Overview of Pharmaceutical Strategy for Europe (2020) and enlightenment to China's pharmaceutical field.

Under the background of major innovations and changes in international pharmaceutical technology, the continuous development of informatization and digitalization of drug R & D, technology, and the COVID-19 pandemic, the European Commission (EC) issued the pharmaceutical Strategy for Europe (PSE) at the end of 2020 in order to meet the unfinished clinical needs, stimulate industry innovation, enhance the adaptability of the regulatory system, and consolidate the international status of the EC drug regulatory system. PSE is regarded as the "cornerstone" of European health policy in the next five years, which has important guiding significance for the development and management of European pharmaceutical industry. This paper combs and analyzes the background, development strategic objectives and specific measures of PSE, and puts forward policy suggestions in combination with the actual work of China's epidemic prevention and control and industry development, pharmaceutical scientific supervision and encouraging innovation.Copyright © 2022 by the Author(s).

A review on water-saving agriculture in Europe

This paper aims to analyze the research on the current situation of water-saving agriculture development in Europe. Water-saving agriculture in Europe started early, governments and farmers in various countries have a strong awareness of water-saving in agriculture and have achieved certain results. Due to the global spread of the COVID-19 pandemic, the lack of up-to-date field research, the complexity of various agricultural disciplines and categories, and the lack of information sharing, the current cognition of recent progress in the development of water-saving agriculture in Europe is not comprehensive enough. This paper selects four representative European countries: Spain, Germany, Italy, and Denmark as the research objects. Based on the existing research of Chinese and Western scholars, this paper analyzes and studies the current situation of water-saving agriculture in Europe. It has far-reaching significance for other countries in the world to have further development in water-saving agriculture and to protect water resources.

Emergencies in dental surgery during the COVID-19 pandemic

Introduction: Patients' negligence and difficult access to healthcare have an impact on the worsening of emergency conditions, which require immediate treatment due to the possibility of exacerbation in a short period of time. Untreated intra- and extraoral abscesses can have serious consequences on the patient's health and in many cases are life-threatening conditions increasing risk of respiratory obstruction, thrombophlebitis, meningitis, mediastinitis and septicemia. Background: The aim of this study is to investigate the impact of the pandemic and the resulting impediments to accessing medical care on the incidence and type of emergencies in the Oral Surgery Department. Material and methods: This was a retrospective study of 85375 patients aged 2 months to 90 years old with diagnosed intra- and extraoral abscesses before COVID-19 pandemic (2018,2019), and during pandemic (2020, 2021) in the Department of Oral Surgery of the Medical University in Lublin. The obtained results were statistically analyzed with the use of a computer program. Conclusions: The fewest patients were admitted in 2020, and the most in 2021, where we can already see the effects of the pandemic. Emergencies occurred most frequently in people aged 21-30, then 31-40. In 365 cases, tooth extraction was performed, and only in 28 cases, root canal treatment was attempted. Conclusions. Oral health service provision has been significantly affected by COVID-19. Patients came to their appointments too late, which in most cases resulted in the necessity of tooth extraction without attempting root canal treatment.

Being a product consumer during the COVID-19 pandemic: profile of the Polish consumer in the organic dairy market

PurposeThe purpose of this paper was to determine the profile of dairy product consumers in the organic market.Design/methodology/approachThe study was based on a survey questionnaire developed by the author and administered to a total of 1,108 respondents. The statistical analysis (including descriptive statistics, the analysis of the discriminative function and the Chi2 test was performed with the use of Statistica 13.1 PL. The respondents' gender was the factor behind the differences in how they behaved.FindingsThe consumers indicated the channels they rely upon to find information on organic dairy products;in addition to trusting the opinions of their family members and experts, they also use web platforms. Further, they specified their preferred locations for buying favorite products during the pandemic: specialized organic food shops, large distribution chains and online stores.Practical implicationsThese outcomes will help in identifying target consumer segments and information channels for specific information and advertising messages. They also form an important resource for developing some potential strategies which the supply chain stakeholders could implement to promote organic consumption of dairy products.Originality/valueThis study identifies consumers' preferred dairy products;motives for purchasing organic dairy products;barriers that consumers believe exist in the market;sources of knowledge about products purchased by consumers;and consumers' preferred channels for purchasing organic dairy products. To the best of the author's knowledge, this is the first study of dairy product consumers in the organic market in Poland.

Economy and diversity of aquaculture production in Bulgaria: status and trends

Aquaculture production in Bulgaria has increased over the last decade, reaching 16 442 tonnes in 2019. Fish production has doubled in comparison with 2007, while that of mussels has increased tenfold. The Bulgarian contribution to EU aquaculture production has been increasing significantly in both volume and value over the years, making up 1.15% of the volume and 1.0% of the value of EU production in 2019. Freshwater aquaculture accounts for 78% of total production. Common carp dominates with about 29.4% (4836 t), followed by rainbow trout with 29.2% (4820 t) in 2019. The cultivation of sturgeon species and caviar production are among the most dynamically developing aquaculture segments. Mariculture in the Black Sea has increased in recent years, with the production of Mediterranean mussel reaching 2932 tonnes in 2019. An average of 405 farms operated during the period 2010-2019. Four regions (Plovdiv, Stara Zagora, Burgas and Montana) account for 50% of the total fish production. Pond aquaculture is the dominant technology used in Bulgaria, and it serves as the basis for numerous other activities, including management of fish stocks in various water bodies mainly for recreational fishing. Approximately 35 net-cage farms currently operate in bigger dams. Recirculating fish farms output made up only 0.15% of the total amount of aquaculture for the period 2010-2019. The aquaculture sector exhibited difficulties in recovering from the financial crisis of 2007-2008, manifested by a slow growth for the period 2010-2014. From 2015 to 2019 there has been a significant growth, manifested in a sharp increase of total revenue and profitability, especially among the larger enterprises in the sector, as well as an increase in the number of employees, and the labour productivity. As a result, in 2019 the registered total revenue per enterprise and total revenue per employee were more than double the respective figures for 2010. The profits of larger enterprises increased more than three times on average, but smaller entities, micro-enterprises with less than 5 employees, operated at the border line between profit and loss. The COVID-19 crisis could have lasting consequences. Despite EUR 1.2 million direct payments in the sector in 2020, there has been a significant drop in the export of aquaculture products. Consumption of fish and other aquaculture products remains low compared to those in the other EU countries.

Consumers' fear regarding food security in Slovenia during the first wave of COVID-19 crisis

The various crises are having a significant impact on the entire food sector and are changing the attitudes of Europeans as well as policies on the importance of food security and sustainably produced quality and safe food for consumer health. The paper focuses on the consumer's fear of food security for the time of the first wave of COVID-19 and the associated concern for food security in the future and the changes in consumer behaviour. The online survey in Slovenia was conducted in June 2020 using a "snowball" method. The sample included 490 individuals. The results showed that both measured forms of fear (i) fear over food security during the first wave of COVID-19 crisis, and (ii) fear over food security in the future were statistically significant, moderately strong and positively associated with almost all forms of self-perceived behaviour change caused by the COVID-19 crisis. The respondents focused more on buying locally produced and processed food, food stockpiling and decreasing food waste. Only minor changes were expressed with regards to their food purchasing channels, with the elderly, the highly educated and those who classified themselves in a higher social class buying more often directly from farmers. In the future, the results of this research should be compared with other countries and the impact of an individual's economic situation and the impact of promotional campaigns on agricultural products on changing consumer behaviour should also be analysed in more detail.

Risk factors for COVID-19 incidence and mortality in patients on maintenance hemodialysis

Patients on maintenance hemodialysis (MHD) are highly susceptible to SARS-CoV-2 and with high mortality rates due to Coronavirus disease 2019, mainly because of the older age in this group of patients, comorbidities, compromised immune status due to uremia, as well as inability to keep social isolation because of the necessity for regular physical presence in dialysis facility. Several retrospective studies of patients on MHD in Europe, America and Asia, show high susceptibility to SARS-CoV-2 in this group of patients with very high rates of critical course of the disease and high mortality rates, reaching more than 40% The aim of this retrospective observational study was to identify risk factors among patients on intermittent hemodialysis for infection with SARS-CoV-2 as well as predictors of severe COVID-19 and fatal outcome. Materials and methods. We analyzed 69 patients receiving intermittent dialysis in Aleksandrovska University Hospital - Hemodialysis Unit. 34 of them have been tested positive for SARS-CoV-2 in the period from September 2020 (when the first case of the disease was registered for our dialysis center) up to March 2022, and are compared with a control group of 35 dialysis-dependent patients without COVID-19. Data about comorbidities, main laboratory and radiologic findings, need of hospitalization and treatment in ICU, as well as data for conducted treatment, are collected from electronic medical records. To identify predictors of severe COVID and poor outcome we compared the group of survivors with the one of non-survivors. Results. There are no significant differences between patients on MHD with and without COVID-19 except higher frequency of COPD and hypoproteinemia in the positive group. Older age, female gender, history of smoking, lymphopenia with neutrophilia, treatment in ICU and need of mechanical ventilation, signs of malnutrition - hypoproteinemia and lower levels of serum creatinine, are risk factors for severe disease and fatal outcomes. Conclusions. The course of COVID infection in dialysis-dependent patients is severe and with high mortality rate, in line with other studies worldwide. Malnutrition is the main risk factor for COVID and also main predictor for poor outcomes.

- Legalapproaches to the regulation ofmigration processesin the EuropeanUnion dna blio-i bliogphy UlirhcAPI), iicbueca . z itvo NilMary Fa-Huto.n?s PhoiDeco lail.@gpoas U i o

Cuestiones Politicas IEPDP-Facultad CdeidJutarcu Enitrte Hutamaasociay, laiidttrmes;froondnccun, iltueso locnavsu loslsccuas UBSTA Re Bib gra Po Peir nes OIRALITH Using an interpretative methodology, the article examines approaches to the regulation of migrationE dp rocesses in the light of the increasing flow of immigrants to the European Union EU. Maria In this context, two main directions of regulation of migration processes are considered: legal regulation and integration measures. It can be concluded that the international legal regulation of migration processes in the EU is based on adopted and ratified declarations, Reittaesv dtadeilu conventions, covenants and protocols, which form a general international DrHter legal basis for the regulation and management of migration processes at the hiloiiromc interstate level. Accordingly, the analysis of migration legislation and state border legislation allows distinguishing three types of documents according to their content, which are related to the fight against irregular migration: a) regulatory legal acts determine the model of legal entry and stay of a migrant on the territory of the country;b) law enforcement rules establish responsibilities and regulate the application of other coercive measures in case of violation of migration rules, and;c) documents of organizational content determine the competence of the authorities involved in the process of combating illegal immigration. de C a u E a u v i ALITH e M i th H loic

Opening Up Opportunities in 2023

"The ongoing journey to standardization on more aspects of submission and data exchange will continue to have an impact," he notes. lan Crone, business unit director Europe-fme Life Sciences, which provides business and technology services, points out that the web-based human variations electronic application form (eAF) for centrally authorized products (CAPs) has been available for use since 4 Nov. 2022 on the European Medicines Agency's (EMA's) new product lifecycle management (PLM) portal. Renato Rjavec, Amplexor Life Sciences "Many biopharmaceutical functions have spent the last decade modernizing their base technologies, most often in a cloud/software as a service environment platform that brings foundational benefit to individual functions," states Steve Gens managing partner. Internal productivity and external regulatory requirements are both driving this data connectivity within industry, he adds, which "requires a clear cross functional digitization strategy and focus on cross-functional data governance, master data management, and ensuring all data from these various authoritative systems [are] at the same high level. " "Many biopharmaceutical functions have spent the last decade modernizing their base technologies, most often in a cloud/ software as a service environment platform that brings foundational benefit to individual functions." -

Keeping Europe's Medicines Stocked

[...]best-in-class pharma companies are focusing on reliability and resilience in the supply chain-if they can't make a product or deliver a product on time, a patient is not served, and no sale is made. People can scale to a certain degree but scaling by a factor of 100 is not possible with people in a short period of time and does not deliver on economies of scale. Pharma companies are also issuing 'green bonds' where investors can expect the contribution of capital to improve the company's sustainability.

Connecting the Dots for Pharma

A major driver for innovation within the bio/pharma sector has been the COVID-19 pandemic, which propelled advances such as the approval of messenger RNA (mRNA) vaccines at record-breaking speeds and led to many companies pivoting to deal with the urgent requirements for capacity and supply chain flexibility needed to overcome pandemic challenges. "Before deciding on a location, we conducted extensive market research, and it quickly became clear, just by the sheer proximity of so many biopharmaceutical companies, associations, and research centres, that the event had to be in Geneva. Organized as four half-days, they will each address a theme related to the four main areas of the supply chain present in the exhibition area: pharmaceutical packaging (primary and secondary), medical devices, pharmaceutical sub-contracting, and pharmaceutical equipment. The dream scenario, the real measure of success, is when a product comes to market that happened as a result of a meeting or discussion that took place at our event.

Cold Comfort for Bio/Pharma

The COVID-19 pandemic highlighted how vital cold chain is for the pharmaceutical industry, particularly as some vaccines needed to be produced, transported, and stored at -70 °C. Market projections for cold chain logistics of pharmaceuticals are projected to grow at a compound annual growth rate of 9.03% by 2025, which is reported to be driven by greater global demand for pharmaceuticals, increasing initiatives to promote cold chain, and more demand for reefer containers from the pharma industry (1). Gilmore (Tower Cold Chain): Putting the European success of the COVID-19 vaccine rollout to one side, the demand for effective temperature-controlled packaging solutions in the pharmaceutical supply chain has increased significantly in recent years. Today, the cold chain is grappling with additional challenges: serving a global market, driving out costs and waste, addressing capacity and resource constraints, and dealing with continually mounting regulations-all whilst handling valuable pharmaceutical cargo. Cold chain logistics providers must invest in the latest on-board equipment built into containers to track temperature and location, and to make data available to partners and customers in real time, to prevent or mitigate loss.

Changes Afoot: 2022 Outlook for Pharma and its People

[...]we've seen more companies diversifying their portfolios and investing in therapies for rare diseases so that advanced therapies, and in particular, gene therapies-which were deemed experimental and risky when I was involved with the European Medicines Agency's Committee for Advanced Therapies some 10-12 years ago-take centre stage," Schneider continues. The year's expectations were unsurprisingly centred around COVID-19 for Martin Lush, global vice president. "Many big pharma companies will continue down the path of externalising services for small molecules and/or known molecules maintenance, to keep their focus on novel molecules," she explains. [...]of this complexity, there can be much negotiation and, hence, delay in access to medicines, he explains.

Building Up to a Bright Future

Dissolution testing is an integral part of pharmaceutical development, providing drug companies with the analytical ability to determine the efficacy, bioequivalence, and bioavailability of the active drug substance, as well as control quality, stability, and consistency of the final drug product. [...]there is also a shift in focus to more novel and personalized dosage forms that is happening within the bio/pharma industry, requiring modifications to many different areas of drug development and manufacturing, including dissolution testing, Spisak added. Novel formulations can pose challenges when using standard apparatus;nanoparticles, for example, are not necessarily sufficiently separated from the dissolution medium with standard techniques. [...]modification of the instrumentation, such as that found in Agilent's NanoDis system, is required to ensure an accurate prediction of in-vivo performance of the drug product can be made.

The Outlook for a Year of Change

"The coronavirus pandemic has highlighted the vital need to strengthen our health systems," said Ursula von der Leyen, president of the European Commission (EC) in a press release on the strategy's publication (1). [...]O'Sullivan continues, many pharma companies have already started taking steps to localize supply chains, which is a trend he believes will become permanent. According to Coleman, industry has not only survived but has thrived in this aspect, demonstrating the ability to audit sites from different continents, collaborating effectively with partners from all over the world, and trusting the workforce to get the job done in a remote capacity. [...]online learning tools have surged in popularity, Raposo continues.

Demonstrating the Value of Collaboration

[...]of the search for effective vaccines and treatments for COVID-19 being a priority, the development and manufacture of other treatments have been delayed, he adds. Through these industry collaborations, many developers have gained benefits, such as reduced time-to-market for new products, he specifies. [...]Quick believes that there will be more companies leaning towards outsourced services in the future, for development work and commercialization phases too. Given the disruption to the global pharmaceutical supply chain that has been experienced during the pandemic, O'Sullivan predicts that there will be opportunities for API suppliers in Europe, and elsewhere, to prosper from increased local demand, so long as the capacity and flexibility to deliver the required quantities are on available. [...]we will see significant investment by European API suppliers in expanded production capacity and capabilities in 2021 in order to attract Europe-based customers on the look-out for new local partners," he says. [...]Cruz emphasizes the rise of electronic health and customer records across Europe as an exciting prospect, particularly as it can lead to companies gaining a greater insight into treatments and customer needs.

Coming Up to ISO IDMP Standards

A revised series of standards from the International Organization for Standardization (ISO), the identification of medicinal products (IDMP), were formulated for the creation of an integrated global data source for medicinal products (1). From an International Council for Harmonization (ICH) perspective, the standardized product identification would be able to support multiple processes, but in the EU, new legislation came into force in 2016 concerning data submission on authorized medicines, to primarily optimize connection of pharmacovigilance (PV) signals to products. ingredients, batches, and so on, using standardized data, replacing the existing Article 57 database. XEVMPD provides for more limited data fields than are required for IDMP submissions, but it has paved the way for data exchange as a means of product information delivery and discovery, reducing reliance on static documents. Making a fundamental change to regulatory information management approaches now, then, is likely to pay dividends in the long run-once multiple documents can be built from one definitive data set based on agreed international standards.

Making Every Effort

While the majority of the world is in isolation to try to slow the spread of the virus responsible for COVID19, companies and regulatory bodies in the bio/pharma industry are facing numerous challenges and committing significant efforts to support the development of novel therapeutics and monitor supply chains. Some notable drugs and vaccines for COVID-19 in development are: * Messenger RNA vaccines, from CureVac and BioNTech, are in preclinical stages. * Remdesivir, from Gilead Sciences, originally developed to treat Ebola, is in Phase III clinical trials. * SNG001, from Synairgen Research, is an inhaled formulation of interferon-beta-1a that is entering Phase II clinical trials. * Chloroquine and hydroxychloroquine are currently being investigated in clinical trials and are being donated by various companies for evaluation. The emptying of the shelves can be attributed to the, as of yet unproven, link with the drug having efficacy in the treatment of COVID-19. [...]in this current climate, it is imperative that pertinent scientific information that can be of reassurance and informative be disseminated with due diligence and care.

Learning Regulatory Lessons in Times of a Crisis

The bio/pharma sector is an industry that has probably been most affected by the pandemic, not only is there an expectation for bio/pharma companies to step up and develop appropriate treatments quickly, resulting in regulatory flexibility and unprecedented collaborations, but there have also been concerns around supply chain security. Agencies have prioritized protocol consultations, shortened the timelines for clinical trial application review and approvals, and there is some focus on implementing fast-track and priority review processes for the evaluation of marketing authorization applications. Marton (Arriello): Authorities that have more experience in evaluation of data adapted quickly, while other authorities, such as those in the Commonwealth of Independent States area, stopped all activities for a period of time or adapted along the way. Gross (ProductLife): There is already some cooperation between the US and Europe, especially in the regulatory development process and in the evaluation process, so it's possible the current situation could reinforce those efforts and lead to some further joint assessments for clinical trial protocols and marketing authorization reviews.

The COVID-19 Vaccine Blind Spot

According to a global survey undertaken by Ipsos, the number of people who would be vaccinated with a COVID-19 vaccine outweighs the number who wouldn't in most countries, but some European countries ranked quite low in terms of public confidence in vaccine safety (5). [...]overcoming misgivings and improving confidence in vaccination programmes are of critical importance to ensure overall success. [...]this complacency may be a result of the eradication of certain diseases, such as polio and smallpox, which could lead to forgetfulness as to how vaccines are effective tools in epidemics.