What do the changes to the guideline mean for your practice?
Webcode 26112480
Dr. Cornelia Hunke
Evangelisches Krankenhaus Göttingen-Weende, GERMANY
Head of the Quality and Risk Management Department Cornelia has many years of experience in industry, public service, and international research. She held a senior position at the Federal Institute for Risk Assessment (2015-2022) with responsibility for the accreditation of laboratories and NRLs. She has several years of consulting expertise as a certified auditor and lead QA in ISO, GxP compliance, and digitization in the laboratory environment. Since the end of 2025, she is a team lead for QM and risk management in hospital management at a clinic in Göttingen.
Dr. Timo Kretzschmar
TiKrESolution - Business and IT Consultancy, GxP Audits/Trainings/Consultation, Vienna, AUSTRIA
After completing his dissertation in technical chemistry, Dr Timo G. Kretzschmar worked at TÜV Austria; starting in 2003, he served as the head of quality at a pharmaceutical analytics CRO near Vienna. From 2016 to 2019, he served as an inspector for GLP and computerized GxP systems at the pharmaceutical regulatory agency AGES/BASG in Vienna, and subsequently worked for six years as a senior consultant for GxP systems and as a project manager. Since 2024, he has returned to his role as Head of Quality at the CRO. In parallel, he has been a lecturer at universities of applied sciences and traditional universities since 1995. Since 2023, he has been leading TiKrESolution (GxP Consulting) in Vienna.
11/11/2026
11/11/2026
from 9:00 am until 1:30 pm CET - online seminar
You may dial in 30 minutes before the lecture starts
online
online
Event - 690€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Event - 690€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
EU GMP Revision: Are you prepared for the guideline changes in Chapter 4 (Documentation), Annex 11 (Computerised Systems), and Annex 22 (AI)? Receive your update - presented in a simple and understandable format - on the (expected) changes, as well as tips for practical implementation from our two experienced experts.
During this half-day seminar, our two experts will provide you, with an overview with relevant details presented in an easy-to-understand format, of the current draft versions of the EU GMP guidelines on Chapter 4 (Documentation), Annex 11 (Computerised Systems), and the new Annex 22 (Artificial Intelligence). You will receive recommendations for action to prepare for the planned changes at an early stage and can already start setting a strategic course for your company. After attending the seminar, you will be able to assess the expected requirements and proactively plan initial adaptation measures.
By participating in the seminar, you will gain a decisive knowledge advantage in "interpreting" the revision of the EU GMP guidelines (draft version presented). You will also save valuable time and resources thanks to the early development of implementation strategies. The half-day format can be easily integrated into your daily work routine.
09:00 Welcome, introduction, expectations
09:15
Dr Cornelia Hunke
09:45
Dr Timo Kretzschmar
11:00 Biobreak
11:15
Dr Timo Kretzschmar
12:30
Dr Cornelia Hunke
13:15
Both Speakers
13:30 End of seminar
Are you looking for this topic for several employees?
We offer the right solution at your location or in a virtual format!
We also offer this seminar as an in-house seminar.
Take advantage of the proven concepts of our open seminars and bring your employees
up to the same level of knowledge quickly and easily.
We would be happy to send you a non-binding offer.
FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.
of 5 stars of all ratings from 2025
of 5 stars on Trustpilot = good
Variation regulation, new classification guideline, eSubmission and variation management: All processes explained in thi...
Erfahren Sie in diesem Online Seminar alles über die juristischen Feinheiten von Verträgen in der Klinischen Forschung: ...
Sie sind Nicht-Jurist*in und an der Erstellung von GDP-Verträgen beteiligt? Dann ist dieses Online-Seminar für Praktiker...
Holen Sie sich praxisnahes Know-how für die GMP-, GLP-, GCP-konforme Archivierung relevanter Dokumente sowie die effizie...
Dieses Online Seminar vermittelt praxisorientiertes Wissen im klinischen Data Management - vom Datenbankaufbau über die ...
