Italy, Belgium and UK.
R&P Legal is an independent law and tax firm, founded in 1949, with 6 offices throughout Italy, major international links, and more than one hundred and seventy highly skilled professionals providing full service assistance. R&P Legal advises clients on marketing of medical devises in the EU (including related regulatory obligations), in the classification of their products and in procedures relating to EC declaration of conformity (according to Directive 93/42/EEC), the establishment of a pathway to authorization, pharmacovigilance obligations, promotion and marketing of products, sales agreements, clinical trial agreements, adverse event reporting, product withdrawals, and data protection obligations.
In particular, Riccardo Sciaudone has a wide experience in litigation before the Court of Justice of the European Union, the European Court of Human Rights and the European Free Trade Agreement (EFTA) Court, including challenges, on behalf of industry clients, to decisions of EU institutions and the validity of EU legislation. Riccardo also assists clients during clinical investigation procedures (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, informed consent, serious adverse event qualification and notification, handling of personal data).
Riccardo is currently assisting an extra-EU manufacturer of medical devises before the Italian Administrative Court and the General Court of the European Union and an European market leader in the production of in vitro diagnostic systems on an antitrust compliance program.
Areas of regulatory/reimbursement support:
Regulatory experts in the field of medical devices (e.g. procedures relating to EC declaration of conformity, classification of products); healthcare, data protection in the healthcare sector, in the pharmaceutical field; data protection in healthcare system, pharmaceutical sector