Expor e debater as inovações da tecnologia de injetáveis, desde a fabricação de ampolas, seringas e carpules, e os avanços na produção de medicamentos até as inovações dos equipamentos de inspeção.
Profissionais das áreas de fabricação, controle e segurança da qualidade, de desenvolvimento tecnológico e de assuntos regulatórios da indústria farmacêutica.
08:00 – Recepção 08:30 – Abertura: Dr. Lauro D. Moretto, Gabriele Peron e Daniel Fritelli 08:30 - Status regulatório para injetáveis e acondicionamento primário: atualização sobre embalagens primárias e injetáveis. Ministrante: ANVISA – TBC 09:00 – Metodologia analítica para controle de delaminação de recipientes de vidro. Ministrantes: Vladimir Pena (CIM) e Odra Pinato (OMPI) 09:30 - Extraíveis & Lixiviáveis de recipientes farmacêuticos Ministrante: Piet Christiaens (Toxicon) 10:00 - Como processar os frascos de vidro para garantir a segurança e eliminar o problema da delaminação e da ruptura com o processo de liofilização Ministrante: Gustavo Ortiz (Ompi) 10:30 - Coffee break 10:45 – Lavado GMP para grandes contenedores, especialmente em Bio BiotecnologicosPF para recipientes de grande volume utilizados em biotecnologia. Ministrante: Christian Muro (Getinge) 11:15 – Inovações tecnológicas em tampas de elastômero para produtos liofilizados. 11:45 – Sistema inovador para enchimento e acabamento de produtos liofilizados Ministrante: Marcos Tilli Reis, IMAUTOMATICHE do BRASIL, Subsidiary of IMA S.p.A. 12:15 – Tecnologia inovadora para inspeção visual de medicamentos liofilizados e soluções de grandes volumes Ministrante: Gaetano Baccinelli (Optrel) 12:45 – Perguntas / Respostas 13h00 – Encerramento
Gabriele Peron, Degree in Sociology of Mass Communication in 1997 and member of Mass Communication Research Group at University of Padua, visiting professor at Media Unit Glasgow in 1999. Mr. Peron has been in the field of marketing services for 15 years, with experience in web applications and advanced interactive technologies for pharmaceutical companies. He is currently Marketing and communication manager at Stevanato Group ( www.stevanatogroup.com ) , a multinational company focused on the production of glass containers for pharmaceutical use, based in Piombino Dese (PD). Coordination and execution of all marketing activities - group communication , organization and coordination of international fairs, participation as a moderator , speaker and conference organizer, design technical presentations in coordination with the R&D, benchmark vs. competition , packaging , brochures, newsletters , corporate identity , media relations, and visual communication within the company. Member of PDA Italy Chapter www.pda-ir.org (secretary), Member of Steering Committee Pharmintech. Member of Steering Committee International Commission on Glass ICG (www.icglass.org). Odra Pinato, Odra Pinato is the SG Lab Analytics Coordinator. SG Lab Analytics is an analytical laboratory entity, which operates under the R&D dept. of OMPI and performs chemical analyses, surfaces and materials characterization and mechanical tests on pharmaceutical packaging. She manages the research activities of the laboratory to support the strategic projects of the R&D dept. for the development of new products and processes, the development of analytical methodologies, as well as to support the internal needs of the manufacturing operation, QA and QC dept. for the products quality improvements, analytical transfers and troubleshooting. Her role is related to the coordinator of the advanced analytical services that SG Lab Analytics offers to the Pharma customers to understand the containers properties and performances with respect to the customer needs and to mitigate and reduce the risk of interaction of containers with the drugs. Formerly, Odra Pinato is a pharmaceutical biotechnologist with a PhD in Biochemistry and Biotechnology. Her academic background is focused on protein chemistry and structural biochemistry with a 2-year post-doctoral experience in pharmaceutical biophysics. She has also GMP Pharma-related expertise on the development and validation of chromatographic methods, force degradation and stability studies for the quality assessment of drug products and on physical and chemical characterization of proteins for biopharmaceutical purposes. Based on these expertise, she is also involved in container-drug interaction consultancy. Piet Christiaens, received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two CRO’s. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, TX (US) working on hydrogenated triblock co-polymers. From 2001 onwards, Mr. Christiaens holds the position of scientific director at Toxikon Europe where he develops analytical methods and protocols for both extractables and leachables studies for the pharmaceutical and medical Industries. Dr. Christiaens oversees all laboratory operations at Toxikon and is also giving support to the business development. Daniel Fritelli, After a career of Engineering, Daniel Fritelli worked principally as consultant for companies acting in energy field , automotives and micro electronic. During this time, he carries out the start up of a Brazilian entity with an Italian company, integrating also the function of sales manager. He operates like responsible for sales in Latin America since 3 years in the Group Stevanato. Christian Muro, Vicepresident for Infection Control LatAm at Getinge Group (2015) - Director of Sales & Service LifeScience LifeScience LatAm at Getinge ( 2013 to 2015) - Area Sales manager for Latin America at ELLAB (2008 – 2013) - Master degree in Economics, University of Copenhagen Deolinda Martins, Graduada em Farmácia Bioquímica pela Universidade Estadual de Maringá - PR, com Mestrado em Análises Toxicológicas pela Universidade de São Paulo, Doutorado em Saúde Pública também pela Universidade de São Paulo e MBA Executivo Internacional pela FIA/USP.Possui mais de 15 anos de experiência nas áreas técnico-comercial e marketing em empresas do segmento de saúde humana e ambiental. E mais de 20 anos de experiência como docente nas áreas de Toxicologia e Saúde Ocupacional. Atualmente, é responsável pela área de Suporte Técnico ao Cliente na West Pharmaceutical Services Brasil, gerenciando a interface entre clientes e a área comercial da empresa e entre a América do Sul e a Matriz, além de oferecer suporte aos clientes quanto à compatibilidade da embalagem e o medicamento, entre outras atividades. Gaetano Baccinelli, is the Sales Manager of Optrel, company of Stevanato Group’s Engineering Division, specialized in manufacturing inspection machines for parenteral products. He spent seven years from 1992 to 1999 working in the USA branch of a well known Italian group worldwide leaders in those field as skilled engineer into the after Sales Dept. He worked as manager of the After Sales and Service Dept. and as Area Sales Manager for Brevetti CEA Spa in Italy leading company in inspection systems following Japan and USA market. His academic background is mainly technical.
02.12.2016
Inscrições Gratuitas –
Vagas Limitadas
Este evento é organizado pela Academia Nacional de Farmácia, com base no Protocolo de Cooperação Técnica firmado com o SINDUSFARMA - Sindicato da Indústria de Produtos Farmacêuticos no Estado de São Paulo
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