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, 2018 and up to four (4) past calendar years (01/01/2015-31/12/2018).
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 diagnostic products and medical devices, in order to be nominated for the awards, their date of marketing authorization in Greece must be until December 31, 2018 and up to two (2) past calendar years (01/01/2017-31/12/2018).

Quality Criteria

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?

In addition, the judging committee reserves the right to award one candidate with the Pro Bono Humanum award, established to the end of rewarding a significant personality, science company, academic institution or NGO for their outstanding scientific and social contribution in the field of healthcare.
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.
The judging committee is comprised of ten members maximum, who serve the institution for one or three years the most. Members are exceptional and distinguished Greek scientists from the fields of healthcare, pharmacology, biology and biosciences, hailing from Greece or abroad. Apart from their exceptional academic credentials, the members of the committee must have a documented experience and understanding of treatment schemes and be knowledgeable in health issues. The decisions of the committee regarding the selection of the awards’ winners are final. Deliberations shall be assumed exclusively by the committee and no one else and must not be influenced by any public or private organization of the health sector, pharmaceutical industry or other sponsors.

SPECIAL PARTICIPATION CRITERIA FOR GREECE

Products eligible to participate in this category are those that have been approved by the European Union and are distributed in Greece.

Candidates’ Summary (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.
Clinical Evaluation (up to 2 pages)
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)

Population Health Impact (up to 5 pages)
This should consider:

  • Anticipated market size and penetration
  • Comparisons with main competitors
  • Anticipated patient impact
  • The predicted population health gain
Conclusions (1 page)
This section is not obligatory but applicants may wish to include conclusions about the merits of the product.

Formatting

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 Biotechnology Product”, please contact us on admin@jpcom.gr or call us on 210-8132828, 210-8132366.

 

CALENDAR FOR APPLICATIONS
The submission of applications will only be made electronically through the official site of the Prix Galien Greece. Starting date will be September 1st 2018  and closing date for Prix Galien Greece 2017 is January 20th 2019.