About RPRC
ABOUT RPRC - RUXANDRA POPESCU REGULATORY CONSULTING
A passionate pharmacist and regulatory expert at your service
Once upon a time in 2017, I met the Clinical Trials Information System (CTIS) in its "cradle" at the European Medicines Agency (EMA). During my tenure there, in the former Committees and Inspections Department, I had the unique opportunity to contribute to its development by testing it and making suggestions for improvement. The EU Clinical Trials Regulation (EU CTR) and CTIS continued being my close friends in the consulting environment, where I have been acting as EU CTR ambassador and, later on, certified EMA CTIS Sponsor Master Trainer since 2021.
I led and advised on the EU CTR implementation at sponsor and consultancy organisations, delivering fit-for-purpose, well-received training sessions and hand-holding for successful clinical trial submissions in CTIS.
My experience in Quality Assurance precedes my EU CTR and CTIS friendship, and they all go hand in hand when creating and updating Quality Documents to ensure compliance with the EU CTR, as well as other regulatory frameworks and applicable GXP guidelines.
Today I am happily pioneering the Regulatory Affairs and Quality Assurance functions at a dynamic Swiss start-up, developing treatments for cancer with life-changing potential for patients. As the passionate pharmacist that I am, I feel I can do even more for patients. This is why I decided to allocate some of my time to consulting.
I created RPRC with the aim to introduce more medicinal product developers to the EU CTR, adjacent regulations and the CTIS environment. My objective is to help them develop a tailored success strategy for planning, conducting and reporting clinical trials under this European regulatory framework and beyond.
If you want to improve your relationship with the EU CTR and CTIS and speed up your clinical development programmes in a compliant manner, let's discuss how I can help you out.
Email, call or use the contact form to discuss how you can have your regulatory needs addressed.
RPRC - Ruxandra Popescu Regulatory Consulting
Zürich, Switzerland
+41 764 816 186
ruxandra.popescu@regulatoryconsulting.ch
www.regulatoryconsulting.ch
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