Our experience in the area of Life Sciences, began in the 1960s and has developed in parallel with the evolution of Italian and European regulation of the sector.

We have specialist expertise in assisting Italian and international clients in both contentious and non-contentious matters relating to the pharmaceutical, cosmetics and medical devices sectors. We advise researchers and companies at the forefront of innovative treatment and clinical, genetic, advanced therapy and biotechnology research in human healthcare and the veterinary and food sectors, our focus being especially on regulatory issues and related litigation.

Combining a high level of experience and professional competence with a practical and interactive approach and with the support of the expertise of other departments in the firm (administrative, IP, antitrust, employment, data protection, etc.), our team delivers top quality service to our clients with a focus on:

  • Contractual matters;
  • Assistance in the relations with the Italian regulatory bodies (Ministry of Health, AIFA) as well as with other associations and bodies in the sector;
  • Marketing Authorizations and related regulatory issues (innovative medicinal products, generic products, biosimilar medicines, parallel imports);
  • Dispute resolution in all civil and administrative jurisdictions, assistance in criminal matters;
  • Investigator-initiated and company-sponsored clinical trials and observational studies concerning medicines and medical devices; research projects in the advanced therapy sector;
  • Promotion of and scientific information concerning medicines (for both human and animal use) and medical devices for health workers and the public; related contracts (co-marketing, co-promotion, market research, conventions, sponsorship, etc.);
  • Regulatory compliance and pharmacovigilance; monitoring of collaboration associations and administrations (research grants, donations); organizational models according to Law no. 231/2001, anti-corruption plans;
  • Public procurement procedures in the pharmaceutical and healthcare sectors;
  • Extraordinary transactions and joint ventures between businesses in the sector; organization of public-private partnerships and of associations between research bodies;
  • Product liability and medical malpractice.

Our experience in the area of Life Sciences, began in the 1960s and has developed in parallel with the evolution of Italian and European regulation of the sector.

We have specialist expertise in assisting Italian and international clients in both contentious and non-contentious matters relating to the pharmaceutical, cosmetics and medical devices sectors. We advise researchers and companies at the forefront of innovative treatment and clinical, genetic, advanced therapy and biotechnology research in human healthcare and the veterinary and food sectors, our focus being especially on regulatory issues and related litigation.

Combining a high level of experience and professional competence with a practical and interactive approach and with the support of the expertise of other departments in the firm (administrative, IP, antitrust, employment, data protection, etc.), our team delivers top quality service to our clients with a focus on:

  • Contractual matters;
  • Assistance in the relations with the Italian regulatory bodies (Ministry of Health, AIFA) as well as with other associations and bodies in the sector;
  • Marketing Authorizations and related regulatory issues (innovative medicinal products, generic products, biosimilar medicines, parallel imports);
  • Dispute resolution in all civil and administrative jurisdictions, assistance in criminal matters;
  • Investigator-initiated and company-sponsored clinical trials and observational studies concerning medicines and medical devices; research projects in the advanced therapy sector;
  • Promotion of and scientific information concerning medicines (for both human and animal use) and medical devices for health workers and the public; related contracts (co-marketing, co-promotion, market research, conventions, sponsorship, etc.);
  • Regulatory compliance and pharmacovigilance; monitoring of collaboration associations and administrations (research grants, donations); organizational models according to Law no. 231/2001, anti-corruption plans;
  • Public procurement procedures in the pharmaceutical and healthcare sectors;
  • Extraordinary transactions and joint ventures between businesses in the sector; organization of public-private partnerships and of associations between research bodies;
  • Product liability and medical malpractice.

LAWYERS

NEWS AND EVENTS

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26 Sep 19: Uso Compassionevole, Off Label e Off-Licence dei medicinali

Uso Compassionevole, Off Label e Off-Licence dei medicinali 26 September 2019 Crowne Plaza Milan City (Via Melchiorre Gioia, 73 – 20124, Milano)       PROGRAMMA: Uso compassionevole, Off-label e Off-licence dei medicinali   Speakers Dr.ssa Barbara Capaccetti, Country Medical Director Pfizer Avv. Agostino Migone de Amicis, Presidente, Comitato Etico Ist. Clinico Humanitas Avv. Claudia Pasturenzi, Studio Legale Astolfi e Associati, Milano Dr. Davide Tassinari, Direttore Unità Operativa Oncologia di Rimini

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25 Mar 19: Life Sciences Practice Group – Annual Meeting

LIFE SCIENCES PRACTICE GROUP – ANNUAL MEETING   Program Monday, 25 March 2019 15,00 Inizio lavori 18,30 visita guidata in inglese alla Pietà Rondanini 19,30 Social Dinner Martedì 26 marzo   Panel 1 Status of EU and national legislation in view of the application (if and when) of Regulation 536/2014; impact of related Regulations, particularly GDPR Speakers: Dr. Liliana Burzilleri (Regione Lombardia) Dr. Felice Lopane (Assolombarda) Avv. Deborah Bolco (Pavia e Ansaldo) on GDPR aspects   Panel 2 Pprofit and non-profit approach in clinical trials in the new (Regulation or not) European environment, in the context of a continuing technological…

Sanità_news
7 Feb 19: Veterinary medicines: the new EU Regulation is published

VETERINARY MEDICINES: THE NEW EU REGULATION IS PUBLISHED Milan, 7 February 2019 – After four years from the first regulation proposal on veterinary medicinal products (“VMP”)[1], on 26th November 2018 the Council approved the new Regulation, which has been published on the Official Journal on 7th January 2019 (EU Regulation 2019/6, the “Regulation”). The Regulation repeals Directive 2001/82/EC and shall apply from 28 January 2022. Since the first regulation proposal on this matter, the European Commission has called for an in-depth revision of the internal market of VMP. In particular, the Commission highlighted the need to harmonise the European legal framework,…

Sanità_news
26 Oct 16: Pavia e Ansaldo sponsor of the 5th Healtcare Summit of Il Sole 24 Ore

PAVIA E ANSALDO SPONSOR OF THE 5TH HEALTHCARE SUMMIT OF IL SOLE 24 ORE “FUTURE HEALTHCARE” Agostino Migone De Amicis, partner of Pavia e Ansaldo, participated as speaker on “Research and independent experimentation: hub or … handicap for the development of Italian excellence?” Milan, 26 October 2016 – The 5th Healthcare Summit organized by Il Sole 24 Ore sponsored by, among others, Pavia e Ansaldo took place today in Rome. Agostino Migone De Amicis, partner and head of the Health and Pharmaceutical (Regulatory) Department of Pavia e Ansaldo as well as Chairman of the Ethics Committee of Humanitas, participated as speaker in…

Dip_Mergers
5 Jul 16: Pavia e Ansaldo with Bio-Techne Corporation in the purchase of space Import-Export S.r.l.

Pavia e Ansaldo with Bio-Techne Corporation in the purchase of space Import-Export S.r.l. Milan, 5 July 2016 – Pavia e Ansaldo assisted Bio-Techne Corporation – an American corporation listed on the Nasdaq in New York and active in the life sciences sector – in the purchase, through an English subsidiary of the group, of the entire corporate capital of Space Import-Export Srl, a distributor of products for biomedical research and diagnostic markets. Partner Francesco Manara, coordinated the team acting for Bio-Techne, composed by partner Paola Carlotti with Francesca Bottani and Miriam Hamdan for contractual and corporate aspects, partner Valentina Simonelli for…

Sanità_news
12 May 15: Fondazione Tettamanti with Pavia e Ansaldo in the transfer of license rights to formula pharmaceuticals for the development of a prioritary next-generation immunotheaphy platform in hematologic oncology

Fondazione Tettamanti with Pavia e Ansaldo in the transfer of license rights to formula pharmaceuticals for the development of a prioritary next-generation immunotheaphy platform in hematologic oncology Milan, 12 May 2015 – Pavia e Ansaldo assisted Fondazione M. Tettamanti, affiliated to Milan-Bicocca University and  dedicated to research and care of children leukemia and hemopathy, in the exclusive licensing rights to develop its proprietary, next – generation, immunotheraphy platform in hematologic oncology to Formula Pharmaceuticals Inc, a privately-held US oncologic drug development company. Fondazione Tettamanti was represented by partner Agostino Migone de Amicis and by associates Maria Chiara Biffi and Iolanda Severino. The exclusive license coincides…