Keeping with its promises, Association of the British Pharmaceutical Industry has launched a clinical-trial disclosure toolkit to help its member businesses observe with transparency needs for information from or about clinical trials.
Therapeutic Innovation Australia Symposium 2017 - SME AssistTGA Australia
The document summarizes the SME Assist program launched by the Australian Therapeutic Goods Administration to help small and medium enterprises navigate the country's complex regulatory framework for medical products. The six components of SME Assist include guidance documents, education/training, interactive tools, phone/email support, improved data capture on SMEs, and signposting to other business support services. Initial results show high utilization of the web resources and workshops. Upcoming expansions will include additional guidance documents, workshops, and one-on-one support for SMEs.
TGA presentation: Data Integrity - an international regulatory perspectiveTGA Australia
This document discusses data integrity from an international regulatory perspective. It provides an overview of guidance documents from various regulatory agencies on data integrity expectations. Key points covered include that data integrity is not a new requirement, but rather has always been expected under good manufacturing practices. Regulators are increasing their focus and collaboration around data integrity inspections. The document also addresses common misconceptions, such as thinking data integrity only applies to fraudulent data or is difficult to comply with. Effective strategies for ensuring data integrity involve a lifecycle approach considering culture, governance, procedures, systems, and behavior.
Adoption of the pics guide to gmp pe009 13TGA Australia
The document discusses the adoption of the latest version of the PIC/S Guide to GMP by the Australian regulatory authority. Key points include:
- Australia aims to adopt the latest international GMP standards to maintain equivalence and assurance for international markets.
- The timeline for adoption includes notifying industry in 2017/2018 and full implementation by January 2019.
- Major changes in the new PIC/S Guide include new requirements for quality manuals, increased emphasis on senior management involvement, additional responsibilities for quality roles, and clarification of document and data integrity standards.
- Annex 15 on validation was expanded to provide more detail on validation master plans and checks to ensure data integrity.
The Indian health ministry plans to revamp guidelines for approving biosimilar drugs to make the process more robust and aligned with global standards. The new guidelines will be finalized after consulting with industry and academics. They aim to provide more specific guidance on areas like clinical trial requirements and monitoring drug safety. The revisions come as biosimilars are increasingly important but the existing 2012 guidelines lacked clarity.
This document provides a competitive analysis between Thomson Reuters Cortellis for Clinical Trials Intelligence and Trialtrove, a competing clinical trials database owned by Citeline. It outlines the major differentiators of Cortellis, including its coverage of medical device and biomarker trials, analytics/visualizations, modern interface, API integration, and inclusion of additional content like literature and press releases. The document also details how Trialtrove positions itself in the market and recommends tactics for promoting Cortellis as a lower-cost replacement for Trialtrove that provides more value.
Be Ready for Your Specialty Pharmacy AccreditationAllison King
Heather Bonome, PharmD, director of pharmacy, URAC, presented "Be Prepared: What You Need to Know to be Ready for Your Specialty Pharmacy Accreditation," at the 2017 Asembia Specialty Pharmacy Summit. Bonome reviewed basic accreditation requirements for specialty pharmacies, share how pharmacies can navigate the accreditation process and discussed why accreditation is an increasingly valuable competitive tool.
The pharmacy market plays a significant role when it comes to collaborating on patient care with other members of the patient’s care team,” says Bonome. “Accredited, patient-centered specialty pharmacies that demonstrate how their interventions improve medication adherence and patient outcomes will be best positioned to win more business as this market becomes more crowded.”
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016TGA Australia
Firsthand overview of the TGA's Pharmacovigilance Inspection programme from the perspective of both the TGA and companies that have participated in the 'Pilot Inspection Programme'.
Complying with Wearable Health Device RegulationTGA Australia
The document discusses regulations for wearable health devices in Australia. It provides an overview of the Therapeutic Goods Administration (TGA), which regulates medical devices to ensure safety, quality and performance. The TGA evaluates devices before and after market access. It also outlines what classifies a device as medical and subject to regulation, and the process for including a device on the Australian Register of Therapeutic Goods (ARTG). Higher risk devices receive more scrutiny. Manufacturers must comply with essential principles for design and safety, and report any issues with devices.
Therapeutic Innovation Australia Symposium 2017 - SME AssistTGA Australia
The document summarizes the SME Assist program launched by the Australian Therapeutic Goods Administration to help small and medium enterprises navigate the country's complex regulatory framework for medical products. The six components of SME Assist include guidance documents, education/training, interactive tools, phone/email support, improved data capture on SMEs, and signposting to other business support services. Initial results show high utilization of the web resources and workshops. Upcoming expansions will include additional guidance documents, workshops, and one-on-one support for SMEs.
TGA presentation: Data Integrity - an international regulatory perspectiveTGA Australia
This document discusses data integrity from an international regulatory perspective. It provides an overview of guidance documents from various regulatory agencies on data integrity expectations. Key points covered include that data integrity is not a new requirement, but rather has always been expected under good manufacturing practices. Regulators are increasing their focus and collaboration around data integrity inspections. The document also addresses common misconceptions, such as thinking data integrity only applies to fraudulent data or is difficult to comply with. Effective strategies for ensuring data integrity involve a lifecycle approach considering culture, governance, procedures, systems, and behavior.
Adoption of the pics guide to gmp pe009 13TGA Australia
The document discusses the adoption of the latest version of the PIC/S Guide to GMP by the Australian regulatory authority. Key points include:
- Australia aims to adopt the latest international GMP standards to maintain equivalence and assurance for international markets.
- The timeline for adoption includes notifying industry in 2017/2018 and full implementation by January 2019.
- Major changes in the new PIC/S Guide include new requirements for quality manuals, increased emphasis on senior management involvement, additional responsibilities for quality roles, and clarification of document and data integrity standards.
- Annex 15 on validation was expanded to provide more detail on validation master plans and checks to ensure data integrity.
The Indian health ministry plans to revamp guidelines for approving biosimilar drugs to make the process more robust and aligned with global standards. The new guidelines will be finalized after consulting with industry and academics. They aim to provide more specific guidance on areas like clinical trial requirements and monitoring drug safety. The revisions come as biosimilars are increasingly important but the existing 2012 guidelines lacked clarity.
This document provides a competitive analysis between Thomson Reuters Cortellis for Clinical Trials Intelligence and Trialtrove, a competing clinical trials database owned by Citeline. It outlines the major differentiators of Cortellis, including its coverage of medical device and biomarker trials, analytics/visualizations, modern interface, API integration, and inclusion of additional content like literature and press releases. The document also details how Trialtrove positions itself in the market and recommends tactics for promoting Cortellis as a lower-cost replacement for Trialtrove that provides more value.
Be Ready for Your Specialty Pharmacy AccreditationAllison King
Heather Bonome, PharmD, director of pharmacy, URAC, presented "Be Prepared: What You Need to Know to be Ready for Your Specialty Pharmacy Accreditation," at the 2017 Asembia Specialty Pharmacy Summit. Bonome reviewed basic accreditation requirements for specialty pharmacies, share how pharmacies can navigate the accreditation process and discussed why accreditation is an increasingly valuable competitive tool.
The pharmacy market plays a significant role when it comes to collaborating on patient care with other members of the patient’s care team,” says Bonome. “Accredited, patient-centered specialty pharmacies that demonstrate how their interventions improve medication adherence and patient outcomes will be best positioned to win more business as this market becomes more crowded.”
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016TGA Australia
Firsthand overview of the TGA's Pharmacovigilance Inspection programme from the perspective of both the TGA and companies that have participated in the 'Pilot Inspection Programme'.
Complying with Wearable Health Device RegulationTGA Australia
The document discusses regulations for wearable health devices in Australia. It provides an overview of the Therapeutic Goods Administration (TGA), which regulates medical devices to ensure safety, quality and performance. The TGA evaluates devices before and after market access. It also outlines what classifies a device as medical and subject to regulation, and the process for including a device on the Australian Register of Therapeutic Goods (ARTG). Higher risk devices receive more scrutiny. Manufacturers must comply with essential principles for design and safety, and report any issues with devices.
This document summarizes Michael Passanante's clinical solutions marketing plan for 2013. The plan's key goals are to enhance awareness of their clinical solutions suite, ensure customer-facing staff are trained, and develop new clinical leads. The plan outlines strategies to displace competitors, upsell existing products, and expand into new areas like academic customers. Metrics include securing pilot programs, generating revenue, and developing sales qualified leads across various campaigns promoting clinical trial, analytics, and services offerings throughout 2013.
SME Assist: Help to navigate the regulatory mazeTGA Australia
Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help
Indegene provides competitive intelligence and analytics solutions for life sciences, payers, and providers to improve health outcomes and business performance. It offers solutions across various areas like risk and quality management, clinical effectiveness, medical solutions, marketing solutions, and population health management. Indegene leverages proprietary medical analytics frameworks, a suite of platforms, global operational expertise, and medical expertise to drive insights. It has over 3,000 employees globally with delivery centers in several countries. Indegene receives recognition from industry analysts for its capabilities in life sciences sales, marketing, and strategic consulting.
The document is a presentation by Obaid Ali on microbiology and pharmaceutical transformation. It discusses topics like clinical trials, new and generic drug manufacturing, vigilance, research, microbiology, human safety and efficacy verification, quality claims, consistency, contamination, surveillance, and signals from vigilance. Ali has experience working at the FDA and Health Canada and is currently leading scientific transformation initiatives at DRAP and advising the Centre for Quality Science.
This document provides an overview of clinical research, including what clinical research is, the clinical research process, types of organizations involved, and the steps involved in clinical trials. It then discusses KSR Clinical Research, a consulting firm that places clinical research professionals with pharmaceutical, biotech, and medical device companies as well as research facilities. KSR provides recruitment, project management support, and competencies across various clinical research functions and therapeutic areas.
This document provides an overview of clinical research, including what clinical research is, the clinical research process, types of organizations involved, and the steps involved in clinical trials. It then discusses KSR Clinical Research, a consulting firm that places clinical research professionals with pharmaceutical, biotech, and medical device companies as well as research facilities. KSR provides recruitment, project management support, and competencies across various clinical research functions and therapeutic areas.
Cortellis for Clinical Trials Intelligence provides a comprehensive resource for clinical trial information to help accelerate strategic decisions. It contains data on over 130,000 global clinical trials, 200,000 press releases, 220,000 literature articles, and 2.25 million articles related to clinical development. The intuitive interface allows users to filter and analyze trial information by various attributes such as indication, intervention, sponsor, phase, and location. Dynamic visualization tools further aid analysis by showing distributions of trial characteristics and timelines in an interactive format.
Making Life Easier for Investigators: A Shared Solution for Smarter, Faster C...Cognizant
The industry's Shared Investigator Platform significantly reduces the time and cost of clinical trials, simplifying work for investigators and bringing promising therapies to market more quickly.
Improving the Patient Experience Through PharmacyCompleteRx
This document discusses how pharmacy impacts the patient experience through its many roles and interactions across the healthcare system. It touches on key areas like patient safety, medication safety, compliance, and proposed CMS changes. The document notes that pharmacy is involved in selecting, procuring, storing, dispensing, administering, and monitoring medications. It also discusses metrics around measuring medication errors and the case for improving sterile compounding practices.
Notifications to prescription medicinesTGA Australia
The document discusses notifications for low risk changes to prescription medicines in Australia. It provides an overview of the notifications process, including the use of an electronic form (e-form) to submit notifications. The e-form allows sponsors to search for their medicines, select the relevant entry, choose a notification type, provide assurances, validate changes, attach supporting information and view a summary. Notifications will be incorporated into updated minor variations guidance and the prescription medicines e-form for notifications will be implemented on December 4, 2017 following an IT deployment.
With the growth and development of the biopharma industry and increasing changing legislations on areas like biosimilars, pediatric drug development and generic drugs in China and East Asia, now is the time for you to bring along your regulatory affairs teams to keep abreast of evolving regulatory environments and requirements at IBC’s 2nd Pharmaceutical Regulatory Summit in China.
http://www.pharmaregulatoryasia.com/
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
This document provides information about an upcoming conference on oncology endpoints and quality of life assessments taking place in November 2015 in Philadelphia. Attendees will learn about (1) selecting clinical trial endpoints and interpreting quality of life measures to satisfy regulatory requirements, (2) understanding patient needs when designing trials and assessing oncology endpoints, and (3) developing patient-reported outcome tools to evaluate the benefits and risks of treatments. Featured speakers will provide insights and case studies on rapidly changing practices for endpoint selection and validation in oncology trials.
Andrew McKusick has over 38 years of experience as a radiopharmacist and nuclear pharmacist. He managed the radiopharmacy at Carolinas Medical Center for 29 years where he prepared radiopharmaceuticals and provided support to nuclear medicine departments. Prior to that, he managed radiopharmacies in Washington D.C. and consulted on molecular imaging. He also has experience as a retail pharmacist and teaching pharmacy students.
Multiple Contract Pharmacies in a Disproportionate Share Hospital Systemanthonylesser
This document summarizes a presentation about the Harris County Hospital District's (HCHD) use of multiple contract pharmacies through an Alternative Methods Demonstration Project (AMDP). HCHD operates three major hospitals and 15 ambulatory pharmacies serving over 1.6 million outpatient visits per year. It applied for an AMDP in 2006 to use an off-site automated central fill pharmacy in Fort Worth to increase efficiency and patient access. The central fill pharmacy now fills 70% of prescriptions using a closed formulary. HCHD realized operational efficiencies, improved wait times, and was able to reduce staff while maintaining compliance.
How To Boost Hospital Performance By Optimizing Your PharmacyCompleteRx
Assessing and managing productivity is a complex process that takes the rights tools and people. While pharmacy may seem to be a small part of an overall organization, it is actually one of the largest cost centers of a hospital, making it one of the most important departments to optimize and streamline. Learn how your pharmacy’s productivity can impact your hospital’s overall costs, quality, safety and patient satisfaction.
Key Points:
- Analyzing productivity
- Pros and cons of pharmacy productivity management tools
- Use of volume indicators
- Workflows to improve productivity and communication with nursing and hospital staff
This document discusses various pharmacy productivity metrics organized into different categories including leadership, medication preparation and delivery, patient care services, medication safety, medication use policy, education, HR management, and financial performance. Key metrics mentioned include turnaround time, clinical interventions, customer satisfaction, medication adverse events, readmission rates, core measure scores, utilization data, talent acquisition, cost reduction, and units of service/productivity. The goal is to evaluate performance across different areas of the pharmacy using measurable benchmarks.
The document discusses how pharmaceutical commercial intelligence (Pharma-CI) is an integral part of decision making across marketing, R&D, and other areas. It provides an overview of the types of quantitative and qualitative data and insights Pharma-CI can provide at different stages, from drug discovery through approval and marketing. Examples of customized intelligence reports and on-demand solutions offered by iData Insights are also presented.
Clinical trial transparency requirements are becoming more complex, with evolving regulations and demands for greater disclosure. This creates compliance risks for sponsors. A technology solution is needed to manage clinical trial content, automate disclosure processes, and ensure accuracy and timeliness across global registries. An effective solution incorporates a platform approach, risk-based validation, SaaS deployment model, and content management foundation to address this challenge. Technology can help sponsors improve efficiency, mitigate risks, and respond to demands for increased transparency.
- CROs (Contract Research Organizations) are organizations contracted by pharmaceutical companies to conduct clinical trials and other drug development services. Outsourcing to CROs allows companies to reduce costs and accelerate drug development timelines without requiring large in-house capabilities.
- Key responsibilities of CROs include managing clinical sites and trials, conducting bioanalytical testing, and performing pharmacokinetic analyses. Proper qualification of CROs and ongoing communication are important for successful partnerships. Outsourcing can increase capacity and reduce development cycles for pharmaceutical sponsors.
This document summarizes Michael Passanante's clinical solutions marketing plan for 2013. The plan's key goals are to enhance awareness of their clinical solutions suite, ensure customer-facing staff are trained, and develop new clinical leads. The plan outlines strategies to displace competitors, upsell existing products, and expand into new areas like academic customers. Metrics include securing pilot programs, generating revenue, and developing sales qualified leads across various campaigns promoting clinical trial, analytics, and services offerings throughout 2013.
SME Assist: Help to navigate the regulatory mazeTGA Australia
Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help
Indegene provides competitive intelligence and analytics solutions for life sciences, payers, and providers to improve health outcomes and business performance. It offers solutions across various areas like risk and quality management, clinical effectiveness, medical solutions, marketing solutions, and population health management. Indegene leverages proprietary medical analytics frameworks, a suite of platforms, global operational expertise, and medical expertise to drive insights. It has over 3,000 employees globally with delivery centers in several countries. Indegene receives recognition from industry analysts for its capabilities in life sciences sales, marketing, and strategic consulting.
The document is a presentation by Obaid Ali on microbiology and pharmaceutical transformation. It discusses topics like clinical trials, new and generic drug manufacturing, vigilance, research, microbiology, human safety and efficacy verification, quality claims, consistency, contamination, surveillance, and signals from vigilance. Ali has experience working at the FDA and Health Canada and is currently leading scientific transformation initiatives at DRAP and advising the Centre for Quality Science.
This document provides an overview of clinical research, including what clinical research is, the clinical research process, types of organizations involved, and the steps involved in clinical trials. It then discusses KSR Clinical Research, a consulting firm that places clinical research professionals with pharmaceutical, biotech, and medical device companies as well as research facilities. KSR provides recruitment, project management support, and competencies across various clinical research functions and therapeutic areas.
This document provides an overview of clinical research, including what clinical research is, the clinical research process, types of organizations involved, and the steps involved in clinical trials. It then discusses KSR Clinical Research, a consulting firm that places clinical research professionals with pharmaceutical, biotech, and medical device companies as well as research facilities. KSR provides recruitment, project management support, and competencies across various clinical research functions and therapeutic areas.
Cortellis for Clinical Trials Intelligence provides a comprehensive resource for clinical trial information to help accelerate strategic decisions. It contains data on over 130,000 global clinical trials, 200,000 press releases, 220,000 literature articles, and 2.25 million articles related to clinical development. The intuitive interface allows users to filter and analyze trial information by various attributes such as indication, intervention, sponsor, phase, and location. Dynamic visualization tools further aid analysis by showing distributions of trial characteristics and timelines in an interactive format.
Making Life Easier for Investigators: A Shared Solution for Smarter, Faster C...Cognizant
The industry's Shared Investigator Platform significantly reduces the time and cost of clinical trials, simplifying work for investigators and bringing promising therapies to market more quickly.
Improving the Patient Experience Through PharmacyCompleteRx
This document discusses how pharmacy impacts the patient experience through its many roles and interactions across the healthcare system. It touches on key areas like patient safety, medication safety, compliance, and proposed CMS changes. The document notes that pharmacy is involved in selecting, procuring, storing, dispensing, administering, and monitoring medications. It also discusses metrics around measuring medication errors and the case for improving sterile compounding practices.
Notifications to prescription medicinesTGA Australia
The document discusses notifications for low risk changes to prescription medicines in Australia. It provides an overview of the notifications process, including the use of an electronic form (e-form) to submit notifications. The e-form allows sponsors to search for their medicines, select the relevant entry, choose a notification type, provide assurances, validate changes, attach supporting information and view a summary. Notifications will be incorporated into updated minor variations guidance and the prescription medicines e-form for notifications will be implemented on December 4, 2017 following an IT deployment.
With the growth and development of the biopharma industry and increasing changing legislations on areas like biosimilars, pediatric drug development and generic drugs in China and East Asia, now is the time for you to bring along your regulatory affairs teams to keep abreast of evolving regulatory environments and requirements at IBC’s 2nd Pharmaceutical Regulatory Summit in China.
http://www.pharmaregulatoryasia.com/
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
This document provides information about an upcoming conference on oncology endpoints and quality of life assessments taking place in November 2015 in Philadelphia. Attendees will learn about (1) selecting clinical trial endpoints and interpreting quality of life measures to satisfy regulatory requirements, (2) understanding patient needs when designing trials and assessing oncology endpoints, and (3) developing patient-reported outcome tools to evaluate the benefits and risks of treatments. Featured speakers will provide insights and case studies on rapidly changing practices for endpoint selection and validation in oncology trials.
Andrew McKusick has over 38 years of experience as a radiopharmacist and nuclear pharmacist. He managed the radiopharmacy at Carolinas Medical Center for 29 years where he prepared radiopharmaceuticals and provided support to nuclear medicine departments. Prior to that, he managed radiopharmacies in Washington D.C. and consulted on molecular imaging. He also has experience as a retail pharmacist and teaching pharmacy students.
Multiple Contract Pharmacies in a Disproportionate Share Hospital Systemanthonylesser
This document summarizes a presentation about the Harris County Hospital District's (HCHD) use of multiple contract pharmacies through an Alternative Methods Demonstration Project (AMDP). HCHD operates three major hospitals and 15 ambulatory pharmacies serving over 1.6 million outpatient visits per year. It applied for an AMDP in 2006 to use an off-site automated central fill pharmacy in Fort Worth to increase efficiency and patient access. The central fill pharmacy now fills 70% of prescriptions using a closed formulary. HCHD realized operational efficiencies, improved wait times, and was able to reduce staff while maintaining compliance.
How To Boost Hospital Performance By Optimizing Your PharmacyCompleteRx
Assessing and managing productivity is a complex process that takes the rights tools and people. While pharmacy may seem to be a small part of an overall organization, it is actually one of the largest cost centers of a hospital, making it one of the most important departments to optimize and streamline. Learn how your pharmacy’s productivity can impact your hospital’s overall costs, quality, safety and patient satisfaction.
Key Points:
- Analyzing productivity
- Pros and cons of pharmacy productivity management tools
- Use of volume indicators
- Workflows to improve productivity and communication with nursing and hospital staff
This document discusses various pharmacy productivity metrics organized into different categories including leadership, medication preparation and delivery, patient care services, medication safety, medication use policy, education, HR management, and financial performance. Key metrics mentioned include turnaround time, clinical interventions, customer satisfaction, medication adverse events, readmission rates, core measure scores, utilization data, talent acquisition, cost reduction, and units of service/productivity. The goal is to evaluate performance across different areas of the pharmacy using measurable benchmarks.
The document discusses how pharmaceutical commercial intelligence (Pharma-CI) is an integral part of decision making across marketing, R&D, and other areas. It provides an overview of the types of quantitative and qualitative data and insights Pharma-CI can provide at different stages, from drug discovery through approval and marketing. Examples of customized intelligence reports and on-demand solutions offered by iData Insights are also presented.
Clinical trial transparency requirements are becoming more complex, with evolving regulations and demands for greater disclosure. This creates compliance risks for sponsors. A technology solution is needed to manage clinical trial content, automate disclosure processes, and ensure accuracy and timeliness across global registries. An effective solution incorporates a platform approach, risk-based validation, SaaS deployment model, and content management foundation to address this challenge. Technology can help sponsors improve efficiency, mitigate risks, and respond to demands for increased transparency.
- CROs (Contract Research Organizations) are organizations contracted by pharmaceutical companies to conduct clinical trials and other drug development services. Outsourcing to CROs allows companies to reduce costs and accelerate drug development timelines without requiring large in-house capabilities.
- Key responsibilities of CROs include managing clinical sites and trials, conducting bioanalytical testing, and performing pharmacokinetic analyses. Proper qualification of CROs and ongoing communication are important for successful partnerships. Outsourcing can increase capacity and reduce development cycles for pharmaceutical sponsors.
The document discusses various ways that the pharmaceutical industry is working with patients and healthcare professionals to increase patient involvement in medicine development. It provides examples of patient groups being more involved in clinical trials and discussions earlier in the process. It also discusses efforts by the industry to increase transparency, such as publishing payments to healthcare professionals and sharing clinical trial data with researchers. There has been steady improvement in disclosure rates for clinical trial results.
To recap the August 2015 month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 18 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
- 483 of PharMEDium Services, LLC (Outsourcing facility)
- 483 of "Walgreens Home Care, Inc. dba Walgreens Infusion Services
EU Non Compliance Report
- EU Non-Compliance Report: TXCELL - BESANCON, France Warning Letters
- Warning letter : Sipra Labs Limited, Hyderabad
- Warning letter : Mylan Laboratories Limited, India
Health Canada Non Compliance Report
- Procter & Gamble Inc., Canada.
Regulations of the Month
- Sec. 211.28 Personnel responsibilities (b) & (c)
- Sec. 211.42 Design and construction features (a) & (b)
This document discusses managing the extended research and development (R&D) supply chain for clinical trials. It presents challenges at different stages of the supply chain from active pharmaceutical ingredient (API) manufacturing through investigational medicinal product (IMP) delivery. Key challenges include forecasting and planning given variable patient enrollment, ensuring visibility and integration across outsourced manufacturing steps, translating complex packaging needs from protocols, and managing drug distribution globally. The article presents different models for R&D supply chains, including fully outsourcing the physical chain or adopting a more patient-oriented model.
The document discusses the ICH GCP guidelines for conducting clinical trials. The key points are:
1) GCP guidelines provide ethical and quality standards for clinical trial conduct to protect subject safety and ensure data credibility.
2) The guidelines establish responsibilities for investigators, sponsors, and ethics committees to follow principles where subject welfare prevails over science and trials must be scientifically sound.
3) The ICH facilitates harmonization across countries/regions to streamline drug development and avoid duplicative trials through consensus guidelines.
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
In this PPt contain the E6 R1 and E6 R2 information , and the GCP training material for the Good prectice. and end of the ppt there is a ink which is use for your online training and generate certificate.
This document provides an overview of regulatory affairs for drugs. It defines key terms like regulatory affairs, dossier, CTD, eCTD, DMF, NDA, ANDA, and INDA. It describes the role of regulatory affairs experts in guiding product development according to regulatory requirements, compiling dossiers for submission, and ensuring post-marketing compliance. The document outlines a 10 step process for regulatory product development and regulatory submission preparation. It also discusses quality management systems for regulatory compliance and the role of regulatory affairs in marketing and advertising compliance.
Here's what bio-pharma organizations need to know when transforming the promotional material review and approval process from a transactional requirement to a competitive advantage.
Delivering real world evidence to demonstrate product safety and valueKishan Patel, MBA
This document discusses how observational research and patient registries can provide real-world evidence on product safety and effectiveness. It outlines Quintiles' capabilities in this area, including experience conducting 195 patient registries and observational studies involving over 9 million patients. Quintiles claims it can help companies demonstrate products' performance in various populations and support regulatory and coverage decisions through generating real-world evidence.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
Ph rma principlesforresponsibleclinicaltrialdatasharingMarilyn Mann
The document outlines commitments by biopharmaceutical companies to responsibly share clinical trial data with qualified researchers and the public. The key commitments are:
1) Sharing patient-level data, study-level data, and protocols with qualified researchers upon request to facilitate legitimate research. Requests will be reviewed by a scientific board.
2) Making clinical study report synopses publicly available after drug approval to help patients and doctors understand trial results. Full reports may also be shared with researchers.
3) Informing trial patients about results in a factual summary developed with regulators.
Four strategies to upgrade clinical trial quality in this computerized world ...Pubrica
• Biostatistics Services is important for collecting, reviewing, presenting, and interpreting data in clinical research.
• Applications of clinical biostatistics services are in different areas, such as epidemiology, clinical trials, population genetics, the biology of structures, and more.
Reference : https://pubrica.com/services/research-services/biostatistics-and-statistical-programming-services/
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Integrate RWE into clinical developmentIMSHealthRWES
With greater application of RWE throughout the pharmaceutical
lifecycle, learnings are emerging that offer guidance for
approaches to derive the maximum value. This article captures
the author’s experience at a leading international biotech, with
insights for smoothing RWE assimilation into clinical
development and realizing the benefits it brings.
This presentation discusses various topics related to clinical research management including:
- Preparation of clinical studies according to ICH guidelines.
- The difference between audits and inspections, who conducts them, and what they audit.
- Monitoring clinical studies to ensure adherence to protocols, SOPs, and regulations.
- Pharmacovigilance including adverse event reporting procedures.
- Documentation requirements for clinical research.
- Budgeting considerations for clinical trials including personnel, technology, data management.
- Vendor management activities like contracting, governance, and relationship management.
This document provides information on registering clinical trials in the Clinical Trials Registry - India (CTRI). It explains that the CTRI is a free, online system for registering all clinical trials conducted in India. Registration is mandatory per the Drugs Controller General (India) and provides transparency. The document outlines the CTRI registration process, including obtaining a username and password, entering trial details online, verification by CTRI, and being assigned a registration number. Key trial details that must be included are described.
Similar to Abpi launched clinical-trial_disclosure_toolkit (20)
Wearable Cardioverter Defibrillators Market forecast to witness phenomenal gr...sushant deshmukh
Wearable cardioverter defibrillators industry is slated to witness a strong growth owing to rapidly growing geriatric population. As per United Nations statistics, 2015, the number of people over 60 years of age has increased significantly over the past few years in most of regions, United Nations further projected that between 2015 and 2030, the number of people over 60 years of age will grow by more than 55% from 901 million to 1.4 billion in 2030 globally.
Clinical research is quite vital in the field of physiotherapy. Physiotherapists depends on information from researches to enhance the knowledge they have already gained through their university education and with continuous education courses.
Clinical research is quite vital in the field of physiotherapy. Physiotherapists depends on information from researches to enhance the knowledge they have already gained through their university education and with continuous education courses.
Problems in using_spreadsheets_to_collect_clinicalsushant deshmukh
Microsoft Excel is a free and a very familiar tool for all of us. Spreadsheets are used for a wide range of projects, but they are far from ideal when it comes to data capture in clinical trials. Excel wasn’t created to build case report forms (CRFs) or to compare and verify patient's data that’s collected in clinical research. Despite technological advances,many organizations still cling to spreadsheets.
The clinical trial industry is gaining continuously a positive metamorphosis in India. Now the clinical trial processes are being viewed as drug discovery rather than drug development destination only. At present, several companies are looking at the innovation. And rise of these companies have led to many more openings for clinical research job in Pune and India as a whole.
The CRB Tech Institute of Clinical Research is a unique year-long education, learning and guidance system for fellows with biology background. It provides a broad education and learning on clinical research methods, research partnerships and managing the demands of family and profession. The goal of CRB Tech Institution is to produce a team of researchers armed with suggestions for clinical research carrying out innovative clinical trials and access to sources to make their concepts a reality.
studies involving people. They are divided into different stages, called phases. The earliest phase trials might focus at whether a drug is safe or the side effects it causes. A later phase trial aims to test and compare whether a new treatment is better than existing ones.also checkwhy clinical trials are important in clinical research.
Types of Classifi
Types Of Clinical Trials And Its Significance Clinical trials means medical research studies involving people. They are divided into different stages, called phases. The earliest phase trials might focus at whether a drug is safe or the side effects it causes. A later phase trial aims to test and compare whether a new treatment is better than existing ones.also checkwhy clinical trials are important in clinical research.
ere we continue with the remaining concept of crowdfunding. As stated crowd-funding is gearing significance in the field of clinical research or medical research in general.
Pharmacists around the world are playing immense roles in the growth of Clinical Research. Some does contribute as a part of their profession and a few are passionate about their behind the scenes role.
Such passionate pharm
Pharmacists around the world are playing immense roles in the growth of Clinical Research. Some does contribute as a part of their profession and a few are passionate about their behind the scenes role.
Keeping with its promises, Association of the British Pharmaceutical Industry has launched a clinical-trial disclosure toolkit to help its member businesses observe with transparency needs for information from or about clinical trials.
Role responsibilities of_a_clinical_research_coordsushant deshmukh
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
Every clinical research project may have one or more study coordinators depending on the workload at the trial site. Clinical trials at site level can be roughly divided into 3 stages. The three stages and the role of the coordinators at these stages are:
1) Before starting the clinical trial
2) During the conduct of the clinical trial
3) After finishing the clinical trial
1) Before starting the clinical trial:
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
Pharmacovigilance is the approach related to making an assessment, detection, understanding and prevention of inappropriate effects or any other problems to drug-related . So those working in the field of pharmacovigilance must have a good working knowledge of the principles of drug safety, regulations and proactive strategies for risk management. So people who want to pursue a clinical research career, can take up Pharmacovigilance training for adding value to their qualification.
Pharmacovigilance is the approach related to making an assessment, detection, understanding and prevention of inappropriate effects or any other problems to drug-related . So those working in the field of pharmacovigilance must have a good working knowledge of the principles of drug safety, regulations and proactive strategies for risk management. So people who want to pursue a clinical research career, can take up Pharmacovigilance training for adding value to their qualification.
The clinical trial industry is gaining continuously a positive metamorphosis in India. Now the clinical trial processes are being viewed as drug discovery rather than drug development destination only. At present, several companies are looking at the innovation. And rise of these companies have led to many more openings for clinical research job in Pune and India as a whole.
Medical Research: Rebuilt, Retooled and Rebooted An early stage mobile medical device company developing a human-centered suite of consumer products using science and technology to empower everyday people to monitor and better understand their own health—anytime, anywhere.
Pharmacists around the world are playing immense roles in the growth of Clinical Research. Some does contribute as a part of their profession and a few are passionate about their behind the scenes role.
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1. ABPI Launched clinical-trial disclosure toolkit
Keeping with its promises, Association of the British Pharmaceutical Industry has
launched a clinical-trial disclosure toolkit to help its member businesses observe with
transparency needs for information from or about clinical trials.
This was initiated in February, when the ABPI unveiled a new set of measures to help
improve compliance with data-transparency clauses in its Code of Practice.
As per the code, all member businesses must register a clinical trial within 21 days of
the first patient being admitted to the trial and post the results within a year of the novel
drug being granted a marketing authorization.
The disclosure toolkit would be updated regularly to depict changes in international
regulatory requirements like the new data transparency policy scheduled for a launch by
the European Medicines Agency , comprises 11 documents including disclosure
checklists, good practice guidelines and a template standard-operating procedure (SOP).
What are the minimum requirements?
It is not intended as regulatory or legal solution. A Points to Consider document
provided as part of the toolkit notes that country laws, the International Federation of
Pharmaceutical Manufacturers and Associations’ Joint Position paper and the ABPI
Code of Practice give the framework and define minimum requirements for disclosure of
clinical-trial information.
But it adds a sponsor company might decide to go beyond the minimum requirements.
Some businesses have chosen to release information about all clinical researches,
regardless of phase, design or participant type, while others at least disclose information
about all patient trials either interventional and non-interventional and regardless of the
phase of the trial.
To mentions, any such decision is endorsed by senior management who would own the
company disclosure policy,as stated by the the document.
Patient-level data
The considerable points also address critical issues for example third-party access to
patient-level data, which calls for a robust process to remove any information that could
contribute to the re-personalization of clinical-trial data.
2. If a business decide to share patient-level data, the document points out, it should
clarify and define in a Disclosure SOP concerns such as :
• Explanation of patient-level data
• Whether requests from any entity either commercial or not will be considered.
• What criteria the requesting party needs to content in terms of evidence of
capability and availability of good analysis practice.
• What the requester requires to submit with respect to an analysis, quality-control
and publication plans.
• Controls to assure adequate anonymity of patient level data and removal of other
sensitive data.
• Timeliness for providing response and satisfying data requests.
Strong advocate
The ABPI is a strong supporter for transparency in clinical research information, as
stated by Stephen Whitehead, the association’s chief executive.
He added that earlier this year they committed to provide a clinical trial disclosure
toolkit to businesses and he's delighted that this is now available on their website for
any company usage.
Whitehead added that as part of a global industry and with the UK contributing fewer
than 2% of all patients recruited to clinical researches worldwide, they are actively
engaging with their European and international counterparts to input into ongoing
discussions around clinical research transparency.
Clinical data transparency is an important issue for all.
• It important to ensure that any research practices are transparent, responsible, and
fully compliant with applicable laws, regulations and guidelines.
• It needs dedicated and trained staff for purposes of timely registration of clinical
trials, communication of trial results, and publication of all sponsored trials and
research studies.
• A proper collaboration with external medical researchers to advance clinical
research and enhance public health.
3. Amidst many organizations CRB Tech Solutions has a big name. Its very popular in
offering the best clinical research training .
Clinical research jobs are increasing in Pune and to meet the emerging need of
efficient professionals , you should consider optimizing yourself with clinical our
clinical research institute.
The Clinical Research review by CRB Tech Solutions will help you in optimizing
your clinical research career in this field.