Sophie Pelé

• A multinational biotechnology company before the Administrative Supreme Court to seek for the cancellation of the decree expanding recommendations for therapeutic use to cases where therapeutic alternatives exist, and the decision imposing such use on one of its major products.
• A US-based laboratory relating to clinical trials, grants, congresses, interactions with healthcare professionals and government officers.
• An originator company before an Administrative Court in summary proceedings to challenge the generic authorization granted to a hybrid inhaled product.
• A multinational US-based pharmaceutical product in the negotiation of a European promotion agreement.
• A leading high tech medical devices US-based company on the antitrust and public procurement aspects of a “dual branch” business model implemented across Europe for the supply of medical devices to public hospitals.
• A leading high tech medical devices US-based company during and further to dawn raids conducted by the French competition authorities relating to alleged bid-rigging practices.
• A leading high tech medical devices US-based company in the interaction with the French professional medical devices association and the French authorities in charge of pricing and reimbursement.
• A leading pharmaceutical company in the termination of a promotion and distribution agreement and the management of regulatory related matters to ensure a proper transition and avoid any shortage of product.
• A US-based biotech company on the settling of clinical trials in France and opening of the French branch; Advising on parallel trade.

Includes matters handled at Dechert or prior to joining the firm. 

• EU Pharmaceutical Law Forum — Virtual conference (May 17-20, 2021)
• EU Pharmaceutical Law Forum — Virtual conference (November 16-20, 2020)
  
• EU Pharmaceutical Law Forum — Brussels (May 21-23, 2019)
• Life Sciences Academy — Paris, France (October 2, 2018)
• EU Pharmaceutical Law Forum — Brussels (May 15-17, 2018)
• EU Pharmaceutical Law Forum — Brussels (May 16-18, 2017)
• 25th Annual EU Pharmaceutical Law Forum 2016 — Informa, Brussels (May 24, 2016)

• Quand et comment peut être déclenché le dispositif de contrôle des investissements étrangers — Blog de l'Usine Nouvelle (October 28, 2024)
  
• Pénurie de MITMS : "Les sanctions risquent de s'alourdir et pourraient accélérer la cessation des produits les plus à risque." — Biotech Finances (October 11, 2024)
  
• Une (énième) année placée sous le signe de la gestion des ruptures d'approvisionnement de médicaments — Blog de l'Usine Nouvelle (February 24, 2024)
• Reconditionnement d'un médicament par l'importateur parallèle : entre garanties de sécurité et principe de libre circulation — Blog de l'Usine Nouvelle (September 22, 2023)
• Clap de fin pour les sociétés vétérinaires radiées — Blog de l'Usine Nouvelle (August 9, 2023)
  
• Ce qu'il faut retenir de la condamnation record de filiales du groupe Urgo pour pratiques commerciales frauduleuses — Blog de l'Usine Nouvelle (February 24, 2023)
• Quels enjeux pour la santé numérique — Blog de l'Usine Nouvelle (December 18, 2022)