9 oktober 2025 10:00 - 15:00
– Understand and Implement Key Updates in ICH GCP E6 (R3) from a Sponsor Perspective
The third revision of the guideline brings important changes to how clinical trials are conducted. It offers greater flexibility, allowing processes that are proportional and fit for the purpose of the specific trial and encouraging use of new technology. At the same time, it strengthens requirements for data governance, trial design, quality management, sponsor oversight and documentation. The flexibility in the updated guideline presents an opportunity to optimize resource allocation but it also brings new challenges in defining processes that are adaptive and that include risk-based decision-making. To implement the necessary updates within your organisation, it is essential to thoroughly understand both the changes introduced in Revision 3 and the rationale behind them.
This training focuses on key sections in revision 3:
• Section 3 Sponsor
• Section 4 Data Governance
• Appendix C Essential Records
Relevant changes in other sections will also be highlighted from the sponsor’s perspective to ensure comprehensive understanding of the updates. This training can serve as a starting point for discussions aiming to evaluate the need for changes in existing clinical trial processes.
The interactive training format combines presentations, exercises, and facilitated discussion groups to support active learning, peer exchange, and practical application.
We are offering this training on two different dates so you can choose the one that best fits your schedule. The session on October 9 is fully booked, but there are still seats available for October 20.
Training details:
📅 Date: 2025-10-09 – FULLY BOOKED
📅 Date: 2025-10-20 – FULLY BOOKED
🕒 Time: 10.00–15.00 CET (including lunch break 12–13, i.e. a total of 4 hours)
📍 Location: Online via Teams (link provided upon registration)
Agenda:
Statement of completion
All participants will receive a statement of completion after the training, confirming your participation and knowledge of the key updates introduced in ICH-GCP E6(R3). This statement can be used for internal documentation and professional development records.
Who Should Attend? This training is tailored for experienced clinical research professionals in small to mid-sized sponsor organizations. Through a mix of presentations and interactive exercises, participants will gain practical insights and hands-on learning.
Price model
2,000 SEK per person exc. VAT
If there are 5 or more people joining from the same organization, we provide a special price.
Please contact beatrice.ostrom@pharmarelations.se directly by sending an email.
Hurry up! Limited number of seats.
You will receive a booking confirmation shortly
Vi kontaktar er så snart vi kan.
Helena has more than 20 years of experience in clinical trials. She has held various roles in the pharmaceutical industry, primarily in quality and training at both country level and global level. She also has experience in operational roles, including Project Manager and CRA. In her current role, Helena advises small pharmaceutical and biotech companies on process management and GCP.
Anna-Karin has broad experience of medical research and clinical trials in both academic and pharmaceutical industry settings. She has 10 years of experience in clinical trials, with solid knowledge of the field in both Europe and the US.
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