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DIA Conference Talk USA, The EU Directive - Germany

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Diana Taylor
Diana Taylor

Managing, Inspecting & Conducting Clinical Trials After the EU Directive. Germany as a Case Study . For DIA colleagues, Feb 22, 2005

Gesundheit & MedizinBusiness
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Managing, Inspecting, and Conducting Clinical Trials after the EU Directive Dr. Diana A. Taylor, MSc Establishing Competitive Advantage in Today’s Pharmaceutical and Biothech Industries: The Integration of Project Management, Financing, and Outsourcing Porcesses The Drug Information Association Philadelphia, USA, February 22 nd 2005
Contents ,[object Object],[object Object],[object Object]
The German Drug Law ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The German Drug Law, AMG ,[object Object],[object Object],[object Object],[object Object]
The Investigator & the Sponsor ,[object Object],[object Object]
The Investigator defined ,[object Object],[object Object]
The Investigator defined ,[object Object],[object Object]
The Investigator as Manager ,[object Object],[object Object],[object Object],[object Object]
Investigator or Doctor? ,[object Object],[object Object],[object Object],[object Object]
Investigator - Sponsor transfer of duties ,[object Object],[object Object],[object Object],[object Object]
Drug Safety in Clinical trials ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Clear ways - uncertain means ,[object Object],[object Object],[object Object],[object Object]
National nuances - international compliance? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Sponsors, Representatives & Logistics ,[object Object],[object Object],[object Object],[object Object]
The changed role of the Ethics Committee ,[object Object],[object Object],[object Object]
Functions of the Ethics Committee ,[object Object],[object Object],[object Object],[object Object],[object Object]
National nuances with the Ethics Committees in D ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Documents for the Ethics Committee ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Patient Information: real time with the doctor ,[object Object],[object Object],[object Object],[object Object],[object Object]
On the presumed will of the minor ,[object Object],[object Object],[object Object]
Group benefit ,[object Object],[object Object],[object Object],[object Object],[object Object]
Protecting the child patient: New demands - New institutions ,[object Object],[object Object]
Procedures & Timelines with the Ethics Committee ,[object Object],[object Object],[object Object],[object Object],[object Object]
Procedures & Timelines with the Ethics Committee ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Procedures & Timelines with the Ethics Committee ,[object Object],[object Object],[object Object],[object Object]
Procedures & Timelines with the Competent Authorities ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
National nuances with the Competent Authority in Germany ,[object Object],[object Object],[object Object],[object Object],[object Object]
Duties of the Competent Authority - the Inspections ,[object Object],[object Object],[object Object],[object Object],[object Object]
Inspections after AMG ,[object Object],[object Object],[object Object],[object Object],[object Object]
Contents ,[object Object],[object Object],[object Object]
Project Management ... Company Processes ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Implementing German Drug Law into company processes ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The EudraCT number ,[object Object],[object Object],[object Object],[object Object],[object Object]
The Application forms ,[object Object],[object Object],[object Object],[object Object],[object Object]
Approval Amendment End ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Inspections in Germany ,[object Object],[object Object],[object Object],[object Object]
Training & Education ,[object Object],[object Object],[object Object],[object Object]
Contents ,[object Object],[object Object],[object Object]
A case study experience ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Request for further information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Documents with the application form ,[object Object],[object Object],[object Object],[object Object]
Tipps and advice ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Thank you Dr. Diana A. Taylor, MSc

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DIA Conference Talk USA, The EU Directive - Germany

  • 1. Managing, Inspecting, and Conducting Clinical Trials after the EU Directive Dr. Diana A. Taylor, MSc Establishing Competitive Advantage in Today’s Pharmaceutical and Biothech Industries: The Integration of Project Management, Financing, and Outsourcing Porcesses The Drug Information Association Philadelphia, USA, February 22 nd 2005
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  • 43. Thank you Dr. Diana A. Taylor, MSc