Актуальное мероприятие
Regulations on organizing and conducting the III International Student Festival "GxP-Fest 2023"
1. General Provisions
1.1 These Regulations (hereinafter - Regulations) establish the procedure of organization and holding of the III International Student Festival "GxP-Fest 2023" (hereinafter - GxP-Fest, Festival, Event) for students of pharmaceutical, chemical, biotechnology faculties and universities of the Russian Federation and member states of the Eurasian Economic Community (hereinafter - EAEC) and countries not included in the list of states approved by the Russian Federation Government Regulation № 430-r dated March 05, 2022.
1.2 The organizer of GxP-Fest is an autonomous non-profit organization of additional professional education "Eurasian Academy of Good Practices" (hereinafter - the Academy, the Organizer) with the support of the Eurasian Economic Commission, the Ministry of Industry and Trade of Russia and the FBU "State Institute of Medicines and Good Practices".
1.3 GxP-Fest is held in accordance with the program of the event (hereinafter - the Program). The current version of the Program is posted on the Event page on the official website of the Academy on the Internet.
1.4 The GxP-Fest competitive program for students and undergraduates is held in a hybrid format.
1.5. GxP-Fest is held in accordance with the legislation of the Russian Federation taking into account the requirements on the organization of public events through the Internet.
1.6. GxP-Fest is conducted in Russian and English.
1.7. GxP-Fest shall be held separately for different contests.
1.8. No fee is charged for participation in GxP-Fest and its contests.
1.9. GxP-Fest is not a lottery or a public promise of an award; it is not held for the purpose of advertising goods, works or services.
1.10. The link to the official GxP-Fest website is posted on the Organizer's website at https://www.gxp-academy.org/
1.11. The Organizer reserves the right to make changes to these Regulations with mandatory publication of these changes on the GxP-Fest official website.
1.12. The link to these Regulations shall be placed on the Event page on the official website of the Academy.
1.13. The Regulations and changes to them shall be approved and put into effect by the order of the Executive Director of the Academy.
1.14. The issues not regulated by the present Regulations shall be solved in accordance with the legislation of the Russian Federation.
2. Purpose and objectives of GxP-Fest
2.1 The main purpose of GxP-Fest is to contribute to the modernization of education of pharmaceutical industry specialists, as well as to popularize industrial pharmacy among the students of the relevant profile.
The objectives of GxP-Fest include:
2.1.1. attracting the attention of specialized students to the pharmaceutical industry;
2.1.2. to create students' interest in building an industrial career;
2.1.3. identifying the most promising students as future professionals in the pharmaceutical industry;
2.1.4. promote the modernization of pharmaceutical education with a focus on industrial pharmacy;
2.1.5. implementation of innovative educational technologies, including simulation technologies, in the training of future specialists.
3. Participants of GxP-Fest
3.1 Undergraduate (specialist, undergraduate, graduate) students of pharmaceutical, chemical, biotechnological faculties permanently residing in one of the EAEU member states and friendly countries, who are studying at a higher educational institution (medical, pharmaceutical, chemical-pharmaceutical and other) with its location on the territory of Russia or EAEU member states and countries not included in the list of states approved by the Russian Federation Government are allowed to participate in the GxP-Fest.
3.2 Students of master's degree programs (part-time form), postgraduate, residency, teachers of educational organizations are not allowed to participate in GxP-Fest competitions.
3.3 International students studying at the above-mentioned faculties (institutes) in higher education institutions of the Russian Federation, the EAEU countries and friendly countries are allowed to participate in the individual competition in English (Gxp-Quest).
4. GxP-Fest program
4.1 The main program of the contest is realized for student teams (4 persons).
4.2.Under the additional program individual participation of students in competitive events implemented in Russian and English is possible.
4.3.The Festival Program includes:
4.3.1 For student teams and individual Participants:
- GxP-Battle (first stage, qualifying) is a multi-subject professional test quiz consisting of test tasks and case studies;
- GxP-Quest (the second stage, final) - a team game (for student teams) or individual (for individual Participants) competition on the development of professional answers-solutions in accordance with the tasks of a special game field, providing different levels of obstacles and opportunities;
- Competition of creative photos on the topic of GxP-practices, industry specifics.
- Professional competitions from pharmaceutical companies;
- master-classes from industry experts;
- a job fair where students can be selected for internships in top pharmaceutical companies, and graduates can start a successful career in the industry.
4.1.2 The free educational master class on the use in the learning process of the innovative simulation complex "Virtual pharmaceutical plant for universities" with the issuance of a certificate of the Academy.
5. Regulations of GxP-Fest
5.1 Announcing and informing about the GxP-Fest.
5.1.1 The Organizer ensures preparation of an information letter about the GxP-Fest and its placement on the Organizer's official website, Internet resources and social networks, sending an information letter to the relevant public authorities, educational institutions of higher education and manufacturers of medicines, sending announcements for publication in the media.
5.2 Registration of GxP-Fest participants.
5.2.1 Registration of student teams - Participants of GxP-Fest:
- is conducted on the Festival page on the Academy website during the period from March 01 to March 14, 2023 inclusive on the official GxP-Fest website with the subsequent formation of a personal account of the team on the Academy training platform
- the team shall consist of not more than 4 and not less than 2 students;
- full name of the team must consist of the abbreviation of the educational organization and with a dash - its name (if the team name does not meet these requirements, the team cannot be registered);
- includes filling in the registration form, providing a portfolio of team members, a photo of the team against the background of the educational organization or its symbols, as well as photos of its participants and documents confirming their status as students (student cards);
- the team captain (the person who fills in the registration form) is sent an individual password to enter the personal account on the Academy educational platform by e-mail indicated during registration. All team members who enter the password received by the team captain have access to the personal office.
5.2.2 Registration of individual student participants:
- is conducted on the Festival page on the Academy website from March 01 to March 14, 2023 inclusive on the official GxP Festival website with the subsequent formation of the Participant's personal account;
- includes filling in the registration form, providing a portfolio, personal photo, as well as a photo of the document confirming the status of the student (student ID card);
- Each Participant is sent an individual password to log in to his personal account on the Academy training platform by e-mail indicated during registration.
5.2.3 Before the qualifying stage, the instructions on its carrying out are placed in the personal cabinet of the Participants, access to the information base on proper practices is provided, as well as technical testing of the Participants is carried out.
5.2.4 Applications are not subject to consideration (rejected) that:
- are submitted after the GxP-Fest application stage has expired;
-Submitted by Participants who do not comply in full with the requirements established by these Regulations.
5.2.5. submission of an application for participation, including via a personal cabinet, means that the Participant agrees with these Regulations and consents to processing of his/her personal data for the purposes of competitions and participation in the present Event in accordance with the requirements of these Regulations and Federal Law No. 152-FZ of 27.07.2006 "On Personal Data".
5.2.6. registration for participation in the creative photo competition:
- is held on the page of the Festival on the website of the Academy from March 01 to April 10, 2023 inclusive on the official website of GxP Fest with the subsequent formation of a personal account of the Participant;
- includes filling of the registration form;
- Each participant receives an individual password by e-mail indicated during registration to enter his personal account on the training platform of the Academy.
5.3 Conducting the qualifying stage of the GxP-Fest competition (pharmaceutical GxP-Battle).
5.3.1 Before the qualifying stage of the GxP-Fest competitions, the Academy organizes the consultation of the Participants on the stage and test connection of the Participants to check the equipment.
5.3.2 The qualifying stage is held separately for the student teams - Participants of the GxP-Fest and individual Participants (except students participating in English [APP1]) ), but at the same time.
5.3.3 The qualifying stage is held on March 15, 2023 in the online format and is a multi-subject professional test-quiz, including the solution of test tasks and situational cases on the software platform of the Organizer;
The tasks of GxP-Battle may include questions on good practices in the field of drug circulation: GMP, GDP, GVP, GLP, GCP.[APP2]
Contest participants are offered to solve:
(a) Closed-ended test tasks, including single-answer, multiple-choice, sequencing, matching, and algorithmic questions. No more than 1 minute is allotted to solve each task;
b) situational tasks, providing for a substantiated team written answer within the strictly allocated time (up to 10 minutes);
Approximate time of the qualifying stage is up to 1 hour, at the end of the time the access to the tasks is closed;
5.3.4 When passing the qualifying stage of the competition program, a number of requirements must be met, the observance of which is controlled by the observers:
1) all team members or an individual Participant must be in one separate room equipped with video equipment with Internet connectivity;
2) no outside persons shall be present in the room in which the team members or individual Participants are present;
3) all necessary software to pass the competition program complies with the requirements (video and audio settings are made in advance, Internet connection is checked according to the instruction "Technical requirements" placed on the Festival page);
4) only one device is used for team answers to questions, for displaying team images (monitor, TV, projector), one keyboard, one manipulator (computer mouse, etc.)
5) all team members and individual Participants are displayed in real time on the working computer screen in the contest program window;
6) the use of phones or other devices with Internet access is prohibited;
7) the use of any auxiliary, informational materials is forbidden;
8) it is forbidden to use any assistance from third parties;
9) if during the competition program there was a break in communication, the team must notify the technical service of the Organizer in accordance with the contact information posted on the page of the Event.
Violation of the above requirements shall be automatically recorded by the platform with the subsequent accrual of penalty points up to complete disqualification.
5.3.5. Assessment of the answers of the Participants is carried out by the Expert Commission of the Competition (hereinafter - the Expert Commission, EC). The Participants - student teams or individual Participants, who scored the highest number of points according to the results of the qualifying stage, are admitted to the final stage;
5.3.6 Publication of the results of the qualifying stage and the list of teams admitted to the final stage will take place on the festival page on the Academy site not later than March 20, 2023.
5.4 Preparing for the final stage of the GxP-Fest.
5.4.1 To prepare for the final stage of the GxP-Fest, video instructions for the final stage of the Festival are posted on the Festival page on the Academy website.
5.4.2 To prepare for the final stage of the GxP-Fest, the Participants are provided with access to information materials on good pharmacy practices.
5.4.3 Before the final stage of the GxP-Fest, counseling of the Participants on the competition and test connection of the Participants to check the equipment is organized.
5.5 Conducting the final stage of the GxP-Fest.
5.5.1 The final stage of the GxP-Fest is held on April 21, 2022. For student teams - in person in Moscow, for individual Participants (in Russian and English) - remotely. The stage is held simultaneously for all Participants, but separately for each type of Participant: student teams, individual Participants in Russian, individual Participants in English.
5.5.2 The main competitive event GxP-Quest is a team (individual) game for working out professional answers-solutions in accordance with the tasks of a special game field, providing different levels of game opportunities. The tasks of GxP-Quest are oriented at identification of competences in the field of GMP and GDP.
The total time of the GxP-Quest is determined by the organizer of the competition (approximately up to 1 hour).
During the Olympiad competition each team gets online access to a single game field with tasks of varying degrees of complexity on the Academy educational platform.
The winners are three teams (or individual participants) who are the first to reach the finish line of the GxP-Quest and get the most points (correct answers).
Winners of the GxP-Quest are defined automatically in the online mode on the computer educational platform of the Academy.
Participants of the competition and members of the EC have the opportunity to monitor the rating of teams online during the GxP-Quest.
5.5.3.The preliminary program of the final stage for the student teams-finalists of the competition in Moscow, who will arrive in person, includes:
-The opening ceremony of GxP-Fest 2023 in Moscow with a presentation by the finalist teams and greetings from officials;
-A unique industry event -an open microphone of expert pharma with specialized students, during which participants will have the opportunity to ask questions in person and online to representatives of regulatory bodies, industry experts and top managers of well-known pharmaceutical companies;
-Lunch;
-GxP-Quest;
-Numerous master classes and competitions from representatives of pharmaceutical companies with awarding of winners;
-Awarding ceremony for the winners of GxP-Fest and closing of the festival;
- fascinating thematic excursions.
5.5.4 The free educational master class on use in the educational process of the innovative simulation complex "Virtual pharmaceutical plant for universities" with the issuance of a certificate of the Academy is provided for university teachers who accompany the student teams. Specialization of the teacher in the field of industrial pharmaceutical technology is required.
5.5.5 Program for remote Participants is broadcasted on information channels Youtube, group in VK, Academy website and includes:
- broadcasting an open dialogue between representatives of relevant public authorities, leading experts of the industry, including EAEC countries, with the core students and faculty;
-conducting of GxP-Quest;
Conducting a GxP-Test; - Job fair for pharmaceutical companies
5.6 Creative photo competition GxP-Fest.
In the framework of the contest Participants are invited to send an author's picture on the topic "Specialist of Pharmacy of the Future. What is he?", reflecting the author's vision of the future profession within the pharmaceutical industry, GxP practices. The use of professional attributes is welcome.
Works are evaluated by the expert committee of the competition.
Three photos with the highest score will be announced as winners and awarded with certificates and prizes, posted on the website of the Academy, in social networks
Works that do not violate the rights and dignity of man and citizen and do not contradict the normative legal acts of the Russian Federation and the conditions of the present Regulations are accepted for the photo contest. Submitted works may be rejected from the competition in the following cases
- the work does not correspond to the contest theme;
- the work contains stories in which elements of propaganda or agitation, inciting social, racial, national or religious hatred and hostility, other forms of discrimination, humiliation can be discerned;
- the work is of low artistic or technical quality;
- the work has a focus that contradicts moral, moral or ethical norms. 6.
6 GxP-Fest Expert Commission
6.1.Formation of GxP-Fest Expert Committee.
6.1.1 In order to carry out a qualified evaluation of entries, the Organizer shall form a competent jury, the GxP-Fest Expert Commission.
6.1.2 The EC consists of representatives of relevant public authorities, the Organizer, leading pharmaceutical companies, including EAEU member states, representatives of educational institutions of higher education and other competent experts at the discretion of the Organizer.
6.2 Assessment of competitive works of student teams - Participants of GxP-Fest and individual Participants of GxP-Fest.[APP3]
6.2.1 Selection of EC teams and individual Participants to pass the qualifying stage of the Festival is held in the period from March 01 to March 20, 2023;
6.2.2 Assessment of test tasks is carried out automatically on the Academy training platform, with the participation of an observer, to check the authenticity and validity of the result (the correct answer to each task is assessed by one point). The EC makes a rating of the Participants of the qualifying stage in accordance with the scored points.
6.2.3 The results of solving each of the two situational tasks by the participants of the qualifying stage are evaluated by all members of the EC by filling out the protocols of expert evaluations in accordance with the given evaluation scale. The number of points received by each participant for solving each situation tasks is the arithmetic average of the evaluations of all EC members, which are summed up in determining the total number of points of the participant according to the results of solving situation tasks.
Scale of scoring the answers to the situational cases of the preliminary stage of "GxP-Fest 2022" (GxP-Battle)
|
0 points |
Incorrectly answered question. |
|
1-2 points |
An answer to a problem is given correctly, but there is no explanation or an incomplete, inconsistent or erroneous formulation of the problem. |
|
Score 3-4. |
The answer to the problem is correct. The explanation of the problem solution is detailed, but with minor inaccuracies in details or with single mistakes in details, some difficulties in theoretical grounding. |
|
5-6 points |
An answer to the question of the problem is given correctly. Explanation of the solution is detailed, coherent, competent, with theoretical justifications and explanations, with correct and fluent use of terminology. |
6.2.4 The final calculation of points received by each participant of the qualifying stage, is made by summing up the points for the solution of test tasks and situational tasks. In accordance with the sum of points, the EC ranks the Participants of the qualifying stage, which is approved by the minutes of its meeting.
6.2.5 The participants who receive the highest number of points at the end of the qualifying stage, but not more than half of the initial number of Participants, separately among student teams and individual Participants (separately in Russian and English), are allowed to participate in the final stage of the contest (GxP-Quest) by the decision of the EC.
6.2.6 No later than April 4, 2023 the results of the first (qualifying) stage are published on the Academy official site and the list of teams and individual participants admitted to the final stage of the contest is published.
6.2.7 Evaluation of the final stage EC is carried out online when the Participants pass the GxP-Quest on the Academy computer educational platform on the basis of automatically registered final results of the Competition Participants.
6.3 Evaluation of the creative photo contest works on the theme of GxP-practices.
6.3.1 Original photos on the topic of GxP Practices are evaluated.
6.3.2 The evaluation of the contest works and the selection of the winner is carried out by April 10, 2022.
6.4 Cases of invalidation of the contest.
The contest is considered to be invalid if:
6.4.1. one application for participation in the competition on the subject of the competition was submitted;
6.4.2. only one application for participation in the tender on the subject of the tender meets the requirements.
6.4.3. the EC has come to the conclusion that according to the results of the competition (selection) the winner can not be determined, due to the fact that the submitted applications or submitted materials do not meet the requirements of the competition (selection), the relevant competition (selection) is considered to be failed.
7. Summing up, awarding the winners of the GxP-Fest and the procedure for issuing the prizes
7.1 Information about the winners and prize-winners shall be placed on the GxP-Fest official web-site upon completion of the contests.
7.2 Awarding of winners and prize-winners of the contests of the Festival is performed on April 21, 2023, during the final stage of GxP-Fest, in person for teams, and online through the Internet for individual Participants.
7.3 The Organizer reserves the right to allocate special prizes to winners and/or Participants, as well as to introduce additional nominations.
7.4 Awarding the winners and prize-winners of the competition among the student teams - Participants of the GxP-Fest:
7.4.1 Based on the results of the contest in accordance with the decision of the EC, three prize places are assigned - first, second and third with the awarding of diplomas of winners and prize-winners of GxP-Fest and a cash prize of the Academy in the following amounts (before payment of all applicable taxes and fees):
I place - 80,000 rubles;
II place - 60 000 rubles;
III place - 40 000 rubles.
7.4.2 The basis for determining the recipient of the cash prize is publication of the corresponding order of the Academy following the results of the final stage.
7.4.3 The cash prize for students - members of the teams of winners and prize-winners of the Festival, is paid to the team captain on the basis of a simple power of attorney signed by all team members and containing the data of the team captain necessary for money transfer. The basis for payment of the prize is an order of the executive director of the Academy and an agreement with the captain of the team that won at the GxP-Fest competitive events.
7.4.4 The cash prize shall be paid on the basis of the contracts with regard to the requirements stipulated in these Regulations.
7.4.5 The members of the winning and prize-winning teams of the Festival have the opportunity, in accordance with the established schedule, to take a week-long educational course "Current aspects of Good Manufacturing Practice (GMP)" at no charge (100% discount) with the issuance of a certificate.
7.4.6 All GxP-Fest participants who participated in the final stage of the competition are sent electronically (in some cases - handed out) certificates confirming their participation in the Event and prizes (if any).
7.4.7 Letters of appreciation are sent to the universities where the winners study.
7.4.8 The winners' portfolios are given to pharmaceutical companies for priority employment.
7.5 Awarding the winners among the individual GxP-Fest Participants (in Russian):
7.5.1. Five winners of the individual GxP-Fest in Russian who have collected the maximum number of points receive certificates of GxP-Fest winners, as well as the opportunity to study a week-long educational course "Current aspects of Good Manufacturing Practice (GMP)" at no cost (100% discount) with the issuance of the Academy certificate.
7.5.2 All individual Participants of GxP-Fest who participated in the final stage of the competition are sent electronically (in some cases - handed over) certificates confirming their participation in the Event.
7.5.3 Letters of appreciation are sent to the universities where the winners study.
7.5.4 The portfolios of the winners of the individual competition are transferred to pharmaceutical companies for priority employment.
7.6 Awarding the winners of the competition among the individual GxP-Fest participants (in English):
7.6.1 The five winners of the individual GxP-Quest in English who score the maximum number of points receive GxP-Fest Winner Certificates.
7.6.2 All individual participants of the GxP-Quest in English are sent electronically certificates confirming their participation in the Event.
7.6.3 Letters of appreciation are sent to the universities where the winners study.
7.7 Awarding the winners of the creative photo contest
7.7.1 The participants of the creative competition who take the first, second and third places according to the results of the competition are awarded with a diploma and a valuable gift.
7.8 The prize fund is determined by the Organizer and cannot be challenged.
7.9 If the winner or winners of GxP-Fest evade signing and executing the agreement regulating the procedure for exercising their right to the award, they shall be deemed to have forfeited their right to it. If there is such an opportunity, the Organizer shall transfer the right to award to the next one in the list of GxP-Fest participants, based on the maximum number of points accumulated and after the EC has confirmed the compliance of the contest work with all the conditions of the Regulations.
7.10. In the event that two or more Participants share the prize by the decision of the EC, the cash prize shall be shared between these Participants in equal shares.
7.11. The certificate, special prizes or other incentives other than cash prizes may not be substituted for the cash payment.
7.12. If within 2 months from the date of notification of winners and prize-winners of competitions about the necessity to submit documents for payment of cash prizes, GxP-Fest Participants do not submit such documents, then no further cash prize payment shall be made and no claims of the Participants in this respect shall be accepted.
7.13. Prizes from pharmaceutical companies based on the results of their competitions for students are awarded to the winners by representatives of pharmaceutical companies. The type of prizes from pharmaceutical companies is determined by the organizations themselves.
8. Copyright and personal data
8.1 GxP-Fest participants, when applying for participation in the Event and participating in GxP-Fest, declare that they are the authors of the materials provided as contest entries and that they are unaware that their actions violate the copyrights and other rights of third parties. Participants of GxP-Fest are fully responsible for observance of copyrights and other rights of third parties, including responsibility for actions of fraudulent nature in case of deception (forgery) in order to receive a prize. Contest works are not published during the Gxp-Fest and may not be available to other Participants.
8.2 By applying for participation in GxP-Fest and participating in GxP-Fest, GxP-Fest participants authorize the Organizer to publish information about their participation in GxP-Fest and its contests.
GxP-Fest participants, by applying for participation in the GxP-Fest and participating in the GxP-Fest, thereby give the Organizer and the persons engaged by it to organize the Event a specific, informed and conscious permission to process [1] their personal data, according to the Academy personal data processing policy - https://gxp-academy.org/policy/, to the extent of the personal data actually transferred to the Organizer. The purpose of the processing of personal data by the Organizer and the persons engaged by it (if necessary) to organize the GxP-Fest: organization and conduct of the GxP-Fest and its contests.[1] Processing of personal data means any action (operation) or a set of actions (operations) performed with or without the use of automation with personal data, including collection, recording, systematization, accumulation, storage, clarification (update, change), extraction, use, transfer (provision, access), depersonalization, blocking, removal, destruction.