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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 Cybersecurity, Data and Tech

Czech Republic: Changes to the Electronic Communications Act new rules relating to cookies and telemarketing effective as of 1 January 2022

by and 6 Mins Read

With effect from 1 January 2022, the provisions of the recent amendment of Act No. 127/2005 Coll., on Electronic Communications and on Amendment to Certain Related Acts relating to the storing and accessing of cookies and other information on users’ devices and telemarketing, have become effective.

In Czech Republic

Czech Republic: Plans to regulate medical device advertising over and above the MDR’s requirements

by 4 Mins Read

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 Czech Republic

New EU and National Export Controls on Face Masks and Medical Protective Equipment

by , , , , , , , and 8 Mins Read

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,…