BioM Course: ICH E6(R3) and GCP Refresher 2026
ICH E6(R3), German Medical Research Act and EU Regulatory Updates
Participants will receive a certificate of attendance as proof of qualification, e.g., for audits/ inspections or for presentation to ethics committees.
Date: Thursday, 8 October 2026
Time: 09.00 am – 05.00 pm
Venue: BioM Biotech Cluster Development GmbH, Am Klopferspitz 19a, IZB West II, 82152 Martinsried
Room: BioM Conference Room „Munich“ at 3rd floor
Clinical research is facing significant regulatory changes. With the implementation of ICH E6(R3), sponsors, investigators and study teams are challenged to adapt their quality systems, processes and oversight activities to new expectations regarding quality, risk management and data governance.
This one-day update course provides an overview of the most important changes introduced by ICH E6(R3) Principles and Annex I as well as their practical implications for clinical research organisations, sponsors and investigator sites. Participants will refresh their knowledge of Good Clinical Practice (GCP) and gain insight into current regulatory developments in Germany and Europe.
In addition, the course will address the impact of the German Medical Research Act (Medizinforschungsgesetz, MFG) on the German Medicinal Product Act (AMG) and the Radiation Protection Act (Strahlenschutzgesetz). Participants will also receive an overview of the proposed EU Biotech Act and its potential implications for the EU Clinical Trials Regulation (EU CTR 536/2014).
According to the requirements of ethics committees (EC), individuals involved in clinical trials with medicinal products (or medical devices) should demonstrate regular participation in a certified GCP course including an update on the legal situation. This course mainly covers GCP, however also provides a comprehensive overview of legislative changes, both in Germany and the EU, which either already happened or are planned to be implemented in the not-too-distant future.
Learning Objectives
After the course, participants will be up to date with ICH GCP, and current developments in Germany and the EU. This course is suitable for both GCP beginners and GCP professionals who would like (or need) to refresh their knowledge.
After completing this course, participants will be able to:
- Understand the structure, scope and key changes of ICH E6(R3)
- Comprehend investigator and sponsor responsibilities under the revised guideline
- Understand current expectations regarding risk-based quality management and monitoring
- Apply key principles of data governance and essential records management
- Understand recent regulatory developments in Germany and the EU affecting clinical research
Target group
This course is designed for individuals involved in clinical trials with drugs from biotech companies, pharmaceutical companies and CROs, e.g. CRA/monitor/project leader, project management, data management, quality assurance and study teams. Members of the study team of investigator sites (e.g. study nurses, study coordinators), can also register.
Speaker
Dr. Dagmar Chase
After studying computer science (with a minor in theoretical medicine), Dagmar Chase initially worked in the computer industry. In 1983, she founded the contract research organization GMI with the biometrician Professor Albrecht Neiß and soon developed the company into a "full service CRO". The work on the company's quality management system as well as the development of many training programs for the drug development industry are - in addition to the management of GMI - among the focal points of Dagmar Chase's work. After receiving her doctorate from the Medical Faculty in Ulm in 1995 and the sale of GMI in 1997 to the American CRO Kendle (now Syneos Health), Dagmar Chase served for many years as Vice-President and Project Director for international development programs at Kendle. In 2004, she founded Clinrex, a clinical trial quality management consulting firm. In addition to training, her responsibilities include gap analysis of GCP SOP systems.
Ms. Chase co-founded the Bundesverband Medizinischer Auftragsinstitute (BVMA e.V.) in 1991 and served as the association's president from 2001 until the end of 2017. In 2005, the corresponding European association was launched under her participation (EU CRO Federation, EUCROF), which she has actively accompanied since its foundation.
In 2019, Dagmar Chase was appointed Senior Expert by the German Pharmaceutical Industry Association (BPI e.V.).
For more information about the course program, please see our agenda.
Registration & Course Details
Participation Fee: 590.00 Euros (+ VAT) includes course materials, catering and a certificate of participation
Secure your spot by registering online using the registration form below.
Select the “Participation Fee” and confirm with a click.
The registration deadline is Wednesday, 23 September 2026!
Please also note our cancellation policies as set forth in our GTC.
If you have any questions, please contact us at events@bio-m.org.