CONSULTING AND OPINIONS FOR REGULATORY RELATED SERVICES FOR CONTRACEPTIVE RESEARCH
CONSULTING AND OPINIONS FOR REGULATORY RELATED SERVICES FOR CONTRACEPTIVE RESEARCH
批准号:
10929632
负责人:
GARY GAMERMAN
金额:
$2.5万
依托单位:
--
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
已结题
起止时间:
2023-09-30 至 2024-09-29
关键词:
Authorization documentationAwardBiological SciencesContraceptive AgentsContraceptive methodsContractsDevelopmentDevicesFundingGoalsGovernmentGrantKnowledgePersonsPharmaceutical PreparationsPublished CommentResearchServicesTechnologyWomanauthoritydesignexperienceinsightmenprogramsresearch and developmentskills
中文摘要
避孕研究分支有几项赠款和合同,重点是开发新的男女避孕药具-每个项目都有监管要求。 增加项目对已确定的申请和资助奖项的这些要求的理解有明显的好处。 增加该领域关于这一主题的知识也有好处。 只有熟悉监管要求的人才能提供评论,设计,包装和向监管机构提交申请的关键见解,才能为该计划做出科学决策,以实现政府的目标:为男性和女性提供新的避孕选择。 Seraphim Life Sciences Consulting的Gamerman先生拥有多年为开发技术的监管要求提供意见的经验(例如,药物和器械),包括避孕药。
英文摘要
The Contraception Research Branch has several grant awards and contracts that focus on the development of new contraceptives for men and women – each project has a regulatory requirement. There is a clear benefit to increasing Program’s understanding of these requirements for identified applications and funded awards. There is also a benefit to increasing the field’s knowledge on this topic overall. Only a person skilled in regulatory requirements can provide the critical insight into commenting, designing, packaging, and submitting applications to regulatory bodies can inform Program in making scientific decisions to meet the government’s goal: new contraceptive options for men and women. Mr. Gamerman of Seraphim Life Sciences Consulting has several years’ experience providing opinions for regulatory requirements on developing technologies (e.g., drugs and devices), including contraceptives.
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