European Communities

Procedural advice for orphan medicinal product designation: Guidance for sponsors

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Mercoledì, Aprile 3, 2024
Community, Reproduction, Letter, European Commission, European Communities, Inn, Patient, Agency, Translation, European Medicines Agency, Council, European, Deference, VSI, Marketing, Legislation, Certification, MHLW, Annex, European Economic Area, PDF, Public, Medication, Committee, Policy, Bibliography, EMA, CAT, COMP, SME, Language, Ministry, CHMP, Decision, Cisco Webex, Prevalence, Disease, Part, Classification, Regulation (European Union), Privacy, Commission, RTF, EEA, Sponsor, PMDA, FDA, Guideline, Diagnosis, Civil service commission, European Council, European Parliament, Recognition, Art, INN, Official Journal, Record, TEAMS, Mutual, Microsoft PowerPoint, ID, Pharmaceutical industry

Frequently asked questions ................................................................... 10

Key Points: 
    • Frequently asked questions ................................................................... 10

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 2/13

      1.

    • This Regulation lays down the procedure for
      the designation of medicinal products as orphan medicinal products and provides incentives for the
      development and placing on the market of designated orphan medicinal products.
    • The Regulation also
      establishes the Committee for Orphan Medicinal Products (COMP) within the European Medicines
      Agency (EMA), which is responsible for examining applications for orphan medicinal product
      designation.
    • As of 28 April 2000, the date this Regulation entered into force, sponsors have been able to
      submit applications for orphan medicinal product designation to the EMA.
    • Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 3/13

      2.

    • Objectives
      In examining an application for orphan medicinal product designation, the COMP will focus on
      determining whether the sponsor has established that the designation criteria are met, i.e.
    • To assist in the development of a policy on orphan medicinal products, an expert network will
      be built up by the Committee, with expert(s) identified as appropriate to be involved in the evaluation
      of applications for orphan medicinal product designation.
    • ?

      The complete application should include:

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 5/13

      Document

      Format

      General administrative and scientific information completed online via the portal.

    • Important:
      In preparing an application for orphan medicinal product designation, sponsors are requested to follow
      the Commission guideline (2022/C 440/02) on the format and content of applications for designation
      as orphan medicinal products.
    • Please refer to the Procedural advice on
      appeal procedure for Orphan Medicinal Product Designation (EMEA/2677/01 Rev.3).
    • The grounds for the

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 9/13

      appeal should be based only on the original information provided in the application for orphan
      designation.

    • ?

      The European Commission will enter the designated medicinal product in the Community Register
      of Orphan Medicinal Products.

    • General advice
      ?

      Full information on the procedure for orphan medicinal products designation is available on the
      EMA orphan designation website.

    • In accordance with Regulation (EC) No 141/2000 of 16 December 1999, the sponsor may submit an
      application for orphan medicinal product designation to the Agency at any stage of development of the

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 10/13

      medicinal product as long as the criteria for designation may be justified.

    • A request for orphan medicinal product designation may be made for
      a new orphan indication for an already authorised medicinal product.
    • Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 11/13

      Which are the sponsor?s options in case of negative outcome for orphan designation?

The macroeconomic effects of global supply chain reorientation

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Sabato, Febbraio 10, 2024
Bank, Control, Quarterly Journal of Economics, Literature, Deutsche Bundesbank, Reconstruction, COVID-19, Monetary policy, Medical classification, Aggregate, Interest, Hail, Motion, Organization, WT, Policy, Smith, Elasticity, American Economic Review, Information, CHiPs, Journal of Economic Perspectives, Reproduction, Tagliapietra, Culture, Journal of International Economics, Section 3, European Commission, Communication, B16, Shock, NTM, European Chips Act, SSC, PHT, B17, Classification, Common, Tradability, Bank of Italy, Congressional Research Service, NT, Central bank, Private, Exercise, NIU, Labour, PDF, Website, European Parliament, Terrorism, Employment, B10, SUBST, Agricultural economics, F62, RTK, Bank of England, European Central Bank, Calibration, Agriculture, Foreign policy, Semiconductor, International Monetary Fund, Research Papers in Economics, Outline, Council, Openness, Bias, Economic system, European Council, Public policy, Deutsch, Statistics, GDP, Real, American Economic Journal, Table, Journal, YT, EAGLE, Household, Grossman, Science, Conference, Journal of Comparative Economics, Horse, SSRN, TC, Consumption, REA, F13, Section 2, University, Section 5, Legislation, Money, NTD, Central Bank of Ireland, Language, Capital, University of Limerick, Intermediate, CBI, Caselli, Macroeconomics, Crowding, Technical report, B14, Tax, Civil service commission, Growth, Commission, UNCTAD, Optimism, Politics, PIM, PX, Work, Social science, JEL, Government, Automation, HTT, Quarterly Journal, Canadian International Council, ECB, XT, METRO, ELAS, Credit, Bolt, Research, European Communities, American Journal, ArXiv, Unilateralism, Lerner, Motivation, International, C6, Committee, Security (finance)

We analyse the macroeconomic

Key Points: 
    • We analyse the macroeconomic
      effects of supply chain reorientation through localisation policies, using a global dynamic
      general equilibrium model.
    • While arguments about comparative advantage, the potential forgone benefits of international specialisation and industry- and product-specific disruptions are familiar, there is less
      analysis on the macroeconomic effects of supply chain changes resulting from localisation policies.
    • The large sensitivity of the global economy to the recent supply chain shocks suggests that
      the international trade reconfiguration implied by localisation policies could also have sizable
      impacts on key macroeconomic variables such as output, employment and inflation.
    • Thus, localisation focuses on the
      goods in our model most closely related to global supply chains.
    • Retaliation also attenuates any positive effects from
      reshoring on output and implies a reduction in the volume of overall international trade.
    • This finding calls for limiting the scope of reshoring, such as by focusing on vital goods that are
      most susceptible to supply chain disruptions.
    • Either that, or the economic costs are considered a worthwhile trade-off for an increase
      in security of supply, for example.
    • While arguments about comparative advantage, the potential forgone benefits of international specialisation and industry- and product-specific disruptions are familiar, there is less
      analysis on the macroeconomic effects of supply chain changes resulting from localisation policies.
    • Recent supply chain shocks have had large effects, with disruptions in 2021 estimated
      to have reduced euro area GDP by around two percent and doubled the rate of manufacturing producer inflation (Celasun et al., 2022).
    • To analyse this issue, we simulate a (partial) reshoring of production back to Europe in
      a global dynamic general equilibrium framework.
    • Thus,
      localisation focuses on the goods in our model most closely related to global supply chains.3 We
      model reshoring through a direct change to the export goods? production-function parameters.
    • Since reshoring
      effectively shortens the supply chain, the sum of markups along the chain falls.
    • This means that imports that are at the end of the supply chain (i.e.
    • In particular, our work relates to papers examining the potential for countries to reduce
      their exposure to global supply chains.
    • (2021) demonstrate that reduced reliance on foreign inputs does not mitigate pandemicinduced contractions in labour supply.
    • (2021) find no evidence of a relationship
      between global value chain integration and macroeconomic volatility.
    • This dynamic, along with factors such as natural disasters, climate-change
      induced volatility and terrorism mean that supply chain disruptions could be a new normal
      (Grossman et al., 2021).
    • Our work contributes to the literature providing dynamic general equilibrium analyses of
      protectionist policies, in particular those using global macroeconomic models to quantify trade
      policy changes.
    • (2008) analyse the effect of a rise in protectionism in response
      to rising global trade imbalances.
    • Linde? and Pescatori (2019) find that although the macroeconomic costs of a
      trade war are substantial, a fully symmetric retaliation is the best response.
    • (2020) consider a rich input-output structure and demonstrate that closer integration amplifies
      the adverse effects of protectionist trade policies.
    • Several recent studies have also examined the economic effects of a global trade fragmentation.
    • First, we modify a dynamic general
      equilibrium model of the global economy in order to analyse the transmission of localisation
      policies.
    • This allows for a comprehensive treatment of cross-border macroeconomic interdependences and spillovers between the different regions.
    • 4

      There is, however, substantial cross-country heterogeneity in terms of impact, with small open economies
      (SOEs) reliant on global supply chains more affected.

    • ECB Working Paper Series No 2903

      7

      Second, we are able to assess both long-run effects and the transition dynamics of localisation
      policies.

    • Our model contains a detailed monetary block and captures inflation dynamics, which is a key
      concern for supply chain reorientation.
    • Overall, our paper contains a careful analysis of the key aspects of the localisation debate,
      including effects of localisation on domestic competition and efficiency.
    • Section 2 provides a brief overview of the model, the modifications to examine
      global supply chain reorientation, some key details on the calibration and a brief discussion of
      the nature of our exercise.
    • (2020) for discussions of the relative strengths and weaknesses of
      trade and macroeconomic models in assessing large economic shocks.
    • 2.1

      Supply chain reorientation

      Our analysis focuses on imported inputs used to produce goods for export, as the introduction
      of localisation policies is in response to recent disruptions to global supply chains.

    • Since reshoring
      effectively shortens the supply chain, the sum of markups along the chain falls.
    • Further to
      these effects, engagement with global firms provides an opportunity for knowledge spillovers to
      local firms (Criscuolo et al., 2017).
    • This finding calls for limiting the scope of reshoring, such as by focusing on vital goods that are
      most susceptible to supply chain disruptions.
    • (B12)

      Adjusting the share of local inputs in export goods, of course, affects prices and quantities all
      along the supply chain.

REPORT on European historical consciousness - A9-0402/2023

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Mercoledì, Gennaio 3, 2024
Crime, Annex, Stanford University Press, Society, Risk, Woman, N/A, Student, Colonialism, Bulletin, Curriculum, European Communities, Culture, CERV, Work of Art, Art, Archive, Parliament, OJ, Communication, Victim, Council, European Heritage Label, Religion, Subjectivity, Politics, PPE, Aggression, Publication, European Education, Citizenship, Love, Knowledge, Commission, Left, Teaching, Gender equality, History, EUROCLIO, Stanford University, Racism, Nazism, International, Method, Anthropology, Time, Treaty, ECR, COM, Policy, Rapporteur, Learning, S&D, Research, Anarchy, Social, Thought, Orientation, Committee, Museum, Tourism

REPORT on European historical consciousnessCommittee on Culture and EducationSabine Verheyen Source : © European Union, 2023 - EP

Key Points: 


REPORT on European historical consciousnessCommittee on Culture and EducationSabine Verheyen Source : © European Union, 2023 - EP

Value Partners Launches the Group's First Article 8 UCITS* ESG Fund

Retrieved on: 
Martedì, Maggio 30, 2023
United Nations Sustainable Development Group, Investment fund, Foodservice, Food, Sustainable Development Goals, Undertakings for Collective Investment in Transferable Securities Directive 2009, Investment, European Commission Investment Plan for Europe, Central bank, Central Bank of Myanmar, Research, Central Bank of Ireland, Value Partners (asset management), UNSDG, Coronation Fund Managers, European, UCITS, European Communities, Growth, ESG, Fund, European Commission, Safety, Renewable energy, Security (finance)

It also marks the first HKSFC-authorized(1) Asia ex-Japan-focused food and nutrition thematic ESG fund.

Key Points: 
  • It also marks the first HKSFC-authorized(1) Asia ex-Japan-focused food and nutrition thematic ESG fund.
  • The Fund is managed by lead portfolio manager Norman Ho, Senior Investment Director, and co-managed with Lilian Cao, Investment Director.
  • Frank Tsui, Managing Director and Head of ESG Investment at Value Partners Group, said, "The launch of the Fund marks a major milestone of Value Partner' ESG franchise to leverage our robust proprietary ESG rating system to enhance and promote ESG practices in the region.
  • (3) The Fund is a sub-fund of Value Partners Ireland Fund ICAV (the "Company").

EMC Filtration Market worth $1.6 billion by 2028 - Exclusive Report by MarketsandMarkets™

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Martedì, Giugno 6, 2023
Telecom, Littelfuse, Federal Communications Commission, Heat, TE Connectivity, EMI, Lighting, TDK, Aerospace, European, EN, European Communities, End user, Region, Brad Laner, Automation, Noise, Radiation, Harmonic, Immunity, Council, Oil lamp, International Electrotechnical Commission, COVID-19, Electronics, TE, EMC, Air filter, Government, Filtration, Ecology, Polymer blend, Electricity, Power, Air handler, Electrical engineering technology, Federal, Conductor, Transmitter power output, Consumer electronics, Wood drying, Electric motor, Heating, ventilation, and air conditioning, Vertical, Others, Application, Health care, Automotive industry, Geography, Passive

This growing awareness encourages the adoption of EMC filters as a means to address and minimize these problems.

Key Points: 
  • This growing awareness encourages the adoption of EMC filters as a means to address and minimize these problems.
  • EMC filters product type to account for larger share of EMC filtration market in 2022.
  • EMC Filters accounted for a larger share of the EMC filtration market in 2021 and it is expected to remain dominant throughout the forecast period.
  • Increasing focus on considering electromagnetic compatibility to calculate the quality of electromagnetic products has accelerated the market potential for EMC filters.

EMC Filtration Market worth $1.6 billion by 2028 - Exclusive Report by MarketsandMarkets™

Retrieved on: 
Martedì, Giugno 6, 2023
Telecom, Littelfuse, Federal Communications Commission, Heat, TE Connectivity, EMI, Lighting, TDK, Aerospace, European, EN, European Communities, End user, Region, Brad Laner, Automation, Noise, Radiation, Harmonic, Immunity, Council, Oil lamp, International Electrotechnical Commission, COVID-19, Electronics, TE, EMC, Air filter, Government, Filtration, Ecology, Polymer blend, Electricity, Power, Air handler, Electrical engineering technology, Federal, Conductor, Transmitter power output, Consumer electronics, Wood drying, Electric motor, Heating, ventilation, and air conditioning, Vertical, Others, Application, Health care, Automotive industry, Geography, Passive

This growing awareness encourages the adoption of EMC filters as a means to address and minimize these problems.

Key Points: 
  • This growing awareness encourages the adoption of EMC filters as a means to address and minimize these problems.
  • EMC filters product type to account for larger share of EMC filtration market in 2022.
  • EMC Filters accounted for a larger share of the EMC filtration market in 2021 and it is expected to remain dominant throughout the forecast period.
  • Increasing focus on considering electromagnetic compatibility to calculate the quality of electromagnetic products has accelerated the market potential for EMC filters.

First Eagle Expands Offering of US Small Cap Strategy to Non-US Investors

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Mercoledì, Settembre 21, 2022
Professional Services, Finance, KIID, Eagle, Risk, First Eagle Investment Management, Sale, International Value Wine Awards, Acquisition, Trader, Undertakings for Collective Investment in Transferable Securities Directive 2009, Growth, Royce Investment Partners, EU, Person, Investment, United Kingdom, Solution, AUM, Market capitalization, European Communities, Marketing, UCITS, ICAV, Communication, First, Risk management, Security (finance), Bank, Financial adviser

First Eagle Investments (First Eagle) today announced it has expanded its portfolio offerings to non-US investors through the launch of its US Small Cap strategy within First Eagles Irish UCITS platform.

Key Points: 
  • First Eagle Investments (First Eagle) today announced it has expanded its portfolio offerings to non-US investors through the launch of its US Small Cap strategy within First Eagles Irish UCITS platform.
  • The sub-fund, which was seeded by First Eagle in February 2022, pursues an opportunistic small cap value strategy.
  • Subsequently, the Small Cap team added Trader/Analyst Mark Salamone and Analyst Connor Sheehy in October 2021 and July 2022, respectively.
  • Small cap stocks represent a particularly volatile and inefficiently priced segment of the US equity market, said Hench.

EMC Filtration Market worth $1,160 million by 2027 - Exclusive Report by MarketsandMarkets™

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Lunedì, Agosto 1, 2022
Knowledge, Row, Cobot, International Electrotechnical Commission, TDK, Equipment, Intelligence, European Communities, Immunity, Electricity, Council, TE, Electrical engineering technology, Component, Food, Commercial, EMI, Union, Government, Electronics, Research, EN, Institute, Federal, Filtration, USD, Robotics, CAGR, Adoption, Ecology, SME, Articulated vehicle, TE Connectivity, Federal Communications Commission, Littelfuse, Growth, Automotive industry, EMC, Automation, GEM, Noise, Marketing, Industry

CHICAGO, Aug. 1, 2022 /PRNewswire/ -- EMC filtration market is projected to grow from USD 861 million in 2022 to USD 1,160 million by 2027; it is expected to grow at a CAGR of 6.1% during the forecast period, according to a new report by MarketsandMarkets.

Key Points: 
  • CHICAGO, Aug. 1, 2022 /PRNewswire/ -- EMC filtration market is projected to grow from USD 861 million in 2022 to USD 1,160 million by 2027; it is expected to grow at a CAGR of 6.1% during the forecast period, according to a new report by MarketsandMarkets.
  • EMC Filters accounted for a larger share of the EMC filtration market in 2021 and it is expected to remain dominant throughout the forecast period.
  • Increasing focus on considering electromagnetic compatibility to calculate the quality of electromagnetic products has accelerated the market potential for EMC filters.
  • Industrial automation to hold high opportunities for EMC filtration market compared to other applications in 2022 and 2027.

EMC Filtration Market worth $1,160 million by 2027 - Exclusive Report by MarketsandMarkets™

Retrieved on: 
Lunedì, Agosto 1, 2022
Knowledge, Row, Cobot, International Electrotechnical Commission, TDK, Equipment, Intelligence, European Communities, Immunity, Electricity, Council, TE, Electrical engineering technology, Component, Food, Commercial, EMI, Union, Government, Electronics, Research, EN, Institute, Federal, Filtration, USD, Robotics, CAGR, Adoption, Ecology, SME, Articulated vehicle, TE Connectivity, Federal Communications Commission, Littelfuse, Growth, Automotive industry, EMC, Automation, GEM, Noise, Marketing, Industry

CHICAGO, Aug. 1, 2022 /PRNewswire/ -- EMC filtration market is projected to grow from USD 861 million in 2022 to USD 1,160 million by 2027; it is expected to grow at a CAGR of 6.1% during the forecast period, according to a new report by MarketsandMarkets.

Key Points: 
  • CHICAGO, Aug. 1, 2022 /PRNewswire/ -- EMC filtration market is projected to grow from USD 861 million in 2022 to USD 1,160 million by 2027; it is expected to grow at a CAGR of 6.1% during the forecast period, according to a new report by MarketsandMarkets.
  • EMC Filters accounted for a larger share of the EMC filtration market in 2021 and it is expected to remain dominant throughout the forecast period.
  • Increasing focus on considering electromagnetic compatibility to calculate the quality of electromagnetic products has accelerated the market potential for EMC filters.
  • Industrial automation to hold high opportunities for EMC filtration market compared to other applications in 2022 and 2027.

Esri Awards GIS Users for Improving Social, Environmental, and Economic Outcomes

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Mercoledì, Luglio 14, 2021
Networks, Internet, Data management, Technology, Software, Geographic data and information, Geography, Esri, Redlands, California, Earth sciences, Jack Dangermond, Esri International User Conference, Geographic information systems, GIS software

"This year's awardees have demonstrated how geospatial technology can transform operations and research that lead to better decision-making and outcomes," said Jack Dangermond, Esri founder and president.

Key Points: 
  • "This year's awardees have demonstrated how geospatial technology can transform operations and research that lead to better decision-making and outcomes," said Jack Dangermond, Esri founder and president.
  • We are proud to showcase the ways these organizations exemplify the use of GIS to innovate data sharing, sustainable growth, and social equity.
  • The Special Achievement in GIS (SAG) Award winners were also recognized at the 2021 Esri User Conference.
  • Esri honored individuals, groups, and institutions from across the globe in a dedicated awards section online .