ENGLISH

Springer Healthcare Italy announces the opening of the competition for the Prix Galien Italy 2024 for pharmaceutical and research innovation.

THE EVENT

The event will take place on June 20th at the venue of the Parco dei Principi Hotel in Rome, concurrently with the Galien International Award, an unprecedented occasion that brings together two prestigious initiatives.

The day will include the presentation of products from pharmaceutical and medical device companies participating in the Prix Galien Italy and a workshop involving stakeholders in the pharmaceutical and healthcare sectors starting at 12:30 PM CET. A light lunch will be provided for registered participants, followed by a networking aperitif in the late afternoon before the evening gala dinner. During the evening, the winners of the Galien Award International and Prix Galien Italy will be honored.

APPLICATIONS

Applications for the Prix Galien Italia can be submitted by national affiliates (or multinational companies with headquarters in Italy) that manufacture/distribute pharmaceuticals and medical devices, as well as researchers operating in Italy. Click on the categories of your interest to download the dossier template that must be used to submit the application.


DRUGS AWARDS

>> Click here to download the general participation criteria

The following award categories are planned:

Non-biological drugs, whose active ingredients are obtained through chemical synthesis.

Download the dossier template

In accordance with the definition of ‘biological drug’ provided by AIFA, the award is reserved for drugs whose active ingredient is represented by a substance produced or extracted from a biological system. This category includes biotechnological drugs produced using recombinant DNA technologies, hormones, enzymes, blood derivatives, immunoglobulins, and monoclonal antibodies (excluding immunological drugs such as sera and vaccines, or allergens, which are specifically reserved for category no. 3).

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For ‘vaccine,’ exclusive reference is made to the definition indicated on the institutional website of AIFA.

Important note: If only one nomination is received for this award category, the category itself will not be activated, and the nominated product will be included in one of the main reference categories (chemical synthesis or biological).

Download the dossier template

Reserved for drugs listed in the relevant AIFA list, including medicines registered in the Community Register of Orphan Medicinal Products and medicines with marketing authorization in Italy indicated for the treatment of rare diseases or conditions listed in the Orphanet register, even if not included in the Community Register of Orphan Medicinal Products.

Important note: If only one nomination is received for this award category, the category itself will not be activated, and the nominated product will be included in one of the main reference categories (chemical synthesis or biological).

Download the dossier template

In accordance with the definition provided by the EMA, Advanced Therapy Medicinal Product (ATMP) include: (a) gene therapy medicinal products, (b) somatic cell therapy medicinal products; (d) tissue-engineered products, (e) combinations of any of the aforementioned ATMPs with a medical device (combined products). The award is exclusively reserved for products classified as ATMPs by the Committee for Advanced Therapies (CAT) of  EMA, and for which EMA has already published the respective ‘Summaries of scientific recommendations on the classification of advanced therapy medicinal products.’

Important note: If only one nomination is received for this award category, the category itself will not be activated, and the nominated product will be included in one of the main reference categories (chemical synthesis or biological).

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Drugs on which post-authorization studies (conducted in Italy or worldwide) have been carried out, capable of confirming or redefining their efficacy and safety in the context of normal clinical practice (real-world) or, through drug investigation, contributing to the understanding of a pathology.

Important note: Only drugs approved by the EMA or AIFA before January 1, 2016, regardless of previous nominations in Italian or foreign editions of the Prix Galien, are eligible for this award category. For this specific category, drugs that have obtained additional indications after January 1, 2016, will also be accepted and evaluated in terms of the completeness of their pharmacological profile, as evidence of the development of the same drug.

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Drugs that AIFA classifies as active ingredients of chemical and biological/biotechnological nature.

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RESEARCH AWARD®

>>Click here to download the general criteria for participating in the Pharmacological Research Award

Pharmacological Research Award in the translational, preclinical, and clinical categories in Italy.

The three awards are given respectively to the authors of a research paper conducted in Italy in the field of translational, preclinical, or clinical pharmacology, and a research project synthesis not necessarily sequential to the work.

Three researchers (one per category) will be awarded who, at the time of the application, primarily conduct their activity in Italy, within university laboratories, public or private research centers, and pharmaceutical companies. Each winner will receive a plaque and a gross amount of 3000 Euros as a prize.

Download the research application template


Deadline

The documentation for the drug categories and research must be submitted by 23:59 (CEST, Central European Summer Time) on February 05, 2024, via email (attached files *doc *docx *pdf) to the following address: shcmilan@springer.com, with a copy to marianna.pasqua@springer.com, specifying in the subject of the email: ‘Application for Prix Galien Italy 2024’.

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