Bilcare GCS provides comparator drug procurement services for global clinical trials. It has expertise sourcing drugs worldwide and providing the necessary documentation and logistics to meet regulatory requirements. Bilcare can source drugs in large volumes and multiple batches with long expiration dates. It aims to provide authentic products, full traceability, and guidance to sponsors to enable cost savings. Bilcare has extensive experience procuring various drug types across multiple countries and regions.
This document discusses the challenges of sourcing comparator drugs for clinical trials and strategies for reducing costs. It outlines regulatory requirements, industry changes, and supply chain complexities that make comparator drug procurement difficult. The document then presents several strategies for reducing costs, such as sourcing directly from innovators, procuring from low-cost markets, using generics, consolidating comparators and placebos, and coordinated supplier relationship management.
Group purchasing involves combining the purchasing power of multiple organizations to obtain lower prices on supplies and equipment. It began in the early 20th century and grew significantly with the establishment of Medicare and Medicaid in the US. The main objectives are cost savings through bulk discounts, ensuring quality and supply of items, and standardizing purchases. There are various types of purchasing groups. Studies estimate that group purchasing saves the US healthcare industry $36 billion annually or 10-18% of total supply spending through lower prices negotiated by purchasing cooperatives. The largest challenges are potential conflicts of interest that need transparency.
The document outlines 10 major trends currently impacting the biotech industry: 1) Biotech pipelines are becoming more diverse with a range of new platforms; 2) Biotech companies are breaking away from large pharma firms; 3) Cell therapies are gaining ground with promising clinical trials; 4) Biosimilar regulatory frameworks are expanding globally; 5) Antibody drug conjugates are on the rise; 6) Flexible fill-finish facilities are becoming the norm; 7) Alternative facility delivery models are being sought; 8) Biotech is embracing continuous processing; 9) Single-use technology is growing for commercial supply; and 10) Biotech is moving towards customizable "iTunes-style" solutions. Each trend faces challenges
The European drug manufacturer is considering launching an anti-anxiety drug in India through either a licensing agreement or contract manufacturing deal. Licensing would allow them to gain brand recognition and capture licensing fees without direct investment, while contract manufacturing would give them greater control over marketing while avoiding large capital expenditures. Either option would allow them to access the growing Indian market for anti-anxiety drugs in a relatively low-risk manner.
This document discusses the biosimilar drug market and opportunities for biosimilar drug developers. It notes that as biologic drug patents expire, biosimilar drugs that are comparable in efficacy and safety to reference biologics at a lower cost represent a major market opportunity. However, biosimilar market uptake faces challenges from regulatory uncertainty, physician concerns about switching patients, and efforts by innovator companies to defend their biologic drugs. The document estimates that biosimilars may not achieve critical mass adoption until 2023-2025.
The New Pharma Ecosystem: 2014 Trends Reshaping the Pharmaceutical Supply ChainLaura Olson
The pharmaceutical industry is undergoing tremendous changes. Numerous forces are re-shaping the new pharmaceutical ecosystem. Technology, demographics, regulations and shifts in wealth are creating transformative change. Increasingly becoming a more patient-centric world, patients use Smart devices to monitor research and evaluate pharmaceutical products. Healthcare reform regulations, the devaluation of the existing pharma model and trend towards patient empowerment and access to information are shaping the changing pharma industry, much as the retail industry was shaped by the multichannel and omni channel retailing trends of recent years. Regulators have become increasingly more cautious when improving innovative medicines. As pharmaceuticals have become more successful in prolonging life and treating illness, many medical conditions are now chronic. Today healthcare providers have become increasingly interested in measuring the outcomes of pharma performance and basing pricing accordingly. There has been a dramatic increase in prescription volume and an increased production and use of generic drugs. Producing pharmaceuticals in other countries can be complicated. Customs, local regulations and other factors impact products and require brands to adapt. Generic pharmaceuticals are becoming the dominant category globally, especially in developing rather than just industrial countries. Adding to the complexity, a large number of pharmaceutical products are made by multiple countries. These factors and the move towards specialty pharmaceuticals and greater production of pharmaceutical products globally have resulted in more pressure on global supply chains. Because supply chains have moved from local to global in operation, even one significant event can interrupt the global supply chain. Events such as hurricanes and typhoons, earthquakes, political and economic upheaval can have serious impacts on global supply chains, adding unforeseen costs and delays. Health care reform magnifies the effect of longer supply chains and increases the intense cost pressure on drug manufacturers. In order to reduce costs, more production as well as research and development are being offshored and outsourced.
This document discusses the fundamentals and purpose of primary competitive intelligence for biopharmaceutical companies. It describes how competitive intelligence can provide actionable insights throughout a drug's lifecycle from pre-clinical to post-marketing. Robust competitive intelligence is needed to understand competitor strategies, monitor the landscape, and position companies for strategic success against competitive forces in the industry.
This document discusses the challenges of sourcing comparator drugs for clinical trials and strategies for reducing costs. It outlines regulatory requirements, industry changes, and supply chain complexities that make comparator drug procurement difficult. The document then presents several strategies for reducing costs, such as sourcing directly from innovators, procuring from low-cost markets, using generics, consolidating comparators and placebos, and coordinated supplier relationship management.
Group purchasing involves combining the purchasing power of multiple organizations to obtain lower prices on supplies and equipment. It began in the early 20th century and grew significantly with the establishment of Medicare and Medicaid in the US. The main objectives are cost savings through bulk discounts, ensuring quality and supply of items, and standardizing purchases. There are various types of purchasing groups. Studies estimate that group purchasing saves the US healthcare industry $36 billion annually or 10-18% of total supply spending through lower prices negotiated by purchasing cooperatives. The largest challenges are potential conflicts of interest that need transparency.
The document outlines 10 major trends currently impacting the biotech industry: 1) Biotech pipelines are becoming more diverse with a range of new platforms; 2) Biotech companies are breaking away from large pharma firms; 3) Cell therapies are gaining ground with promising clinical trials; 4) Biosimilar regulatory frameworks are expanding globally; 5) Antibody drug conjugates are on the rise; 6) Flexible fill-finish facilities are becoming the norm; 7) Alternative facility delivery models are being sought; 8) Biotech is embracing continuous processing; 9) Single-use technology is growing for commercial supply; and 10) Biotech is moving towards customizable "iTunes-style" solutions. Each trend faces challenges
The European drug manufacturer is considering launching an anti-anxiety drug in India through either a licensing agreement or contract manufacturing deal. Licensing would allow them to gain brand recognition and capture licensing fees without direct investment, while contract manufacturing would give them greater control over marketing while avoiding large capital expenditures. Either option would allow them to access the growing Indian market for anti-anxiety drugs in a relatively low-risk manner.
This document discusses the biosimilar drug market and opportunities for biosimilar drug developers. It notes that as biologic drug patents expire, biosimilar drugs that are comparable in efficacy and safety to reference biologics at a lower cost represent a major market opportunity. However, biosimilar market uptake faces challenges from regulatory uncertainty, physician concerns about switching patients, and efforts by innovator companies to defend their biologic drugs. The document estimates that biosimilars may not achieve critical mass adoption until 2023-2025.
The New Pharma Ecosystem: 2014 Trends Reshaping the Pharmaceutical Supply ChainLaura Olson
The pharmaceutical industry is undergoing tremendous changes. Numerous forces are re-shaping the new pharmaceutical ecosystem. Technology, demographics, regulations and shifts in wealth are creating transformative change. Increasingly becoming a more patient-centric world, patients use Smart devices to monitor research and evaluate pharmaceutical products. Healthcare reform regulations, the devaluation of the existing pharma model and trend towards patient empowerment and access to information are shaping the changing pharma industry, much as the retail industry was shaped by the multichannel and omni channel retailing trends of recent years. Regulators have become increasingly more cautious when improving innovative medicines. As pharmaceuticals have become more successful in prolonging life and treating illness, many medical conditions are now chronic. Today healthcare providers have become increasingly interested in measuring the outcomes of pharma performance and basing pricing accordingly. There has been a dramatic increase in prescription volume and an increased production and use of generic drugs. Producing pharmaceuticals in other countries can be complicated. Customs, local regulations and other factors impact products and require brands to adapt. Generic pharmaceuticals are becoming the dominant category globally, especially in developing rather than just industrial countries. Adding to the complexity, a large number of pharmaceutical products are made by multiple countries. These factors and the move towards specialty pharmaceuticals and greater production of pharmaceutical products globally have resulted in more pressure on global supply chains. Because supply chains have moved from local to global in operation, even one significant event can interrupt the global supply chain. Events such as hurricanes and typhoons, earthquakes, political and economic upheaval can have serious impacts on global supply chains, adding unforeseen costs and delays. Health care reform magnifies the effect of longer supply chains and increases the intense cost pressure on drug manufacturers. In order to reduce costs, more production as well as research and development are being offshored and outsourced.
This document discusses the fundamentals and purpose of primary competitive intelligence for biopharmaceutical companies. It describes how competitive intelligence can provide actionable insights throughout a drug's lifecycle from pre-clinical to post-marketing. Robust competitive intelligence is needed to understand competitor strategies, monitor the landscape, and position companies for strategic success against competitive forces in the industry.
Healthcare Procurement - Custom Contracting through GPOsThe Boeing Center
Vera Tilson, associate professor of operations management at the University of Rochester, made a visit to The Boeing Center to present her research on the impact of custom contracting and the infomediary roles of healthcare GPOs to our OMM students and faculty.
For more research, connect with The Boeing Center on:
Facebook: http://j.mp/BCTIM-fb
Twitter: http://j.mp/BCTIM-tw
LinkedIn: http://j.mp/BCTIM-li
Instagram: http://j.mp/BCTIM-ig
SlideShare: http://j.mp/BCTIM-ss
Google+: http://j.mp/BCTIM-gp
Blog: http://j.mp/BCTIM-bl
The document discusses trends in the pharmaceutical industry through 2020. It notes ongoing challenges like unmet medical needs, aging populations, and chronic diseases. Future drivers include these aging and underserved populations in developing countries and effects of global warming. The industry will see more integrated value chains between pharma, payers, and providers. Treatment costs are unsustainable so the focus will shift to prevention and pharma providing full healthcare packages with payment for outcomes not just treatment. Pharma business models will change significantly, moving from blockbuster drug sales to more services across the healthcare spectrum. Laboratories of the future will need to develop new capabilities and talent to achieve this changed vision.
There has been an increase in R&D spending but a decline in research productivity, potentially leaving drug developers with insufficient pipelines. Mergers and acquisitions have aimed to strengthen pipelines and gain scale but larger companies now focus on blockbuster drugs. Licensing has become a major source of new products for large pharmaceutical companies and deals are occurring earlier in development stages.
Product lifecycle management in the pharmaceutical industryGeorgi Daskalov
Pharmaceutical companies face pressure to improve product pipelines, accelerate time to market, and improve margins on existing products, while maintaining strict regulatory compliance. A comprehensive product lifecycle management (PLM) solution can help address these challenges by providing visibility and control across the entire drug development process from discovery through commercialization. PLM focuses on leveraging research and development efforts to efficiently develop new drugs and move them through the various phases of the drug lifecycle from the different internal and external functions involved. This allows for improved collaboration and management of changes to optimize profitability throughout the drug's economic life.
WHAT IS THE DIFFERENCE BETWEEN PCD, GENERIC, AND ETHICAL PHARMA SECTORS?ambitbiomedix12
DIFFERENCE BETWEEN PCD, GENERIC, AND ETHICAL PHARMA SECTORS. Read More: https://bit.ly/2GFIONg
Are you a little bit confused about the difference between PCD, Generic, and Ethical Pharma Sectors? This blog gives the required information concisely and precisely.
Website: http://ambitbiomedix.com/
Social Media:
Facebook - https://www.facebook.com/ambitbiomedix/?ref=settings
Instagram - https://www.instagram.com/ambit_bio_medix/
Twitter - https://twitter.com/ambitbiomedix?lang=en
Linkedin - https://www.linkedin.com/company/ambit%E2%84%A2-bio-medix/about/
Youtube - https://www.youtube.com/watch?v=GPzB82AjvQA&t=3s
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
Jim Fitzgerald from CA and FCA spoke about group purchasing organizations (GPOs) and introduced HealthTrust, CoreTrust, and Parallon Business Solutions. HealthTrust is a global GPO owned by hospitals and health systems. It aggregates spending to negotiate pricing across 1,400+ hospitals. CoreTrust, a division of HealthTrust, extends this leveraged buying model to commercial companies. Parallon provides outsourced business services to the healthcare industry.
Contract research and manufacturing services (CRAMS) refers to outsourcing research and manufacturing services from low-cost providers. India has become an important destination for CRAMS due to its lower costs, skilled workforce, regulatory expertise, and US FDA-approved facilities. Indian companies provide contract research like clinical trials and contract manufacturing of APIs, intermediates, and formulations to pharmaceutical multinationals seeking to reduce costs and maintain profitability.
A brief introduction of the outsourcing methods in Pharma Supply Chain, Types of Outsourcing, Framework to decide correct outsourcing partner, factors to consider while selecting a partner, Process of outsourcing and Outsourcing models.
This research service provides an in-depth analysis of the global pharmaceutical contract manufacturing market with particular focus on the finished dose formulations such as solid, liquid and semi-solid, and injectable dose formulations. Segment analysis, trends and revenue forecast for the global, U.S. and European regions have been provided in detail. Strategic recommendations for the success of market participants have also been discussed.
Hi
I am Rahul Ranjan Rai, perusing MBA from Jaypee Business School and I have completed this Project under the supervision of Pro. Evan Costle (france). I hope this presentation will help you to understand the emerging concepts in Generic Industry
Thank you
Regards
Rahul
Complex Generics Overview - Outlooks and ChallengesSanjay Chaturvedi
The document summarizes a presentation given at the 5th Regulatory Conference on the evolving global regulatory environment. The presentation discusses complex generics known as "SuperGenerics", which are improved versions of existing drugs that have lost patent protection. They include modified release formulations, transdermal patches, and other delivery methods. SuperGenerics provide advantages like quicker action, fewer side effects, and more convenient dosing. Global pharmaceutical companies are placing significant focus and investment on SuperGenerics as a way to gain competitive advantages and higher profits in the generic drug market. The development of SuperGenerics presents opportunities but also regulatory and clinical challenges.
Navigating Drug Pricing Trends Webinar - May 23, 2017PSG Consults
This document summarizes a presentation on navigating drug pricing trends. It discusses factors influencing rising drug prices like utilization growth, manufacturer price inflation, and rebates. It also covers PBM contracting considerations like definitions, methodologies, flexibility, and protection. The presentation recommends conducting annual "market checks" to benchmark PBM contract terms and ensure competitive pricing. Conducting independent third-party analyses of industry pricing data is a best practice. Overall the presentation aims to inform attendees about industry trends impacting drug prices and contracting.
This document discusses outsourcing in the pharmaceutical industry. It defines outsourcing as transferring portions of work to outside suppliers in order to reduce costs. The main types of outsourcing in pharma include research and development, clinical trials, manufacturing, packaging, and sales/marketing. The key drivers of outsourcing are focusing on core strengths, reducing costs, and decreasing time to market. While outsourcing provides advantages like cost reductions, it also presents risks such as loss of managerial control and internal talent. Overall, outsourcing allows pharma companies to exploit new drug technologies while solving problems, though successful management of vendor relationships is critical.
The document discusses generic drug product development. It defines a generic drug as having the same active ingredients, dosage form, strength, quality, and intended use as the branded version. Generic drugs are available after patent expiration or waiver. The generic product development process involves concept development, system-level design, detail design, testing and refinement, and production ramp-up to launch the product.
This document provides an overview of the US healthcare reimbursement model and strategic reimbursement planning. It outlines four main steps to developing a reimbursement plan: 1) identifying who influences product use, 2) defining the market model by finding existing codes, 3) identifying any coding gaps, and 4) determining any regulatory issues. Key tactics include training opinion leaders, collaborating with medical societies, and publishing clinical data. FDA registration involves establishment, product listing, and approval processes which can take up to a year and cost over $60,000 for monoclonal antibodies. Consultants can help navigate the FDA process.
Know about Contract manufacturing of pharma products marketactizapharma
Here's some discuss and news regarding actizapharma which are working on the contract pharmaceutical production worldwide. They proficient enough to customize the entire range of medicines, to meet client’s requirements.
An employer approached Marsh & McLennan Agency (MMA) concerned about rising medical and pharmacy costs and potential penalties from the Cadillac Tax. MMA conducted an analysis and found the employer's benefits were richer than competitors and pharmacy spending was higher than expected. MMA engaged their pharmacy experts to evaluate the employer's pharmacy benefit manager contract. Experts identified opportunities to improve drug pricing and rebate sharing. After negotiations, the employer achieved $250,000 in annual pharmacy savings through a revised contract without changing their PBM or plan design.
Este documento describe diferentes instrumentos de medición utilizados en maquinaria y reconstrucción de motores, incluyendo flexómetros, calibradores vernier, micrómetros exteriores e interiores, reloj comparador, alexómetro y calibrador de laminas. Además, ofrece consejos sobre el cuidado y manejo adecuado de estas herramientas.
The document provides an overview of a 5-week IT testing course. It discusses the aims of testing including understanding what testing is, why it is needed, and common testing methodologies. It also describes testing documentation like test plans, test cases, and traceability matrices. Finally, it covers topics like test scenarios, test case templates, levels of testing, and the bug life cycle.
Healthcare Procurement - Custom Contracting through GPOsThe Boeing Center
Vera Tilson, associate professor of operations management at the University of Rochester, made a visit to The Boeing Center to present her research on the impact of custom contracting and the infomediary roles of healthcare GPOs to our OMM students and faculty.
For more research, connect with The Boeing Center on:
Facebook: http://j.mp/BCTIM-fb
Twitter: http://j.mp/BCTIM-tw
LinkedIn: http://j.mp/BCTIM-li
Instagram: http://j.mp/BCTIM-ig
SlideShare: http://j.mp/BCTIM-ss
Google+: http://j.mp/BCTIM-gp
Blog: http://j.mp/BCTIM-bl
The document discusses trends in the pharmaceutical industry through 2020. It notes ongoing challenges like unmet medical needs, aging populations, and chronic diseases. Future drivers include these aging and underserved populations in developing countries and effects of global warming. The industry will see more integrated value chains between pharma, payers, and providers. Treatment costs are unsustainable so the focus will shift to prevention and pharma providing full healthcare packages with payment for outcomes not just treatment. Pharma business models will change significantly, moving from blockbuster drug sales to more services across the healthcare spectrum. Laboratories of the future will need to develop new capabilities and talent to achieve this changed vision.
There has been an increase in R&D spending but a decline in research productivity, potentially leaving drug developers with insufficient pipelines. Mergers and acquisitions have aimed to strengthen pipelines and gain scale but larger companies now focus on blockbuster drugs. Licensing has become a major source of new products for large pharmaceutical companies and deals are occurring earlier in development stages.
Product lifecycle management in the pharmaceutical industryGeorgi Daskalov
Pharmaceutical companies face pressure to improve product pipelines, accelerate time to market, and improve margins on existing products, while maintaining strict regulatory compliance. A comprehensive product lifecycle management (PLM) solution can help address these challenges by providing visibility and control across the entire drug development process from discovery through commercialization. PLM focuses on leveraging research and development efforts to efficiently develop new drugs and move them through the various phases of the drug lifecycle from the different internal and external functions involved. This allows for improved collaboration and management of changes to optimize profitability throughout the drug's economic life.
WHAT IS THE DIFFERENCE BETWEEN PCD, GENERIC, AND ETHICAL PHARMA SECTORS?ambitbiomedix12
DIFFERENCE BETWEEN PCD, GENERIC, AND ETHICAL PHARMA SECTORS. Read More: https://bit.ly/2GFIONg
Are you a little bit confused about the difference between PCD, Generic, and Ethical Pharma Sectors? This blog gives the required information concisely and precisely.
Website: http://ambitbiomedix.com/
Social Media:
Facebook - https://www.facebook.com/ambitbiomedix/?ref=settings
Instagram - https://www.instagram.com/ambit_bio_medix/
Twitter - https://twitter.com/ambitbiomedix?lang=en
Linkedin - https://www.linkedin.com/company/ambit%E2%84%A2-bio-medix/about/
Youtube - https://www.youtube.com/watch?v=GPzB82AjvQA&t=3s
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
Jim Fitzgerald from CA and FCA spoke about group purchasing organizations (GPOs) and introduced HealthTrust, CoreTrust, and Parallon Business Solutions. HealthTrust is a global GPO owned by hospitals and health systems. It aggregates spending to negotiate pricing across 1,400+ hospitals. CoreTrust, a division of HealthTrust, extends this leveraged buying model to commercial companies. Parallon provides outsourced business services to the healthcare industry.
Contract research and manufacturing services (CRAMS) refers to outsourcing research and manufacturing services from low-cost providers. India has become an important destination for CRAMS due to its lower costs, skilled workforce, regulatory expertise, and US FDA-approved facilities. Indian companies provide contract research like clinical trials and contract manufacturing of APIs, intermediates, and formulations to pharmaceutical multinationals seeking to reduce costs and maintain profitability.
A brief introduction of the outsourcing methods in Pharma Supply Chain, Types of Outsourcing, Framework to decide correct outsourcing partner, factors to consider while selecting a partner, Process of outsourcing and Outsourcing models.
This research service provides an in-depth analysis of the global pharmaceutical contract manufacturing market with particular focus on the finished dose formulations such as solid, liquid and semi-solid, and injectable dose formulations. Segment analysis, trends and revenue forecast for the global, U.S. and European regions have been provided in detail. Strategic recommendations for the success of market participants have also been discussed.
Hi
I am Rahul Ranjan Rai, perusing MBA from Jaypee Business School and I have completed this Project under the supervision of Pro. Evan Costle (france). I hope this presentation will help you to understand the emerging concepts in Generic Industry
Thank you
Regards
Rahul
Complex Generics Overview - Outlooks and ChallengesSanjay Chaturvedi
The document summarizes a presentation given at the 5th Regulatory Conference on the evolving global regulatory environment. The presentation discusses complex generics known as "SuperGenerics", which are improved versions of existing drugs that have lost patent protection. They include modified release formulations, transdermal patches, and other delivery methods. SuperGenerics provide advantages like quicker action, fewer side effects, and more convenient dosing. Global pharmaceutical companies are placing significant focus and investment on SuperGenerics as a way to gain competitive advantages and higher profits in the generic drug market. The development of SuperGenerics presents opportunities but also regulatory and clinical challenges.
Navigating Drug Pricing Trends Webinar - May 23, 2017PSG Consults
This document summarizes a presentation on navigating drug pricing trends. It discusses factors influencing rising drug prices like utilization growth, manufacturer price inflation, and rebates. It also covers PBM contracting considerations like definitions, methodologies, flexibility, and protection. The presentation recommends conducting annual "market checks" to benchmark PBM contract terms and ensure competitive pricing. Conducting independent third-party analyses of industry pricing data is a best practice. Overall the presentation aims to inform attendees about industry trends impacting drug prices and contracting.
This document discusses outsourcing in the pharmaceutical industry. It defines outsourcing as transferring portions of work to outside suppliers in order to reduce costs. The main types of outsourcing in pharma include research and development, clinical trials, manufacturing, packaging, and sales/marketing. The key drivers of outsourcing are focusing on core strengths, reducing costs, and decreasing time to market. While outsourcing provides advantages like cost reductions, it also presents risks such as loss of managerial control and internal talent. Overall, outsourcing allows pharma companies to exploit new drug technologies while solving problems, though successful management of vendor relationships is critical.
The document discusses generic drug product development. It defines a generic drug as having the same active ingredients, dosage form, strength, quality, and intended use as the branded version. Generic drugs are available after patent expiration or waiver. The generic product development process involves concept development, system-level design, detail design, testing and refinement, and production ramp-up to launch the product.
This document provides an overview of the US healthcare reimbursement model and strategic reimbursement planning. It outlines four main steps to developing a reimbursement plan: 1) identifying who influences product use, 2) defining the market model by finding existing codes, 3) identifying any coding gaps, and 4) determining any regulatory issues. Key tactics include training opinion leaders, collaborating with medical societies, and publishing clinical data. FDA registration involves establishment, product listing, and approval processes which can take up to a year and cost over $60,000 for monoclonal antibodies. Consultants can help navigate the FDA process.
Know about Contract manufacturing of pharma products marketactizapharma
Here's some discuss and news regarding actizapharma which are working on the contract pharmaceutical production worldwide. They proficient enough to customize the entire range of medicines, to meet client’s requirements.
An employer approached Marsh & McLennan Agency (MMA) concerned about rising medical and pharmacy costs and potential penalties from the Cadillac Tax. MMA conducted an analysis and found the employer's benefits were richer than competitors and pharmacy spending was higher than expected. MMA engaged their pharmacy experts to evaluate the employer's pharmacy benefit manager contract. Experts identified opportunities to improve drug pricing and rebate sharing. After negotiations, the employer achieved $250,000 in annual pharmacy savings through a revised contract without changing their PBM or plan design.
Este documento describe diferentes instrumentos de medición utilizados en maquinaria y reconstrucción de motores, incluyendo flexómetros, calibradores vernier, micrómetros exteriores e interiores, reloj comparador, alexómetro y calibrador de laminas. Además, ofrece consejos sobre el cuidado y manejo adecuado de estas herramientas.
The document provides an overview of a 5-week IT testing course. It discusses the aims of testing including understanding what testing is, why it is needed, and common testing methodologies. It also describes testing documentation like test plans, test cases, and traceability matrices. Finally, it covers topics like test scenarios, test case templates, levels of testing, and the bug life cycle.
Este documento describe diferentes instrumentos de medición utilizados en maquinaria y reconstrucción de motores, incluyendo flexómetros, calibradores vernier, micrómetros exteriores e interiores, reloj comparador, alexómetro y calibrador de laminas. Además, ofrece consejos sobre el cuidado y manejo adecuado de estas herramientas.
El documento describe el pie de rey o calibrador, incluyendo sus partes, escalas, tipos y cómo usarlo para tomar medidas precisas. El pie de rey se utiliza para medir longitudes externas, internas y profundidades mediante el uso de su escala fija y nonio. El nonio permite medidas con una precisión inferior al milímetro al complementar las divisiones de la escala principal. Se deben tomar precauciones como asegurar un contacto adecuado y una alineación correcta para obtener medidas precisas.
GCS - The fundamentals for nurses and nursing studentsRavi Dadlani
The Glasgow Coma Scale (GCS) is used to assess severity of head injuries. It evaluates eye opening, verbal response, and motor response on a scale of 3-15, with lower scores indicating more severe injury. The GCS was developed in 1974 by neurosurgeons in Glasgow to standardize assessment. Scores help determine prognosis and recovery using the Glasgow Outcome Score. The document outlines how each component is assessed and scored, including stimuli used to check responses to pain. It emphasizes the GCS evaluates purposeful motor responses rather than reflexes alone.
The Glasgow Coma Scale is a neurological scale used to assess and record a person's state of consciousness after brain injury. It evaluates motor response, verbal response, and eye opening on a scale of 1 to 6 for motor, 1 to 5 for verbal, and 1 to 4 for eye opening. The scores are added up to give a total between 3 and 15, with lower scores indicating more severe brain injury and worse prognosis. The scale categorizes levels of injury from mild to severe disability, vegetative state, and brain death.
The Glasgow Coma Scale (GCS) is used to assess level of consciousness in patients with brain injuries or illnesses. It evaluates eye opening, verbal response, and motor response on a scale of 3-15, with lower scores indicating a worse level of consciousness ranging from mild to severe coma. Common causes of coma include cerebrovascular diseases like stroke, subarachnoid hemorrhage, brain hemorrhage or infarction leading to increased intracranial pressure or brainstem herniation. Other causes are hypotension, head trauma, infections like meningitis, toxic-metabolic disturbances, and lack of oxygen. A thorough neurological examination including vital signs, pupil response, eye and motor movements can help
The Glasgow Coma Scale (GCS) was developed as a simple, practical tool for assessing neurological injury and monitoring patients. It evaluates eye opening, verbal response, and motor response on a scale of 3-15. A lower score indicates a lower level of consciousness and worse prognosis. While initially created for adults, modified versions have been made for children who cannot communicate verbally. Though developed decades ago, the GCS remains the standard for initial assessment of brain injury severity and predicting outcomes.
Este documento presenta el objetivo y contenido de un curso de metrología. El objetivo es que los técnicos aprendan sobre los instrumentos de medición y verificación usados en talleres. El contenido incluye conceptos matemáticos, metrología, unidades de medida, elementos de verificación y medición como pie de rey y micrómetro, y ejercicios finales sobre especificaciones.
HealthPRO is a healthcare procurement organization in Canada that aggregates volumes to achieve the greatest value for its members. It represents over 250 members across seven provinces and territories, with purchasing power over 800 hospitals. For clinical contracts involving capital equipment used across departments or clinically complex products with innovation potential, HealthPRO follows a 5-step approach: 1) Develop a strategy with clinical input, 2) Prequalify products against criteria, 3) Commit members in advance to contracts, 4) Issue RFPs and award contracts, 5) Implement and provide ongoing local and national support. This approach delivers the best overall value while meeting members' unique needs.
This document summarizes HealthPRO's contract approach for pharmacy contracts. It discusses HealthPRO's role in aggregating volumes to achieve the greatest value for members. The contract process involves planning strategy, issuing requests for proposals, evaluating products, awarding contracts, and providing ongoing support. Key aspects of the process include separating contracts into packages, evaluating products based on criteria like safety and quality, monitoring vendors, managing drug shortages, and driving policy changes to support members.
Stabicon has been ambitiously established in 2010. Professionally managed with 75 scientists from diverse background expertise. Our organization is specialized in managing product quality process, upgrading and introducing advanced technology into products. we are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business.
Kenneth Wu has extensive experience providing clinical consulting and subject matter expertise to pharmaceutical and medical device companies. He has helped clients with regulatory submissions, clinical trial management, standard operating procedure development, vendor management, and regulatory inspection preparation. Some of his roles include interim clinical operations director, clinical program manager, conference moderator, and regulatory submission author. His consulting work has helped clients streamline processes, reduce costs and timelines, and prepare for successful regulatory interactions and inspections.
HealthPRO is a healthcare procurement organization in Canada that aggregates volumes to achieve value for its members, which include over 250 members representing more than 800 hospitals. It uses a clinical service contract approach to contracting for capital equipment, clinically complex products, and those with potential for innovation. The process involves planning and developing a strategy, prequalifying products, having members commit to contracts, issuing requests for proposals and awarding contracts, and implementing and supporting contracts. Working with HealthPRO provides suppliers national reach, regulatory compliance, high contract commitment levels, and market intelligence insights.
The document discusses procurement and warehousing of drugs and pharmaceuticals. It covers key topics like procurement process, components of an effective drug procurement policy, strategies for good procurement, methods of procurement, proper drug storage conditions and requirements, pest control measures, and expiry date management. The main points are procurement involves acquiring supplies through various purchase methods, an efficient policy has elements like essential drug lists and quality assurance, and proper storage, organization and safety protocols are vital to preserve drug quality.
HealthPRO is a healthcare procurement organization that aggregates volumes from over 250 member facilities across Canada to negotiate contracts for pharmacy products. They develop contract strategies tailored for different product categories and issue regular and market response RFPs. Products are evaluated based on clinical and operational criteria by pharmacists and nurses. Contracts are awarded for 3-4 years based on price, quality, and supply assurance. Ongoing support is provided to both members and awarded suppliers throughout the contract period.
The document provides an overview of pharmaceutical analytical and stability study outsourcing to Stabicon Life Sciences Pvt. Ltd. It discusses the changing industry trends driving outsourcing, criteria for selecting an offshore outsourcing partner, the outsourcing process, and the benefits of outsourcing to Stabicon. Key points include:
1) Pharmaceutical companies are outsourcing more to reduce costs, focus on core competencies, and gain access to technical expertise. India is a top destination due to its skilled workforce and lower costs.
2) When selecting a partner, criteria include quality systems, regulatory compliance, infrastructure, expertise, and reliability.
3) The outsourcing process at St
Pfizer is the world's largest pharmaceutical company with revenues of $49.6 billion in 2014. It has over 78,000 employees worldwide and key products include Lipitor, Lyrica, Viagra, and Celebrex. In India, Pfizer has over 3,000 employees and a manufacturing facility in Thane, Maharashtra. Pfizer utilizes a complex global supply chain network involving over 300 suppliers to procure and deliver materials and finished products to customers in over 175 distribution centers worldwide while managing risks such as cargo theft and counterfeiting.
TGA webinar: The Good Manufacturing Practice (GMP) Clearance Framework – an o...TGA Australia
The document provides an overview of Australia's Good Manufacturing Practice (GMP) Clearance Framework. It discusses the legislative basis for manufacturing requirements, the roles and activities of the Manufacturing Quality Branch, and the two pathways for obtaining a GMP Clearance - a desk-based assessment through a Mutual Recognition Agreement or Compliance Verification, or an on-site TGA inspection. It also outlines the history of GMP Clearance, recognized authorities through agreements like MRAs, and the MRA assessment pathway.
SAI Global Traceability in Supply ChainsSwitzerland09
The document provides an overview of a presentation on traceability in supply chains given by Dr. Bob Strong. It discusses why traceability is important, defining traceability, benefits of traceability, traceability challenges, and traceability best practices. Traceability is required by food safety regulations worldwide and certification standards to enable rapid recall of contaminated products and ensure food safety. Effective traceability requires tracking food inputs and outputs at each stage of the supply chain.
Regulatory 101 for Medical Device Start UpsEMMAIntl
In this webinar hosted from EMMA International's Lead Quality Engineer, Nikita Angane, she will go over the different FDA Centers, as well as the pathways to market, what a RTA (Refuse to Accept) is, and also reviewing labeling, registration, and device listings.
Bilcare_GCS Quality and Regulatory OveriewBilcare GCS
Bilcare is committed to providing innovative clinical trial material supply services globally according to quality and regulatory standards. It offers services including clinical trial manufacturing, packaging, labeling, sourcing of drugs, and storage and distribution. Bilcare aims to provide cost-effective and creative solutions through strategic partnerships to help customers succeed. It focuses on customer satisfaction, continual self-improvement, and compliance with regulations like cGMP, GCP, and ISO 9001. Bilcare works to improve through learning from audits and implementing systems improvements.
- The document discusses Antares Pharma, a pharmaceutical company focused on developing drug-device combination products. It provides an overview of Antares' approved and in-development products, including Gelnique gel for overactive bladder which was recently approved by the FDA. It also summarizes partnerships with companies like Teva and Watson, the financial position and growth of the company, and potential milestones in the next 12-18 months including product launches.
An Abbreviated New Drug Application (ANDA) is an application for approval of a generic drug that is comparable to an existing brand-name drug in dosage form, strength, quality and intended use. An ANDA contains data demonstrating the generic drug is bioequivalent to the reference listed drug. If approved, the generic drug may be marketed as a lower-cost alternative. The goal of the ANDA process is to expedite availability of affordable generic drugs while ensuring they are safe, effective and bioequivalent to the brand-name version.
This document discusses Antares Pharma, a pharmaceutical company developing drug delivery systems. It provides an overview of the company's technology platforms, product pipeline, partnerships, and financial status. Key points include that Antares has three FDA-approved products, multiple products in development through partnerships with companies like Teva and Pfizer, and is focusing on developing self-injection products like its Vibex methotrexate auto-injector to treat conditions like rheumatoid arthritis.
Similar to Bilcare GCS Comparator Procurement (20)
2. Speed | Innovation | Happiness
The comparator procurement process is becoming tedious and time consuming due to:
• Increasing complexity of clinical trials
• Lack of meticulous planning
• Stringent Regulatory requirements
• Counterfeit dangers
• Over/under ordering
• Sponsor’s reservation to disclose Trial Information resulting in challenges in procuring
Innovator Drugs
Business Challenges
Not gaining reliable access to comparator can delay the trials
or lead to its early termination making it critical
3. Speed | Innovation | Happiness
Bilcare GCS – Comparator Procurement Services
• Confidentially access drugs worldwide for global clinical trials
• Provide Regulatory compliance and necessary product documentation
• Capability to provide large volume of drugs in multiple or single lot batches
with long expiration dates
• Provide drug related documents like COA, MSDS as applicable
• Procure authentic products and full batch traceability
• Guidance to Sponsors to enable Proactive Planning for sustainable &
significant cost savings
• Providing Cost Effective Cold Chain Logistics
Complete and a sound understanding of all critical issues
involved in sourcing comparators for Global Clinical Trials
5. Speed | Innovation | Happiness
Bilcare GCS - Project Handling expertise
• Succefully handled procurement of vaccines, medicines for ulcerative colitis,
cancer, Diabetes, Heart disease etc and Hormonal contraceptives
• Completed Procurement of Vaccines of Phase III trial for one of a Big Pharma
company. (The procurement was done directly from Vaccine Manufacturer & was also a
cost competitive proposal for our client)
• Handled numerous small quantity (RLD requirements) of various drugs for
clinical trial
• Drug in single and multiple batches
• Drugs requiring controlled temperatures
6. Speed | Innovation | Happiness
Expertise in managing cost of supplies
• Sourcing products through Wholesalers and Direct from Manufacturers
(most competitive options for clients)
• Repeat orders to the Wholesalers and Manufacturers further add to the
price benefits
• Preferably procure the products from the country of origin (save on time)
• Capability to provide Alternate product if required by our client (needs a
detailed description of the comparator such as its name and strength of
active ingredient)
Bilcare has extensive global references, indicators, and expertise
that provide us with valuable insight during comparator inquiries
and purchases to have a better price advantage and helps in negotiations
7. Speed | Innovation | Happiness
Costing Model
• Costs of material Sourcing/procurementProduct Cost
• Provide complete Project Management (coordinate supplies, compile resources, prepare
instructions, and perform other necessary functions to enable the successful completion
of this project) throughout the entire duration.
Project Management
• This is inclusive of but not limited to Storage, packaging, domestic
Transportation/warehousing (if applicable), shipping documentation preparation and
other overseas transportation related cost etc.
Logistics & Distribution Cost
• This includes cost of import & export licenses obtained from respective regulatory agencyRegulatory Licensing Cost
• Custom Clearances & Duties (as applicable) and Transit InsuranceDocumentation
• As applicable in various countriesValue Added Tax
8. Speed | Innovation | Happiness
Comparator drug procurement – Activity Flow
For any enquiry following activities are done along with lead time required for each
Availability Check
Initial check of comparator drug
availability in designated country (lead
time should be counted upon receiving
availability inquiry to submission of
availability results to clients)
Maximum three working days
Quotation
Provide quotation and expected sourcing
lead time to clients
Bilcare can meet a 48-hour turn around
time in providing a quotation for the
Comparator services. Complex procurement orders may
take longer depending on the nature of the request
Material sourcing and
shipping preparation
Source comparator drug, prepare related
external packaging/shipping documents,
arrange export and shipping etc (lead
time should be counted upon order
confirmation to comparator drug
shipment ready for shipping)
Lead time for certain comparator products can vary as they
depend on which world market the product is being
sourced and the type of product (i.e. Controlled drugs etc,
Import/export regulatory compliance). Bilcare coordinates
extensively with all vendors to ensure that we obtain the
comparator products requested within the most efficient and
effective amount of time. Till now, Bilcare has fulfilled the
delivery requirement in max 40 days from date of order
confirmation.
9. Speed | Innovation | Happiness
Regulatory Support
Well versed with handling requirements to obtain Import/Export
license required for importing/exporting of Comparator drugs
from a particular country
Expertise in handling custom clearances
Well organized in Providing required documents for EXIM and
Customs
10. Speed | Innovation | Happiness
Bilcare GCS - Depot Network
Expertise in handling temperature controlled shipments, monitor the temperature
during its storage and transportation to required destination
Asia – Pacific
Pune, India
Depot Partners
Australia & New Zealand
China
Japan
Malaysia
Philippines
Sri Lanka
Singapore
South Korea
Taiwan
Thailand
Afro- Gulf
Depot Partners
Malawi
South Africa
Israel
EU
Depot Partners
France
Germany
Netherlands
Turkey
Russia
Ukraine
UK
Americas
Depot Partners
Argentina
Brazil
Mexico
USA
17. Speed | Innovation | Happiness
Thank you
www.bilcareGCS.com
“Experience Bilcare - Experience World Class Services”
Dr. Abhigyan Upadhyay, Vice President- Business Operations
abhigyan.upadhyay@bilcare.com