DIA Conference Talk USA, The EU Directive - Germany

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 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]

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]

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

DIA Conference Talk USA, The EU Directive - Germany

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DIA Conference Talk USA, The EU Directive - Germany