In recent years there has been an increased emphasis on Scientific Advice Group meetings as a precursor to CHMP deliberation and ruling on a Marketing Authorization Application or MAA submission. We support and coordinate all meetings related to the EMA and will work closely with your team to ...
1. providingscientific adviceto companies researching and developing new medicines; 向研究和开发新药的公司科学提供建议。 2. preparingscientific guidelinesand regulatory guidance to help pharmaceutical companiesprepare marketing authorisation applications for human medicines; 起草科学指南和法规以帮助医药企业准备 人...
EMA Finds Scientific Advice Leads to Stronger Trial Design
欧盟为了促进安全、有效和高质量的兽药研发和供应,申请人在提交上市许可申请之前可以使用EMA在线IRIS平台向EMA进行科学咨询,EMA可以就兽药研发过程中的相关试验和研究内容,由CVMP的科学咨询工作组(Scientific Advice Working Party,SAWP)向申请人提供...
药物被批准进入PRIME 计划后,专用的EMA联络员将会联系申请人,以尽快组织召开1 次启动会议(kick-off meeting),参会方包括申请人、CHMP 报告起草人、来自欧盟药品监管网络的相关专家( 尤其是来自PDCO、COMP、PRAC、SAWP和CAT 的专家) 及EMA 的工作人员[5]。
提交事前咨询请求: 针对FDA,您可以通过Pre-Submission(事前咨询)程序向FDA提交请求,而EMA可以通过Scientific Advice(科学建议)程序提供咨询。 3. 制定和提交申请: 制定全面的申请: 根据监管机构的要求,制定全面的申请文件,确保包括所有必要的信息和支持文件。
提交初步研究计划(Protocol Assistance,FDA)或药物开发咨询(Scientific Advice,EMA)申请,以获取监管机构的意见。 申请准备: 制定完整的研究计划,包括研究设计、试验流程、数据收集和分析计划等。 编写适当的文档,包括研究方案、病例报告表(Case Report Form,CRF)、知情同意书等。
•Contribution toscientific advice procedures as required. •按要求支持科学建议程序 3.2. Evaluationand supervision activities评估和监管活动 •Contribution to marketingauthorisation procedures as required; • 按要求支持上市许可程序 •Agreement on EMA’s...
The Agency also supervises the safety of medicines in the EU after they have been authorised. It can also give scientific opinions on medicines at the request of Member States or the European Commission. 同样的,再药品获批后,在欧盟范围内机构需要监督药品的安全性。鉴于欧盟成员国的请求,同样需要给...
252handledonacase-by-casebasisandearlyinteraction(scientificadvice)withtheregulatoryagenciesis 253recommended.However,alsoforstartingmaterialsofnon-peptidestructuralmoieties(e.g.PEG- 254chains),compliancewiththerequirementsaslaiddowninICHQ11anditsassociatedQAisexpected ...