{"id":72327,"date":"2023-06-26T17:38:35","date_gmt":"2023-06-26T21:38:35","guid":{"rendered":"https:\/\/www.agribusinessglobal.com\/?p=72327"},"modified":"2023-06-26T17:39:55","modified_gmt":"2023-06-26T21:39:55","slug":"staphyt-eurofins-and-reach24h-discuss-latest-trends-in-contract-research-organization-and-regulations-update","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/pt\/agrochemicals\/staphyt-eurofins-and-reach24h-discuss-latest-trends-in-contract-research-organization-and-regulations-update\/","title":{"rendered":"Staphyt, Eurofins e Reach24H discutem as \u00faltimas tend\u00eancias em organiza\u00e7\u00e3o de pesquisa contratual e atualiza\u00e7\u00e3o de regulamenta\u00e7\u00f5es"},"content":{"rendered":"

\"\"<\/a>Agroneg\u00f3cio Global<\/em> AO VIVO!<\/a> convidou tr\u00eas especialistas para atuarem como palestrantes do painel Organiza\u00e7\u00f5es de Pesquisa Contratadas<\/a> (CROs) e atualiza\u00e7\u00e3o da regulamenta\u00e7\u00e3o em 14 de junho de 2023. Vincent Dreze, Diretor Executivo da Eurofins Agroscience Services<\/a>; Garth Drury, Consultor Principal da Estafilo<\/a>; e Ivy Zhang, Gerente T\u00e9cnica S\u00eanior, Grupo de consultoria REACH24H<\/a>, discutiram tend\u00eancias para CROs para os pr\u00f3ximos tr\u00eas a cinco anos e mudan\u00e7as importantes nas regulamenta\u00e7\u00f5es para Brasil, China, Uni\u00e3o Europeia (UE), \u00cdndia e EUA. Aqui est\u00e3o algumas perguntas que o p\u00fablico do webinar fez aos nossos especialistas.<\/p>\n

ABG: Como voc\u00ea verifica a reputa\u00e7\u00e3o geral e o hist\u00f3rico de um CRO para um estudo espec\u00edfico se voc\u00ea est\u00e1 se envolvendo com eles pela primeira vez e nenhum outro membro da ind\u00fastria est\u00e1 compartilhando as informa\u00e7\u00f5es? Como voc\u00ea obt\u00e9m esses dados?<\/strong><\/p>\n

\"\"

Vincent Dreze, Diretor Geral, Eurofins Agroscience Services<\/p><\/div>\n

DV:<\/strong> CROs com uma reputa\u00e7\u00e3o s\u00f3lida s\u00e3o aqueles que geralmente est\u00e3o bem conectados a associa\u00e7\u00f5es da ind\u00fastria, como CropLife Europe, CropLife International, International Biocontrol Manufacturers' Association e European Biostimulants Industry Council. Eles est\u00e3o participando ativamente de grupos de trabalho que lidam com quest\u00f5es t\u00e9cnicas e regulat\u00f3rias. Eles tamb\u00e9m s\u00e3o aqueles que contribuem para o estabelecimento e valida\u00e7\u00e3o de metodologias e testes a serem usados em uma estrutura regulat\u00f3ria.<\/p>\n

ABG: No desenvolvimento de campo de pesticidas, \u00e9 importante saber o \u201ccomo, quando e onde\u201d quando o produto funciona bem; mas tamb\u00e9m \u201ccomo, quando e onde\u201d quando n\u00e3o funciona. Fico preocupado quando os resultados s\u00e3o bons demais. Como podemos interagir e desafiar uma CRO a lidar com isso? Como uma CRO deve ser capaz de avaliar nossas preocupa\u00e7\u00f5es sobre um poss\u00edvel vi\u00e9s na coleta de dados?<\/strong><\/p>\n

DV:<\/strong> Os ensaios de campo s\u00e3o conduzidos de acordo com as boas pr\u00e1ticas experimentais (GEP), por exemplo, seguindo as orienta\u00e7\u00f5es da Organiza\u00e7\u00e3o Europeia e Mediterr\u00e2nea de Prote\u00e7\u00e3o Vegetal (EPPO). Sob essas condi\u00e7\u00f5es, h\u00e1 menos espa\u00e7o para interpreta\u00e7\u00e3o potencial. Os resultados devem ser relevantes, independentemente da efic\u00e1cia real. N\u00e3o deve haver nenhuma preocupa\u00e7\u00e3o sobre os resultados serem bons demais se realizados de acordo com os padr\u00f5es estabelecidos. Para produtos biol\u00f3gicos, \u00e9 muito comum que os resultados n\u00e3o sejam bons o suficiente de acordo com os padr\u00f5es, mas esses s\u00e3o padr\u00f5es definidos para produtos qu\u00edmicos convencionais. Al\u00e9m disso, se quisermos atingir o mesmo n\u00edvel de efic\u00e1cia em compara\u00e7\u00e3o com a qu\u00edmica convencional, os produtos biol\u00f3gicos precisar\u00e3o ser aplicados em programas para que os resultados possam se aproximar o m\u00e1ximo poss\u00edvel do n\u00edvel de efic\u00e1cia esperado.<\/p>\n

\"\"

Garth Drury, Consultor Principal, Staphyt<\/p><\/div>\n

GD:<\/strong> A maioria dos ensaios GEP na Europa agora s\u00e3o avaliados usando ferramentas de tecnologia da informa\u00e7\u00e3o em campo (ARM, SCOUT, etc.) que permitem ao patrocinador e ao cliente acesso ao vivo \u00e0s avalia\u00e7\u00f5es e dados brutos por meio de um portal seguro, antes da conclus\u00e3o dos relat\u00f3rios do ensaio. Dessa forma, o patrocinador tem supervis\u00e3o e controle sobre o conjunto de dados de ensaios de efic\u00e1cia em desenvolvimento ativo, durante todo o projeto.<\/p>\n

ABG: Nos EUA, a National Alliance of Independent Crop Consultants (NAICC) tem muitas CROs que s\u00e3o membros. Este \u00e9 um \u00f3timo recurso para descobrir uma nova CRO. H\u00e1 algo semelhante em outros pa\u00edses?<\/strong><\/p>\n

GD:<\/strong> Sim. Existem v\u00e1rios diret\u00f3rios e cat\u00e1logos de contratantes de boa-f\u00e9 na Europa, sejam laborat\u00f3rios de boas pr\u00e1ticas de laborat\u00f3rio (GLP), organiza\u00e7\u00f5es de ensaios de campo certificadas pelo GEP ou consultores regulat\u00f3rios, por exemplo, o Guia de provedores de servi\u00e7os globais, Chemical Watch, 2022<\/a>. No entanto, um exerc\u00edcio de due diligence de segundo n\u00edvel \u00e9 recomendado para refinar a lista de CROs candidatos adequados.<\/p>\n

ABG: H\u00e1 credibilidade extra na qualidade do estudo e dos dados gerados se o CRO conduzir um estudo n\u00e3o-GLP (campo e an\u00e1lise) em uma instala\u00e7\u00e3o certificada em GLP e com equipes treinadas em GLP, em vez de um estudo n\u00e3o-GLP realizado por CROs sem experi\u00eancia em GLP?<\/strong><\/p>\n

DV:<\/strong> Se eu tivesse que realizar um estudo n\u00e3o-GLP, eu definitivamente iria com um CRO com experi\u00eancia em GLP. Esteja ciente de que na UE os requerentes (e laborat\u00f3rios) devem notificar informa\u00e7\u00f5es sobre estudos encomendados ou realizados para dar suporte a uma futura aplica\u00e7\u00e3o \u00e0 Autoridade Europeia para a Seguran\u00e7a Alimentar (EFSA). Portanto, \u00e9 essencial que os estudos sejam projetados e realizados corretamente. Eu tamb\u00e9m recomendaria que o requerente (se n\u00e3o tiver experi\u00eancia em encomendar um estudo e supervision\u00e1-lo internamente) esteja contratando um consultor regulat\u00f3rio para o monitoramento do estudo (valida\u00e7\u00e3o de protocolo, relat\u00f3rios, comunica\u00e7\u00e3o com diretores de estudo, etc.), ent\u00e3o o GLP \u00e9 importante, mas mais importante \u00e9 a aceitabilidade regulat\u00f3ria do estudo.<\/p>\n

GD:<\/strong> A acredita\u00e7\u00e3o GLP n\u00e3o significa automaticamente que o estudo ser\u00e1 aceito pela autoridade nem que o laborat\u00f3rio tem um alto n\u00edvel de experi\u00eancia no t\u00f3pico. \u00c9 por isso que verifica\u00e7\u00f5es adicionais devem ser feitas na sele\u00e7\u00e3o de CRO, al\u00e9m da acredita\u00e7\u00e3o GLP.<\/p>\n

ABG: E quanto \u00e0 harmoniza\u00e7\u00e3o global de regulamenta\u00e7\u00f5es? H\u00e1 algum movimento nessa dire\u00e7\u00e3o?<\/strong><\/p>\n

DV:<\/strong> Mesmo dentro de uma regi\u00e3o, por exemplo, Acordo de Livre Com\u00e9rcio da Am\u00e9rica do Norte (NAFTA), UE\/\u00c1rea Econ\u00f4mica Europeia\/Reino Unido, Acordo de Com\u00e9rcio \u00c1sia-Pac\u00edfico (APTA), a harmoniza\u00e7\u00e3o \u00e9 dif\u00edcil de ser alcan\u00e7ada. Como Garth mencionou, j\u00e1 h\u00e1 harmoniza\u00e7\u00e3o na forma como os dados e dossi\u00eas s\u00e3o estruturados e apresentados (o formato da Organiza\u00e7\u00e3o para Coopera\u00e7\u00e3o e Desenvolvimento Econ\u00f4mico (OCDE), Banco de Dados Internacional de Informa\u00e7\u00f5es Qu\u00edmicas Uniformes (IUCLID), por exemplo), mas a quest\u00e3o \u00e9 mais sobre como os dados est\u00e3o sendo avaliados. Esse era o objetivo do Regulamento da UE 1107\/2009, que deveria agilizar os processos de avalia\u00e7\u00e3o de registro em toda a Europa. Mas ainda hoje, os resultados est\u00e3o longe das expectativas iniciais e os processos de registro ainda s\u00e3o muito longos, especialmente considerando as metas ambiciosas da Comiss\u00e3o da UE em rela\u00e7\u00e3o \u00e0 redu\u00e7\u00e3o do uso de pesticidas. Com o sistema atual em vigor, as alternativas aos produtos qu\u00edmicos n\u00e3o chegar\u00e3o ao mercado a tempo.<\/p>\n

GD:<\/strong> Na UE, com o sistema atual em vigor, alternativas de biocontrole a produtos qu\u00edmicos convencionais ainda levam um tempo significativamente maior para chegar ao mercado do que em outras regi\u00f5es. No entanto, uma abordagem de dossi\u00ea central pode ser adotada para projetos globais, com refinamento e adi\u00e7\u00f5es adequados fornecidos em n\u00edvel regional e nacional.<\/p>\n

ABG: Para um pesticida ser registrado na China, ele precisa ser autorizado pela Comiss\u00e3o Europeia?<\/strong><\/p>\n

\"\"

Ivy Zhang, Gerente T\u00e9cnica S\u00eanior, REACH24H Consulting Group<\/p><\/div>\n

IZ:<\/strong> O registro de uma mistura na Europa n\u00e3o \u00e9 um requisito obrigat\u00f3rio para que a mistura seja registrada na China. Desde que uma mistura possa cumprir os requisitos de registro de pesticidas na China, ela pode ser registrada. Requisitos detalhados de registro de pesticidas podem ser encontrados no Regulamento da Administra\u00e7\u00e3o de Pesticidas e seus documentos relacionados.<\/p>\n

ABG: Quais s\u00e3o as perspectivas para que os agentes de biocontrole atendam efetivamente aos segmentos de culturas que atualmente s\u00e3o atendidos por \u201ccandidatos \u00e0 substitui\u00e7\u00e3o\u201d na UE?<\/strong><\/p>\n

DV:<\/strong> Gostaria aqui de me referir especificamente a Programa-Quadro Horizonte Europa (HORIZONTE<\/a>).<\/p>\n

Neste contexto, a Eurofins est\u00e1 contribuindo para a prepara\u00e7\u00e3o de v\u00e1rias propostas em colabora\u00e7\u00e3o com start-ups, academia, oxidantes t\u00e9rmicos regenerativos (RTOs) e fabricantes para dar suporte \u00e0 inova\u00e7\u00e3o para atingir um n\u00edvel de prontid\u00e3o tecnol\u00f3gica que ser\u00e1 aceit\u00e1vel para que as inova\u00e7\u00f5es cheguem ao mercado e substituam candidatos para substitui\u00e7\u00e3o. O aspecto colaborativo do trabalho combinando os melhores especialistas da classe e apoiado financeiramente pela UE \u00e9 um grande acelerador para a introdu\u00e7\u00e3o do produto.<\/p>\n

GD:<\/strong> No geral, a inova\u00e7\u00e3o em produtos de biocontrole e bioestimulantes est\u00e1 avan\u00e7ando bem, mas \u2014 como mencionado acima e em outros lugares \u2014 os tempos de aprova\u00e7\u00e3o na UE est\u00e3o atualmente desacelerando o uso mais extensivo. A extens\u00e3o de seu uso no Brasil para culturas forrageiras de amplo alcance mostra o potencial futuro pr\u00f3ximo para o biocontrole em outras regi\u00f5es agr\u00edcolas importantes. No entanto, \u00e9 necess\u00e1rio cuidado ao considerar a substitui\u00e7\u00e3o 1:1 de um produto convencional (incluindo aqueles designados como "candidatos para substitui\u00e7\u00e3o" na UE, que se baseia principalmente no risco intr\u00ednseco (incluindo classifica\u00e7\u00e3o), n\u00e3o em usos aprovados com mitiga\u00e7\u00e3o protetora apropriada) com uma solu\u00e7\u00e3o de biocontrole, pois o n\u00edvel de controle pode n\u00e3o ser aceit\u00e1vel ou consistente. Ensaios extensivos mostraram que um programa personalizado de manejo integrado de pragas (MIP) combinando solu\u00e7\u00f5es convencionais e de biocontrole \u00e9 normalmente ideal para a produ\u00e7\u00e3o de culturas, por exemplo, usando produtos de biocontrole para os \u00faltimos tratamentos para uma determinada cultura antes da colheita para reduzir res\u00edduos bem dentro dos n\u00edveis m\u00e1ximos de res\u00edduos (MRLs) atuais. As necessidades locais de controle de pragas, doen\u00e7as e ervas daninhas variam amplamente na UE e de esta\u00e7\u00e3o para esta\u00e7\u00e3o. Isso significa que \u2014 juntamente com as medidas de controle de resist\u00eancia necess\u00e1rias \u2014 uma mistura de ferramentas convencionais e de biocontrole ser\u00e1 necess\u00e1ria em um futuro pr\u00f3ximo.<\/p>\n

ABG: Como est\u00e1 o processo de formaliza\u00e7\u00e3o de uma defini\u00e7\u00e3o clara e oficial de produtos de biocontrole na Europa?<\/strong><\/p>\n

DV:<\/strong> Uma defini\u00e7\u00e3o da UE de controle biol\u00f3gico que abrange as quatro categorias de biocontrole foi inclu\u00edda no Regulamento de Uso Sustent\u00e1vel. Essas categorias s\u00e3o agentes de biocontrole de invertebrados, micr\u00f3bios, semioqu\u00edmicos e subst\u00e2ncias naturais.<\/p>\n

GD:<\/strong> O rascunho atual do SUR (22\/06\/2022) afirma que o controle biol\u00f3gico significa o controle de organismos prejudiciais \u00e0s plantas ou produtos vegetais usando meios naturais de origem biol\u00f3gica ou subst\u00e2ncias id\u00eanticas a eles, como microrganismos, semioqu\u00edmicos, extratos de produtos vegetais conforme definido no Artigo 3(6) do Regulamento (CE) n.\u00ba 1107\/2009, ou macrorganismos invertebrados. A frase \u201cde origem biol\u00f3gica\u201d poderia ser alterada para \u201cde origem natural\u201d para tamb\u00e9m abranger minerais dentro da defini\u00e7\u00e3o de controle biol\u00f3gico.<\/p>\n

Ver o webinar<\/a><\/p>","protected":false},"excerpt":{"rendered":"

CROs l\u00edderes compartilham insights sobre mudan\u00e7as importantes em regulamenta\u00e7\u00f5es para Brasil, China, UE, \u00cdndia e EUA<\/p>","protected":false},"author":112,"featured_media":72105,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4],"tags":[54],"class_list":["post-72327","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-agrochemicals","tag-featured-home"],"yoast_head":"\nStaphyt, Eurofins, and Reach24H Discuss Latest Trends in Contract Research Organization and Regulations Update - AgriBusiness Global<\/title>\n<meta name=\"description\" content=\"Leading CROs share insight into important changes in regulations for Brazil, China, EU, India, and the U.S.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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