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

REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS 10

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

Relacionamentos