About Us
Principals
Dr. Monika Pietrek, MD, PhD, MSc
Managing Director
Over 20 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, life-cycle risk management, and pharmaco-epidemiology.
Rosalind Coulson, MSc, FRPharmS
Senior Consultant
25 years of experience in the UK regulatory agency. Assessment of CT and PLA for new drugs. Group Manager Post Licensing Division and specialist in Pharmacovigilance Information Management. Setting standards: ICH M1 (MedDRA), ICH E2B (Data elements of ICSRs), ICH M2 (Electronic transmission of data).
Christina Vogt, M.A.
Managing Director
15 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, and generation of periodic safety reports.
Melanie Weber, MSc
Drug Safety Manager
Over 10 years of experience in the CRO industry, expert in drug safety processes and regulatory requirements. Special interests include process analysis and enhancement, pharmacovigilance system audits and mock inspections as well as in-depth knowledge of international PV regulations and guidelines.
The Extended Team includes Medical Directors, Regulatory Affairs Experts, Epidemiologists and Statisticians.
Current Affiliations
- DIA’s Special Interest Area Communities (SIACs):
- Clinical Safety and Pharmacovigilance and
- Professional Education, Training and Career Development
- Editorial Board of DIA Journal
- European Forum for Good Clinical Practice (EFGCP)
- Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V.
- International Society for Pharmacoepidemiology
- European Pharmacovigilance Working Group
- Deutsche Gesellschaft für Gute Forschungspraxis e.V. (DGGF)
Please also have a look at our recent publications and presentations.
