Strategic Research Partner of the American Bar Association's Section of International LawThe Queen's Award for Enterpise 2012

Maurits JF Lugard

Maurits JF Lugard
Office:
Sidley Austin LLP
NEO Building
Rue Montoyer 51 Montoyerstraat
1000
City:
Brussels
Country:
Belgium
Tel:
+32 2 504 6417
Fax:
+32 2 504 6401

Biography • Life Sciences - Regulatory

Maurits Lugard leads the EU life sciences regulatory team, part of Sidley's leading global life sciences group. Maurits has an uncommon wealth of experience in EU law, drawing on his tenure within the European Commission and on years of private practise in the regulatory capitals of Brussels and Washington, DC.

Maurits's practice focuses on helping clients navigate the complex web of EU and member state rules and procedures with an emphasis on food, drugs, medical devices, cosmetics and biotechnology. He helps corporate clients and trade associations shape future legislation and advises on the complex legal issues of the current regulations in areas such as pharmacovigilance (drug safety), clinical trials, marketing authorisations, advertising and promotional issues, labeling and the application of the precautionary principle.

Maurits also advises clients on a broad range of market access and product safety issues such as GMP compliance, life-cycle management, product recall procedures, adverse events, health claims, in-vitro diagnostics, implantable medical devices, food additives, parallel trade and supply chain management. He also advises on pharmaceutical contractual issues, including distribution, supply, manufacturing, R&D and other cooperation agreements in Europe. He has represented clients in matters before the European Commission, the European Medicines Agency, the European Food Safety Authority and member state authorities.

In addition to EU life sciences regulatory issues, Maurits also advises on EU regulatory issues involving chemicals and the environment. He helps clients conduct risk assessments and advises on anti-corruption compliance and government enforcement, including FCPA investigations.

Maurits graduated from the University of Michigan, the University of Leiden (The Netherlands), and the Johns Hopkins Paul H Nitze School of Advanced International Studies (SAIS).

This biography is an extract from The International Who's Who of Life Sciences Lawyers which can be purchased from our Shop.

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