Alexander Roussanov, Partner
Alexander Roussanov, a former senior legal adviser in the Legal Department of the EMA, focuses his practice on a broad range of issues related to the life-cycle of medicinal products and medical devices. His experience includes product classification, authorization and conduct of clinical trials for medicinal products and clinical investigations for medical devices, marketing authorization for medicinal products and CE marking of medical devices, pharmacovigilance and device vigilance, marketing and promotional activities, and interactions with health care professionals.
Alexander has extensive practical experience assisting clients in ensuring compliance with the GDPR. He advises clients concerning many aspects of the GDPR that are of particular importance in the Life Sciences sector.
Pharmaceutical companies must make sure that they anticipate as much as possible the consequences of the COVID-19 outbreak, including increased demand for their medicinal products, potential shortages and import or supply issues.
The COVID-19 may also impact and delay the conduct of clinical trials, regulatory submissions and overall regulatory strategy. This could include delays in the conduct of paediatric clinical trials, generation and regulatory review of the related clinical data and delays in the submissions of applications for paediatric extension of SPCs.
It is yet unclear if the COVID-19 would lead to changes in the regulatory regime in the EU. The current EU legal framework and the exemptions and flexibilities offered by the competent authorities seem to be overall effective in the present situation.
