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Gabriela Klasa is a Polish associate at the Covington Brussels office. She was an intern at the firm in the Summer of 2007, and permanently joined Covington in October 2008 after completing her legal education in Belgium. She worked at the firm’s head office in Washington, DC during the Fall of 2011.
Ms. Klasa’s practice comprises regulatory counseling regarding pharmaceuticals, medical devices and other health products, as well as foods, feed and cosmetics under European Union law and the national laws of various EU Member States. She provides advice on matters such as marketing approval, labeling and advertising, borderline issues and product liability, and assists in litigation before EU and Belgian courts. Ms. Klasa also handles various environmental matters and advises pharmaceutical companies on intellectual property issues.
Representative Matters
- Comprehensive advice to major international drug manufacturers on issues related to marketing approval of medicines, through centralized and national authorization procedures.
- Detailed advice on market and data exclusivity, as well as supplementary protection certificates.
- Pan-European advice on several issues related to labeling and advertising of medicines, medical devices, foods and cosmetics.
- Advice to a leading association of biotechnology companies on complicated matters related to biologics and biosimilars.
- Regulatory advice regarding veterinary medicines, on issues such as relating to vaccines and maximum residue limits.
- Pan-European advice to major international food manufacturers regarding strategic and regulatory food issues. In particular: phrasing and approval of nutritional health claims, various food labeling and nutrition issues (additives, addition of vitamins and minerals, phrasing of claims and ingredient labeling), food supplements, sweeteners, novel foods, probiotics, PARNUTs (infant formula, dietary products, sports foods), contamination and residues, product safety and recalls, packaging materials.
Memberships and Affiliations
- Brussels Pharma Law Group (BPLG), Member
Publications and Speeches
- "Social security system in Belgium," Belgian Regulatory Affairs Society: Introduction to Pricing & Reimbursement in Belgium (November 2012)
- "Legal Perspectives of Clinical Research Studies," 5th International Workshop Nutrition & Health Claims Europe: Designing Clinical Studies for Success (April 2010)
- "PLC Life Science Handbook 2009/2010 - Belgium. The law and leading lawyers worldwide," Practical Law Company (January 2010), Co-Author
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