Current position and relevant professional experience:
I have a strong scientific background in medicine, pharmacology and clinical and social pharmacy, with 26 years' experience of working full (and then part-time) in medicine, and more than 22 years of working in the pharma industry. I am very experienced in building and leading regional and global RA teams; developing both Rx and OTC products; in clinical trials; registration; life cycle management; and in GCP. I have undertaken various roles in R&D, clinical trials, site and market Regulatory Affairs at both EU and global levels. I am managing currently an RA organisation of approximately 150 people operating in Europe as well as in CEE regions, and I will be taking shortly the role of Global Head of Regulatory, Pharmacovigilance and Medical for the company operating in the Europe and in emerging markets (Middle East, Africa, LATAM and CIS). As a result of the roles I’ve held within the Industry, I have a thorough understanding of both the needs of the Pharmaceutical Industry and the working practices of not only the Competent Authorities in the EU Member States, but also of regulatory agencies in CIS countries, Asia, TGA or LATAM.
Current or previous involvement in TOPRA activities:
I have been a Module leader and Co-leader for TOPRA MSc postgraduate studies since 2007, in addition I have been lecturing for the Pharmaceutical Faculty at Brno University (Czech Republic) since 2009 and for the Medical Faculty at Olomouc University (Czech Republic). I have lecturing experience in a variety of external settings on regulatory, GCP, and GMP in both the EU and overseas. I am author of several scientific publications, including one book on GCP.
In 2016 I won the TOPRA Award in Regulatory Excellence in the “Contribution” category. I addition, I have been awarded the TOPRA Distinguished Service Award, and been granted the honorary title of Visiting Industrial Fellow at University of Hertfordshire, UK.
I have joined TOPRA board as the Director for Europe in 2019 and have worked on “Engagement and connectivity” activities defined in TOPRA Strategic plan 2020-2025. The goal of this stream was to enhance education programme to TOPRA’s emerging and CEE markets. We performed deep analysis of current TOPRA membership and the needs of our members and increased significantly educational and training activities which were accepted very positively especially under Covid-19 situation. We were able to connect not only TOPRA members but as well non-members via a wide series of online training, webinars and workshops raising the profile of regulatory affairs and the value of our profession when we were really needed to bring emergent anti-Covid products on the markets with high speed and agility. In addition, the new CEE Spin group was created and further activities to reach regulatory affairs professionals in CEE and emerging are being planned.
Personal statement:
Being a truly international and independent professional organization, TOPRA is in the ideal position to facilitate understanding of the EU regulatory system globally and to promote it in the emerging markets. TOPRA should continue to expand its role in both education and in emphasizing the importance of the Regulatory Affairs profession internationally and I believe that with my regulatory knowledge and experience I can continue to make a significant contribution to TOPRA in the role of EU Representative on the Board.
Nomination information
Proposer: Steve Hayes; Seconders: Angela Stokes, Anne Nallen