临床试验: 我, GCP规则, 监管 (EMEA, FDA) GCP检查. 关键文件.

GCP培训上线 (GCP认证)

医学会议

gcp certificate

1) GCP course for Investigators and CRAs

2) GCP course for Auditors

(see below or for detailed information click here)

 

GCP training curriculum

(1) GCP training for Beginners

ICH-GCP (E6-R2) international guidelines

1: Introduction to GCP
1.1 背景
1.2 What is GCP?
1.3 New GCP Guide 2019
1.4 The Principles of ICH GCP – 2019
1.5 Some General Points
1.6 Documentation and Version Control
1.7 Quality Assurance

2: Competent Authorities (CA) and Independent Ethics Committee (IEC)

2.1 Responsibilities of the CA
2.2 Responsibility of the IEC
2.3 Subject Informed Consent Forms (ICF)
2.4 Composition, Functions, Operations, Procedures and Records

3: Investigator

3.1 Investigator Responsibilities
3.2 Investigator Qualifications and Agreements
3.3 Adequate Resources
3.4 Medical Care of Trial Subjects
3.5 Communication with IRB/IEC
3.6 Compliance with the Protocol
3.7 Investigational Medicinal Product
3.8 Randomization Procedures and Un-blinding
3.9 Informed Consent of Trial Subjects
3.10 Records and Reports I
3.11 Premature Termination or Suspension of a Trial
3.12 Progress Reports and Final Report(s) by Investigator
3.13 Archiving
3.14 Considerations for the use of electronic systems in clinical trial management
3.15 Updated information on electronic records and use of EMRs in clinical research.В

4: Sponsor’s Responsibilities

4.1 Quality Assurance and Quality Control
4.2 合同研究组织
4.3 Trial Design
4.4 Trial Management, Data Handling and Record Keeping
4.5 Investigator Selection
4.6 Financing
4.7 Notification/ Submission to Regulatory Authorities
4.8 Gaining CA approval in the EU
4.9 Confirmation of Review by IRB/IEC
4.10 Information on IMP
4.11 Manufacturing, Packaging, Labelling and Coding Investigational Products
4.12 Supplying and Handling Investigational Products
4.13 Record Access
4.14 Audit and Inspection
4.15 Noncompliance
4.16 Premature Termination or Suspension of a Trial
4.17 Clinical Trial/Study Reports
4.18 Multicentre Trials

5: Monitor’s Responsibilities

5.1 About this Chapter
5.2 介绍
5.3 Monitoring I

6: Safety & Adverse Event Reporting

6.1 Adverse Drug Reaction Reporting

7: Clinical Trial Protocol and Amendments

7.1 Trial Objectives and Purpose
7.2 Trial Design
7.3 Selection and Withdrawal of Subjects
7.4 Treatment of Subjects
7.5 Assessment of Efficacy
7.6 Assessment of Safety
7.7 Statistics
7.8 Direct Access to Source Data/Documents
7.9 Ethics
7.10 Financing and Insurance
7.11 Publication Policy

8: Investigator Brochure

9: Essential Documents

9.1 Archiving
9.2 Documents to be Present Pre-Study
9.3 Documents to be Added During the Study
9.4 Documents to be Added Post-Study

10 Examples

10.1 Practical examples of good (and poor!) practice in relation to conducting clinical trials

ICH-GCP (E6-R2) international guidelines

 

医学会议

gcp certificate

 

(2) Advanced GCP training

1: Introduction to GCP
1.1 背景
1.2 What is GCP?
1.3 New GCP Guide
1.4 The Principles of ICH GCP
1.5 Some General Points
1.6 Documentation and Version Control
1.7 Quality Assurance

2: Competent Authorities (CA) and Independent Ethics Committee (IEC)

2.1 Responsibilities of the CA
2.2 Responsibility of the IEC
2.3 Subject Informed Consent Forms (ICF)
2.4 Composition, Functions, Operations, Procedures and Records
2.5 How to avoid Ethics Committee issues;
2.6. How to minimize safety issues;
2.7. Measures to protect confidentiality of clinical trial subjects;
2.8 Revisions and updates to the section on HIPAA and privacy.В В

3: Investigator

3.1 Investigator Responsibilities
3.2 Investigator Qualifications and Agreements
3.3 Adequate Resources
3.4 Medical Care of Trial Subjects
3.5 Communication with IRB/IEC
3.6 Compliance with the Protocol
3.7 Investigational Medicinal Product
3.8 Randomization Procedures and Un-blinding
3.9 Informed Consent of Trial Subjects
3.10 The best practices in obtaining informed consent;
3.11 How to assess good oversight by a Principal Investigator;
3.12 Records and Reports I
3.13 Premature Termination or Suspension of a Trial
3.14 Progress Reports and Final Report(s) by Investigator
3.15 Archiving
3.16 В Considerations for the use of electronic systems in clinical trial management
3.17 Updated information on electronic records and use of EMRs in clinical research.В

4: Sponsor’s Responsibilities

4.1 Quality Assurance and Quality Control
4.2 合同研究组织
4.3 Trial Design
4.4 Trial Management, Data Handling and Record Keeping
4.5 Investigator Selection
4.6 Financing
4.7 Notification/ Submission to Regulatory Authorities
4.8 Gaining CA approval in the EU
4.9 Confirmation of Review by IRB/IEC
4.10 Information on IMP
4.11 What clinical trial processes should be covered by SOPs;

4.12 The impact and principles of good vendor oversight;

4.13 Optimal management of IMP;

4.14 How to avoid Ethics Committee issues;

4.15 Ensuring data quality by enhancing data management systems.

4.16 Manufacturing, Packaging, Labelling and Coding Investigational Products

4.17 Supplying and Handling Investigational Products

4.18 Record Access
4.19 Audit and Inspection
4.20 Noncompliance
4.21 Premature Termination or Suspension of a Trial
4.22 Clinical Trial/Study Reports

4.23 Multicentre Trials

 

5: Monitor’s Responsibilities

 

5.1 About this Chapter

5.2 介绍

5.3 Monitoring I

5.4 Understand current thinking on risk based monitoring approaches and develop appropriate monitoring strategies for your study

5.5. Develop superior strategies for selecting sites, recruiting patients and motivating investigational sites

5.6. Significantly improve your performance as a monitor to an advanced level

5.7. Use effective planning and tracking tools to maximize efficiency as a monitor

5.8. Develop strategies for dealing with complex monitoring issues

5.9.Gain expertise in monitoring oversight activities

 

6: Safety & Adverse Event Reporting

 

6.1 Adverse Drug Reaction Reporting

 

7: Clinical Trial Protocol and Amendments

 

7.1 Trial Objectives and Purpose

7.2 Trial Design

7.3 Selection and Withdrawal of Subjects

7.4 Treatment of Subjects

7.5 Assessment of Efficacy

7.6 Assessment of Safety

7.7 Statistics

7.8 Direct Access to Source Data/Documents

7.9 Ethics

7.10 Financing and Insurance

7.11 Publication Policy

 

8: Investigator Brochure

 

9: Essential Documents

 

9.1 Archiving

9.2В В Documents to be Present Pre-Study

9.3 Documents to be Added During the Study

9.4 Documents to be Added Post-Study

 

10. GCP audits and inspections;

 

10.1The difference between audits and inspections;

10.2 The types of inspections at a sponsor or CRO or investigational site;

10.3 How best to prepare for an inspection;

10.4 Best practice for conduct during an inspection;

10.5 Common inspection findings and how to prevent their occurrence;

10.6 How to respond to inspection findings;

10.7 Construction of a plan for corrective and preventative actions.

10.8 The most common findings in Health Authority GCP inspections;

10.9 Review the regulations and guidance that governs clinical research compliance

10.10 Discuss GCP Auditing as a profession and how it differs from monitoring

10.11 Determine who gets audited and key factors and metrics for assessing when or why to audit

10.12 Explore how the FDA,EMEA,MHRA and local RB trains its inspectors to audit Clinical Investigators (Sites), Sponsors, and В Institutional Review Boards (IRBs)

10.13 Apply a quality-systems framework for assessing data and systems

10.14 Implement data trend analysis to identify regulatory risks

10.15 Develop practical auditing skills using real-life audit examples

10.16 Participate in role-play to enhance communication proficiency (Intake and Output)

10.17 Communicate comprehensive findings with writing exercises and group discussions

 

11 Examples

 

11.1 Practical examples of good (and poor!) practice in relation to conducting clinical trials

 

12. Pharmacovigilance for Clinical Trials

医学会议

gcp certificate

A training package has been developed on the basis of the documents developed by ICH指导委员会成员. 我们要感谢以:

 

博士. 彼得Arlett
部门负责人药物警戒和风险管理
欧洲药品管理局英国伦敦

 

博士. 托马斯Salmonson
医药产品署
临床前和临床研究单位乌普萨拉, 瑞典

 

博士. 恭莉莎Julou
欧洲制药的
工业协会 – EFPIA布鲁塞尔, 比利时

博士. AndrР№ W. Broekmans
先灵葆雅研究所荷兰

 

先生. 忍UZU
卫生部, 劳工 & 福利东京, 日本

 

博士. 丰岛聪
药品和医疗
器械局 (PMDA) 东京, 日本

 

先生. 市川和隆
日本制药工业
协会 – 东京JPMA, 日本先生. 和田耕平
亚洲临床开发部
第一三共公司, 公司. 东京, 日本

 

博士. Justina的一. Molzon
药品审评中心和研究 (CDER)
食品和药物管理局罗克维尔, MD, 美国

 

博士. 罗伯特. 的Yetter
中心生物制品评价和研究 (CBER)
食品和药物管理局罗克维尔, MD, 美国

 

博士. 爱丽丝
科学政策和技术事务
美国药品研究与制造商 – PhRMA的
华盛顿特区, 美国

 

博士. 彼得ķ. 蜂蜜
全球监管事务和产品安全
默克研究实验室北威尔士, PA, 美国

 

艾丽西亚d. 格里尼奇
医药国际联盟
制造商协会 – IFPMA日内瓦, 瑞士

 

博士. 奥德特莫兰
监管和科学事务总监
医药国际联盟
制造商协会 – IFPMA日内瓦, 瑞士

 

先生. 迈克·沃德
国际政策课
政策和协调局
治疗产品
保健品和食品局加拿大卫生部

博士. Lembit拉戈
质量保证和安全 : 药物
HTP / EDM / QSM
世界卫生组织日内瓦, 瑞士

博士. 佩特拉·杜尔
瑞士医药管理局, 瑞士机构治疗产品
伯尔尼, 瑞士

1) GCP course for Investigators and CRAs

 

东欧国家的培训师:

 

博士. Werner Gielsdorf, 高速钢- 德国

欧盟委员会独联体TACIS项目总经理, 贸发会议经理, 在那里面, 国贸中心 ,

一世, 世界银行, 贸发会议/世贸组织,

GCP培训师, GLP, 国内生产总值,GMP

 

扎多林·尤金博士, 博士, 工商管理硕士
国际生物制药协会,
, GersonВ Lehrman healthcare Council, First Clinical Research LLC Speakers
局,head of the Department of Clinical Research of NBScience, Zintro Inc. (美国 )

 

资质认证

已要求国际认可:
HSC德国 ,NBScience

 

GCP认证

GCP certification is the formal recognition of clinical research professionals who have met professional eligibility requirements and demonstrated job-related knowledge and skills. 授予NBScience的证书是为了认可记录和验证的工作经验以及多项选择考试的成功表现.

医学会议

程序:

 

Main principles of Good Clinical Practice (GCP).

Regulatory acts of the European Union and International Conference of Harmonization (我).

Responsibilities and the rights of the parties participating in clinical trials.

Interaction of Sponsor and Investigator.

Responsibilities of Investigator, Sponsor according to principles of Good Clinical Practice (GCP)

 

Ethical aspects of clinical trials of medical products.

Informed consent .

File of Investigator; keeping of documentation.

 

Legal and regulatory base of clinical trials of medical products in Europe.

FDA and EMEA.

The basic requests to the documentation for clinical trials of medical products.
Regulatory inspections of FDA and SPhC.

Types of inspections.

Responsibilities of Sponsor, Investigator and Inspector at the time of audits.

Specific clinical trials and GCP regulations in your country

 

Testing. GCP认证.

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2) 对GCP审计和检查在线培训课程

 

(for detailed information click here)

概观 :

This GCP auditing course is designed to provide practical training resulting in a harmonised, 在欧洲常见的审计方法. 该 我GCP guideline implemented in the EU, 日本和美国被广泛纳入全球准则. 系统审计, previously seen as advanced auditing, 已成为许多审计组的基本任务,目前在欧洲视察的基本要素.

课程材料定期与客观的经验分享和共同的专业方法更新,以铺平道路,相互认可和接受的方式, 降低成本和刺激效率, 允许更快的医药产品的开发,以患者和医疗保健的好处.

 

对GCP审计和检查在线培训课程

 

gcp certificate

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