Pharmaceutical Industry - Business Perspectives for IT TeamsSatheesh Kadiam
The document provides an overview of the pharmaceutical industry and drug development process. It discusses how the industry is highly regulated and the various stages of drug development from target discovery through clinical trials and regulatory approval. It also outlines the major areas of pharmaceutical manufacturing including biochemical and chemical API production, bulk manufacturing, and packaging. Regulatory compliance and good manufacturing practices are essential throughout the manufacturing process.
The document provides an overview of careers in the biopharmaceutical industry. It describes the long process of developing new drugs, which involves identifying drug targets, designing and testing compounds, conducting preclinical and clinical trials, gaining regulatory approval, and post-launch monitoring. Many roles are needed across research, development, manufacturing, regulatory affairs, sales, and other functions. The average time to get a new drug to market is 14 years and over $1 billion.
10 Most Innovative CRO’s To Watch In 2022.pdfinsightscare
During the COVID-19 pandemic, if clinicians, healthcare service-providing staff, nurses, and doctors were battling at the forefront, then the Clinical Research Organizations (CROs) have been working hard
Tools Available to the FDA to Assess Patient SafetyEMMAIntl
Patient Safety must be at the center point of all operations in the health care industry. Whether it is the manufacturer who is responsible for designing and developing the drug or the device, doctors and nurses administering the drug or the device, or the FDA who is responsible for regulating the use of such products on patients...
BIOMEDICAL ENGINEERING - FINAL (2) (3).pdfsamikshaUkey
This document provides an overview of biomedical engineering, including:
1) What biomedical engineering is and what biomedical engineers do, such as research and development across many fields.
2) The 10 main interdisciplinary fields of biomedical engineering, including biomechanics, biomaterials, biomedical optics, and more.
3) Medical devices are discussed as extremely broad and regulated to ensure safety and effectiveness. Regulation is important to address incidents and ensure quality.
Role of Pharmacovigilance in Drug Discovery and Post Marketing Surveillanceijtsrd
Pharmacovigilance is a cornerstone of both the pharmaceutical industry and the healthcare system. It is aimed to ensure guaranteed patient safety and is considered an arm of patient care. Pharmacovigilance is essential at many stages of the drug discovery and development process. Drug safety assures that a patients safety and well being are protected throughout the whole drug development lifecycle, including when the drug is easily available on the market. Pharmacovigilance comprises pre and post marketing surveillance. Pre clinical screening, which collects information on ADRs from phases I to III of clinical trials, and post marketing surveillance, which gathers data from the post approval stage and during the course of a drugs shelf life. During clinical trials pharmacovigilance mandates the timely submission of reports on adverse events during clinical trials to regulatory authorities, notification of such events to all investigators and ethics committees, and a safety review by independent Drug Safety Monitoring Boards DSMB . Predicting or evaluating potential ADRs at this early stage of the drug development pipeline is the focus of PV. Finding previously unrecognized adverse effects as well as good effects is the major goal of PMS research by utilizing various pharmacovigilance methodologies. K. Sravanathi Bai | V. Venu "Role of Pharmacovigilance in Drug Discovery & Post-Marketing Surveillance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-3 , June 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd57400.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/other/57400/role-of-pharmacovigilance-in-drug-discovery-and-postmarketing-surveillance/k-sravanathi-bai
10 Most Trusted Infectious Disease Solution Providers in 2022.pdfinsightscare
MicuRx Pharmaceuticals is a biotech company focused on developing new antibiotics to address the growing problem of antimicrobial resistance. Founded in 2007 by CEO Zhengyu Yuan based on his experience in the field, MicuRx takes a rational drug design approach to efficiently develop new treatments. The company identified a need for antibiotics that are both effective against resistant pathogens and safe for use outside hospitals. MicuRx leverages trans-Pacific operations between the US and China to conduct research and development at lower costs while meeting international standards. This allows the company to progress drug candidates through screening and development to identify those with balanced potency, safety and resistance profiles to meet significant unmet medical needs.
Pharmaceutical Industry - Business Perspectives for IT TeamsSatheesh Kadiam
The document provides an overview of the pharmaceutical industry and drug development process. It discusses how the industry is highly regulated and the various stages of drug development from target discovery through clinical trials and regulatory approval. It also outlines the major areas of pharmaceutical manufacturing including biochemical and chemical API production, bulk manufacturing, and packaging. Regulatory compliance and good manufacturing practices are essential throughout the manufacturing process.
The document provides an overview of careers in the biopharmaceutical industry. It describes the long process of developing new drugs, which involves identifying drug targets, designing and testing compounds, conducting preclinical and clinical trials, gaining regulatory approval, and post-launch monitoring. Many roles are needed across research, development, manufacturing, regulatory affairs, sales, and other functions. The average time to get a new drug to market is 14 years and over $1 billion.
10 Most Innovative CRO’s To Watch In 2022.pdfinsightscare
During the COVID-19 pandemic, if clinicians, healthcare service-providing staff, nurses, and doctors were battling at the forefront, then the Clinical Research Organizations (CROs) have been working hard
Tools Available to the FDA to Assess Patient SafetyEMMAIntl
Patient Safety must be at the center point of all operations in the health care industry. Whether it is the manufacturer who is responsible for designing and developing the drug or the device, doctors and nurses administering the drug or the device, or the FDA who is responsible for regulating the use of such products on patients...
BIOMEDICAL ENGINEERING - FINAL (2) (3).pdfsamikshaUkey
This document provides an overview of biomedical engineering, including:
1) What biomedical engineering is and what biomedical engineers do, such as research and development across many fields.
2) The 10 main interdisciplinary fields of biomedical engineering, including biomechanics, biomaterials, biomedical optics, and more.
3) Medical devices are discussed as extremely broad and regulated to ensure safety and effectiveness. Regulation is important to address incidents and ensure quality.
Role of Pharmacovigilance in Drug Discovery and Post Marketing Surveillanceijtsrd
Pharmacovigilance is a cornerstone of both the pharmaceutical industry and the healthcare system. It is aimed to ensure guaranteed patient safety and is considered an arm of patient care. Pharmacovigilance is essential at many stages of the drug discovery and development process. Drug safety assures that a patients safety and well being are protected throughout the whole drug development lifecycle, including when the drug is easily available on the market. Pharmacovigilance comprises pre and post marketing surveillance. Pre clinical screening, which collects information on ADRs from phases I to III of clinical trials, and post marketing surveillance, which gathers data from the post approval stage and during the course of a drugs shelf life. During clinical trials pharmacovigilance mandates the timely submission of reports on adverse events during clinical trials to regulatory authorities, notification of such events to all investigators and ethics committees, and a safety review by independent Drug Safety Monitoring Boards DSMB . Predicting or evaluating potential ADRs at this early stage of the drug development pipeline is the focus of PV. Finding previously unrecognized adverse effects as well as good effects is the major goal of PMS research by utilizing various pharmacovigilance methodologies. K. Sravanathi Bai | V. Venu "Role of Pharmacovigilance in Drug Discovery & Post-Marketing Surveillance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-3 , June 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd57400.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/other/57400/role-of-pharmacovigilance-in-drug-discovery-and-postmarketing-surveillance/k-sravanathi-bai
10 Most Trusted Infectious Disease Solution Providers in 2022.pdfinsightscare
MicuRx Pharmaceuticals is a biotech company focused on developing new antibiotics to address the growing problem of antimicrobial resistance. Founded in 2007 by CEO Zhengyu Yuan based on his experience in the field, MicuRx takes a rational drug design approach to efficiently develop new treatments. The company identified a need for antibiotics that are both effective against resistant pathogens and safe for use outside hospitals. MicuRx leverages trans-Pacific operations between the US and China to conduct research and development at lower costs while meeting international standards. This allows the company to progress drug candidates through screening and development to identify those with balanced potency, safety and resistance profiles to meet significant unmet medical needs.
10 Most In-Demand Anti-Infective Medicine Brands of 2023.pdfinsightscare
MicuRx Pharmaceuticals is a biotech company focused on developing new antibiotics to address the growing problem of antimicrobial resistance. Founded in 2007 by CEO Zhengyu Yuan based on his experience in the field, MicuRx takes a rational drug design approach to identify compounds that are both effective against drug-resistant bacteria and have improved safety profiles over existing drugs. The company operates using a trans-Pacific model with labs in both the US and China to leverage lower costs. MicuRx's mission is to develop "better therapies through superior medicines" by addressing unmet medical needs with new oral and IV antibiotic options that have flexibility of use in both hospital and outpatient settings.
Pharmaceutical microbiology involves studying microorganisms associated with developing, manufacturing, and minimizing microorganisms in pharmaceuticals to ensure sterility. It also includes using microbes to test drugs and make products like insulin. Key aspects are endotoxin detection and testing, environmental monitoring, microbial detection systems, and mycoplasma detection to ensure products are sterile and safe. Quality control microbiology through pharmacopeias sets guidelines for consistency, safety, sterility and potency during drug development and manufacturing. Major pharmacopeias are the USP, European Pharmacopoeia and Japanese Pharmacopoeia which set standards, while ICH works to harmonize them internationally.
Clinical Research is a most knowledge-intensive and interesting field in the pharmaceutical industry. There are more than 2, 50,000 positions unemployed in global Pharmaceutical industry.
The document discusses the healthcare and pharmaceutical industries. The healthcare industry provides goods and services for curative, preventive, rehabilitative, and palliative care and includes medical equipment, supplies, and healthcare services like hospitals and nursing homes. The pharmaceutical industry develops, produces, and markets drugs and deals in generic and brand medications. Some reputable healthcare companies mentioned are Sanofi, Hoffman la Roche, Johnson and Johnson, and Novartis, while reputable pharmaceutical companies include Catalent MSP, DuPont, BASF, and Amgen. Important roles in the industries include scientist, chemist, laboratory technician, clinical trials manager, nurse, and research associate.
Careers in Pharmacy in India, 1. Pharmacist, 2. Drug Inspector, 3. Governmental Agencies, 4. As Government Analyst, 5. Clinical Pharmacy, 6. Community Pharmacy, 7. Nuclear Pharmacy, 8. Pharmaceutical Industry, 9. Drug researcher, 10. As Manufacturing Chemist, 11. In Quality Control / Quality Assurance, 12. Clinical Research, 13. Medical Communications/ Information, 14. Medical Transcription, 15. Medical Coding 16. In Regulatory Affairs 17. Sales and Marketing 18. Pharma-Biotechnology, 19. Academic Pharmacy, 20. Health policy makers, 21. Specialized Area Opportunities, 22. Higher Studies With Research Fellowship
Unilife Corporation (NASDAQ:UNIS - News) is a U.S.-based developer, manufacturer and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in 2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines. Unilife has developed a broad, differentiated proprietary portfolio of its own injectable drug delivery products, including the Unifill® and Unitract® product lines of safety syringes with automatic, operator controlled needle retraction. Unifill represents the world's first prefilled syringe technology integrating safety within the primary drug container. The products are ideally positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and enhance patient care. Unifill syringes, together with other devices that are part of the Unilife technology platform, can either be supplied to pharmaceutical customers ready for use, or customized to address the specific requirements of targeted novel drugs. For more information on Unilife, please visit www.unilife.com.
Since its founding in 1935, Morgan Stanley and its people have helped redefine the meaning of financial services. The firm has continually broken new ground in advising our clients on strategic transactions, in pioneering the global expansion of finance and capital markets, and in providing new opportunities for individual and institutional investors. Click below to see a timeline of Morgan Stanley's growth, which parallels the history of modern finance
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
Europe's Top 5 Medical Device Companies to Watch in 2023.pdfinsightscare
The latest edition of Insights Care, Europe’s Top 5 Medical Device Companies to Watch in 2023, sheds light on the prominent leader, John O’Dea, CEO of Palliare.
The document discusses the product lifecycle of medical devices. It begins with an introduction that defines the basic phases of a product lifecycle as research, development, production, and end of life. It then outlines 6 key phases in the medical device product lifecycle: 1) Concept, 2) Planning, 3) Design, 4) Validation, 5) Launch, and 6) Post-market. Each phase is described in 1-2 sentences. For example, the Concept phase involves initially defining the product and exploring funding/routes to market, while the Post-market phase includes ongoing surveillance and reporting to continuously evaluate safety.
Introduction to Regulatory Affairs - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, June 14, our colleagues Fiorenzo Savoretti, Senior Regulatory and Quality Consultant at Pfizer and Nick Deschacht, Senior RA Consultant at GSK, gave an interesting “Introduction to Regulatory Affairs”.
Fiorenzo and Nick talked about RA and their projects, each from their unique angle. They delivered their presentations for ## attendees at our Brussels office at the Lambroekstraat 5a in Diegem.
India Microbiology Testing Market: Size, Share, and In-Depth Competitive Anal...Kumar Satyam
According to TechSci Research report, "Microbiology Testing Market – India Industry Size, Share, Trends, Competition Forecast & Opportunities, 2028", the India Microbiology Testing Market was valued at USD 130.59 million in 2022 and is anticipated to grow with a CAGR of 6.41% during the forecast period, 2024-2028. The increasing awareness among individuals regarding microbiology testing has fostered favorable market conditions, driving growth across various microbiology testing products. This report delves into the factors propelling the market's expansion, recent trends, and key players shaping the competitive landscape.
Increasing Disease Burden
The India Microbiology Testing Market is intricately linked to the country's escalating disease burden. Microbiology testing has emerged as a critical tool in disease management, offering early detection, monitoring of antibiotic resistance, and outbreak control. With ongoing advancements and investments, the market is poised for substantial growth, contributing to India's efforts to combat the rising health challenges it faces.
10 Most Efficient Drug Delivery Solution Providers in 2023V2_compressed.pdfinsightscare
Insights Care’s latest edition, 10 Most Efficient Drug Delivery Solution Providers in 2023, navigates you to the rapidly changing healthcare landscape.
Postmarketing surveillance (PMS) involves monitoring the safety of pharmaceutical drugs and medical devices after they have been approved for public use. PMS is important because pre-approval clinical trials involve relatively small numbers of participants and may not detect rare or long-term adverse effects. PMS uses various methods like spontaneous reporting, cohort studies, and case-control studies to monitor drug and device safety in larger populations over longer time periods after approval. The goal of PMS is to further evaluate or confirm the safety profile of products as they are used in real-world clinical settings by more diverse patients than clinical trials.
Must know things if working in Pharma Industry.pptxsurajbitsindri1
This document provides secrets for customer success in the pharmaceutical industry. It summarizes key aspects of the industry including the drug discovery process, regulatory compliance, and opportunities for process improvement. The drug discovery process involves discovery and development, preclinical research, clinical development, FDA review, and post-market safety monitoring. Regulatory bodies like the FDA aim to bring safe treatments to patients through a thorough review and approval process. Leveraging data, analytics, AI and machine learning can help digitalize processes and minimize errors to improve compliance and innovation.
As we understand more about the human body and how it functions and degrades, biotechnology will progress. This is only the beginning, but when new technology and procedures become accessible, certain themes will start to develop in biopharma trends.
Product type- Drug development - Departments of facility- Registration pathwa...Asmaa Khalil
In this video you will know the detailed information about:
🔸Departments of the manufacturing sites.
🔸Steps of drug product development.
🔸Regulatory Affairs department.
🔸Registration pathway.
🔸Product Type (Innovator "RLD" / Generic / Hybrid).
🔸All medicines must grant a Marketing Authorization (MA) in order to be placed on the market legally in the country.
🔸The ultimate purpose of marketing authorization is to ensure that safe, effective & high-quality medicines, as to protect public health.
https://youtu.be/edUEFt681iM
#asmaa_khalil_ctd
This presentation is about the current trends in pharmacy profession. It will give the brief insight about the direction in which current pharmacy market is going.
This document provides information about the 5th Pharmacovigilance Congregation conference taking place on November 20th, 2013 in Mumbai, India. The conference will discuss ensuring safer drugs reach the market through analyzing developments in pharmacovigilance, drug safety, and risk management. It will feature keynote speakers from various pharmaceutical companies and overviews of the latest challenges and opportunities in pharmacovigilance. The event aims to provide a platform for stakeholders to discuss best practices and advancing pharmacovigilance in India.
Matching Customer's expectations for Innovative FutureRuby Med Plus
Genentech is a leading biotechnology company founded in 1976 that discovers, develops, and commercializes pharmaceutical products. It has over 1,100 researchers and focuses on developing treatments for cancer, immunology, tissue disorders, and neuroscience. In 2020, Genentech will need to focus on monitoring industry trends and developing new therapies using molecular-level research. It will face challenges from regulatory restrictions on emerging technologies and uncertainties around whether new treatments will succeed or be accepted by customers. Genentech's success will depend on its researchers' ability to continuously innovate and develop specialized, effective drugs.
This presentation covers the Introduction to Healthcare & different Products, Role of Pharmaceutical in Healthcare, Drug Details, What a drug is made of ?, Classification of drugs, Product Life Cycle of a Drug, Drug Development Phases, Regulatory Framework & various Regulatory Bodies
This document provides an introduction to Git and GitHub. It begins with an overview of source control and the history of version control systems like SVN and CVS. It then discusses key Git concepts like its three-tree architecture, branches and merging, and undoing changes. The document concludes with an introduction to GitHub, including how to clone repositories, collaborate through pull requests, and link a local Git repository to a remote GitHub repository.
Git is a distributed version control system that allows for collaborative development of software. GitHub is a hosting service for Git repositories that provides a web interface and additional features. The document provides step-by-step instructions for installing Git, configuring it with GitHub, working locally and remotely with repositories, and additional resources for learning more about Git and GitHub.
10 Most In-Demand Anti-Infective Medicine Brands of 2023.pdfinsightscare
MicuRx Pharmaceuticals is a biotech company focused on developing new antibiotics to address the growing problem of antimicrobial resistance. Founded in 2007 by CEO Zhengyu Yuan based on his experience in the field, MicuRx takes a rational drug design approach to identify compounds that are both effective against drug-resistant bacteria and have improved safety profiles over existing drugs. The company operates using a trans-Pacific model with labs in both the US and China to leverage lower costs. MicuRx's mission is to develop "better therapies through superior medicines" by addressing unmet medical needs with new oral and IV antibiotic options that have flexibility of use in both hospital and outpatient settings.
Pharmaceutical microbiology involves studying microorganisms associated with developing, manufacturing, and minimizing microorganisms in pharmaceuticals to ensure sterility. It also includes using microbes to test drugs and make products like insulin. Key aspects are endotoxin detection and testing, environmental monitoring, microbial detection systems, and mycoplasma detection to ensure products are sterile and safe. Quality control microbiology through pharmacopeias sets guidelines for consistency, safety, sterility and potency during drug development and manufacturing. Major pharmacopeias are the USP, European Pharmacopoeia and Japanese Pharmacopoeia which set standards, while ICH works to harmonize them internationally.
Clinical Research is a most knowledge-intensive and interesting field in the pharmaceutical industry. There are more than 2, 50,000 positions unemployed in global Pharmaceutical industry.
The document discusses the healthcare and pharmaceutical industries. The healthcare industry provides goods and services for curative, preventive, rehabilitative, and palliative care and includes medical equipment, supplies, and healthcare services like hospitals and nursing homes. The pharmaceutical industry develops, produces, and markets drugs and deals in generic and brand medications. Some reputable healthcare companies mentioned are Sanofi, Hoffman la Roche, Johnson and Johnson, and Novartis, while reputable pharmaceutical companies include Catalent MSP, DuPont, BASF, and Amgen. Important roles in the industries include scientist, chemist, laboratory technician, clinical trials manager, nurse, and research associate.
Careers in Pharmacy in India, 1. Pharmacist, 2. Drug Inspector, 3. Governmental Agencies, 4. As Government Analyst, 5. Clinical Pharmacy, 6. Community Pharmacy, 7. Nuclear Pharmacy, 8. Pharmaceutical Industry, 9. Drug researcher, 10. As Manufacturing Chemist, 11. In Quality Control / Quality Assurance, 12. Clinical Research, 13. Medical Communications/ Information, 14. Medical Transcription, 15. Medical Coding 16. In Regulatory Affairs 17. Sales and Marketing 18. Pharma-Biotechnology, 19. Academic Pharmacy, 20. Health policy makers, 21. Specialized Area Opportunities, 22. Higher Studies With Research Fellowship
Unilife Corporation (NASDAQ:UNIS - News) is a U.S.-based developer, manufacturer and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in 2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines. Unilife has developed a broad, differentiated proprietary portfolio of its own injectable drug delivery products, including the Unifill® and Unitract® product lines of safety syringes with automatic, operator controlled needle retraction. Unifill represents the world's first prefilled syringe technology integrating safety within the primary drug container. The products are ideally positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and enhance patient care. Unifill syringes, together with other devices that are part of the Unilife technology platform, can either be supplied to pharmaceutical customers ready for use, or customized to address the specific requirements of targeted novel drugs. For more information on Unilife, please visit www.unilife.com.
Since its founding in 1935, Morgan Stanley and its people have helped redefine the meaning of financial services. The firm has continually broken new ground in advising our clients on strategic transactions, in pioneering the global expansion of finance and capital markets, and in providing new opportunities for individual and institutional investors. Click below to see a timeline of Morgan Stanley's growth, which parallels the history of modern finance
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
Europe's Top 5 Medical Device Companies to Watch in 2023.pdfinsightscare
The latest edition of Insights Care, Europe’s Top 5 Medical Device Companies to Watch in 2023, sheds light on the prominent leader, John O’Dea, CEO of Palliare.
The document discusses the product lifecycle of medical devices. It begins with an introduction that defines the basic phases of a product lifecycle as research, development, production, and end of life. It then outlines 6 key phases in the medical device product lifecycle: 1) Concept, 2) Planning, 3) Design, 4) Validation, 5) Launch, and 6) Post-market. Each phase is described in 1-2 sentences. For example, the Concept phase involves initially defining the product and exploring funding/routes to market, while the Post-market phase includes ongoing surveillance and reporting to continuously evaluate safety.
Introduction to Regulatory Affairs - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, June 14, our colleagues Fiorenzo Savoretti, Senior Regulatory and Quality Consultant at Pfizer and Nick Deschacht, Senior RA Consultant at GSK, gave an interesting “Introduction to Regulatory Affairs”.
Fiorenzo and Nick talked about RA and their projects, each from their unique angle. They delivered their presentations for ## attendees at our Brussels office at the Lambroekstraat 5a in Diegem.
India Microbiology Testing Market: Size, Share, and In-Depth Competitive Anal...Kumar Satyam
According to TechSci Research report, "Microbiology Testing Market – India Industry Size, Share, Trends, Competition Forecast & Opportunities, 2028", the India Microbiology Testing Market was valued at USD 130.59 million in 2022 and is anticipated to grow with a CAGR of 6.41% during the forecast period, 2024-2028. The increasing awareness among individuals regarding microbiology testing has fostered favorable market conditions, driving growth across various microbiology testing products. This report delves into the factors propelling the market's expansion, recent trends, and key players shaping the competitive landscape.
Increasing Disease Burden
The India Microbiology Testing Market is intricately linked to the country's escalating disease burden. Microbiology testing has emerged as a critical tool in disease management, offering early detection, monitoring of antibiotic resistance, and outbreak control. With ongoing advancements and investments, the market is poised for substantial growth, contributing to India's efforts to combat the rising health challenges it faces.
10 Most Efficient Drug Delivery Solution Providers in 2023V2_compressed.pdfinsightscare
Insights Care’s latest edition, 10 Most Efficient Drug Delivery Solution Providers in 2023, navigates you to the rapidly changing healthcare landscape.
Postmarketing surveillance (PMS) involves monitoring the safety of pharmaceutical drugs and medical devices after they have been approved for public use. PMS is important because pre-approval clinical trials involve relatively small numbers of participants and may not detect rare or long-term adverse effects. PMS uses various methods like spontaneous reporting, cohort studies, and case-control studies to monitor drug and device safety in larger populations over longer time periods after approval. The goal of PMS is to further evaluate or confirm the safety profile of products as they are used in real-world clinical settings by more diverse patients than clinical trials.
Must know things if working in Pharma Industry.pptxsurajbitsindri1
This document provides secrets for customer success in the pharmaceutical industry. It summarizes key aspects of the industry including the drug discovery process, regulatory compliance, and opportunities for process improvement. The drug discovery process involves discovery and development, preclinical research, clinical development, FDA review, and post-market safety monitoring. Regulatory bodies like the FDA aim to bring safe treatments to patients through a thorough review and approval process. Leveraging data, analytics, AI and machine learning can help digitalize processes and minimize errors to improve compliance and innovation.
As we understand more about the human body and how it functions and degrades, biotechnology will progress. This is only the beginning, but when new technology and procedures become accessible, certain themes will start to develop in biopharma trends.
Product type- Drug development - Departments of facility- Registration pathwa...Asmaa Khalil
In this video you will know the detailed information about:
🔸Departments of the manufacturing sites.
🔸Steps of drug product development.
🔸Regulatory Affairs department.
🔸Registration pathway.
🔸Product Type (Innovator "RLD" / Generic / Hybrid).
🔸All medicines must grant a Marketing Authorization (MA) in order to be placed on the market legally in the country.
🔸The ultimate purpose of marketing authorization is to ensure that safe, effective & high-quality medicines, as to protect public health.
https://youtu.be/edUEFt681iM
#asmaa_khalil_ctd
This presentation is about the current trends in pharmacy profession. It will give the brief insight about the direction in which current pharmacy market is going.
This document provides information about the 5th Pharmacovigilance Congregation conference taking place on November 20th, 2013 in Mumbai, India. The conference will discuss ensuring safer drugs reach the market through analyzing developments in pharmacovigilance, drug safety, and risk management. It will feature keynote speakers from various pharmaceutical companies and overviews of the latest challenges and opportunities in pharmacovigilance. The event aims to provide a platform for stakeholders to discuss best practices and advancing pharmacovigilance in India.
Matching Customer's expectations for Innovative FutureRuby Med Plus
Genentech is a leading biotechnology company founded in 1976 that discovers, develops, and commercializes pharmaceutical products. It has over 1,100 researchers and focuses on developing treatments for cancer, immunology, tissue disorders, and neuroscience. In 2020, Genentech will need to focus on monitoring industry trends and developing new therapies using molecular-level research. It will face challenges from regulatory restrictions on emerging technologies and uncertainties around whether new treatments will succeed or be accepted by customers. Genentech's success will depend on its researchers' ability to continuously innovate and develop specialized, effective drugs.
This presentation covers the Introduction to Healthcare & different Products, Role of Pharmaceutical in Healthcare, Drug Details, What a drug is made of ?, Classification of drugs, Product Life Cycle of a Drug, Drug Development Phases, Regulatory Framework & various Regulatory Bodies
This document provides an introduction to Git and GitHub. It begins with an overview of source control and the history of version control systems like SVN and CVS. It then discusses key Git concepts like its three-tree architecture, branches and merging, and undoing changes. The document concludes with an introduction to GitHub, including how to clone repositories, collaborate through pull requests, and link a local Git repository to a remote GitHub repository.
Git is a distributed version control system that allows for collaborative development of software. GitHub is a hosting service for Git repositories that provides a web interface and additional features. The document provides step-by-step instructions for installing Git, configuring it with GitHub, working locally and remotely with repositories, and additional resources for learning more about Git and GitHub.
Thymeleaf is a Java template engine that can be used as a view technology in Spring applications. It integrates well with Spring and allows templates to be defined using HTML/XML syntax with additional Thymeleaf attributes and expressions. Templates can include static elements as well as dynamic content through standard dialect expressions. Templates can also be extended and customized through additional dialects. Thymeleaf provides advantages such as support for multiple template modes, internationalization, caching, and extensibility, though it can be slower than some other template engines.
The document introduces iBatis as an alternative to Hibernate for reducing the complexity of mapping Java objects to database tables without using JDBC code directly, as iBatis uses XML configuration files to define SQL statements and maps data between objects and database rows similarly to Hibernate but without being an full ORM solution. IBatis provides simpler configuration than Hibernate through SQL mapping files that define queries to retrieve and save Java objects without mixing Java and SQL code directly in the application.
The document provides an overview of Spring concepts including annotations, MVC, dependency injection, bean management, and unit testing. It also covers Spring modules, inversion of control, bean scopes, wiring beans, Spring MVC, form validation, pre-populating models, and Spring Security. Code examples demonstrate CRUD operations using Spring, Hibernate and MySQL as well as Spring Security configuration. The document concludes with exercises on bean scopes and annotations.
The document provides an overview of new features in Java 8 including lambda expressions, functional interfaces, default and static interface methods, method references, stream API, and date/time API. Lambda expressions allow for anonymous functions and functional interfaces provide functional signatures. Default and static interface methods allow interfaces to define implementations. Method references provide shorthand syntax for lambda expressions. The stream API supports functional-style processing of collections through intermediate and terminal operations. The new date/time API replaces the Calendar class with more easily used and immutable classes like LocalDate.
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPTblessyjannu21
Prepared by Prof. BLESSY THOMAS, VICE PRINCIPAL, FNCON, SPN.
Emphysema is a disease condition of respiratory system.
Emphysema is an abnormal permanent enlargement of the air spaces distal to terminal bronchioles, accompanied by destruction of their walls and without obvious fibrosis.
Emphysema of lung is defined as hyper inflation of the lung ais spaces due to obstruction of non respiratory bronchioles as due to loss of elasticity of alveoli.
It is a type of chronic obstructive
pulmonary disease.
It is a progressive disease of lungs.
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdfVedanta A
Air Ambulance Services In Rewa works in close coordination with ground-based emergency services, including local Emergency Medical Services, fire departments, and law enforcement agencies.
More@: https://tinyurl.com/2shrryhx
More@: https://tinyurl.com/5n8h3wp8
English Drug and Alcohol Commissioners June 2024.pptxMatSouthwell1
Presentation made by Mat Southwell to the Harm Reduction Working Group of the English Drug and Alcohol Commissioners. Discuss stimulants, OAMT, NSP coverage and community-led approach to DCRs. Focussing on active drug user perspectives and interests
Emotional and Behavioural Problems in Children - Counselling and Family Thera...PsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
CHAPTER 1 SEMESTER V COMMUNICATION TECHNIQUES FOR CHILDREN.pdfSachin Sharma
Here are some key objectives of communication with children:
Build Trust and Security:
Establish a safe and supportive environment where children feel comfortable expressing themselves.
Encourage Expression:
Enable children to articulate their thoughts, feelings, and experiences.
Promote Emotional Understanding:
Help children identify and understand their own emotions and the emotions of others.
Enhance Listening Skills:
Develop children’s ability to listen attentively and respond appropriately.
Foster Positive Relationships:
Strengthen the bond between children and caregivers, peers, and other adults.
Support Learning and Development:
Aid cognitive and language development through engaging and meaningful conversations.
Teach Social Skills:
Encourage polite, respectful, and empathetic interactions with others.
Resolve Conflicts:
Provide tools and guidance for children to handle disagreements constructively.
Encourage Independence:
Support children in making decisions and solving problems on their own.
Provide Reassurance and Comfort:
Offer comfort and understanding during times of distress or uncertainty.
Reinforce Positive Behavior:
Acknowledge and encourage positive actions and behaviors.
Guide and Educate:
Offer clear instructions and explanations to help children understand expectations and learn new concepts.
By focusing on these objectives, communication with children can be both effective and nurturing, supporting their overall growth and well-being.
Hypertension and it's role of physiotherapy in it.Vishal kr Thakur
This particular slides consist of- what is hypertension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is summary of hypertension -
Hypertension, also known as high blood pressure, is a serious medical condition that occurs when blood pressure in the body's arteries is consistently too high. Blood pressure is the force of blood pushing against the walls of blood vessels as the heart pumps it. Hypertension can increase the risk of heart disease, brain disease, kidney disease, and premature death.
Joker Wigs has been a one-stop-shop for hair products for over 26 years. We provide high-quality hair wigs, hair extensions, hair toppers, hair patch, and more for both men and women.
As Mumbai's premier kidney transplant and donation center, L H Hiranandani Hospital Powai is not just a medical facility; it's a beacon of hope where cutting-edge science meets compassionate care, transforming lives and redefining the standards of kidney health in India.
Sectional dentures for microstomia patients.pptxSatvikaPrasad
Microstomia, characterized by an abnormally small oral aperture, presents significant challenges in prosthodontic treatment, including limited access for examination, difficulties in impression making, and challenges with prosthesis insertion and removal. To manage these issues, customized impression techniques using sectional trays and elastomeric materials are employed. Prostheses may be designed in segments or with flexible materials to facilitate handling. Minimally invasive procedures and the use of digital technologies can enhance patient comfort. Education and training for patients on prosthesis care and maintenance are crucial for compliance. Regular follow-up and a multidisciplinary approach, involving collaboration with other specialists, ensure comprehensive care and improved quality of life for microstomia patients.
3. Introduction to
Life Science
The Key objective of the Life Science
industry is to improve patient’s health while
ensuring their safety.
Highly regulated
Strictly adherence to processes
Compliance
4. Segments of Life Science
Pharmaceuticals Medical Devices and
Diagnostic equipment.
Biologics
5. Pharmaceuticals
Pharmaceuticals companies
manufacture medicines are
used to treat conditioned
from acute to chronic
diseases.
A Pharmaceuticals is any
kind of drug used for
medicinal purposes , like
cough syrup or sleeping pills.
Pharmaceuticals
6. Medical Devices and
Diagnostic Equipment
Device used for diagnosis, treatment,
prevention and cure of various medical
conditions of disease are developed,
manufactured and marketed by medical
devices and diagnosis companies
Medical Devices range from simple
band-aid and bedpan to complex
programable peacemaker with micro-
chip technology and laser surgical
devices.
7. Biologics
The vaccines are developed by
Biologics companies using living
organisms which are “Large-molecule”
compounds derived from living
organisms or their products , such as
bacteria or enzymes , to manufacture
medicines.
Biologics are not just vaccines , there
are other forms of biological products
such as Insulin.
8. Life science value chain
RESEARCH AND
DEVELOPMENT.
MANUFACTURING. SALES AND
MARKETING.
POST MARKET
SURVEILLANCE OF
PRODUCTS.
9. Research and
Development
The Research and development
process focuses on the innovation
of new medicines or
conceptualization of devices that are
safe for human testing.
10. Manufacturing
The commercial manufacturing
process begins only after the
approval the process and it is
different for each sub-sector.
The manufacturing process is
important in the pharmaceutical
and biotech industries. It provides
comprehensive expertise and
innovative products to customers
to make this process better.
11. Sales and Marketing
Once the medicine or device
manufactured the sales and
marketing teams gets into action
using channels like
C&F agents
Field force
Retail chains and vendors
12. Post market surveillance
Post the launch of medicine or device, the post market
surveillance process begins to monitor the safety of the medicine
or device.
Even after a medicine or device is approved and marked the Life
sciences companies conduct ongoing research to identity any
additional safety problems not covered during clinical testing.
13. Summary
Understanding adherence to process and
compliance which directly impacts the health and
safety of patients.
Understanding of fundamentals of the Life Science
industry , sub-sectors and value chain.