínuo (VPC)
Elizabeth Plaza, Founder & Chairwoman, Pharma-Bio Serv
REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 18
Sept. 9th, 2016
INSPECTION TRENDS AND INDUSTRY EXPERIENCE WITH FDA AND ANVISA
Tendências de Inspeção e Experiência da Indústria com FDA e ANVISA
Dr. Fernando Otero, Executive Director Operations Management, MSD, SP Brazil
REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 19
Coffee Break– 15 mins.
We are taking a short break.
Please enjoy some coffee and refreshments while networking with fellow participants.
Sept. 9th, 2016
THE BENEFITS OF SINGLE AUDITS AND RATIONAL NEW CHALLENGES
Benefícios da Auditoria Única e Novos Desafios de Racionalização
Dhalia Gutemberg, Câmara Brasileira de Diagnóstico Laboratorial
REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 21
PARTICIPANT PILOT PLAN TESTIMONY
Depoimento de participante do plan piloto
Marina Costa Xavier de Oliveira, Gerente de assuntos regulatórios e garantia de qualidade
Abbott vascular, Abbot Laboratórios do Brasil Ltda.
Sept. 9th, 2016
THE ROLE OF INCQS IN THE QUALITY CONTROL OF BIOLOGICS AND BIOTECHNOLOGICAL MEDICINES
O papel do INCQS no Controle de Medicamentos Biológicos e Biotecnológicos
Eduardo Chaves Leal, Director of Fiocruz, Oswaldo Cruz Foundation,
National Institute for Quality Control in Health
REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 23
Sept. 9th, 2016
PANEL DISCUSSION: FDA, ANVISA, INDUSTRY SPEAKERS AND Q & A’S
Painel de Discussão: Palestrantes da FDA, ANVISA e Indústria
REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 24
Networking
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