{"id":69238,"date":"2022-07-24T18:30:09","date_gmt":"2022-07-24T22:30:09","guid":{"rendered":"https:\/\/www.agribusinessglobal.com\/?p=69238"},"modified":"2022-07-25T14:03:05","modified_gmt":"2022-07-25T18:03:05","slug":"cros-and-regulatory-processes-interview-with-staphyts-fanny-vanel","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/pt\/markets\/cros-and-regulatory-processes-interview-with-staphyts-fanny-vanel\/","title":{"rendered":"CROs e processos regulat\u00f3rios: entrevista com Fanny Vanel da Staphyt"},"content":{"rendered":"<p><em>Agroneg\u00f3cio Global<\/em> entrou em contato com Fanny Vanel, gerente de marketing e comunica\u00e7\u00f5es da <a href=\"https:\/\/www.staphyt.com\/\" target=\"_blank\" rel=\"noopener\">Estafilo<\/a>, para obter sua perspectiva sobre os principais desafios que os formuladores enfrentam atualmente. Vanel, que est\u00e1 na Staphyt desde 2014, compartilha suas ideias sobre o processo de aprova\u00e7\u00e3o do produto, trabalhando com formuladores em torno de bloqueios regulat\u00f3rios e a recente expans\u00e3o da Staphyt para novas regi\u00f5es.<\/p>\n<p><strong>ABG: Quais voc\u00ea acha que s\u00e3o os principais desafios para o atual processo regulat\u00f3rio?<\/strong><\/p>\n<p><strong>VF:<\/strong> Na Europa, o registro de produtos \u00e9 altamente complexo e \u00e9 um dos maiores desafios tanto na qu\u00edmica sint\u00e9tica tradicional quanto nos setores de biocontrole. Portanto, \u00e9 essencial ter um n\u00edvel muito alto de experi\u00eancia e conhecimento tanto em n\u00edvel regional quanto nacional na Europa para garantir o sucesso \u2014 e nem mesmo as maiores empresas tentam cobrir todos os t\u00f3picos e geografias. \u00c9 aqui que consultores especialistas como a Staphyt desempenham um papel cr\u00edtico na entrega de objetivos de neg\u00f3cios para todos os tipos de fabricantes neste mercado.<\/p>\n<p>No Brasil, o processo de registro de produtos tamb\u00e9m \u00e9 complexo, pois \u00e9 um sistema tripartite: o Minist\u00e9rio da Agricultura \u00e9 respons\u00e1vel por emitir o registro, mas as aprova\u00e7\u00f5es v\u00eam da ANVISA (Minist\u00e9rio da Sa\u00fade) e do IBAMA (Minist\u00e9rio do Meio Ambiente). Um dos pontos mais cr\u00edticos no processo brasileiro \u00e9 o cronograma para obter a aprova\u00e7\u00e3o. Os produtos levam em m\u00e9dia de 4 a 5 anos ap\u00f3s a submiss\u00e3o para receber a aprova\u00e7\u00e3o de um produto t\u00e9cnico equivalente. Nos \u00faltimos meses de 2021, um novo decreto foi publicado destacando alguns pontos importantes para agilizar esse processo, tornando-o mais eficiente, mas ainda seguindo todo o rigor t\u00e9cnico para garantir a seguran\u00e7a tanto para as pessoas quanto para o meio ambiente.<\/p>\n<p>Outros pa\u00edses da Am\u00e9rica Latina ainda enfrentam limita\u00e7\u00f5es das ag\u00eancias locais para fazer uma an\u00e1lise mais t\u00e9cnica dos pedidos de registro, o que demanda mais tempo para intera\u00e7\u00e3o direta entre as autoridades e os solicitantes regulat\u00f3rios.<\/p>\n<p><strong>ABG: Quais s\u00e3o algumas ideias de como os formuladores podem contornar esses bloqueios regulat\u00f3rios?<\/strong><\/p>\n<p><strong>VF:<\/strong> Os formuladores podem trabalhar com consultores regionais experientes e CROs, como a Staphyt, que trabalham diariamente em v\u00e1rios sistemas regulat\u00f3rios para novos produtos e para defesa de produtos estabelecidos.<\/p>\n<p>A obten\u00e7\u00e3o de um registro de produto ou subst\u00e2ncia requer muitas habilidades diferentes. Os CROs continuam sendo, mais do que nunca, uma atra\u00e7\u00e3o de expertise e conhecimento que fabricantes e formuladores podem usar para gerenciar uma parte de seus programas ou um dossi\u00ea de registro completo. Eles podem personalizar servi\u00e7os para ajudar os clientes a lidar com picos de carga de trabalho, resolver problemas regulat\u00f3rios e t\u00e9cnicos espec\u00edficos e criar e enviar um dossi\u00ea de registro.<\/p>\n<p><strong>ABG: Como sua empresa ajuda os formuladores?<\/strong><\/p>\n<p><strong>VF:<\/strong> Temos muitos clientes que n\u00e3o sintetizam seus pr\u00f3prios ingredientes ativos, mas os obt\u00eam de terceiros, portanto, efetivamente formuladores. No entanto, esta categoria abrange uma ampla gama de empresas, desde grandes multinacionais at\u00e9 empresas locais ou regionais menores que se concentram em produtos gen\u00e9ricos e inovadores, sendo este \u00faltimo de import\u00e2ncia, particularmente no crescente segmento de biocontrole. Ajudamos os formuladores, como fazemos com qualquer outro cliente, apoiando a realiza\u00e7\u00e3o de seus objetivos de neg\u00f3cios, entregando ao mercado novos produtos da maneira mais eficaz, bem como defendendo seu portf\u00f3lio existente.<\/p>\n<p>Internamente, temos um painel de cientistas, agr\u00f4nomos de campo e especialistas em assuntos regulat\u00f3rios que podem gerenciar totalmente todo o trabalho para nossos clientes. Al\u00e9m da divis\u00e3o de campo e laborat\u00f3rio em agroci\u00eancias, a Staphyt desenvolveu um forte departamento de assuntos regulat\u00f3rios. Hoje, mais de 90 pessoas no departamento regulat\u00f3rio ajudam nossos clientes a planejar desde o in\u00edcio a melhor estrat\u00e9gia para cada produto e situa\u00e7\u00e3o, visando um processo de registro r\u00e1pido, eficiente e robusto. Nossas equipes locais s\u00e3o capazes de auxiliar melhor nossos clientes com especificidades para cada regi\u00e3o, implementando um acompanhamento muito eficiente com as autoridades locais, ao mesmo tempo em que lhes d\u00e1 uma vis\u00e3o clara de seus processos de registro.<\/p>\n<p><strong>ABG: Voc\u00eas t\u00eam presen\u00e7a global, com escrit\u00f3rios em v\u00e1rios pa\u00edses. H\u00e1 algum desafio regional que voc\u00eas enfrentam?\u00a0\u00a0<\/strong><\/p>\n<p><strong>VF:<\/strong> Na Staphyt, temos mais de 500 pessoas, mais de 80 esta\u00e7\u00f5es de testes de campo e escrit\u00f3rios de assuntos regulat\u00f3rios. Na Europa, nossa equipe gerencia mais de 7.000 testes todos os anos. Nossa presen\u00e7a global \u00e9 um dos nossos pontos fortes e um valor agregado real para nossos clientes, pois temos uma presen\u00e7a local em todas as principais regi\u00f5es agr\u00edcolas. Somos os olhos e ouvidos de nossos clientes, gerenciando testes em campo e em laborat\u00f3rio, construindo protocolos, conhecendo pr\u00e1ticas agr\u00edcolas locais, bem como restri\u00e7\u00f5es regulat\u00f3rias e requisitos de dados necess\u00e1rios em um programa de registro.<\/p>\n<p>Dez anos atr\u00e1s, enfrentamos o desafio de trabalhar e testar produtos biol\u00f3gicos. Nos \u00faltimos tr\u00eas anos, o n\u00famero de subst\u00e2ncias de baixo risco aprovadas em n\u00edvel europeu dobrou, o n\u00famero de microrganismos tamb\u00e9m quase dobrou e o n\u00famero de subst\u00e2ncias naturais triplicou. Em 2011, respondemos a esse desafio e criamos uma equipe transversal de especialistas dedicada ao estudo de biossolu\u00e7\u00f5es (BioTeam), porque as biossolu\u00e7\u00f5es est\u00e3o em ascens\u00e3o e exigem uma abordagem t\u00e9cnica e regulat\u00f3ria distinta.<\/p>\n<p><strong>ABG: Com o aumento dos produtos biol\u00f3gicos no Brasil, como sua empresa est\u00e1 respondendo a esse desenvolvimento?<\/strong><\/p>\n<p><strong>VF:<\/strong> Temos uma nova presen\u00e7a no Brasil, o que \u00e9 um grande passo no desenvolvimento da nossa empresa. A Staphyt tem uma equipe de mais de 50 pessoas na \u00e1rea regulat\u00f3ria no Brasil <a href=\"https:\/\/www.agribusinessglobal.com\/pt\/markets\/staphyt-acquires-brazilian-regulatory-company-plurie-solucoes-regulatorias\/\">ap\u00f3s aquisi\u00e7\u00f5es da Plurie<\/a> e <a href=\"https:\/\/www.agribusinessglobal.com\/pt\/markets\/staphyt-acquires-brazilian-regulatory-services-firm-leisor\/\">Leitor<\/a> em 2022, tornando-nos a principal empresa de servi\u00e7os regulat\u00f3rios do Brasil. Estamos em fase final de aquisi\u00e7\u00e3o de uma CRO, o que nos permitir\u00e1 oferecer uma grande variedade de servi\u00e7os na \u00e1rea de pesquisa e desenvolvimento. Nosso objetivo \u00e9 cobrir as principais \u00e1reas agr\u00edcolas do Brasil com uma equipe muito forte e instala\u00e7\u00f5es de pesquisa capazes de dar suporte \u00e0s necessidades de nossos clientes.<\/p>","protected":false},"excerpt":{"rendered":"<p>Vanel compartilha suas ideias sobre o processo de aprova\u00e7\u00e3o do produto, o trabalho com formuladores em torno de bloqueios regulat\u00f3rios e a recente expans\u00e3o da Staphyt para novas regi\u00f5es.<\/p>","protected":false},"author":1461,"featured_media":69243,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[5],"tags":[54,583,1669],"class_list":["post-69238","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-markets","tag-featured-home","tag-regulatory","tag-staphyt"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - 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