Kateřina Šejdová
Biography
Practice Focus
Kateřina's practice focuses on ensuring compliance with legal regulations and ethical standards relating to pharmaceuticals and medical devices. In particular, Kateřina advises clients on matters related to clinical trials, manufacturing, distribution, labelling and advertising of pharmaceuticals and medical devices, as well as interactions with relevant stakeholders in the area of healthcare, such as distributors, healthcare institutions and healthcare professionals. She routinely provides support in the selection and implementation of the appropriate distribution/agency schemes, and assists with various supply chain issues. She has experience in advising on various market access issues, including in relation to product pricing and reimbursement, and regularly represents clients in negotiations of maximum price, cost limitation and risk-sharing agreements with health insurance companies.
In addition, Kateřina has regulatory experience in the area of M&A and other corporate transactions in the pharmaceutical and healthcare sector, advising on regulatory steps pertaining to business reorganization, including in relation to regulatory key personnel, marketing authorization transfers and products registrations, as well as distribution, manufacturing and other establishment licenses.
Kateřina also regularly participates in compliance investigations and privacy audits, and provides counsel on privacy and data protection issues, including in relation to personal data processing, cross-border data transfers, whistleblowing systems and e-monitoring. Kateřina is experienced in commercial law and assists clients with general contractual matters.
Professional Associations and Memberships
- Czech Bar Association
Admissions
- Czech Republic (Attorney-at-Law) (2021)
Education
- Charles University, Prague (Master's Degree in Law) (2017)
- University of Economics, Prague (Master's Degree in International Politics and Diplomacy) (2014)
- Katholieke Universiteit Leuven (Faculty of Law, Erasmus program) (2013)
Languages
- Czech
- English