Current position and relevant professional experience:
I work for Acino International as a Global Head of Regulatory Affairs, Medical and Pharmacovigilance leading 200+ RA, PV, MA, and clinical trials professionals.
I have 35+ years combined experience of healthcare and pharmaceutical industry in different positions. After spending 12 years in the hospital environment as a medical doctor, I moved to R&D and later Regulatory Affairs where I have built and lead different Regulatory Affairs,
Pharmacovigilance and Medical Affairs teams and organization supporting R&D activities, new submissions, lifecycle activities for finished products and active substances.
I hold 1st and 2nd degrees in Internal Medicine from Olomouc University, MSc. in Regulatory Affairs from Cardiff University in the UK, and Ph.D. in Pharmacy from Charles University in Prague.
From the roles I’ve held within the healthcare system and pharmaceutical industry, I have a thorough understanding of both the needs of the pharmaceutical industry and the working practices of the Competent Authorities in the EU, CEE, FDA, TGA, Middle East, Africa, LATAM and other regulatory authorities in high growth markets. I am passionate Regulatory Affairs professional and transformation leader, coach, and mentor with a scientific and business mind-set.
Being a truly international and independent professional organization, TOPRA is in the ideal position to facilitate understanding of the EU, USA, Japan, and other regulatory system globally. I believe my extensive regulatory knowledge and close working with the industry and regulators will enable me to make a significant contribution to TOPRA in the role of Director.
Current or previous involvement in TOPRA activities:
- I completed TOPRA MSc studies in 2007.
- Since when, I have been continuously a Module leader and Co-leader for 4 TOPRA MSc postgraduate modules.
- I have supervised several students with their MSc dissertations on RA, GCP and PV topics.
- In 2016, I won the TOPRA Award in Regulatory Excellence in “Contribution” category.
- I have also been awarded the TOPRA Distinguished Service Award.
- I served on the TOPRA Board as a Director for the EU from 2019-2022 and championed organisation of the TOPRA symposium in Prague in 2021.
Personal statement:
I am very passionate about development of RA professionals and the RA profession. I believe that sharing our knowledge, expertise, best practices and investing in our successors has significant impact on bringing needed medication to our patients.
I have been involved in TOPRA activities for more than 20 years, being a student, lecturer and TOPRA Board Director. I have a very good overview and understanding of TOPRA activities, strategy, roles, responsibilities, and needed competencies for the role of TOPRA Director. I particularly understand the needs of TOPRA members and professionals working in Healthcare RA.
Nomination information
Proposer: Steve Hayes; Seconders: Michael Banks, Sarah Roberts