European legal framework of rural development policy

New social demands, opportunities in the green economy, opportunities opened up by digital technology, and the consequences of the COVID-19 pandemic and the spread of remote work have again drawn attention to rural areas. In 2020, the European Commission conducted a public consultation on the long-term vision for rural areas. Support for rural areas is already provided under several EU policies, which contributes to their balanced, fair, green and innovative development. To support the implementation of the action plan, the common agricultural policy (CAP) and the cohesion policy will be of particular importance, which will be accompanied by a whole range of policies from other areas. The aim of this paper is an analysis of the EU legal framework of rural development policy, together with an analysis of the further development of the LEADER approach. Finally, a special focus is placed on the analysis of documents (long-term vision for the EU's rural areas) that deal with the future of rural development in the EU.

First Patient Reports in Montenegro

Introduction: In August 2020, the new Law on Medicines was adopted in Montenegro, which for the first time allows patients to report suspected adverse drug reactions (ADRs) directly to the Institute for Medicines and Medical Devices (CInMED) [1]. According to the experience of many countries, patient reports are an important source of information on the safety of medicines [2, 3, 4]. Objective(s): Analyze reports submitted to CInMED by patients Methods: A retrospective analysis of reports submitted by patients from August 2020 to May 2022 was performed. Reported ADRs were coded using the appropriate Lowest Level Term (LLT) of the Med- DRA. Results were analised at MedDRA Preferred Term (PT) level. Important Medical Events (IME) list was used in assessing seriousness of cases. Descriptive statistics were used. Result(s): All reports submitted by patients were valid. In the mentioned period, patients submitted 45 reports, which contained 200 reactions (4.4 reactions per report). Of these, 40 reports (88.9%) were related to adverse events following immunization (AEFIs) with COVID-19 vaccines. This represents 9.1% of the total number of reported AEFIs for COVID-19 vaccines in Montenegro. The majority of patient reports (32;71.1%) were submitted via the eReporting module for VigiFlow [5]. Women submitted 28 (62.2%) reports, and men 17 (37.8%). Reports were mostly submitted by adult patients, 18-64 years old (34;75.5%). A total of 8 (17.8%) reports described serious adverse reactions. In 14 (31.1%) cases, a follow-up request was made and patients provided additional information. Although the majority of reported adverse reactions were expected, 72 of 176 (40.9%) reactions to COVID-19 vaccines reported by patients were unexpected-not listed in the relevant Summary of Product Characteristics at the time of reporting (e.g. chest pain, chest discomfort, arrhythmia, face oedema, hypoaesthesia, musculoskeletal stiffness, pain in extremity). Conclusion(s): Patient reports are of good quality. Patients prefer the electronic way of reporting and are willing to answer follow-up inquiries. Patient reports are valuable source of new information on the safety of medicines and can be precious for signal detection, especially when it comes to new medicines. Further promotion of patient reporting and cooperation with patient associations are needed to increase the number of patient reports.

First Patient Reports in Montenegro: An International Journal of Medical Toxicology and Drug Experience

Introduction: In August 2020, the new Law on Medicines was adopted in Montenegro, which for the first time allows patients to report suspected adverse drug reactions (ADRs) directly to the Institute for Medicines and Medical Devices (CInMED) [1]. According to the experience of many countries, patient reports are an important source of information on the safety of medicines [2, 3, 4]. Objective: Analyze reports submitted to CInMED by patients Methods: A retrospective analysis of reports submitted by patients from August 2020 to May 2022 was performed. Reported ADRs were coded using the appropriate Lowest Level Term (LLT) of the MedDRA. Results were analised at MedDRA Preferred Term (PT) level. Important Medical Events (IME) list was used in assessing seriousness of cases. Descriptive statistics were used. Results: All reports submitted by patients were valid. In the mentioned period, patients submitted 45 reports, which contained 200 reactions (4.4 reactions per report). Of these, 40 reports (88.9%) were related to adverse events following immunization (AEFIs) with COVID-19 vaccines. This represents 9.1% of the total number of reported AEFIs for COVID-19 vaccines in Montenegro. The majority of patient reports (32;71.1%) were submitted via the eReporting module for VigiFlow [5]. Women submitted 28 (62.2%) reports, and men 17 (37.8%). Reports were mostly submitted by adult patients, 18-64 years old (34;75.5%). A total of 8 (17.8%) reports described serious adverse reactions. In 14 (31.1%) cases, a follow-up request was made and patients provided additional information. Although the majority of reported adverse reactions were expected, 72 of 176 (40.9%) reactions to COVID-19 vaccines reported by patients were unexpected-not listed in the relevant Summary of Product Characteristics at the time of reporting (e.g. chest pain, chest discomfort, arrhythmia, face oedema, hypoaesthesia, musculoskeletal stiffness, pain in extremity). Conclusion: Patient reports are of good quality. Patients prefer the electronic way of reporting and are willing to answer follow-up inquiries. Patient reports are valuable source of new information on the safety of medicines and can be precious for signal detection, especially when it comes to new medicines. Further promotion of patient reporting and cooperation with patient associations are needed to increase the number of patient reports.

Market Segmentation in the Film Industry Based on Genre Preference: the Case of Millennials

One of the industries that has been hit the most by the Covid-19 is the film industry. Practitioners and experts in the field are in need to better understand the changed consumers and their new behaviour so that they can adequately communicate with them. The population segment which attracts the most attention are the Millennials due to the fact they have a high level of self-interest, they mix streaming services, and their purchase intention building is much slower compared to other generations. This study aimed to propose a segmentation approach in the film industry based on genre preference. To verify the proposed approach, an online survey on consumer habits and attitudes towards different elements of film marketing mix was conducted at the beginning of the Covid-19 lockdown in Serbia. Upon that, biclustering algorithm was employed to segment the respondents. Finally, similarities and differences between retained segments were explored, which provided insights on which elements of film (elements of product, Word of Mouth, Frequency of consumption, and elements of promotion) respondents pay attention to based on their genre preference. The observed similarities and differences led to the creation of tailored communication strategies for each segment, which could improve the effectiveness of marketing activities in the film industry during the Covid-19 era, and could be extended in the post-Covid era. © 2022, Kauno Technologijos Universitetas.

Development of a Model for Evaluating the Efficiency of Transport Companies: PCA-DEA-MCDM Model

The efficiency of transport companies is a very important factor for the companies themselves, as well as for the entire economic system. The main goal of this paper is to develop an integrated model for determining the efficiency of representative transport companies over a period of eight years. An original model was developed that includes the integration of DEA (Data Envelopment Analysis), PCA (Principal Component Analysis), CRITIC (Criteria Importance Through Inter criteria Correlatio), Entropy and MARCOS (Measurement Alternatives and Ranking according to the COmpromise Solution) methods in order to determine the final efficiency of transport companies based on 10 input-output parameters. The results showed that the most efficient business performance was achieved in the period 2014-2017, followed by slightly less efficient results. Then, extensive sensitivity analysis and comparative analysis were performed, which confirmed, to some extent, the previously obtained results. In the sensitivity analysis, 30 scenarios with changes in the weights of criteria were created, while the comparative analysis was carried out with three other MCDM (Multi-Criteria Decision-Making) methods. Finally, the rank correlation index was determined using the Spearman and WS (Wojciech Salabun) correlation coefficients. According to the final results, very efficient years can be separated that can be the benchmark for furthering the business.

ORAL MANIFESTATIONS IN PATIENTS INFECTED WITH COVID-19

Introduction:In addition to the characteristic clinical picture of respiratory infection, patients with COVID-19 can also be diagnosed with oral manifestations.Aim: The aim of this study was to review current literature for the prevalence of changes in the oral cavity i.e., the presence of oral symptoms in patients with COVID-19, in order to indicate that oral manifestations may occur due to viral infection with SARS-CoV-2.Methods: Important information relevant to the study was obtained by searching the available electronic PubMed and Google Scholar database.Results: Oral lesions were found in different locations in patients with COVID-19: tongue mucosa (dorsum and lateral sides of the tongue), buccal mucosa, hard and soft palate, inner lip and gingiva. The most common were ulcerations in different parts of the oral cavity. It is still unclear whether oral lesions in SARS-CoV-2 virus infection were a consequence of the primary effect of the virus itself or a secondary manifestation of the infection. The high presence of angiotensin-converting enzyme 2 in oral epithelial cells of the tongue and salivary glands indicates that the oral cavity may be particularly susceptible to SARS-CoV-2 infection. Taste disorder is the most common oral symptom in patients with COVID-19.Conclusion: Oral lesions, xerostomia, taste disorders can occur in patients diagnosed with COVID-19. Therefore, a comprehensive intraoral examination is necessary in order to determine changes in the oral cavity and apply proper treatment © 2021. Medicinski fakultet Niš. Klinika za stomatologiju Niš. Sva prava zadržana

Spontaneously Reported Adverse Events Following Immunisation with Sputnik V Vaccine in Montenegro: An International Journal of Medical Toxicology and Drug Experience

Background/Introduction: Sputnik V (Gam-Covid-Vac, Gamaleya Research Institute of Epidemiology and Microbiology) was the first vaccine against Covid-19 available in Montenegro [1]. The vaccine was not registered in Montenegro, but it was imported in line with the Government's decision on medicines supply during the pandemic. In February and March 2021, 7000 doses of the Gam-Covid-Vac Component I and 7000 doses of the Gam-Covid-Vac Component II were imported. Objective/Aim: To assess safety profile of the vaccine. Methods: All Adverse Events Following Immunisation (AEFIs) related to Sputnik V received by CInMED until 15 June 2021 were coded using appropriate Lowest Level Term of the MedDRA (version 24.0) and analysed. Results are presented at MedDRA Preferred Term (PT) level. Follow-up information was requested as needed for the sake of clarification and obtaining data on the outcome. Descriptive statistics were used. Results: In total, 218 reports describing 746 adverse reactions were received. Majority were reported by physicians (215;98.6%). One case (0.5%) was reported by a pharmacist, and two by patients (0.9%). Only 7 (3.2%) reports were related to older patients (C 65 years), while in one case (0.5%) age was not reported. Four cases were assessed as Important Medical Events;no other serious cases were recorded. Out of the 218 reports, 188 described 636 reactions related to Gam- Covid-Vac Component I (27 reports per 1000 imported doses) and 30 described 110 reactions related to GamCovid-Vac Component II (4 reports per 1000 imported doses). Majority of reports concerning both Component I (147;78.2%) and Component II (23;76.7%) related to female patients. Most of the 188 reports received for Component I described reactions related to General disorders and administration site conditions (178;94.7%);Musculoskeletal and connective tissue disorders (84;44.7%), and Nervous system disorders (68;36.2%). The most frequently reported reactions for Component I are presented in Table. Similar distribution was noted for Component II. The number of linked cases describing AEFIs reported for the same patient after Component I and Component II was 18. Conclusion: No signal detected. No safety concerns raised based on spontaneously reported AEFIs. The most frequently reported AEFIs were in line with the available information on the safety profile of the Sputnik V vaccine [2, 3] and similar to those identified with other anti Covid-19 vaccines [4, 5]. Due to small number of doses only frequent AEFIs could be detected.