Email:
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Phone:
Give us a call
+49 6201 18 26 27
Fax:
Or send us a fax
+49 6201 96 22 46
Address:
Pietrek Associates GmbH
Prankelstr. 88
69469 Weinheim, Germany
Managing Directors
Monika Pietrek, MD, PhD, MSc
Over 28 years experience in clinical research and safety/ risk management in both pharmaceutical and CRO industries as well as in a regulatory agency. Broad range of therapeutic expertise, e.g. cardio-vascular disorders, CNS, gastroenterology, immunology, metabolic disorders, and oncology. Special interests include: clinical development strategies, quantitative benefit-risk evaluations, life-cycle risk management, pharmaco-epidemiology and organizational excellence.
Christina Vogt, M.A.
20 years of experience in both pharmaceutical and CRO industries, with demonstrated leadership in pre- and post-marketing pharmacovigilance and drug safety. Areas of interest include: creating processes and written procedures, quality and project management in safety operations, vendor selection and compliance monitoring as well as generation of periodic safety reports, safety data exchange agreements, and data reconciliation for MAA submission purposes.