Terms and Conditions
Terms and Conditions
1.1. The present Terms and Conditions (hereinafter T&C) shall apply to the organization and running of the 2023 edition of the GxP-Profi contest (hereinafter GxP-Profi, the Contest) among pharmaceutical companies of the Russian Federation and the Eurasian Economic Union member-states (hereinafter the EAEU).
1.2. The organizer of GxP-Profi is the Autonomous Non-Profit Organization of Continuing Professional Education “The Eurasian Academy of Good Practices” (hereinafter the Organizer, and the Academy, respectively), in cooperation with the Ministry of Industry and Trade of the Russian Federation, and with the support of the Eurasian Economic Commission.
1.3. T&C shall be published on the Contest page of the Academy’s website. The Organizer has the right to make changes to the present T&C, which shall be duly published.
1.4. The Contest Organizer guarantees confidentiality of the entries and objectivity of expert judging.
1.5. Participation in the Contest is free of charge.
2. Goals and objectives of GxP-Profi
2.1. The goal of the Contest is fostering the pharmaceutical industry’s potential by developing and implementing innovations in order to improve quality in pharmaceutical manufacturing.
2.2. The objectives of the Contest include:
2.2.1. Identifying the leading EAEU pharmaceutical manufacturers in terms of quality assurance
2.2.2. Promoting the best innovative solutions across the industry
2.2.3. Enhancing the image of the EAEU pharma companies, and boosting their competitive advantage in the global market.
3. Participation requirements
3.1. Contest participants shall be legal entities, regardless of the type of business and ownership, whose main activity is pharmaceutical manufacturing.
3.2. By applying for the Contest, the Participant automatically accepts all the points of the present T&C.
3.3. The Participant guarantees that the information submitted to the Contest is valid.
3.4. The Participant shall bear all the costs associated with preparation and submission of the Contest entry.
3.5. By signing the Contest entry, the head of the enterprise participating in the Contest gives consent to the disclosure of the entry-related information and the achievements for the purpose of experience exchange, and confirms that the information contained therein does not represent state, trade or any other secret.
4. Requirements for the Contest entries
4.1. The Contest is open to projects that meet the requirements of the present T&C.
4.2. The Contest entry shall meet the following requirements:
4.2.1.How relevant the project is for quality assurance in pharma manufacturing;
4.2.2. How innovative the solution is;
4.2.3. Whether the solution has been implemented at the production site with proven success;
4.2.4. Whether the project can be discussed publicly.
4.3. The Contest entry can be presented in various forms, including:
- as a component of a program that offers specification and details of top-priority development areas in pharmaceutical manufacturing;
- as an independent solution to a local problem that addresses a specific activity of a pharmaceutical enterprise;
- other.
4.4. The entry shall not contain confidential corporate information. Projects with restrictive markings shall not be accepted as entries.
5. Organization of GxP-Profi
5.1. In order to organize and run the Contest, the Organizer forms the Organizing Committee and the Expert Committee of the Contest.
5.1.1. The Organizing Committee of the Contest shall advise the participants on the organization of the Contest, submission, and the requirements for the entries; handle submissions; assign members to the Expert Committee and supervise its work; inform the participants about the decisions on their entries; organize project presentations and the award ceremony.
5.1.2. The Expert Committee reviews the Contest entries. It features representatives of the Ministry of Industry and Trade of the Russian Federation, as well as leading pharmaceutical industry experts from Russia and other countries.
Expert Committee members participate in running the qualification round and the finals of the Contest, and select the winners of the Contest in the final round.
5.2. In order to guarantee confidentiality of the entries and objectivity of expert judging:
- the Participants and experts shall create their user accounts;
- project descriptions submitted for the qualification round shall be de-identified;
- members of the Organizing Committee and the Expert Committee shall sign a non-disclosure agreement that protects any information made available to them while handling the projects.
6. Stages of GxP-Profi
6.1. Public announcements and updates on the Contest.
6.1.1. The Organizer drafts a Contest announcement and shares it on the Academy’s website and elsewhere on the internet, sends out a newsletter to regulatory authorities and pharmaceutical companies, and provides information about the Contest to be published in the media.
6.2. Registration of the Contest Participants and submission of the Contest entries.
6.2.1. Registration of the Participants is conducted via a link to the Academy’s website from 1 July through 15 October 2023, including the creation of a user account on the Academy’s website and filling in the Contest Participant registration form.
6.2.2. Contest Participants submit their entries from their user account from 1 July through 15 October 2023. The de-identified entries shall meet the submission requirements set by the Organizer and conform with the templates available from the user account.
The size of the team is determined by the company’s leadership, but shall not be more than three people including team lead.
6.2.3. The Participant has the right to submit other materials in addition to their Contest entry, provided that they meet the requirements for the entries.
6.2.4. If the Participant has submitted an incomplete Contest entry before the application deadline, he or she shall not be permitted to enter the Contest.
6.2.5. Any changes made to the Contest entry after its submission to the Organizing Committee shall not be valid.
6.2.6. Every Participant has the right to submit a written inquiry from their user accounts concerning the terms and conditions of the Contest, submission of the Contest entry, and the content of its components. The Organizer shall respond to the Participant’s inquiry orally or in a digital format within three business days from the receipt of the inquiry, provided that the inquiry has been received by the Organizer no later than three business days before the application deadline.
6.2.9. Every Participant has the right to request a consultation from the Organizer, including one-on-one consultations. Confidentiality of the information shared therein shall be guaranteed.
6.3. The qualification round of the Contest.
6.3.1. The qualification round of the Contest is held remotely from 16 through 27 October 2023 and involves an expert review of the entries by the Expert Committee.
6.3.2. For the qualification round, the de-identified entries shall be uploaded to the Expert Committee user accounts, each under an individual code number. Each entry is judged on the criteria adopted at the first meeting of the Expert Committee
The main judging criteria are the following:
- how important the project is for the industry and the enterprise, whether it can be scaled up to be applied industry-wide, and whether it has competitive advantages in the domestic and international markets;
- how technologically advanced it is, and whether the solution has a solid scientific and technological rationale;
- whether the product, technology, technique, approach and solutions applied represent an innovation;
- whether it has evidential basis;
- how big its economic impact is;
- how successful the entry’s preparation, execution and presentation are.
The results will be made available to the Participants from their user account on 14 November 2023.
6.3.3. The Contest page of the Academy’s website shall only include the list of the Participants selected for the finals by the Expert Committee, as reflected in the minutes of its meeting.
6.4. The final round of the Contest.
6.4.1. The projects selected by the Expert Committee in the qualification round enter the final round of the Contest.
6.4.2. The final round of the Contest shall take place as a hybrid event in November 2023.
6.4.3. In the final round, the teams present and discuss their projects on-site and/or via videoconferencing.
Duration of the speech is up to 15 minutes.
6.4.4. In order to get ready for the finals, the Participants prepare a presentation of their project in accordance with the requirements available from their user accounts.
6.4.5. In the final round, the projects shall be judged on the criteria adopted by the Expert Committee meeting.
In the final round, in addition to the main criteria defined in 6.3.2, the projects shall be judged by the Expert Committee on the following basic criteria:
- how mature and thought-out the project is
- how elaborate the project presentation is
- how successful the project discussion (answering questions on the project) is
The winners will be decided by the Expert Committee on the basis of the project discussion.
6.4.6. The winning companies shall be announced at a press-conference following the final round.
7. Honoring the winners of the Contest.
7.1. The award ceremony shall take place in early December 2023 at an official meeting of industry leaders.
7.2. The heads of the Ministry of Industry and Trade of the Russian Federation shall honor the winning companies’ directors with the 2023 GxP-Profi award. The winning team members shall be recognized for their innovative solution with the 2023 GxP-Profi award pins and special gifts.
7.3. The Organizing Committee has the right to establish additional awards (special prizes) sponsored by a third-party organization. The judging criteria for these awards shall be determined by the third-party organization independently.