Date to be announced
Contact us for more infoTRAINING TIMES
the updates and intent behind ICH E6 R3 and its application to analytical labs.
how data integrity and documentation responsibilities are shared and auditable.
what qualifies as personal data under GDPR and how to handle it securely.
to act in alignment with GCP expectations during audits and sponsor interactions.
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.
Designed for professionals who want to enhance their expertise and advance their careers
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!
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(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.
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