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Milena Hoffmanová

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Milena Hoffmanová heads the Prague office Pharmaceuticals & Healthcare group. Her practice covers pharmaceuticals and healthcare matters, compliance, general commercial law, administrative law, as well as data protection and privacy law matters. She studied law at the University of Limerick in Ireland prior to graduating from the Law Faculty of Charles University in Prague in 2008. Ms. Hoffmanová’s practice focuses mainly on ensuring compliance with legal regulations as well as ethical standards relating to medicinal products and medical devices, including assisting with drafting of internal company guidelines and policies and labeling/packaging requirements. She also advises on anti-corruption compliance matters, including the extraterritorial application of US law, such as application of the Foreign Corrupt Practices Act and foreign bribery laws. She has experience in a broad range of compliance matters, including corporate and regulatory investigations, FCPA and global anti-corruption compliance, compliance program development and anti-corruption due diligence, including data privacy issues such as cross-border data flows, data security, whistle-blower hotlines, e-monitoring and other privacy-related issues. Admission Czech Republic (2008)

In brief In relation to the adaptation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (MDR) the Czech government has…

In response to the growing impact of the COVID-19 Coronavirus in Europe, a number of countries have implemented national controls to restrict the export of medicines and medical equipment, such as face masks, gloves, and protective clothing. Over the weekend, the EU Commission reviewed actions taken by Member States and,…