GCP Basics

• ICH-GCP R2 and outlook on R3
• EU Legislation for Clinical Trials including EU Clinical Trials Regulation (536/2014)
• A Look into FDA Requirements

09.02.2023 

9:30 am - 5:00 pm

EU Clinical Trial Regulation 536/2014(CTR)

Clinical Trial Information System (CTIS)

4. AMG Änderungsgesetz

28.02.2023 

9:30 am - 5:00 pm

GCP Refresher 

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

15.03.2023 

9:30 am - 5:00 pm

Non-interventional Studies (NIS)

By arrangement

Investigator Initiated Trials (IITs)

By arrangement

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

By arrangement

Fundamental Course: Planning, Conduct and Evaluation of Clinical Trials

By arrangement

Project Management in Clinical Trials / Working with CROs

By arrangement

Biometrics Made Easy - Including an Introduction to CDISC

By arrangement

Oncology for Non-Medics

By arrangement

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

By arrangement