The document proposes reforms to Greece's pharmaceutical pricing and reimbursement system. It suggests allowing "free" prices in the private market while maintaining government control over reimbursed prices. Pharmaceutical companies would pay rebates on reimbursed drugs. Reimbursement would be structured with tiers based on disease severity and treatment cost, introducing patient co-payments to incentivize cheaper options. The goals are improving access to medicines while reducing public spending on pharmaceuticals to 1% of GDP.
Pharma Maket Access - Southeast Europe & TurkeyZdravko Mauko
Key figures about pharmaceutical market access in southeast Europe and Turkey. Summary about market authorisations, pricing and reimbursement for Croatia, Serbia, Bosnia and Herzegovina, Macedonia, Kosovo, Albania, Bulgaria, Romania and Turkey
Kiriasis Savvas, EIPG Greek Delegate
Presentation at Malta Qualified Persons Association-European Industrial Pharmacists Group-University of Malta joint seminar “The Successes And Challenges Of Today’s Pharmaceutical Industry”, Malta 2008.
APIFARMA, the Portuguese pharmaceutical industry assocation, holds a series of conference throughout they year. OHE's Jorge Mestre-Ferrandiz, an expert on pricing and reimbursement (P&R) in Europe, was the lead speaker at the October 2014 conference on access to innovation. His presentation covers existing and potential approaches to evaluating new medicines as a condition for P&R in France, Germany and the UK.
Pharmaceutical pricing in european countries - Valérie Paris - 22-01-15Carlos Betancur Gálvez
Valery Paris, analista senior de Política Sanitaria, División de Salud, de la Organización de Desarrollo y Cooperación Económica (OCDE), ha destacado en su ponencia la importancia de considerar en la asignación de los precios de los medicamentos “los beneficios más allá del sector de la salud”, en referencia al coste de oportunidad y a otras variables económicas de lo que supone la entrada de un medicamento en un determinado mercado. París también ha señalado la dificultad de establecer una política común de asignación de precios en los diferentes países europeos: “Los países no siempre llegan a un acuerdo, por ejemplo, en el grado de innovación de nuevos productos”.
Drug prices and_market_access_across_europe_webcast_european_turmoil_2012IHS
The slides from the IHS Healthcare and Pharma webcast held on 15 November, 2012 titled European Turmoil 2012: A Review of Drug Prices and Market Access Across Europe
The document provides an overview of P&R systems in 5 European countries: Netherlands, Sweden, Poland, Italy, and Germany.
1. P&R processes typically involve regulatory approval, followed by reimbursement decisions based on factors like clinical benefit and cost-effectiveness, and then price negotiations.
2. Countries differ in their pricing approaches, with some like Netherlands using external price referencing and others like Sweden not directly negotiating prices.
3. Reimbursement criteria generally examine clinical value and budget impact, with an emphasis on cost-effectiveness. Reimbursement levels and conditions vary between countries.
The presentation summarises recent changes implemented or being discussed in pricing and reimbursement/HTA systems in France, Germany and the UK. In Germany and France, the emphasis of the recent reforms is centred around the evidence requirements and, in particular, the use of comparator and head-to-head trials. In the UK, however, VBP is about the weighting given to the evidence and the social value of a drug. Overall, emphasis is increasing on 'proving' innovation and/or an additional health benefit as a precondition for a price higher than competitors.
This document discusses pricing and reimbursement systems for pharmaceuticals in Germany and the Netherlands. It provides timelines for reimbursement processes, data requirements for dossiers submitted for assessment and reimbursement, how incremental clinical benefit is assessed, the role of health economics analyses, exceptions to rules, and implications. The key lessons are that incremental clinical benefit evidence from RCTs is crucial for successful reimbursement outcomes, health economics is gaining importance in Germany with new legislation, dossiers must be prepared well in advance, and following scientific advice can help optimize applications. Exceptions apply for orphan drugs in both countries.
Pharma Maket Access - Southeast Europe & TurkeyZdravko Mauko
Key figures about pharmaceutical market access in southeast Europe and Turkey. Summary about market authorisations, pricing and reimbursement for Croatia, Serbia, Bosnia and Herzegovina, Macedonia, Kosovo, Albania, Bulgaria, Romania and Turkey
Kiriasis Savvas, EIPG Greek Delegate
Presentation at Malta Qualified Persons Association-European Industrial Pharmacists Group-University of Malta joint seminar “The Successes And Challenges Of Today’s Pharmaceutical Industry”, Malta 2008.
APIFARMA, the Portuguese pharmaceutical industry assocation, holds a series of conference throughout they year. OHE's Jorge Mestre-Ferrandiz, an expert on pricing and reimbursement (P&R) in Europe, was the lead speaker at the October 2014 conference on access to innovation. His presentation covers existing and potential approaches to evaluating new medicines as a condition for P&R in France, Germany and the UK.
Pharmaceutical pricing in european countries - Valérie Paris - 22-01-15Carlos Betancur Gálvez
Valery Paris, analista senior de Política Sanitaria, División de Salud, de la Organización de Desarrollo y Cooperación Económica (OCDE), ha destacado en su ponencia la importancia de considerar en la asignación de los precios de los medicamentos “los beneficios más allá del sector de la salud”, en referencia al coste de oportunidad y a otras variables económicas de lo que supone la entrada de un medicamento en un determinado mercado. París también ha señalado la dificultad de establecer una política común de asignación de precios en los diferentes países europeos: “Los países no siempre llegan a un acuerdo, por ejemplo, en el grado de innovación de nuevos productos”.
Drug prices and_market_access_across_europe_webcast_european_turmoil_2012IHS
The slides from the IHS Healthcare and Pharma webcast held on 15 November, 2012 titled European Turmoil 2012: A Review of Drug Prices and Market Access Across Europe
The document provides an overview of P&R systems in 5 European countries: Netherlands, Sweden, Poland, Italy, and Germany.
1. P&R processes typically involve regulatory approval, followed by reimbursement decisions based on factors like clinical benefit and cost-effectiveness, and then price negotiations.
2. Countries differ in their pricing approaches, with some like Netherlands using external price referencing and others like Sweden not directly negotiating prices.
3. Reimbursement criteria generally examine clinical value and budget impact, with an emphasis on cost-effectiveness. Reimbursement levels and conditions vary between countries.
The presentation summarises recent changes implemented or being discussed in pricing and reimbursement/HTA systems in France, Germany and the UK. In Germany and France, the emphasis of the recent reforms is centred around the evidence requirements and, in particular, the use of comparator and head-to-head trials. In the UK, however, VBP is about the weighting given to the evidence and the social value of a drug. Overall, emphasis is increasing on 'proving' innovation and/or an additional health benefit as a precondition for a price higher than competitors.
This document discusses pricing and reimbursement systems for pharmaceuticals in Germany and the Netherlands. It provides timelines for reimbursement processes, data requirements for dossiers submitted for assessment and reimbursement, how incremental clinical benefit is assessed, the role of health economics analyses, exceptions to rules, and implications. The key lessons are that incremental clinical benefit evidence from RCTs is crucial for successful reimbursement outcomes, health economics is gaining importance in Germany with new legislation, dossiers must be prepared well in advance, and following scientific advice can help optimize applications. Exceptions apply for orphan drugs in both countries.
The document provides an overview of pharmaceutical pricing and reimbursement regulations across European countries. It discusses how different countries approach price controls, reimbursement decisions, and supply-side measures to influence the pharmaceutical market. Price controls are implemented through various methods including price negotiation, international price comparisons, and price-volume agreements. Countries also use positive and negative drug formularies, reference pricing, and pharmacoeconomic evaluations to make reimbursement determinations and control pharmaceutical spending. Overall the approaches vary significantly between countries and aim to balance health priorities with industrial and budgetary considerations.
This document discusses marketing strategies for pharmaceutical companies to retain market share after patent expiration, including reclassifying prescription drugs as over-the-counter (OTC). It analyzes sales data from four allergy drugs in Bulgaria before and after they were reclassified from prescription to OTC. All four drugs saw increases in sales after becoming available OTC, with one drug's sales increasing nearly threefold. However, sales trends varied between drugs, with lower-priced options maintaining stronger sales growth over time. Reclassifying drugs to OTC can help companies extend brand viability and increase accessibility but must consider various stakeholder impacts.
This document discusses marketing strategies for pharmaceutical companies to retain market share after patent expiration, including reclassifying prescription drugs as over-the-counter (OTC). It analyzes sales data from four allergy drugs in Bulgaria before and after they were reclassified from prescription to OTC. All four drugs saw increases in sales after becoming available OTC, with one drug's sales increasing nearly threefold. However, sales trends varied between drugs, with cheaper options maintaining stronger sales growth over time. Reclassifying drugs to OTC can help companies extend brand viability and increase accessibility but must consider various stakeholder impacts.
This study investigates the possibility of a harmonized EU approach to assessing the added therapeutic value (ATV) of medicines. It finds that while ATV is not systematically assessed for marketing authorization, most EU countries do consider it as part of pricing and reimbursement decisions. The study reviews the EU legal framework, explores ATV practices across the EU-28, and provides an in-depth analysis of ATV in six countries. It closes by outlining recommendations for a possible European harmonization of ATV assessment within the current legal framework.
This document provides information about the European Pharmacopoeia. It notes that the pharmacopoeia has 36 member states and 23 observer countries. It establishes quality standards for active substances, excipients, finished dosage forms and other medicinal products. The pharmacopoeia engages stakeholders and seeks to remain innovative while maintaining technical standards. It aims to harmonize standards internationally through organizations like the Pharmacopoeial Discussion Group.
The document discusses standards and guidelines for tissues and cells used for human application developed by the Council of Europe. It provides an overview of the Guide to the Quality and Safety of Tissues and Cells for Human Application, which contains guidance for professionals involved in various aspects of donation, processing, storage and use of tissues and cells. The Guide aims to ensure tissues and cells used are of high quality and safety to minimize risks of disease transmission and respect ethical principles of donation.
This presentation by Italy was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
The document discusses the role of patients, healthcare professionals, and academics in the European Medicines Agency's (EMA) process of approving medicines in the European Union. It describes how patients and patient organizations can provide input and expertise at various stages of the medicine development and review process. This includes involvement in scientific committees, evaluation of product information for patients, and review of safety communications. While patient participation has increased in recent years, challenges remain around representation, measuring impact, and ensuring comprehensive training. The EMA also facilitates collaboration with healthcare professionals and academics to enhance regulation and research.
International Regulatory Overview 2009 Rev LinkedlnMdbio
Roger Leclerc presented on international medical device regulatory challenges and overviews. He discussed regulatory bodies and their challenges in Canada, the US, Europe, Australia and Asia. For Health Canada, he outlined strategic objectives like modernization, adequate funding, and improved governance. Key regulatory issues from 2008-2009 included standards recognition, special access programs, significant changes, and sale of unlicensed devices.
This presentation by Duncan Matthews was made during the Workshop on Recent Challenges in Competition and IP in Pharmaceutical Markets on 26 February 2019. More material on the workshop can be found at www.oecd.org/daf/competition/workshop-on-recent-challenges-in-competition-and-ip-in-pharmaceutical-markets.htm
Thomas Müller, MD & Pharmacist, Head of Pharmaceuticals Dept Federal Joint Committee.
Pharma Pricing & Market Access Congress 2017
22 February 2017
London
This document provides guidelines on evaluating similar biological medicinal products. It outlines the regulatory framework and scope of such products. The key principles are:
1) Comparability studies are required to demonstrate similarity in quality, safety and efficacy between a new product and an authorized reference product.
2) The level of characterization required depends on the product's complexity, with highly purified products more readily characterized than others.
3) Whether a product can use the "similar biological" approach depends on available analytical procedures and manufacturing control, as well as clinical experience. Relevant guidelines are provided for specific types of biological products.
This presentation by the French Competition Authority was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
What is Efficacy
Why Efficacy is required for Herbal products
How Efficacy of Herbal products ensured
What are the various avenues of determining efficacy
The document summarizes drug regulatory news from March 2014. It discusses new EMA fees for pharmacovigilance activities that will significantly impact pharmaceutical companies. It also outlines several ongoing safety reviews by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) of various drugs like codeine-containing medicines, testosterone medicines, and medicines acting on the renin-angiotensin system. National regulatory authorities like Fimea are updating terms for modified-release pharmaceutical forms.
This presentation by the Turkish Competition Authority was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
Indian Pharmaceutical Industry; its Challenges WHILE Exportation of pharmaceu...Manukonda sravani Reddy
The Indian pharmaceutical industry is currently the largest provider of generic drugs globally, accounting for 20% of global exports. It is expected to expand rapidly to reach $55 billion by 2020. The industry meets 70% of India's domestic drug demands and includes over 8,000 small companies and 250 large companies. India is the third largest pharmaceutical market by volume and exports over $16 billion worth of drugs annually, with the largest importer being Europe. Pharmaceutical companies in India are regulated by the Drugs and Cosmetics Act and must obtain regulatory approval through various procedures to market drugs in India and other countries.
The European Medicines Agency (EMA) was founded in 1995 and is responsible for coordinating the evaluation and supervision of medicinal products in the European Union. Some key milestones include recommending authorization of 975 human medicines in its first 20 years and marking its 20th anniversary in 2015. The EMA operates through various committees that assess different drug types and ensures clinical trials and medicines meet EU standards of quality, safety and efficacy. There are centralized, mutual recognition and national procedures for marketing authorization, and the EMA plays an important role in reviewing applications and facilitating approval across EU states.
Pharmaceutical industry and unit processibtihal osman
Pharmaceutical manufacturing involves the industrial scale synthesis and processing of drug products. Key steps include active pharmaceutical ingredient (API) synthesis, combining APIs and excipients, and processing the mixture into solid oral dosage forms like tablets through unit operations such as milling, blending, granulation, drying, compression, and coating. Quality is ensured through strict adherence to good manufacturing practices (GMP) regulations. Excipients are other ingredients included in drug products that aid processing and delivery of the active drug. Common processing routes for solid oral dosage forms are direct compression, dry granulation, and wet granulation which involve different sequences of unit operations.
The document provides an overview of pharmaceutical pricing and reimbursement regulations across European countries. It discusses how different countries approach price controls, reimbursement decisions, and supply-side measures to influence the pharmaceutical market. Price controls are implemented through various methods including price negotiation, international price comparisons, and price-volume agreements. Countries also use positive and negative drug formularies, reference pricing, and pharmacoeconomic evaluations to make reimbursement determinations and control pharmaceutical spending. Overall the approaches vary significantly between countries and aim to balance health priorities with industrial and budgetary considerations.
This document discusses marketing strategies for pharmaceutical companies to retain market share after patent expiration, including reclassifying prescription drugs as over-the-counter (OTC). It analyzes sales data from four allergy drugs in Bulgaria before and after they were reclassified from prescription to OTC. All four drugs saw increases in sales after becoming available OTC, with one drug's sales increasing nearly threefold. However, sales trends varied between drugs, with lower-priced options maintaining stronger sales growth over time. Reclassifying drugs to OTC can help companies extend brand viability and increase accessibility but must consider various stakeholder impacts.
This document discusses marketing strategies for pharmaceutical companies to retain market share after patent expiration, including reclassifying prescription drugs as over-the-counter (OTC). It analyzes sales data from four allergy drugs in Bulgaria before and after they were reclassified from prescription to OTC. All four drugs saw increases in sales after becoming available OTC, with one drug's sales increasing nearly threefold. However, sales trends varied between drugs, with cheaper options maintaining stronger sales growth over time. Reclassifying drugs to OTC can help companies extend brand viability and increase accessibility but must consider various stakeholder impacts.
This study investigates the possibility of a harmonized EU approach to assessing the added therapeutic value (ATV) of medicines. It finds that while ATV is not systematically assessed for marketing authorization, most EU countries do consider it as part of pricing and reimbursement decisions. The study reviews the EU legal framework, explores ATV practices across the EU-28, and provides an in-depth analysis of ATV in six countries. It closes by outlining recommendations for a possible European harmonization of ATV assessment within the current legal framework.
This document provides information about the European Pharmacopoeia. It notes that the pharmacopoeia has 36 member states and 23 observer countries. It establishes quality standards for active substances, excipients, finished dosage forms and other medicinal products. The pharmacopoeia engages stakeholders and seeks to remain innovative while maintaining technical standards. It aims to harmonize standards internationally through organizations like the Pharmacopoeial Discussion Group.
The document discusses standards and guidelines for tissues and cells used for human application developed by the Council of Europe. It provides an overview of the Guide to the Quality and Safety of Tissues and Cells for Human Application, which contains guidance for professionals involved in various aspects of donation, processing, storage and use of tissues and cells. The Guide aims to ensure tissues and cells used are of high quality and safety to minimize risks of disease transmission and respect ethical principles of donation.
This presentation by Italy was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
The document discusses the role of patients, healthcare professionals, and academics in the European Medicines Agency's (EMA) process of approving medicines in the European Union. It describes how patients and patient organizations can provide input and expertise at various stages of the medicine development and review process. This includes involvement in scientific committees, evaluation of product information for patients, and review of safety communications. While patient participation has increased in recent years, challenges remain around representation, measuring impact, and ensuring comprehensive training. The EMA also facilitates collaboration with healthcare professionals and academics to enhance regulation and research.
International Regulatory Overview 2009 Rev LinkedlnMdbio
Roger Leclerc presented on international medical device regulatory challenges and overviews. He discussed regulatory bodies and their challenges in Canada, the US, Europe, Australia and Asia. For Health Canada, he outlined strategic objectives like modernization, adequate funding, and improved governance. Key regulatory issues from 2008-2009 included standards recognition, special access programs, significant changes, and sale of unlicensed devices.
This presentation by Duncan Matthews was made during the Workshop on Recent Challenges in Competition and IP in Pharmaceutical Markets on 26 February 2019. More material on the workshop can be found at www.oecd.org/daf/competition/workshop-on-recent-challenges-in-competition-and-ip-in-pharmaceutical-markets.htm
Thomas Müller, MD & Pharmacist, Head of Pharmaceuticals Dept Federal Joint Committee.
Pharma Pricing & Market Access Congress 2017
22 February 2017
London
This document provides guidelines on evaluating similar biological medicinal products. It outlines the regulatory framework and scope of such products. The key principles are:
1) Comparability studies are required to demonstrate similarity in quality, safety and efficacy between a new product and an authorized reference product.
2) The level of characterization required depends on the product's complexity, with highly purified products more readily characterized than others.
3) Whether a product can use the "similar biological" approach depends on available analytical procedures and manufacturing control, as well as clinical experience. Relevant guidelines are provided for specific types of biological products.
This presentation by the French Competition Authority was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
What is Efficacy
Why Efficacy is required for Herbal products
How Efficacy of Herbal products ensured
What are the various avenues of determining efficacy
The document summarizes drug regulatory news from March 2014. It discusses new EMA fees for pharmacovigilance activities that will significantly impact pharmaceutical companies. It also outlines several ongoing safety reviews by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) of various drugs like codeine-containing medicines, testosterone medicines, and medicines acting on the renin-angiotensin system. National regulatory authorities like Fimea are updating terms for modified-release pharmaceutical forms.
This presentation by the Turkish Competition Authority was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
Indian Pharmaceutical Industry; its Challenges WHILE Exportation of pharmaceu...Manukonda sravani Reddy
The Indian pharmaceutical industry is currently the largest provider of generic drugs globally, accounting for 20% of global exports. It is expected to expand rapidly to reach $55 billion by 2020. The industry meets 70% of India's domestic drug demands and includes over 8,000 small companies and 250 large companies. India is the third largest pharmaceutical market by volume and exports over $16 billion worth of drugs annually, with the largest importer being Europe. Pharmaceutical companies in India are regulated by the Drugs and Cosmetics Act and must obtain regulatory approval through various procedures to market drugs in India and other countries.
The European Medicines Agency (EMA) was founded in 1995 and is responsible for coordinating the evaluation and supervision of medicinal products in the European Union. Some key milestones include recommending authorization of 975 human medicines in its first 20 years and marking its 20th anniversary in 2015. The EMA operates through various committees that assess different drug types and ensures clinical trials and medicines meet EU standards of quality, safety and efficacy. There are centralized, mutual recognition and national procedures for marketing authorization, and the EMA plays an important role in reviewing applications and facilitating approval across EU states.
Pharmaceutical industry and unit processibtihal osman
Pharmaceutical manufacturing involves the industrial scale synthesis and processing of drug products. Key steps include active pharmaceutical ingredient (API) synthesis, combining APIs and excipients, and processing the mixture into solid oral dosage forms like tablets through unit operations such as milling, blending, granulation, drying, compression, and coating. Quality is ensured through strict adherence to good manufacturing practices (GMP) regulations. Excipients are other ingredients included in drug products that aid processing and delivery of the active drug. Common processing routes for solid oral dosage forms are direct compression, dry granulation, and wet granulation which involve different sequences of unit operations.
Apresentação seminários de pesquisa 2012 lucianasergiocirino
O documento discute como educadoras/professoras e bebês de até um ano se desenvolvem como seres humanos na creche. Ele investigará o perfil das educadoras, como elas se tornam educadoras, como os bebês se desenvolvem, e como os documentos oficiais se relacionam com as práticas educativas.
Facts and figures for the Online Beauty Market were presented at the “1st Athens Beauty Conference” of Boussias Conferences.
For the first time, we showcased data and key takeways for Online Beauty Stores & FMCG Brands.
1. AJSI is an engineering company that provides services for pharmaceutical, food, chemical, and biopharmaceutical industries including validation, automation, equipment supply, cleanroom design and construction.
2. The company's services include pharmaceutical validation, biotechnology projects, maintenance and industrial automation, manufacturing and supplying equipment, and cleanroom design, construction, qualification and validation.
3. AJSI aims to cater to all technical and commercial needs of customers seeking industrial projects with reliability, high quality services, and compliance with regulations.
ApiVita is a Greek cosmetics company that was founded in 1979. Over the past 31 years, it has grown from a single pharmacy to a company with a complete range of over 300 natural and organic skincare, haircare, and other personal care products. ApiVita uses natural ingredients sourced from Greek flora and works with organic farmers and beekeepers around Greece. The company has an in-house R&D team of 11 scientists that focuses on researching unique natural ingredients like propolis. ApiVita is now distributed internationally in over 10 countries through pharmacies, department stores, and its own stores.
Pharmaceutical Research "from lab to factory"Ahmed horiz
- My session at the third international educational fair in Egypt (Edu link fair 2017).
- Session explains what is the research and it's steps, and how it can be applied to for production on different scale.
- Two examples of my work at the R&D department in Heliopolis University.
- Finally discovering a new era and it's benefits.
This document provides an investment recommendation and analysis of Supreme Industries Ltd, an Indian plastics company. It recommends buying shares of Supreme Industries and provides a target price range and portfolio allocation strategy. The summary highlights Supreme's market leadership in plastic pipes and fittings, strong brand, nationwide production facilities, and opportunities for growth in India's underpenetrated plastics market.
This document provides an overview of key economic concepts related to the price system and theory of the firm. It covers topics such as demand and supply, costs of production, market structures, and profit maximization. Several examples and exercises are provided to illustrate key points. The document is intended as a supplemental guide for students taking an A-Level Economics course. It defines important terminology and uses graphs and data to explain fundamental economic principles in the subject areas.
حددت وزارة الصحة أسعار البيع للعموم للأدوية الأصلية والجنيسة والمماثلة الحيوية المسوقة في المغرب، وكذلك سعرها الخاص في المستشفى.
وتضمنت اللائحة أزيد من 5300 دواء.
This document outlines the key processes and modules within a pharmaceutical ERP system. It includes processes for administration, purchasing, sales, accounting, stores and warehousing, production, excise transactions, and human resources. The main modules covered are master data, purchasing, sales, accounts, stores, production, and HR. Key transactions within each process like purchase orders, sales orders, inventory movements, and payroll are also summarized.
This document discusses organizational structures for pharmaceutical quality assurance. It states that the heads of production and quality control must be independent of each other according to EU GMP guidelines. It also lists the typical educational backgrounds needed for various roles in pharmaceutical production, quality assurance/quality control, and management. Finally, it provides a flow chart illustrating the process flow from receiving to shipping in a pharmaceutical manufacturing facility.
This document discusses plant layout and provides definitions, characteristics, and types of plant layouts. It defines plant layout as the physical arrangement of equipment and facilities within a plant. The main types of plant layouts discussed are functional layout, line layout, static product layout, group layout, and combination layout. Functional layout groups similar machines together by process. Line layout arranges machines in a linear sequence of operations. Group layout groups equipment for similar parts into cells. The document also covers factors that influence layout choices and tools used for layout planning.
Group G's presentation topic is a marketing mix analysis of Incepta Pharmaceuticals Ltd. The document provides background information on Incepta, including that it is a leading pharmaceutical company in Bangladesh established in 1999. It also discusses Incepta's competitors, market share, products, pricing, distribution channels, inventory management, transportation, warehousing, and promotional activities.
This document summarizes the key considerations for selecting a pharmaceutical factory location and layout. It discusses factors to consider for location such as availability of raw materials, labor, transportation and climate. Special Economic Zones that provide tax benefits are also described. For layout, it explains different types like process and product layouts and their advantages. Plant location and layout planning are guided by objectives like minimizing costs while allowing efficient production flow.
The document discusses production functions and costs. It defines production functions as relating physical output to inputs like labor and capital. Production functions can be expressed as short-run or long-run depending on whether inputs are fixed or variable. The document also discusses laws of returns like increasing, decreasing, and constant returns. Isoquants and isocost curves are presented, where isoquants show input combinations for a given output and isocost curves show input combinations at a given cost.
Αποδοτικές Κινήσεις του brand στο e-shop για πωλήσεις online & offlineConvert Group
This document discusses strategies for brands to improve their online sales and presence. It provides insights from an e-commerce consulting firm on trends in the Greek e-commerce market, such as the growth of online pharmacies and supermarkets. It also offers tips for brands, such as ensuring their product images and information are up to date online, partnering with retailers, and offering free shipping thresholds. Overall, the document aims to help brands optimize their online strategies and sales.
This document provides an overview of key plant support services required for a pharmaceutical manufacturing facility. It discusses services related to manufacturing such as security offices, fuel storage, scrap yards, and toilets. It also covers services for employees like vehicle parking, canteens, gardens, administrative blocks, and training centers. The document includes descriptions and considerations for designing each of these important support areas to ensure successful operations.
This document outlines techniques for process analysis and improvement. It defines key process terminology and describes how to create a process flow diagram. The document provides an example of analyzing a scooter assembly process, including calculating activity times, capacity, cycle time, and worker utilization. It demonstrates how line balancing can increase process capacity and efficiency by reallocating tasks between workers.
Here are the definitions for the terms in the question:
1. Inferior goods - Goods for which demand decreases when income increases, as consumers switch to higher quality substitutes when they become richer.
2. Giffen goods - Rare goods that people demand more of as the price rises because it is considered a necessity, and it becomes a higher priority when money is tight.
3. Consumer surplus - The difference between the maximum price a consumer would be willing to pay for a good or service and the actual price paid. It measures the benefit consumers receive from purchases.
4. Perfectly elastic demand - Demand curve is horizontal, meaning any change in price results in an infinite change in quantity demanded between zero and
1) Physicians are divided between hospital employment and private practice, weakening their collective voice.
2) Fee cuts are applied broadly rather than targeting specific providers, so no one group bears the full burden.
3) Providers fear losing public support and future funding if seen as obstructing cost containment efforts.
Biopharma Sales Resilience through Economic RecessionHealth Advances
The document analyzes how sales of branded drug classes were impacted during the 2008/2009 economic recession. It hypothesizes that drug classes treating severe or acute conditions effectively with few alternatives would be most resilient. The analysis found biopharma generally more resilient than healthcare, though sales faced pressure from rising uninsured/Medicaid populations and tighter payer management. Drug classes addressing less severe issues or with low-cost options required ensuring continued access.
This presentation by Martin WENZL from the OECD Health Division was made during the discussion “Excessive Pricing in Pharmaceuticals” held at the 130th meeting of the OECD Competition Committee on 28 November 2018. More papers and presentations on the topic can be found out at oe.cd/exph.
This document discusses key concepts related to the economic environment of business and finance. It covers topics such as shifts in demand and supply curves and adjustment to equilibrium. It also defines and provides examples of different types of elasticities including price elasticity of demand, income elasticity, and cross elasticity. The document also discusses market structures like perfect competition, monopoly, monopolistic competition, oligopoly, and duopoly. It covers factors that can cause market failures like market imperfections and externalities. Finally, it discusses various approaches to measuring business performance including qualitative and quantitative measures, operational and financial measures, and the balanced scorecard framework.
This document provides an executive summary and analysis of key financial and operational metrics for various hospital peer groups. It analyzes metrics such as total profit margin, operating profit margin, labor costs, staffing levels, and accounts receivable collection rates for over 6 years of data across different hospital types. The metrics are stratified into quartiles to benchmark performance from poor to exceptional. Healthcare Management Partners collected this data to help hospitals assess their financial health and performance relative to peers.
This presentation looks at ways in which governments can set prices, including “cost plus”, value, and the external referencing of prices elsewhere. It looks at the role that competition can play in keeping down prices. In that context it briefly discusses pricing proposals being considered in Malaysia. It makes the case for using HTA to inform pricing decisions.
Adrian Towse
This presentation by Sabine Vogler was made at the 2014 Global Forum on Competition (27-28 February) during the session on competition issues in the distribution of pharmaceuticals. Find out more at http://www.oecd.org/competition/globalforum
This document summarizes key concepts related to pricing systems, demand and supply equilibrium, and elasticity in economics. It discusses how price acts as a signal in markets to balance supply and demand between consumers and suppliers. Equilibrium occurs at the price and quantity where supply and demand are equal. Elasticity refers to the responsiveness of supply or demand to changes in price. Inelastic demand means quantity demanded changes little despite price changes, while externalities occur when production or consumption impacts third parties not involved in the market transaction.
The Greek pharmaceutical market has faced challenges since 2010 due to austerity measures implemented in response to the financial crisis. Public pharmaceutical expenditures were cut substantially between 2009 and 2013 in an effort to reduce costs. Reforms were implemented including price cuts, changes to pricing systems, increased generic drug usage, and other measures. Total sales in the Greek pharmaceutical market declined in value between 2009 and 2014 for hospitals, pharmacies, and total sales. The top 10 pharmaceutical companies, which are mostly large multinational companies, maintained a majority market share between 2010 and 2013. A SWOT analysis identified strengths for these major companies including established brands and distribution, but also weaknesses like limited profit margins and threats from ongoing financial instability and regulatory changes in Greece.
The document discusses the Jan Aushadhi scheme launched by the Government of India to provide quality generic medicines at affordable prices. The key points are:
1. The scheme aims to make medicines available to all, especially the poor, through exclusive outlets called "Pradhan Mantri Bhartiya Janaushadhi Kendra".
2. Generic medicines provided under the scheme are 50-95% cheaper than branded medicines but have equal efficacy. They are procured and tested by the Bureau of Pharma PSUs of India to ensure quality.
3. The scheme provides financial assistance up to Rs. 2 lakhs for establishing outlets and reimburses costs of furniture, fixtures and computer
The document provides information about the Jan Aushadhi scheme, which aims to make quality generic medicines available at affordable prices through exclusive outlets called Pradhan Mantri Bhartiya Janaushadhi Kendras. The key objectives are to reduce healthcare costs and make treatment more affordable for all, especially the poor. The Bureau of Pharma PSUs of India implements the scheme by procuring generic drugs from suppliers and distributing them through warehouses and franchise agents. Jan Aushadhi store owners can receive financial assistance and earn a 20% profit margin. The scheme also aims to create awareness about generic drugs and increase their demand and use.
MyChem aims to be a one-stop-shop mobile app for medical needs that connects consumers directly to local pharmacies. The app will allow consumers to order prescribed medicines and health products from nearby pharmacies with just one click. MyChem will operate similarly to ride-hailing apps by connecting consumers to a network of pharmacy shops for delivery. The goal is to become the market leader in pharmacy retail and reach 100,000 consumers within the first year.
Reimbursement and pricing strategies for drugs for ultra rare diseases: What can Canada learn from experiences across the pond?
Tania Stafinski, University of Alberta
Rare Disease Day Conference 2020 March 9-10
Sustainability and Transition Policy in Action (GF Session) - Tural Gulu, Az...OECD Governance
This presentation was made by Tural Gulu, Azerbaijan, at the 2nd Health Systems joint Network Meeting for Central, Eastern and Southeastern European Countries held in Tallinn, Estonia, on 1-2 December 2016
This presentation by Valérie Paris, Senior Health Policy Analyst, OECD, was made during the discussion “Excessive prices in pharmaceutical markets" held at the OECD Competition Open Day on 27 February 2019. More documents and presentations on this topic can be found at oe.cd/comp-open-day-19.
This presentation by Panos Kanavos was made at the 2014 Global Forum on Competition (27-28 February) at the session on competition issues in the distribution of pharmaceuticals. Find out more at http://www.oecd.org/competition/globalforum
Global pharmaceutical companies are modeled with a supply chain, which ensures that the right drug reaches the right people at the right time and in the right condition. The supply chain also ensures 100% product availability at optimum cost by carrying huge inventory, which maintains 100% fill rate. Manufacturers are trying to cut down development time to save costs. For example, a drug manufacturer who can trim development time by 19% can save up to USD 100 million. But if a drug is getting delayed to reach the market, the time delay costs the company around USD 1 million a day. So, pharmaceutical companies today are designing the supply chain to be as responsive as possible to reduce entry time to the market thereby increasing profit margins.
Market analysis of medicine segment in health careVartika Bisht
This document provides a market analysis of the medicine segment of the Indian healthcare industry. It notes that the healthcare industry in India has grown at a CAGR of 17% from 2008-2020 and is expected to reach $280 billion by 2020. The pharmaceutical sector is the largest segment, making up 71% of healthcare expenditures. Key drivers of growth include rising incomes, increased health insurance coverage, and government policies supporting the industry. Major players like Dr. Reddy's, Lupin, Cipla, and Aurobindo control over 20% of the domestic pharmaceutical market. The industry faces high competition but low threat of new entrants or substitutes.
Five Steps to Find your 'Beyond the Pill' Strategyexecutiveinsight
A short window of opportunity exists for pharmaceutical companies to establish indispensable beyond the pill services, which may even help them 'own' particular disease areas.
Similar to Pharmaceutical Pricing and Reimbursement in Greece (20)
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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4. Pharmaceutical Reimbursement Today
• Negative Reimbursement List
– All other medicines reimbursed
• 3 levels of co-pay for reimbursed medicines
based on combination of medicine & disease
– 0%
– 10%
– 25%
25/5/2011 ΣfΕΕ 4
5. Contradictions to Free Market
Principles that Exist Today
• Legislated prices, margins and discounts
between two private businesses
– Government created cartels
• Legislated cost burdens between two private
businesses
– Who pays for goods shipment
– Who pays for insurance
– Who pays for destruction of expired goods
• Government should not legislate any of these
25/5/2011 ΣfΕΕ 5
7. Government Benefits
• No medicine shortages
• Total Public Pharmaceutical Expenditure will gradually reach
approximately 1% of GDP
• Decrease in social security waste
• Increase in VAT
• Increase in Income Tax
• IMF & EU goals for free markets
• Benefits for employment in pharmaceutical & other industries
– Increased contributions to social security
• Clearer horizon for pharmaceutical investment in research &
development
• Ability to fund social policy to help patients who need lower co-pay
25/5/2011 ΣfΕΕ 7
8. Prerequisites
• Must Have:
Full Electronic Medicine Supply Chain Tracking
– All medicines bought by the government must be recorded
electronically
– All medicines sold by pharmacies must be recorded electronically
– All medicines sold by wholesalers and private clinics must be recorded
electronically
– All medicines sold by pharma industry must be recorded electronically
– Monthly updated data for calculating % of medicines sold that are
reimbursed
• Useful to Have:
Full Electronic Patient Health Record
– Would allow reliable and verifiable indication based reimbursement
– Would lead to savings in other areas of healthcare
25/5/2011 ΣfΕΕ 8
10. Pricing Goals
• Government should be involved and control prices only
where government pays
• All prices that government does not pay should be “free”
– In essence “Free” prices are not free
– Market forces shape prices more efficiently than any forced
control:
• Competition
• Customers
• Distribution channels
• European Pricing - Parallel Import / Export
• Internal Company Policies
– Free prices will force society (physicians & patients) to become
more price sensitive
25/5/2011 ΣfΕΕ 10
11. Pricing
Free Price Reimbursement
for private market buyers for government only
• Pharma Company Sets Wholesale • Social Security will calculate reimbursed wholesale
Price (Price to pharmacist) and price
– E.g value based price, international reference price
Suggested Retail Price – all prices will be recalculated once a year
– Pharma company may offer discounts • New products reimbursed when price is available
– Wholesalers may offer discounts in at least one other European country
– Pharmacists may offer discounts – quick access to new medicines for patients
– new products repriced every quarter for first 12
– Private clinic may offer discounts quarters (3 years) to capture new cheaper countries
– Public hospitals must transfer • Reasonable pharmacy markup/discount
discounts to social security • Social Security will reimburse private clinics at
• Published online in official SfEE wholesale price + 5%
price bulletin quarterly • Public Hospitals will purchase at hospital price
– SfEE publishes next quarters prices • Social Security will reimburse public hospitals at
online two weeks before quarter their purchase price + x%
starts • Reimbursed wholesale price cannot be higher than
– Companies responsible for free wholesale price (RWP <= FWP)
submitting prices electronically to • Prices not published
SfEE two weeks before publish date
25/5/2011 ΣfΕΕ 11
12. Reimbursed Money Flow
Government money
Private money
(margins and prices
not controlled by
government)
25/5/2011 ΣfΕΕ 12
13. 3 part Pharma Industry Rebate
• Euro amount for each unit reimbursed
Fixed • Difference between free wholesale price and reimbursed
Amount wholesale price
• % of reimbursed wholesale price
• Based on proportion of total units sold reimbursed
Variable % • As % of units reimbursed falls from 100% this variable
rebate % increases
4% Fixed • 4% of reimbursed wholesale price
Rebate • Same as today
25/5/2011 ΣfΕΕ 13
14. Rebate Paid by Pharma Companies
(does not include price difference part)
16%
14%
Rebate % of reimbursed price
12%
10%
8%
6%
4%
2%
0%
50%
95%
90%
85%
80%
75%
70%
65%
60%
55%
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%
100%
% of total units sold reimbursed
25/5/2011 ΣfΕΕ 14
15. Variable Rebate Mechanism
• At each quarter close government will
calculate total number of each medicine
purchased by social security and will compare
to total sales provided by pharmaceutical
companies to EOF.
• For every 1% point of non-reimbursed sales
rebate will increase by 0.1%
– 0% non-reimbursed sales = 0% + 4% rebate
– 100% non-reimbursed sales = 10% + 4% rebate
25/5/2011 ΣfΕΕ 15
18. Co-payment
• Government will legislate social security
contribution.
– Patient co-payment will be on free price
• Will give a small benefit for social security
• This benefit will finance the necessity for some
populations to have reduced co-payment
25/5/2011 ΣfΕΕ 18
19. Rebate & Sales Example
(retail market, fixed units, 25% free price premium, 0% co-pay)
180,000 0%
160,000 -2%
140,000
-4%
120,000
-6%
Pharma Sales (Before Rebate)
100,000
Pharmacy Sales
euro
Total Pharma Rebate
-8%
80,000 Total Gov Expenditure (After Rebate)
Total Pharma Revenue (After Rebate) -10%
60,000 Rebate %
-12%
40,000
20,000 -14%
0 -16%
100% 95% 90% 85% 80% 75% 70% 65% 60% 55% 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0%
% of total units sold reimbursed
25/5/2011 ΣfΕΕ 19
20. Generics
• The use of generics could significantly reduce government pharmaceutical
expenditure
IF
1. There is ongoing official accreditation to ensure quality of generic
medicines
2. There is full implementation of generic pricing rules
(IMF says 60%)
3. Price sensitivity in society increases by the application of this proposal
• When a molecule has gone off patent and generic competition begins,
the value of the contribution of social security can decrease.
– For example: social security contribution can move to 60% of prototype
product reimbursed wholesale price for all medicines with that active
ingredient
25/5/2011 ΣfΕΕ 20
21. Issues not yet resolved
• Pharmacy Reimbursed Margin
– Options could include:
• Fixed markup
• Variable discount on total amount purchased
• Variable discount on how fast payment is made
– 25% markup used here for examples
as mentioned in IMF document:
• reduced profit margin of pharmacies on retail prices directly
to 15-20 percent or indirectly through rebates
(25% markup = 20% margin)
• VAT
– For government VAT is in one pocket out the other
– For private payers VAT is revenue for government
– State buyers should not pay VAT
25/5/2011 ΣfΕΕ 21
23. Reimbursement Goals
1. No reimbursement for lifestyle ailments
2. Reimbursement for other illnesses with
varying levels of patient co-payment
3. Incentive for physicians, pharmacists and
patients to prefer treatments that represent
better value for money
25/5/2011 ΣfΕΕ 23
24. 1. Negative List
• Certain products are not reimbursed
– Lifestyle
– Over the counter
– Inadequate efficacy (do not work)
• Reimbursement for certain diseases with co-pay
– For some patients these products are not lifestyle
treatments but chronic illness treatments
– Some products made lead to significant savings in
other health care expenses (e.g. smoking cessation)
25/5/2011 ΣfΕΕ 24
25. 2. Reimbursement Contribution
Social security contribution should also have social criteria
(patient ability to afford, age group, etc)
Contribution categories:
• Full contribution for chronic life threatening diseases /
therapies
• Large contribution for serious diseases / therapies
• Medium contribution for less serious diseases / therapies
• Low social security contribution
• Very low social security contribution
(similar to Belgian reimbursement system)
25/5/2011 ΣfΕΕ 25
26. 3. Incentive for lower cost
• Create an incentive for cheaper therapies with
patients as drivers
– Social security must increase price sensitivity in
patients who will then influence physicians and
pharmacists
– Co-payment is the only way to incent patients to
select cheaper medicines
25/5/2011 ΣfΕΕ 26
27. Government Benefits
• No medicine shortages
• Total Public Pharmaceutical Expenditure will gradually reach
approximately 1% of GDP
• Decrease in social security waste
• Increase in VAT
• Increase in Income Tax
• IMF & EU goals for free markets
• Benefits for employment in pharmaceutical & other industries
– Increased contributions to social security
• Clearer horizon for pharmaceutical investment in research &
development
• Ability to fund social policy to help patients who need lower co-pay
25/5/2011 ΣfΕΕ 27
28. Contradictions to Free Market
Principles that Exist Today
• Legislated prices, margins and discounts
between two private businesses
– Government created cartels
• Legislated cost burdens between two private
businesses
– Who pays for goods shipment
– Who pays for insurance
– Who pays for destruction of expired goods
• Government should not legislate any of these
25/5/2011 ΣfΕΕ 28