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Nicola Landolfi

He/himLawyer
About

Nicola is a Life Sciences regulatory lawyer, with extensive experience advising global companies in developing their business strategies in accordance with their specific needs.

Nicola assists on a variety of legal and regulatory matters under both EU and Italian law, including clinical trials, licensing and approval of products, regulatory compliance, interactions with HCPs and patient organizations, advertising and post market obligations.

His area of expertise covers a broad range of products, including medicines, medical devices, food supplements, cannabis products and cosmetics.

Nicola regularly speaks and writes on life-sciences topics.

 
Areas of FocusIntellectual Property
Professional QualificationsAvvocato admitted to the Rome Bar

EXPERIENCE

  • Advised a pharmaceutical company on the regulatory procedure for obtaining a centralized marketing authorization for a vaccine against the COVID-19 in the EU.
  • Advised several companies on the transitional provisions governing the placing on the market of medical devices under Regulation (EU) 2017/745 (MDR).
  • Advised a US biotech company on compliance with the EU Tissue & Cell directive and its national implementation in Italy and other European jurisdictions.  
  • Assisted a Swiss company in assessing the possible classification of a well-being app as a medical device under Regulation (EU) 2017/745 (MDR).
  • Advised an Italian leading pharmaceutical company on the regulatory classification of a product as a medicine vs. food supplement in the context of criminal proceedings.
  • Assisted a US company on the implementation of certain home care clinical trial-related services in more than fifty (50) jurisdictions worldwide.  
  • Advised a UK company on the applicable rules to disseminate non-promotional and promotional materials on medical devices to the general public in France, Germany, Ireland, Italy, the Netherlands, Spain and the UK.
  • Assisted a Japanese pharmaceutical company in defending its data exclusivity and market protection rights pertaining to a triple combination medicinal product from two potential competitors preparing to enter the market with generic versions of the product.
  • Assisted a US biotech company running clinical trials in Italy and the EU on the review of all research and clinical trial agreements.
 
Languages
  • Italian
  • English
  • Spanish
Education
  • Roma Tre University of Rome, Law degree, 2014
  • University of Buenos Aires, Thesis abroad, 2014
  • University of Cordoba, Erasmus program, 2013

Prior Experience

Before joining DLA Piper, Nicola worked with leading Italian and international law firms.

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