Prague, Czech Republic. I come to Moscow 2-3 times a year
ELC-Group, Director of Regulatory Affairs and Strategy
I have assisted in the developments in novel vaccines. From an agency perspective, I was part of the Working Groups during the creation of the current regulations in EU.
My core expertise is from European Regulatory Affairs as my training came from two Health agencies. I am competent in building a development strategy accounting for all RA steps and knowkedge required as well as pooling expertise in order to expedite developments.
I would like to be a mentor in order to assist in novel developments. My experience has been that, especially in biotech circles, the developments are primarily focussed on the science and not the regulation they will have to face. I would like to share my knowledge and perhaps even network in order to give back to the startup community where innovation is coming from. I am willing to give my advise and support to companies/groups that are in a certain phase of development and help them navigate the regulatory minefield
I have no specific preference yet of kind of startups, however for use of my knowledge, it would be preferable if the startups is beyond the Discovery only phase and perhaps has some invivo data (animal, cell lines etc)