GCP & Data Integrity for Analytical Laboratories – ICH E6 R3 in Practice

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

WHY SHOULD YOU ATTEND?

Grasp

the updates and intent behind ICH E6 R3 and its application to analytical labs.

Recognize

how data integrity and documentation responsibilities are shared and auditable.

Understand

what qualifies as personal data under GDPR and how to handle it securely.

Be prepared

to act in alignment with GCP expectations during audits and sponsor interactions.

OUR ONLINE TRAINING EXPERIENCE INCLUDE

Three days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.

All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.

Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.

WHO IS THIS TRAINING FOR?

Designed for professionals who want to enhance their expertise and advance their careers

Project Managers

Regulatory Affairs Specialists

Clinical Data Managers

Data Integrity Managers

KEY TOPICS

What does GCP mean in your daily work?

Analytical CRO Responsibilities under GCP R3

Interactive Q&A and Case Reflections

TRAINERS

Simone Ahrens-Mende

Biometrics Specialist, Ahrens-Mende Associates

Simone Ahrens-Mende holds a Diploma in Mathematics and a Master’s degree in Clinical Trial Management. She is a highly experienced leader in clinical research, with over 25 years of expertise in Data Management, Statistical Programming, and Biostatistics. Throughout her career, she has held senior positions in international CROs, where she has successfully led cross-functional teams, optimized clinical processes, and ensured compliance with global regulatory standards. Simone is known for her strategic leadership, process innovation, and dedication to quality, having contributed to the success of numerous clinical trials across various therapeutic areas. She brings a unique combination of technical expertise and a strong commitment to mentoring and developing professionals in biometrics and clinical research. We are live on webchat!

Learn More →

Dr. Karl-Heinz Huemer

(Formerly a Clinical Assessor at the Austrian Agency for Health and Food Safety and the European Medicines Agency)

Dr. Huemer received his MD in medicine at the Medical University of Vienna and his PhD in Biology at the University of Vienna and subsequently specialized in Medical Physiology, followed by a long medical career in research, teaching, medical practice. Between 2007 – 2023 he worked at the Austrian Medicines & Medical Devices Agency (scientific office) and was a member of the Paediatric Committee (PDCO) and the Scientific Advice Working Party (SAWP) at the European Medicines Agency (EMA) for 15 years. Currently Dr Huemer is now regulatory and scientific consultant.