DUBLIN, Nov. 27, 2023 /PRNewswire/ -- The 'Registration of Veterinary Vaccines in the USA and Canada Training Course' conference has been added to  ResearchAndMarkets.com's offering.

都柏林，2023年11月27日/PRNewswire/-“兽医疫苗在美国和加拿大培训课程”会议上的注册已添加到ResearchAndMarkets.com的产品中。

The programme will address the transferability of EU dossiers for USDA submission, which will be beneficial in planning your regulatory strategy.

该计划将针对美国农业部提交的欧盟档案的可转让性，这将有助于规划您的监管战略。

Veterinary biological products, including vaccines, are regulated independently of veterinary pharmaceuticals and topical insecticides/pesticides in Canada and the USA.

兽医生物制品，包括疫苗，在加拿大和美国独立于兽药和局部杀虫剂/杀虫剂进行管理。

Three different acts, with associated regulations and guidance, govern the three different product categories, with the result that regulation is quite dissimilar. The requirements for licensing of vaccines with USDA and CFIA are also significantly different from those for licensing of vaccines in the individual EU member states, or centrally in the EU..

三种不同的行为，以及相关的法规和指导，管理三种不同的产品类别，结果法规非常不同。美国农业部和CFIA疫苗许可的要求也与欧盟各成员国或欧盟中央的疫苗许可要求明显不同。。

This intensive course will explain the licensing process for vaccines with USDA and CFIA, and will provide comprehensive insight into the requirements to achieve a successful application.

这个密集的课程将解释美国农业部和CFIA疫苗的许可程序，并将提供对实现成功应用的要求的全面了解。

Benefits of attending:

参加的好处：

Gain a comprehensive insight into the difference of approach to licensing in the USDA/CFIA vs EU

全面了解USDA/CFIA与欧盟的许可方法差异

Understand the phased-submission process for vaccine licensing

了解疫苗许可的分阶段提交流程

Learn the format and content specifications for the required dossier components

了解所需档案组件的格式和内容规格

Review the USDA regulations (9 CFR) and guidance - memoranda, notices, supplemental information formats (SIFs), supplemental assay methods (SAMs)

审查美国农业部的规定（9 CFR）和指导-备忘录，通知，补充信息格式（SIF），补充测定方法（SAM）

Compare the regulatory fee structures for the USA and Canada

比较美国和加拿大的监管费用结构

Discuss the transferability of EU dossiers for USDA submission

讨论欧盟档案对美国农业部提交的可转让性

Certification:

认证：

CPD: 6 hours for your records

CPD：记录6小时

Certificate of completion

完成证书

Who Should Attend:

谁应该参加：

Regulatory affairs professionals

监管事务专业人员

Registration managers

注册经理

Global vaccines regulatory associates

全球疫苗监管协会

Programme managers for biologics

生物制剂项目经理

Business development directors

业务发展总监

Agenda:

议程：

Day 1

第1天

USDA Regulatory Jurisdiction

美国农业部监管管辖

Overview of what fits into USDA, FDA or EPA

美国农业部，FDA或EPA的适应情况概述

Why does it matter who regulates a product?

为什么管理产品很重要？

How is it determined which organization regulates a product?

它如何确定哪个组织管理产品？

Project planning and timescales

项目规划和时间表

Development plans to guide USDA Licensing projects

制定计划指导美国农业部许可项目

Why start with a development plan?

为什么要开始开发计划？

What should be included in the Development Plan?

发展计划应包括哪些内容？

How does this guide the entire project?

这如何指导整个项目？

Import and Transport Permits

进口和运输许可证

For Research and Development

用于研究和开发

For Sale and Distribution

出售和分销

103.3 movement

103.3运动

Master Seed, Master Cell Stocks and Master Sequences

主种子，主细胞库存和主序列

Required/recommended testing

必需/推荐的测试

Additional USDA requirements

美国农业部的其他要求

Best practices

最佳做法

Required Studies

必要的研究

Efficacy

功效

Safety

安全

Field Safety

现场安全

Back Passage / Reversion to Virulence (BPRTV)

反向传代/回复毒力（BPRTV）

Day 2

第2天

Outline of Production

生产概要

Required Sections

必需的部分

Difference between Outline and production documents

大纲和生产文件之间的区别

Labeling and Packaging

标签和包装

Single Tier vs old four-tier wording

单层与旧四层措辞

Current labelling requirements

目前的标签要求

Common issues with labelling

标签常见问题

Establishing a Licensed Facility

建立许可设施

Facility Document basics

设施文档基础

Common Issues with Facility Documents

设施文件的常见问题

USDA Facility Inspections

美国农业部设施检查

In-person

面对面

Virtual

事实上的

Autogenous vaccines

自体疫苗

What are autogenous vaccines and how are they different from 'regular' vaccines?

什么是自体疫苗，它们与“常规”疫苗有何不同？

Common questions about autogenous vaccines

关于自体疫苗的常见问题

USDA Web Portal

美国农业部门户网站

The Role of quality in a USDA regulated environment

质量在美国农业部监管环境中的作用

Standard operating procedures (SOPs) writing, use and review

标准操作程序（SOP）的编写，使用和审核

QA vs QC (USDA's expectations)

质量保证与质量控制（美国农业部的预期）

Speakers: Nick Wills knoell Nick Wills is a regulatory affairs advisor with over 10 years of experience in Veterinary Biologics development in a regulatory and quality assurance capacity. In his current position as an Advisor for Veterinary Product Development at knoell Animal Health, Nick assists clients with a wide range of regulatory projects including licensing of new products, preparation of regulatory documents and inspection readiness..

发言人：Nick Wills knoell Nick Wills是一名监管事务顾问，在监管和质量保证能力方面拥有超过10年的兽医生物制剂开发经验。Nick目前担任knoell Animal Health兽医产品开发顾问，为客户提供广泛的监管项目，包括新产品许可，监管文件准备和检查准备。。

Nick's prior experiences within a CRO/CMO, as well as within large veterinary biologics company allow him to bring USDA regulated expertise, ranging from licensing new products and preparing facilities for inspections to solving regulatory issues for existing products. Nick also has significant experience with labeling and registration of US products in foreign countries.

尼克在CRO/CMO以及大型兽医生物制品公司内的先前经验使他能够带来美国农业部监管的专业知识，从许可新产品和准备检查设施到解决现有产品的监管问题。尼克在美国产品在国外的标签和注册方面也有丰富的经验。

Nick particularly enjoys the complicated problem solving and scientific elements of regulatory affairs work.For more information about this conference visit https://www.researchandmarkets.com/r/w93gt6.

尼克特别喜欢解决问题和监管事务工作的科学要素。有关此次会议访问的更多信息https://www.researchandmarkets.com/r/w93gt6.

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SOURCE Research and Markets

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