Harmonization of Clinical Trials in the EU since 2022

Since the Regulation on Clinical Trials (Regulation EU No. 536/2014) came into force in 2022, the way they are conducted has changed significantly. Submission, evaluation, and supervision procedures are to be unified with the Clinical Trials Information System (CTIS).

Logistics of Clinical Trials

Getting the labeling and logistics right for clinical trials has not been a challenge only since the new EU regulation and its legal acts: The workshops provide practical tips with concrete case examples. You can experience the practice firsthand during a visit to a storage and distribution center for clinical trial drugs.

Update for Investigational Medicinal Products (IMPs)

You will learn about these updates for IMPs:

– Requirements for labeling according to the CTR, Annex VI
– Requirements according to the Delegated Regulation C(2017) 8179 Detailed Guideline
– Regulations regarding customs for import and export
– Some requirements for IMPs are harmonized or transferred into other legal regulations