GCP Refresher 

• EU Clinical Trials Regulation including 4. Amendment to the German Medicinal Product Act
• ICH-GCP Addendum
• Current Questions on GCP/AMG

23.11.2021 

9:30 am - 5:00 pm

EU Clinical Trial Regulation 536/2014(CTR)

Clinical Trial Information System (CTIS)

4. AMG Änderungsgesetz

By arrangement

GCP Basics

• ICH-GCP including Addendum
• EU Legislation for Clinical Trials including EU Clinical Trials Regulation (536/2014)
• A Look into FDA Requirements

By arrangement

Investigator Initiated Trials (IITs)

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Clinical Trial Assistance at Sponsors/CROs:
What you should know about GCP

By arrangement

Non-interventional Studies (NIS)

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Fundamental Course: Planning, Conduct and Evaluation of Clinical Trials

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Project Management in Clinical Trials / Working with CROs

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Biometrics Made Easy - Including an Introduction to CDISC

By arrangement

Oncology for Non-Medics

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Grundlagenkurs für Prüfer und Mitglieder der Prüfgruppe zur klinischen Prüfung von Arzneimitteln

By arrangement