REGULATORY INNOVATIONS

Transcrição

1 REGULATORY INNOVATIONS FDA AND ANVISA COMPLIANCE TRENDS AGENDA, OBJECTIVES AND ACKNOWLEDGEMENTS AGENDA, OBJETIVOS E RECONHECIMENTOS

2 WELCOME Boas Vindas Dr. Nelson dos Santos Júnior, SINDUSFARMA REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS Sept. 9 th,

3 PROUDLY SPONSORED BY: REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS Sept. 9 th,

4 PROUDLY ORGANIZED & SUPPORTED BY: REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS Sept. 9 th,

5 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 Sept. 9 th,

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. REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS Sept. 9 th,

7 ACKNOWLEDGEMENTS BY ORDER OF PRESENTATION: Dr. José Carlos Magalhães da Silva Moutinho, Dir. of Board of Control & Monitoring Health, ANVISA Dr. Fabio Pereira Quintino, Manager Medical Device, Cosmetics & Sanitary Products Inspections, ANVISA Scott Gottlieb, MD, Former FDA Deputy Commissioner for Medical and Scientific Affairs Eng. Luis Merle, Partner at CMA Architects and Engineers LLP REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS Sept. 9 th,

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 REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS Sept. 9 th,

9 ACKNOWLEDGEMENTS BY ORDER OF PRESENTATION: Dhalia Gutemberg, M. Sc., Technical Consultant, Camara Brasileira de Diagnostico Laboratorial Marina Costa Xavier de Oliveira, Regulatory Affairs Manager, and Quality Assurance Abbott Vascular, Abbot Laboratórios do Brasil Ltda. Eduardo Chaves Leal, Director of Fiocruz, Oswaldo Cruz Foundation, National Institute for Quality Control in Health REGULATORY INNOVATIONS: FDA & ANVISA COMPLINACE TRENDS Sept. 9 th,

10 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 Sept. 9 th,

11 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 Sept. 9 th,

12 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 Sept. 9 th,

13 BREAK 15 mins. We are taking a short break. Please enjoy some coffee and refreshments while networking with fellow participants.

14 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 Sept. 9 th,

15 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 Sept. 9 th,

16 Lunch Recess 1.5 hr. Intervalo para Almoço 1.5 hr.

17 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 Sept. 9 th,

18 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 Sept. 9 th,

19 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 Sept. 9 th,

20 Coffee Break 15 mins. We are taking a short break. Please enjoy some coffee and refreshments while networking with fellow participants.

21 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 Sept. 9 th,

22 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.

23 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 Sept. 9 th,

24 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 Sept. 9 th,

25 Networking Relacionamentos