About the Study Start-Up & CTIS Expert
Greetings!
I'm Mat Parowicz, a highly accomplished professional in the field of Regulatory Affairs and Study Start-Up, boasting over two decades of hands-on experience within the pharmaceutical and clinical research industry.
My journey began during my university studies when I ventured into a job in this fascinating field, and I quickly fell in love with the intricacies of regulatory affairs and clinical research.
Professional Experience as a Consultant in Regulatory Affairs & Clinical Study Start-Up and as a Senior Regulatory Affairs Lead & Manager of Global Regulatory Affairs
In my role as a Consultant in Regulatory Affairs and Clinical Study Start-Up, I've been actively engaged in consultancy and project activities for both Contract Research Organizations (CROs) and Pharmaceutical Companies. My focus revolves around the EU Clinical Trial Regulation (EU CTR 536/2014) and the implementation of the Clinical Trial Information System (CTIS).
As a Senior Regulatory Affairs Lead and Manager of Global Regulatory Affairs, I've not only provided expert regulatory advice but also played a crucial role in the development and execution of successful Clinical Trial Applications (CTA) for international clinical trials.
Expertise Highlights
Global Trial Management
Managing submissions from monocentric to global trials across diverse therapeutic areas, including oncology, CNS, and respiratory & infectious diseases.
Regulatory Documentation Support
Offering guidance on the development of regulatory documentation and ensuring compliance with ICH-GCP & country-specific requirements.
Regulatory Strategy Development
Crafting tailored submission and life-cycle strategies aligned with the EU Clinical Trial Regulation (EU CTR 536/2014) for successful trial initiation and planning.
Compliance Assurance
Ensuring compliance with EU536/2014 and CTIS requirements, providing country-specific adaptations for seamless submissions.
Continuous Learning
My commitment to staying at the forefront of industry advancements is reflected in my extensive participation in training programs, webinars, and conferences. Notably, I've completed the EMA/DIA Sponsor Master Training Programme, ensuring a mastery of the regulatory landscape. Additionally, I've actively engaged in advanced trainings, including topics such as CTIS, transitional trials, and the latest developments in the regulatory environment.
Languages and Memberships
Fluent in German, English, and Polish, I actively engage with industry professionals as a member of RAPS Germany, DIA, and TOPRA.
How I Can Help You
My journey in the industry, born out of a university job, has equipped me not only with a broad theoretical foundation but also with the hands-on expertise to navigate complex regulatory challenges. Whether you're seeking a country-specific Study Start-Up specialist, a Study Start-Up Manager supporting and supervising submissions globally, or a partner for CRO activities, I offer a comprehensive skill set to ensure successful clinical trials.
Ready to elevate your clinical trial journey?
Whether you're navigating the complexities of EU CTR, transitioning from Directive 2001/20/EC to Regulation 536/2014, or seeking guidance on CTIS, I am here to support you.
Book a consultation, short or long-term, via Calendly or reach out via my contact form, and let's embark on a journey of regulatory excellence together.