Annabelle Bruyndonckx

Of Counsel

Brussels

T + 32 2 542 09 64
annabelle.bruyndonckx@simmons-simmons.com

General Experience

Annabelle specialises in advising clients in the life sciences industries on the full range of regulatory matters. She assists pharmaceutical companies and medical device manufacturers, as well as biotech, nutritional supplements and cosmetic companies. She also advises related industry associations and service providers for the industry sector.
Her practice covers all parts of the life cycle from R&D to marketing authorisation/CE marking, pricing & reimbursement manufacture and distribution, advertising, tendering, compliance and liability issues.

She also assists clients in drafting and reviewing contracts pertaining to healthcare products and advises on relationships between pharmaceutical companies and healthcare professionals.
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Recent Work
  • advising companies with respect to the qualification of products they intend to put on the market (biocide-medical devices - medicines, etc)
  • advising medical devices and pharmaceutical companies on the regulatory, commercial and competition law aspects of discounts schemes, notably in the framework of public tenders
  • advising medical devices and pharmaceutical companies on various aspects of the Belgian legislation, including legal audits of their regulatory activities and the drafting of standard operating procedures and standard agreements (services agreements, consultancy agreements, proctorship agreements, code of ethics, etc.)
  • reviewing the company website of medical devices companies for compliance under regulatory and data protection laws.
Background

Annabelle joined Simmons & Simmons in 2013, after more than 14 years at another international law firm, where she headed the Pharmaceuticals & Healthcare group. She was admitted to the Brussels bar in 1998.

She was educated at the Catholic University of Louvain and also spent an half year on an exchange programme at the Rijksuniversiteit of Leiden.

She was a part time lecturer at the Catholic University of Louvain from 1997 to 2003.

She is a member of the Brussels Pharma Law Group, European Food Law Association and the Belgian Regulatory Affairs Society (BRAS) where she is also a board member and the President of the Education Group organising training sessions for BRAS members.

She is also a redaction committee member at Healthcare Executive Magazine.

She is frequently invited to speak at international conferences and has published numerous articles in legal and trade journals relating to regulatory matters. Since 2010, she is a regular lecturer of the European Healthcare Compliance Ethics & Regulation programme organised by Sciences Po and Seton Hall Law.

Annabelle speaks French, Dutch and English.