GCP Basics

• ICH Guideline E6 (R3) (ICH-GCP)
• EU Clinical Trials Regulation (536/2014)
• A Look into FDA Requirements

23 January 2025

9:30 am - 5:00 pm

GCP Refresher:

• ICH Guideline E6 (R3) (ICH-GCP)
• CTR / CTIS
• 4. AMG Änderungsgesetz und Medizinforschungsgesetz (MFG)
• Current Questions on GCP

18 February 2025

9:30 am - 5:00 pm

Non-interventional Studies (NIS)

11 March 2025

9:30 am - 5:00 pm

Project Management in Clinical Trials

Working with CROs

Sponsor Oversight

20 March 2025

9:30 am - 5:00 pm

EU Clinical Trial Regulation 536/2014(CTR)

Clinical Trial Information System (CTIS)

4. AMG Änderungsgesetz

27 March 2025

9:30 am - 5:00 pm

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

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