GENERAL PARTICIPATION CRITERIA FOR GREECE
Pharmaceutical and biotechnology products eligible to be evaluated by Prix Galien Greece Award must be built on innovation and developed by chemical, biological or biotechnological methods with details and accuracy in their specifications for the production process and clinical trials’ results. Products nominated for the awards must be marketing authorized (for treatment indication-not necessarily priced), in Greece (through a central, national process or by mutual recognition) until December 31, 2020 and up to four (4) past calendar years (01/01/2017-31/12/2020).
The above category also includes older medicinal products approved for a new innovative treatment indication or a new therapeutic entity (NTE) incorporated, however, in the past four (4) years.
With regard to the category best medical technology product, in order to be nominated for the awards, their date of marketing authorization in Greece must be until December 31, 2020 and up to two (2) past calendar years (01/01/2019-31/12/2020).
Candidate medicinal products can belong to any therapeutic category. However, the awards shall be bestowed to those which contribute to the improvement of the quality of life or save lives, on the basis of two criteria:
1. Which was the innovation during the course of the product’s scientific development, the way it acts and its clinical use?
2. Which is the benefit for the future of medical science from the introduction of the product in clinical practice?
Each awarding category shall declare only one winner, however, in the case of a tie in votes of one or more nominees, the judging committee reserves the right to designate a second Hors Prix winner.
SPECIAL PARTICIPATION CRITERIA FOR GREECE
The right to participate in this category have both orphan and non-orphan products approved in the European Union, that have only rare disease indication and are being marketed in Greece.
Candidates’ Summary (up to 1 page)
This must be a brief summary mentioning the principal treatment indications of the product and the essential content of its proposal for nomination.
Concept (up to 3 pages)
This should include :
- An outline of how/why the product was developed.
- Whether the product involved has a unique and specific target.
- Whether innovative techniques were used in the development of the product.
- The uniqueness of its chemical/biotechnological development.
This should outline:
Executive summary of clinical development program, including key facts of mechanism of action, dose-finding and trial design.
The application should not provide information for more than 10 publications (peer-reviewed)
Conclusions (up to 1 page)
This section is not obligatory but applicants may wish to include conclusions about the merits of the product.
The total number of pages of each submission in the category in question must not exceed 12 Α4 size pages, 1 ½ spaced with 12-point Arial type fonts and 2 cm margins.
All documents/certificates must be submitted on-line together with the participation application.
FEE FOR APPLICATIONS
For more information regarding the application fee and the sumbission amenities of the “Best Orphan Drug (Rare Disease)”, please contact us on email@example.com or call us on 210-8132828, 210-8132366.