Who we are

I have been a lawyer for 40 years, advising clients in relation to the regulation of medicinal products and medical devices in the EU throughout their entire life cycle. As a result, there really is very little that I have not seen before.

I am admitted to practice in Belgium, Ireland, and the United Kingdom.

I work regularly with legal, clinical and technical experts including the Genotype Network. Information concerning the Network is available on this Site.

My areas of expertise include:

Legal and Regulatory Support

  • I advise clients on the regulation of their medicinal products throughout the entire product life cycle. This includes support in:

    • the determination of the appropriate classification of the product;

    • scientific advice procedures;

    • clinical trials including interactions with investigators and CROs;

    • interactions with competent authorities;

    • interactions with clients and suppliers;

    • applications for marketing authorization;

    • packaging and labelling.

    Should the need arise I also support clients in crisis management.

    I also advise clients in relation to promotion and marketing activities related to their product, helping prepare, or reviewing promotional materials.

  • I advise clients on the regulation of their medical devices throughout the complete life cycle of the device. This includes support in:

    • determination of the appropriate classification of a device;

    • clinical investigations including interactions with investigators and CROs;

    • interactions with competent authorities and notified bodies;

    • the conformity assessment process:

    • packaging and labelling.

    I have particular experience in the regulation of diagnostic and companion diagnostic devices, and in the intersection between medicinal products and medical devices.

    Should the need arise I also support clients in crisis management.

    I also advise clients in relation to promotion and marketing activities, helping prepare or reviewing promotional materials.

  • I have substantial experience in the preparation of Compliance Policies and related SOPs and in conduct of related training activities.

    I also prepare template agreements for clients including clinical trial agreements, quality agreements, critical supply agreements, consulting agreements, data exchange agreements, and agreements concerning interactions with patient organisations.

  • I support clients in relation to audits conducts by competent authorities and notified bodies. This includes preparation of response to audit findings and related discussion with competent authorities and notified bodies.

    I also prepare and conduct compliance audits and support clients in relation to the conduct of third party audits, including audits by customers and suppliers.

  • I advise clients in relation to promotion and marketing activities including participation in Medical Review Committees and Promotional Review Committees.

Agreements

  • I support clients in the preparation of quality agreements, critical supply agreements, manufacturing agreements, distribution agreements, clinical trial agreements, CRO agreements, Authorised Representative Agreements, and Legal Representative Agreements.

  • I assist and support clients in the pharmaceutical and medical device sectors in their interactions with healthcare professionals.

    This includes the preparation and negotiation of consultation agreements, promotion and marketing activities, and negotiation of investigator-initiated study agreements.

  • I advise and support clients in the regulatory aspects of transactions related to their corporations and products.

    This includes conduct of regulatory due diligence in transactions and support in preparation of relevant provisions of sales agreements, APAs, and transition services agreements.

Litigation

  • I am a former référendaire at the European Court of Justice. I have substantial experience in litigation before the European Courts of Justice and the EFTA Court and in complaint procedures before EU and national competent authorities.