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Partner Giorgio Calesella Contact

Giorgio Calesella is a partner in Carnelutti Studio Legale Associato; Giorgio is the senior accountable member of the firm’s health care and life sciences department; he has 30 years’ experience in compliance and criminal law connected to compliance, and has comprehensive knowledge of all regulatory and administrative matters.
He graduated in law from the University of Milan in 1981 and he has been a member of the Italian Bar since 1987.
Giorgio is fluent in English and French, in addition to his native Italian.

If you would like more information about Giorgio Calesella’s experience, e-mail him directly: gcalesella@carnelutti.com.

The new EU Regulation on Medical Devices 2017/745 - (MDR): Possible Impact on the Procurement Code

May 10, 2018
Giorgio Calesella organized an in house seminar entitled: "The new EU Regulation on medical devices 2017/745 - (MDR): possible impact on the Procurement Code". The objective of the seminar was to gather thoughts on new legislations (new European regulation on medical devices and Procurement code) that strongly impact orders by government entities and the supply of medical devices, and dedicate time to focus on: Product specifications and description of product specifications in tender specifications; Special law on procurement and causes of exclusion for technical reasons; The person responsible for compliance with regulations (art. 15).

The New EU Regulation on Medical Devices 2017/745 - (MDR): Possible Impact on the Procurement Code

April 19, 2018
Giorgio Calesella organized an in house seminar entitled: "The new EU Regulation on medical devices 2017/745 - (MDR): possible impact on the Procurement Code". The objective of the seminar is to gather thoughts on new legislations (new European regulation on medical devices and Procurement code) that strongly impact orders by government entities and the supply of medical devices, and dedicate time to focus on: Product specifications and description of product specifications in tender specifications; Special law on procurement and causes of exclusion for technical reasons; The person responsible for compliance with regulations (art. 15).

Medical Devices 2018

February 15, 2018
Carnelutti Studio Legale Associato sponsored the conference “Medical Devices 2018 – Regulatory framework, market access and supply chain”, organized by AboutPharma. Giorgio Calesella was among the main speakers. The conference took place in Milan, at Palazzo delle Stelline, from 9:00 am to 5:00 pm. The 2018 edition aimed at consolidating the dialogue that started in recent years between manufacturers, regulators and others for the driving up of market standards. Through meetings and debates with major industry stakeholders, the following issues were analyzed:
  • Global and domestic market trends in Medical Devices;
  • Adaptation to EU Regulations: what was done, what remains to be done;
  • The Role of the Responsible Person: legal, organization and management impact;
  • Quality and ISO 13485 certification;
  • Supervision and the fight against counterfeiting;
  • Supply chain, logistics and traceability of devices;
  • Market access, centralized calls for tenders and purchase policies.
https://www.aboutpharma.com/blog/2017/12/21/dispositivi-medici-2018/

Compliance after the Introduction of the New MedTech Europe Code

November 22, 2017
Giorgio Calesella organized an in house seminar entitled: "La compliance ai tempi del nuovo codice MedTech Europe: come cambiano i rapporti tra aziende e professionisti della sanità” (Compliance after the introduction of the new MedTech Europe code: changes in relations between health companies and health professionals).

Transparency and Prevention of Corruption in the Healthcare Industry

October 3, 2017
Giorgio Calesella organized an in-house seminar together with AboutPharma, entitled: Transparency and prevention of corruption in the healthcare industry.

New Public Procurement Act: First Court Decisions

September 20, 2017
Giorgio Calesella organized an in house seminar entitled: "New Public Procurement Act: First Court Decisions". The administrative law team participated as speaker in the seminar.

Real World Evidence in Italy

November 23, 2016
Giorgio Calesella was a key-note speaker at the conference organized by 3P Solution on “Real world evidence in Italy”.

Functions and Criminal Sanctions for the Surveillance Committee

November 10, 2016
Giorgio Calesella was a speaker at the seminar organized by Assobiomedica on “Attività e rischi penali dell’Organismo di Vigilanza” (Functions and criminal sanctions for the Surveillance Committee).

Limitations in the Current Legal Framework and Future Outlook

September 26, 2016
Giorgio Calesella was a key-note speaker at the Meeting organized by MA Provider on “Limiti dell’attuale stato normativo e prospettive future” (Limitations in the current legal framework and future outlook).

Ethics in Health Care

June 15, 2016
Giorgio Calesella spoke at the conference organized by Assobiomedica on “Etica in Sanità: un valore e una sfida per le imprese e per il SSN” (Ethics in health care: a standard and challenge for businesses and for the national health service).

Ethical Committees in Clinical Trials

June 8, 2016
Giorgio Calesella was a key-note speaker at the conference organized by 3P Solution on “I comitati etici nella sperimentazione clinica cosa sta cambiando con il nuovo regolamento europeo in ambito RWE in Italia” (Ethical committees in clinical trials, what is changing in RWE in Italy with the new European regulations).

Legislative Decree no. 231/2001 Positive and Negative aspects

May 27, 2016
Giorgio Calesella was a key-note speaker at the conference organized by Ordine dei Dottori Commercialisti of Benevento on “D.Lgs.231/2001 luci ed ombre dopo 15 anni di applicazioni” (Legislative Decree no. 231/2001 positive and negative aspects 15 years on).

Privacy in Clinical Trials

May 18, 2016
Giorgio Calesella was a key-note speaker at the conference organized by Assobiomedica on “privacy negli studi clinici” (Privacy in clinical trials).

Non Compliance with Appropriateness in Government Tenders

March 7, 2016
Giorgio Calesella was a key-note speaker at the conference organized by Ma Provider on “Il mancato rispetto dell’appropriatezza “nell’espletamento delle gare pubbliche” (Non compliance with appropriateness in government tenders).

The Risk of Self-Laundering in Light of False Accounting

December 10, 2015
Giorgio Calesella was a speaker at the conference organized by Assobiomedica on “Il rischio relativo al reato di autoriciclaggio alla luce del falso in bilancio” (The risk of self-laundering in light of false accounting).

Environmental Crimes

October 21, 2015
Giorgio Calesella spoke at the Workshop organized by HQL –High Quality Labs s.r.l. and Remedia on “Ecoreati, gestione del rifiuto, efficientamento energetico, novità Legislative e nuovi obblighi per le aziende” (Environmental crimes, waste management, improving power efficiency, new legislation and obligations applicable to companies).

Insight into Potential Conflicts of Interest in Assessing Training Plans

October 14, 2015
Giorgio Calesella spoke at the Seminar organized by Fonservizi on “Riflessioni sui possibili conflitti di interesse nella valutazione dei Piani Formativi” (Insight into potential conflicts of interest in assessing Training Plans).

Preventing Corruption in Health Services

May 25, 2016
Giorgio Calesella spoke at the conference organized by “Mylan” on “Prevenire la corruzione in sanità. Dalle nomine agli acquisti” (Preventing corruption in health services. From appointments to purchases).

The Criminal Liability of Companies

May 20, 2015
Giorgio Calesella spoke at the conference organized by Fonservizi on “La responsabilità amministrativa delle società ed il reato di autoriciclaggio: un nuovo approccio ai reati presupposto ed i conseguenti adeguamenti dei modelli di controllo” (The criminal liability of companies and the crime of self-laundering: a new approach to presumptive offenses and consequent adjustment of control systems)

The Interface in government-Private Relations

May 18, 2015
Giorgio Calesella was a key-note speaker at the conference organized by MA Provider on “il confine del rapporto pubblico-privato: turbativa d’asta e nuove specifiche tecniche sugli appalti pubblici” (The interface in government-private relations: bid rigging and new specific techniques for government contracts). The event took place at Hotel Michelangelo in Milan.

The Application of the 231 Model in Fonservizi

April 28, 2015
Giorgio Calesella was a speaker at the seminar organized by Fonservizi on “Responsabilità Amministrativa delle Società e modelli di organizzzione, gestione e controllo. “L’applicazione del Modello 231 in Fonservizi” (Criminal liability of companies: Organization, management and control models. "The application of the 231 Model in Fonservizi”.

Implementing the Model and Role of the Surveillance Committee

April 14, 2015
Giorgio Calesella was a key-note speaker at the conference organized by Assobiomedica on “Implementazione del Modello e attività dell’ODV” (Implementing the Model and Role of the Surveillance Committee”.

The Crime of Self-Laundering

February 18, 2015
Giorgio Calesella spoke at the conference organized by Assobiomedica on “The crime of self-laundering: the new conditions in Leg. Dec. 231/2001”.

Split payment

January 22, 2015
Giorgio Calesella was a key-note speaker at the conference organized by Assobiomedica on “Split payment”.

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