Watch the video here: https://bit.ly/2SxsAxO
Validation concerns can hold companies back from adopting innovations in their clinical systems
Validation concerns can hold companies back from adopting the latest innovations in their EDC systems. Differing opinions on the appropriate level of system validation can also add stress within an organization. It is possible to implement new features and stay validated with relatively little effort if you use validation techniques tailored to cloud-based systems.
In this session, we address how to set the right approach, what to expect from a cloud EDC software provider and what you should expect to do as a sponsor or CRO to perform the initial validation and maintain a validated state following subsequent releases.
Who Will Benefit:
* Clinical Data Manager
* Clinical Data Director
* Head of Clinical Data
* Clinical Operations Manager
* Clinical Operations Director
* Data management
* Biostatistics
* Data science
* Clinical science
* EDC
* Biometrics
* eClinical
Meet Your Presenters:
Natalie Townsend
Senior Solution Consultant, Vault CDMS
As Senior Solution Consultant for Vault CDMS Natalie is responsible for understanding customer challenges and objectives and providing technical product demonstrations tailored to address these needs. Natalie has 16+ years industry experience in designing, implementing and supporting eClinical solutions to address the myriad of challenges faced across biopharmaceutical organizations. Her experience with clinical trials spans a broad range of sponsors and therapeutic areas across all phases and regions, allowing her to appreciate the differing technology considerations and needs.
Tanya du Plessis
Vice President of data strategies and solutions, Bioforum the Data Masters
Tanya is Vice President of data strategies and solutions at Bioforum. She has vast experience across the industry through her current role at Bioforum, as well as the 14 years she spent with IQVIA (legacy Quintiles). Throughout her career, Tanya has worked with multinational pharmaceutical companies as well as small-to-mid size biotechs and startups. She has led various data management operations and programs, heading numerous innovation teams and spearheading the development of strategies for customized data delivery solutions, focusing on timely, quality data. A certified clinical data manager (CCDM, SCDM), Tanya holds a M.Med.Sc in Hematology and Cell Biology from University of the Free State in South Africa. She also has a project management professional certification (PMP, PMI).
University of Louisville: Enabling Research During COVID-19 and BeyondVeeva Systems
The University of Louisville shares how they adapted their operations in the midst of the COVID-19 pandemic to keep research moving forward. Watch the full presentation at https://bit.ly/UofLResearch.
Practical Strategies for Taking on New Studies Post COVID-19Veeva Systems
Hear expert guidance for ensuring readiness when opening your doors and making data-driven, evidence-based decisions on which studies to accept post COVID-19.
Unify quality manufacturing to drive speed, compliance and collaborationVeeva Systems
Whether you are an emerging CDMO looking to scale and attract sponsors or an established generics org looking to transform legacy systems, there is an approach to consider! Learn how you can drive efficiency, collaboration, and compliance and how to get started in unifying your quality manufacturing processes.
Demystifying cloud system and validation practices for life sciencesVeeva Systems
Watch the on-demand recording here: bit.ly/GxPValidationwithCloud
Cloud-based regulated systems greatly accelerate the GxP validation process, improving IT efficiency. By performing and documenting the installation qualification (IQ) and operational qualification (OQ) procedures, modern cloud applications ease the validation burden on IT teams and speed validation process.
However, common misconceptions about the cloud prevent IT teams from taking advantage of a faster and better validation process.
During this webinar, "Demystifying Cloud Systems and Validation Best Practices for Life Sciences", we discuss this topic and with PricewaterhouseCoopers (PwC). By watching, you will learn GxP validation best practices in a cloud environment and gain insights into:
- How to evaluate various types of cloud-based quality systems
- How traditional vs. cloud validation approaches impact your business
- How to apply a tactical framework to validation
Micro-learning, Macro-compliance: Improving GxP Compliance with Modern Learni...Veeva Systems
Watch the webinar: https://go.veeva.com/microlearning-ondemand
Micro-learning, Macro-Compliance: Improving GxP Compliance with Modern Learning Techniques
Today's fast-paced and increasingly virtual world is challenging life sciences companies to apply modern learning practices like micro-learning for both GxP and non-GxP training requirements.
While micro-learning has taken the learning and development world by storm, there are still misconceptions about what it is and how to incorporate it into an existing training strategy.
John Constantine, SVP of Talent Solutions at Orchestrall Inc., and Kent Malmros, Senior Director of Vault Training at Veeva Systems, team up to discuss the benefits of micro-learning and a practical approach to applying it into your existing GXP training program.
Join this webinar to learn:
- About micro-learning and how it can boost your GxP training compliance
- How to overcome the common misconceptions about micro-learning
- How to implement micro-learning into your GxP training program
Who Will Benefit:
- Director/Manager of Quality Training
- Compliance Training Manager/Director
- Compliance Policy and Training, Manager/Director
- Director/Manager, QA Training
- Document Control and Training Manager
- VP/Director of Quality and Compliance (QA or QC), Quality Systems
- VP/Director of Information Technology, Quality Management Systems, Quality Systems
- VP/Director of Clinical Operations
Transforming Pharmacovigilance from Operational to Scientifically DrivenVeeva Systems
Learn how scientifically driven pharmacovigilance can enable safety teams to provide faster, more comprehensive benefit-risk assessment to improve patient’s lives. Watch the on-demand webinar: https://go.veeva.com/transforming-pv
Site Connect — The Next Big Step Toward a Collaborative Clinical EcosystemVeeva Systems
Automating information exchange in clinical trials is key to improving how sponsors, CROs, and sites work together. This webinar shares how Veeva Vault Site Connect seamlessly connects sponsor and site operations for better collaboration and faster study execution.
Hear this webinar on-demand: https://go.veeva.com/collaborative-clinical-ecosystem
Building a Foundation for Proactive and Predictive PharmacovigilanceVeeva Systems
Learn how PV teams can easily keep up with evolving compliance requirements with modern safety applications that provide better data control and drive greater efficiencies.
View on-demand session: https://bit.ly/3vIzQG9
University of Louisville: Enabling Research During COVID-19 and BeyondVeeva Systems
The University of Louisville shares how they adapted their operations in the midst of the COVID-19 pandemic to keep research moving forward. Watch the full presentation at https://bit.ly/UofLResearch.
Practical Strategies for Taking on New Studies Post COVID-19Veeva Systems
Hear expert guidance for ensuring readiness when opening your doors and making data-driven, evidence-based decisions on which studies to accept post COVID-19.
Unify quality manufacturing to drive speed, compliance and collaborationVeeva Systems
Whether you are an emerging CDMO looking to scale and attract sponsors or an established generics org looking to transform legacy systems, there is an approach to consider! Learn how you can drive efficiency, collaboration, and compliance and how to get started in unifying your quality manufacturing processes.
Demystifying cloud system and validation practices for life sciencesVeeva Systems
Watch the on-demand recording here: bit.ly/GxPValidationwithCloud
Cloud-based regulated systems greatly accelerate the GxP validation process, improving IT efficiency. By performing and documenting the installation qualification (IQ) and operational qualification (OQ) procedures, modern cloud applications ease the validation burden on IT teams and speed validation process.
However, common misconceptions about the cloud prevent IT teams from taking advantage of a faster and better validation process.
During this webinar, "Demystifying Cloud Systems and Validation Best Practices for Life Sciences", we discuss this topic and with PricewaterhouseCoopers (PwC). By watching, you will learn GxP validation best practices in a cloud environment and gain insights into:
- How to evaluate various types of cloud-based quality systems
- How traditional vs. cloud validation approaches impact your business
- How to apply a tactical framework to validation
Micro-learning, Macro-compliance: Improving GxP Compliance with Modern Learni...Veeva Systems
Watch the webinar: https://go.veeva.com/microlearning-ondemand
Micro-learning, Macro-Compliance: Improving GxP Compliance with Modern Learning Techniques
Today's fast-paced and increasingly virtual world is challenging life sciences companies to apply modern learning practices like micro-learning for both GxP and non-GxP training requirements.
While micro-learning has taken the learning and development world by storm, there are still misconceptions about what it is and how to incorporate it into an existing training strategy.
John Constantine, SVP of Talent Solutions at Orchestrall Inc., and Kent Malmros, Senior Director of Vault Training at Veeva Systems, team up to discuss the benefits of micro-learning and a practical approach to applying it into your existing GXP training program.
Join this webinar to learn:
- About micro-learning and how it can boost your GxP training compliance
- How to overcome the common misconceptions about micro-learning
- How to implement micro-learning into your GxP training program
Who Will Benefit:
- Director/Manager of Quality Training
- Compliance Training Manager/Director
- Compliance Policy and Training, Manager/Director
- Director/Manager, QA Training
- Document Control and Training Manager
- VP/Director of Quality and Compliance (QA or QC), Quality Systems
- VP/Director of Information Technology, Quality Management Systems, Quality Systems
- VP/Director of Clinical Operations
Transforming Pharmacovigilance from Operational to Scientifically DrivenVeeva Systems
Learn how scientifically driven pharmacovigilance can enable safety teams to provide faster, more comprehensive benefit-risk assessment to improve patient’s lives. Watch the on-demand webinar: https://go.veeva.com/transforming-pv
Site Connect — The Next Big Step Toward a Collaborative Clinical EcosystemVeeva Systems
Automating information exchange in clinical trials is key to improving how sponsors, CROs, and sites work together. This webinar shares how Veeva Vault Site Connect seamlessly connects sponsor and site operations for better collaboration and faster study execution.
Hear this webinar on-demand: https://go.veeva.com/collaborative-clinical-ecosystem
Building a Foundation for Proactive and Predictive PharmacovigilanceVeeva Systems
Learn how PV teams can easily keep up with evolving compliance requirements with modern safety applications that provide better data control and drive greater efficiencies.
View on-demand session: https://bit.ly/3vIzQG9
Best Practices for Managing Regulatory Binders ElectronicallyVeeva Systems
- Industry drivers for change and benefits of eRegulatory
- Tips for choosing the right system and evaluating a vendor
- Best practices and mistakes to avoid when going electronic
Designing an EDC System to Work for a CRAVeeva Systems
Watch the video here: https://bit.ly/3h8gHIU
Targeted source data verification (SDV) might be well established, but many clinical teams are still verifying 100% of their data, making monitoring costly and inefficient.
By warching this on demand webinar, you will hear established RBM experts share the measures and metrics that organizations need to realize the true value of targeted SDV. Learn better ways to implement a risk-based strategy for SDV to ensure that CRAs focus on the most important data and how doing so can:
* Improve data quality
* Speed data collection and analysis
* Result in higher confidence and user satisfaction
Learn how Veeva is reinventing EDC to work for a CRA, creating significant speed and quality improvements.
Who Will Benefit:
Senior professionals working with clinical data/clinical documentation, including:
* Clinical Development/ R&D
* Clinical Data Management
* eClinical Operations
* Data Monitoring & Management
* Development Strategic Operations
* Information Strategy & Analytics, Clinical Informatics & Innovation
* Information Technology, R&D IT
* IT R&D Business Partner
Meet Your Presenters:
Drew Garty
Chief Technology Officer, Veeva Vault CDMS, Veeva
Drew Garty’s career in pharmaceutical technology spans over 20 years and includes significant expertise in EDC, clinical site monitoring, platform integrations and clinical trial management solutions. Drew’s innovative solutions in risk-based monitoring earned him a prestigious industry “Clinical Innovator of the Year” award in 2015. Drew joined Veeva in 2016 as Vice President of Product Management, and led the ground-up design of Veeva’s Vault EDC solution. In his current role of Chief Technology Officer at Vault CDMS, Drew shares and collaborates with customers, partners and the industry to set vision and direction of Veeva’s CDMS product.
Dawn Anderson
Managing Director, Life Sciences Strategy and Operations, Deloitte
Dawn has more than 30 years of industry and consulting experience in pharmaceutical, biotechnology, CROs, and technology companies. Her practice is focused on clinical development and she works with clients to design and deploy global operating strategy, performance improvement and technology implementations across the development of new drugs, biologics and devices. Dawn has spoken frequently about clinical transformation and the future of clinical trials, including topics around adaptive design, protocol complexity, risk assessments and the use of technology including virtual trials, digital, mHealth and the use of clinical analytics platforms and cognitive automation in transforming clinical trial delivery.
Shorten Database Builds by 60% with Agile DesignVeeva Systems
Watch the video here: https://bit.ly/3f64wJZ
See the Packed #SCDM2019 Session
Radical time savings aren’t possible with incremental process improvements. An agile EDC enables process transformation that shortens database builds by 40-60%. Join a live webinar of the packed SCDM product showcase to hear the technologies and processes behind those savings, including real-time UAT, data-driven rules and dynamics, and easy amendments.
Transform Your Digital Content to Improve Speed to Market While Maintaining C...Veeva Systems
Watch the full webinar to learn industry challenges and how Roche Diagnostics is transforming its digital content management with Veeva Vault PromoMats to improve speed to market:
https://go.veeva.com//transform-content-management-to-improve-speed-to-market
By better managing the lifecycle of digital assets, it will be possible to reduce expensive duplication of assets, maintain control of the brand image, and stay compliant in a complex regulatory environment.
Webinar: Driving Operational Agility with Digital Quality ManagementVeeva Systems
Watch the webinar here: https://go.veeva.com/Driving-Operational-Agility_webinar
This presentation is from a Veeva Systems Quality Team webinar series hosted by Contract Pharma.
Is the disconnected technology landscape slowing down operations and draining resources?
New-market demands, increasingly complex supply chains, and changing regulations will continue as the norm. Modern technologies can help manufacturers manage these external forces effectively, enabling them to be more agile, data-driven, and future-ready.
Today many manufacturers are digitizing quality management to increase operational agility and supply chain collaboration, meeting continually-changing market and customer demands.
Join Veeva experts in this webinar to learn how digitalizing quality management bridges gaps between manufacturing and quality management, improving cycle times and agility.
In this webinar, you will learn:
- About the opportunities to transform quality management
- How the right technology streamlines global quality processes, increasing automation and operational agility
- The industry best practices for driving successful digital transformation
Best practices for implementing and maintaining successful standardsVeeva Systems
Watch the video here: https://bit.ly/3uvar1u
This webinar provides best practices, check-lists and case studies for leveraging standards in clinical trials. From creation and implementation, to governance tools (both internal and with external partners), attendees walk away with actionable insights to leverage with their own organization.
* Understand what to standardize
* Learn several approaches to standards development and when they make sense
* Ensure alignment with key stakeholders
* Maintain and govern standards over time
* Reduce overall configuration time
Who Will Benefit:
* Clinical Data (manager/director/head of) Clinical ops
* Data management
* Biostatistics
* Data science
* Clinical science
* EDC
* Biometrics
* eClinical
* Data standards
* Quantitative sciences
* Informatics
* Data monitoring
* Clinical leads
* Study managers
* Clinical study
* Data manager
* CRA
* CDISC
Meet Your Presenters:
Carla Reis
Director, Client Services, 4G Clinical
Carla Reis, Director of Client Services at 4G Clinical, has over 18 years of experience as an operational leader in developing and implementing RTSM systems in a global pharmaceutical company. Carla was a leader in her organization in establishing vendor management standards and processes. She has helped lead major RTSM process improvement initiatives where she established new and innovated approaches to drug assignment verification and vendor integrations. Carla has presented at industry conferences as a subject matter expert on best practices using RTSM solutions for complex strategies in supply chain management. Carla holds a BS in Neurobiology and Physiology from the University of Connecticut and a certification as Lean Six Sigma Yellow Belt. Carla also holds a Masters in Science in Health Administration with a concentration in Health Informatics from Saint Joseph's University.
Paul MacDonald
Senior Director, Strategy Vault CDMS, Veeva Systems
Paul is Senior Director Vault CDMS, responsible for strategy and direction in data management. With 25+ years experience working in life science at pharma, CRO and technology organisations, Paul brings a strong operational focus in relation to eClinical technology for data management and clinical operations that stretches from EDC, through CTMS to risk based monitoring.
Apellis Pharmaceuticals Selects a Modern Safety SolutionVeeva Systems
Apellis Pharmaceuticals shares evaluation criteria for a pharmacovigilance system and why they chose a modern safety solution. Watch the on-demand webinar to learn more: http://bit.ly/374MdP8
How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDCVeeva Systems
Watch the video here: https://bit.ly/3urhVSi
CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management. They’ll share insights into how to:
* Build a database from standards and your protocol (not a spec)
* Replace manual documentation with system-generated reports
* Provide real-time visibility into the status of data collection and cleaning
Hear their first-hand accounts of adopting an Agile Design methodology with Veeva Vault CDMS and reaping the rewards of a straightforward build and a modern EDC.
Simplifying Postmarket Surveillance: Introducing Veeva Vault Product Surveill...Eric Burniche, MBA
To watch the full webinar:
The growing complexity of medical products and rapidly changing global regulations require a more holistic and consistent approach to postmarket surveillance (PMS).
However, disconnected and highly-customized solutions - historically serving med-tech companies - have fallen short of meeting the evolving needs of the industry.
Can your PMS system quickly adapt to regulatory changes and enable you to meet global submission timelines?
In this webinar, Carl Ning, Sr Director of Strategy at Veeva systems, discusses recent trends driving organizations to transform systems and processes for better product quality and reliability. You will also hear about Veeva Vault Product Surveillance, Veeva’s new application that simplifies and standardizes global postmarket surveillance.
Attend the webinar to learn:
- How to address common challenges in managing complaints and submissions
- How a unified approach to postmarket surveillance streamlines end-to-end quality management
- How Vault Product Surveillance standardizes and consolidates the complaint reportability process for various health authorities
Learn what inspectors are looking for and how to prepare for inspections in eTMF. This deck will cover an inspections overview, inspection preparation, inspector access, and inspection readiness. For more info, visit http://bit.ly/VaulteTMF
Eisai EMEA: Laying the foundation for centralised medical information managem...Veeva Systems
Veeva Vault MedComms Customer Eisai EMEA
Elizabeth Rance, head of EMEA medical information, and David Robertson, EMEA business solutions director from Eisai discussed the following:
-An overview of Eisai’s journey so far to centralize medical information
-The initial feedback from their transformation project and longer-term objectives
-The benefits from instant visibility of metrics
GSK: Preparing the Business for Study Start-up ChangeVeeva Systems
At the 2020 Veeva R&D and Quality Summit, GSK detailed their journey to transform study start-up. See their presentation slides for practical advice on gaining stakeholder alignment, issue resolution, and best practices to institute governance around a unified clinical program.
Watch on-demand: https://www.veeva.com/events/rd-summit/presentations/
Clinlogix - Improving Pharmacovigilance Outsourcing with Modern Technologies Veeva Systems
Learn how pharma companies and vendors are collaborating and simplifying processes with modern safety solutions. View the on-demand webinar here: https://bit.ly/30eAlJC
The Benefits of a Seamless IRT and EDC Integration in Clinical Trial ExecutionVeeva Systems
Watch the video here: https://bit.ly/3upehbN
Veeva and Suvoda have combined their offerings into a powerful streamlined integration, which accommodates advanced study designs while driving down build and casebook complexity.
Hear Catherine Munera, head of biometrics at Cara Therapeutics, share the benefits of moving from a single provider to taking a harmonized, best-of-breed approach with IRT and EDC.
Speed Clinical Trials from Start to Close: The Path to a Modern CTMSVeeva Systems
Learn how a modern CTMS leads to better oversight, study analytics, and risk identification. This presentation also covers common barriers to the migration process and how to overcome them. Watch a demonstration of Veeva Vault CTMS: http://bit.ly/VaultCTMSDemo
Using Vault eTMF Milestones and EDLs to Support Inspection ReadinessVeeva Systems
Hear how Daiichi Sankyo is using milestones and expected document lists (EDLs) to enable ongoing inspection readiness and proactive TMF management and oversight.
Vertex Reduces EDC Study Build Times by 50%Veeva Systems
Watch the video here: https://bit.ly/3oUi6Vg
The clinical data team at Vertex asked themselves, how can we reduce our development timelines and costs—make things go faster, for less?
Answering those questions set Vertex on a path to challenge themselves and their vendors to improve speed without sacrificing quality. As a result, they’re reducing database build times by as much as 50% and reliably lock data in 15-18 days.
This webinar covers:
* How Vertex reaches 80-90% compliance with sites entering data within 2 days of the event
* Their #1 goal for transforming the UAT process
* Their novel recommendation for when to go live
* The technology strategy supporting their process improvements
Who Will Benefit:
* Clinical data executives
* Heads of clinical
* Heads of clinical research
Meet Your Presenters:
Vikas Gulati
Senior Director of Clinical Data Management and Metrics, Vertex Pharmaceuticals
Vikas Gulati has over 20 years’ experience focused on clinical data management, data standards and governance. He has led several global cross-functional teams to successful outcomes in Biotech/Pharma and CROs. He is currently the Global Head of Clinical Data Management at Vertex Pharmaceuticals, Inc.
Richard Young
Vice President, Vault EDC, Veeva Systems
Richard Young has nearly 25 years of expertise in data management, clinical solutions, and advanced clinical strategies. At Veeva, Young is establishing Vault EDC as the leading solution for clinical data management.
Michelle Harrison
Associate Director of Clinical Data Management and Metrics, Vertex
Michelle Harrison is currently working at Vertex Pharmaceutical in Boston Massachusetts as an Associate Director of Data Management. Prior to joining Vertex, she worked as a consultant for BioBridges. For 2 years there she consulted for a number of small Biotechs assisting with Vendor oversight and start up activities.
This presentation reviews the regulatory requirements for intended use validation of SaaS-based EDC systems from the Sponsor and CRO perspective and provides best practices for implementing the proper validation in your organization.
Enabling Proactive Quality Management Across Quality and ManufacturingVeeva Systems
Imagine a quality system that allows you to predict and address quality issues before they occur, increase efficiency through intelligent automation, and increase visibility and collaboration across the supply chain.
Today more than 450 pharma, biotech, medtech, and contract services have turned this vision into reality by redesigning their legacy processes and modernizing their quality infrastructure. Using industry best practices and a strong technology foundation, they standardized business processes across GxPs and unified and connected quality and manufacturing systems for speed and efficiency.
In this presentation, you will learn:
- How digital transformation enables companies to pursue quality excellence
- Opportunities to unify and streamline systems and processes
- Best practices from leading companies to enable proactive quality management
Fitman webinar 2015 06 Verification and Validation methodologyFITMAN FI
A webinar on the Verification and Validation (V&V) Methodology developed in the FITMAN project. The V&V methodology is a general, holistic method for verifying, validating and evaluating a software product from its conception to final release and implementation. Presented by Fenareti Lampathaki from the National Technical University of Athens (NTUA).
Best Practices for Managing Regulatory Binders ElectronicallyVeeva Systems
- Industry drivers for change and benefits of eRegulatory
- Tips for choosing the right system and evaluating a vendor
- Best practices and mistakes to avoid when going electronic
Designing an EDC System to Work for a CRAVeeva Systems
Watch the video here: https://bit.ly/3h8gHIU
Targeted source data verification (SDV) might be well established, but many clinical teams are still verifying 100% of their data, making monitoring costly and inefficient.
By warching this on demand webinar, you will hear established RBM experts share the measures and metrics that organizations need to realize the true value of targeted SDV. Learn better ways to implement a risk-based strategy for SDV to ensure that CRAs focus on the most important data and how doing so can:
* Improve data quality
* Speed data collection and analysis
* Result in higher confidence and user satisfaction
Learn how Veeva is reinventing EDC to work for a CRA, creating significant speed and quality improvements.
Who Will Benefit:
Senior professionals working with clinical data/clinical documentation, including:
* Clinical Development/ R&D
* Clinical Data Management
* eClinical Operations
* Data Monitoring & Management
* Development Strategic Operations
* Information Strategy & Analytics, Clinical Informatics & Innovation
* Information Technology, R&D IT
* IT R&D Business Partner
Meet Your Presenters:
Drew Garty
Chief Technology Officer, Veeva Vault CDMS, Veeva
Drew Garty’s career in pharmaceutical technology spans over 20 years and includes significant expertise in EDC, clinical site monitoring, platform integrations and clinical trial management solutions. Drew’s innovative solutions in risk-based monitoring earned him a prestigious industry “Clinical Innovator of the Year” award in 2015. Drew joined Veeva in 2016 as Vice President of Product Management, and led the ground-up design of Veeva’s Vault EDC solution. In his current role of Chief Technology Officer at Vault CDMS, Drew shares and collaborates with customers, partners and the industry to set vision and direction of Veeva’s CDMS product.
Dawn Anderson
Managing Director, Life Sciences Strategy and Operations, Deloitte
Dawn has more than 30 years of industry and consulting experience in pharmaceutical, biotechnology, CROs, and technology companies. Her practice is focused on clinical development and she works with clients to design and deploy global operating strategy, performance improvement and technology implementations across the development of new drugs, biologics and devices. Dawn has spoken frequently about clinical transformation and the future of clinical trials, including topics around adaptive design, protocol complexity, risk assessments and the use of technology including virtual trials, digital, mHealth and the use of clinical analytics platforms and cognitive automation in transforming clinical trial delivery.
Shorten Database Builds by 60% with Agile DesignVeeva Systems
Watch the video here: https://bit.ly/3f64wJZ
See the Packed #SCDM2019 Session
Radical time savings aren’t possible with incremental process improvements. An agile EDC enables process transformation that shortens database builds by 40-60%. Join a live webinar of the packed SCDM product showcase to hear the technologies and processes behind those savings, including real-time UAT, data-driven rules and dynamics, and easy amendments.
Transform Your Digital Content to Improve Speed to Market While Maintaining C...Veeva Systems
Watch the full webinar to learn industry challenges and how Roche Diagnostics is transforming its digital content management with Veeva Vault PromoMats to improve speed to market:
https://go.veeva.com//transform-content-management-to-improve-speed-to-market
By better managing the lifecycle of digital assets, it will be possible to reduce expensive duplication of assets, maintain control of the brand image, and stay compliant in a complex regulatory environment.
Webinar: Driving Operational Agility with Digital Quality ManagementVeeva Systems
Watch the webinar here: https://go.veeva.com/Driving-Operational-Agility_webinar
This presentation is from a Veeva Systems Quality Team webinar series hosted by Contract Pharma.
Is the disconnected technology landscape slowing down operations and draining resources?
New-market demands, increasingly complex supply chains, and changing regulations will continue as the norm. Modern technologies can help manufacturers manage these external forces effectively, enabling them to be more agile, data-driven, and future-ready.
Today many manufacturers are digitizing quality management to increase operational agility and supply chain collaboration, meeting continually-changing market and customer demands.
Join Veeva experts in this webinar to learn how digitalizing quality management bridges gaps between manufacturing and quality management, improving cycle times and agility.
In this webinar, you will learn:
- About the opportunities to transform quality management
- How the right technology streamlines global quality processes, increasing automation and operational agility
- The industry best practices for driving successful digital transformation
Best practices for implementing and maintaining successful standardsVeeva Systems
Watch the video here: https://bit.ly/3uvar1u
This webinar provides best practices, check-lists and case studies for leveraging standards in clinical trials. From creation and implementation, to governance tools (both internal and with external partners), attendees walk away with actionable insights to leverage with their own organization.
* Understand what to standardize
* Learn several approaches to standards development and when they make sense
* Ensure alignment with key stakeholders
* Maintain and govern standards over time
* Reduce overall configuration time
Who Will Benefit:
* Clinical Data (manager/director/head of) Clinical ops
* Data management
* Biostatistics
* Data science
* Clinical science
* EDC
* Biometrics
* eClinical
* Data standards
* Quantitative sciences
* Informatics
* Data monitoring
* Clinical leads
* Study managers
* Clinical study
* Data manager
* CRA
* CDISC
Meet Your Presenters:
Carla Reis
Director, Client Services, 4G Clinical
Carla Reis, Director of Client Services at 4G Clinical, has over 18 years of experience as an operational leader in developing and implementing RTSM systems in a global pharmaceutical company. Carla was a leader in her organization in establishing vendor management standards and processes. She has helped lead major RTSM process improvement initiatives where she established new and innovated approaches to drug assignment verification and vendor integrations. Carla has presented at industry conferences as a subject matter expert on best practices using RTSM solutions for complex strategies in supply chain management. Carla holds a BS in Neurobiology and Physiology from the University of Connecticut and a certification as Lean Six Sigma Yellow Belt. Carla also holds a Masters in Science in Health Administration with a concentration in Health Informatics from Saint Joseph's University.
Paul MacDonald
Senior Director, Strategy Vault CDMS, Veeva Systems
Paul is Senior Director Vault CDMS, responsible for strategy and direction in data management. With 25+ years experience working in life science at pharma, CRO and technology organisations, Paul brings a strong operational focus in relation to eClinical technology for data management and clinical operations that stretches from EDC, through CTMS to risk based monitoring.
Apellis Pharmaceuticals Selects a Modern Safety SolutionVeeva Systems
Apellis Pharmaceuticals shares evaluation criteria for a pharmacovigilance system and why they chose a modern safety solution. Watch the on-demand webinar to learn more: http://bit.ly/374MdP8
How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDCVeeva Systems
Watch the video here: https://bit.ly/3urhVSi
CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management. They’ll share insights into how to:
* Build a database from standards and your protocol (not a spec)
* Replace manual documentation with system-generated reports
* Provide real-time visibility into the status of data collection and cleaning
Hear their first-hand accounts of adopting an Agile Design methodology with Veeva Vault CDMS and reaping the rewards of a straightforward build and a modern EDC.
Simplifying Postmarket Surveillance: Introducing Veeva Vault Product Surveill...Eric Burniche, MBA
To watch the full webinar:
The growing complexity of medical products and rapidly changing global regulations require a more holistic and consistent approach to postmarket surveillance (PMS).
However, disconnected and highly-customized solutions - historically serving med-tech companies - have fallen short of meeting the evolving needs of the industry.
Can your PMS system quickly adapt to regulatory changes and enable you to meet global submission timelines?
In this webinar, Carl Ning, Sr Director of Strategy at Veeva systems, discusses recent trends driving organizations to transform systems and processes for better product quality and reliability. You will also hear about Veeva Vault Product Surveillance, Veeva’s new application that simplifies and standardizes global postmarket surveillance.
Attend the webinar to learn:
- How to address common challenges in managing complaints and submissions
- How a unified approach to postmarket surveillance streamlines end-to-end quality management
- How Vault Product Surveillance standardizes and consolidates the complaint reportability process for various health authorities
Learn what inspectors are looking for and how to prepare for inspections in eTMF. This deck will cover an inspections overview, inspection preparation, inspector access, and inspection readiness. For more info, visit http://bit.ly/VaulteTMF
Eisai EMEA: Laying the foundation for centralised medical information managem...Veeva Systems
Veeva Vault MedComms Customer Eisai EMEA
Elizabeth Rance, head of EMEA medical information, and David Robertson, EMEA business solutions director from Eisai discussed the following:
-An overview of Eisai’s journey so far to centralize medical information
-The initial feedback from their transformation project and longer-term objectives
-The benefits from instant visibility of metrics
GSK: Preparing the Business for Study Start-up ChangeVeeva Systems
At the 2020 Veeva R&D and Quality Summit, GSK detailed their journey to transform study start-up. See their presentation slides for practical advice on gaining stakeholder alignment, issue resolution, and best practices to institute governance around a unified clinical program.
Watch on-demand: https://www.veeva.com/events/rd-summit/presentations/
Clinlogix - Improving Pharmacovigilance Outsourcing with Modern Technologies Veeva Systems
Learn how pharma companies and vendors are collaborating and simplifying processes with modern safety solutions. View the on-demand webinar here: https://bit.ly/30eAlJC
The Benefits of a Seamless IRT and EDC Integration in Clinical Trial ExecutionVeeva Systems
Watch the video here: https://bit.ly/3upehbN
Veeva and Suvoda have combined their offerings into a powerful streamlined integration, which accommodates advanced study designs while driving down build and casebook complexity.
Hear Catherine Munera, head of biometrics at Cara Therapeutics, share the benefits of moving from a single provider to taking a harmonized, best-of-breed approach with IRT and EDC.
Speed Clinical Trials from Start to Close: The Path to a Modern CTMSVeeva Systems
Learn how a modern CTMS leads to better oversight, study analytics, and risk identification. This presentation also covers common barriers to the migration process and how to overcome them. Watch a demonstration of Veeva Vault CTMS: http://bit.ly/VaultCTMSDemo
Using Vault eTMF Milestones and EDLs to Support Inspection ReadinessVeeva Systems
Hear how Daiichi Sankyo is using milestones and expected document lists (EDLs) to enable ongoing inspection readiness and proactive TMF management and oversight.
Vertex Reduces EDC Study Build Times by 50%Veeva Systems
Watch the video here: https://bit.ly/3oUi6Vg
The clinical data team at Vertex asked themselves, how can we reduce our development timelines and costs—make things go faster, for less?
Answering those questions set Vertex on a path to challenge themselves and their vendors to improve speed without sacrificing quality. As a result, they’re reducing database build times by as much as 50% and reliably lock data in 15-18 days.
This webinar covers:
* How Vertex reaches 80-90% compliance with sites entering data within 2 days of the event
* Their #1 goal for transforming the UAT process
* Their novel recommendation for when to go live
* The technology strategy supporting their process improvements
Who Will Benefit:
* Clinical data executives
* Heads of clinical
* Heads of clinical research
Meet Your Presenters:
Vikas Gulati
Senior Director of Clinical Data Management and Metrics, Vertex Pharmaceuticals
Vikas Gulati has over 20 years’ experience focused on clinical data management, data standards and governance. He has led several global cross-functional teams to successful outcomes in Biotech/Pharma and CROs. He is currently the Global Head of Clinical Data Management at Vertex Pharmaceuticals, Inc.
Richard Young
Vice President, Vault EDC, Veeva Systems
Richard Young has nearly 25 years of expertise in data management, clinical solutions, and advanced clinical strategies. At Veeva, Young is establishing Vault EDC as the leading solution for clinical data management.
Michelle Harrison
Associate Director of Clinical Data Management and Metrics, Vertex
Michelle Harrison is currently working at Vertex Pharmaceutical in Boston Massachusetts as an Associate Director of Data Management. Prior to joining Vertex, she worked as a consultant for BioBridges. For 2 years there she consulted for a number of small Biotechs assisting with Vendor oversight and start up activities.
This presentation reviews the regulatory requirements for intended use validation of SaaS-based EDC systems from the Sponsor and CRO perspective and provides best practices for implementing the proper validation in your organization.
Enabling Proactive Quality Management Across Quality and ManufacturingVeeva Systems
Imagine a quality system that allows you to predict and address quality issues before they occur, increase efficiency through intelligent automation, and increase visibility and collaboration across the supply chain.
Today more than 450 pharma, biotech, medtech, and contract services have turned this vision into reality by redesigning their legacy processes and modernizing their quality infrastructure. Using industry best practices and a strong technology foundation, they standardized business processes across GxPs and unified and connected quality and manufacturing systems for speed and efficiency.
In this presentation, you will learn:
- How digital transformation enables companies to pursue quality excellence
- Opportunities to unify and streamline systems and processes
- Best practices from leading companies to enable proactive quality management
Fitman webinar 2015 06 Verification and Validation methodologyFITMAN FI
A webinar on the Verification and Validation (V&V) Methodology developed in the FITMAN project. The V&V methodology is a general, holistic method for verifying, validating and evaluating a software product from its conception to final release and implementation. Presented by Fenareti Lampathaki from the National Technical University of Athens (NTUA).
A Guide to UAT and its Effective ExecutionSerena Gray
If you are looking forward to implementing user acceptance testing for your specific software development project, then do get connected with a premium software testing services company that will provide you a strategic testing roadmap that is in line with your testing and project specific requirements. Read more https://bethwilsonuk.wixsite.com/my-site/post/a-guide-to-uat-and-its-effective-execution
Verification and Validation with Innoslate Slide DeckSarahCraig7
Review these slides to learn all the features in Innoslate that implement Verification and Validation. These slides will cover:
- Ensuring end-to-end traceability in your project
- Model test processes through Diagrams View and Test Center
- Developing test cases and test suites in Test Center
- Creating Independent Verification and Validation (IV&V) plans and test plans through Documents View
-Generate a traceability matrix
These slides will give you a step by step approach to Verification and Validation.
This is a case study on conducting User Acceptance Testing (UAT) of a complex B2E software application. Involved testing of several critical HR and Payroll modules.
Software validation do's and dont's may 2013John Cachat
Software validation is often times a very misunderstood concept. For FDA regulated industries, there are clear expectations including “the least burdensome approach.” Validation alone does not guarantee software quality—many other aspects of software engineering are required.
Join software expert, John Cachat, as he discusses how to solve several software validation issues, including:
Requirements
Defect Prevention
Time and Effort
Software Life Cycle
Plans
Procedures
Software Validation After a Change
Validation Coverage
Independence of Review
Flexibility and Responsibility
Learn how to establish a greater sense of confidence in your release cycle, along with the practices and processes to create a high-performing engineering culture within your team.
Unraveling the Life Cycle of Software Development_ Insights from Betatest Sol...JamesParker406701
The life cycle of software development, often referred to as the Software Development Life Cycle (SDLC), is a structured process that encompasses several distinct phases.
Test Automation using UiPath Test Suite - Developer Circle Part-1.pdfDiana Gray, MBA
Test Suite Product Overview
In Part 1 of Test Automation using UiPath Test Suite - Developer Series, we'll cover,
-What is Software Testing
-Why Software Testing is Required
-Typical Test Types and Levels
-Continuous Testing and Challenges
-Introduction to UiPath Test Suite
Test Suite and UiPath Automation Platform
Speaker: Atul Trikha
Similar to Validation strategies for cloud-based EDCs: more innovation, less effort (20)
Strategies and Best Practices for Transforming Enterprise TrainingVeeva Systems
Webinar with Carol Benson, associate director of quality systems at Incyte, and Kent Malmros, senior director of Vault Training. They discuss best practices and strategies for successfully transforming learning management systems. There are benefits of starting learning management system selection and implementation with diligent and comprehensive change management approaches.
Topics include:
- Organizational governance strategies for LMS
- How to build on a foundation of GxP compliance
- How to build cross-functional oversight
- Selecting the right learning technologies to eliminate all paper processes
- Best practices for delivering a single system
The Industry’s Move Toward Digitally Connected Clinical TrialsVeeva Systems
The rapid adoption of decentralized trials is causing significant challenges – sites are burdened by too many technologies and the use of multiple patient-facing applications adds complexity for patients.
In these slides, we discuss the implications of decentralized trials, share findings from the Veeva Digital Clinical Trials Survey, and explore how clinical leaders are accelerating digital transformation to make studies more site and patient-centric.
Access the Veeva Digital Clinical Trials Survey Report (https://bit.ly/35eAeDn) for additional insights from more than 280 clinical leaders worldwide on the industry’s progress toward digital trial strategies, lessons learned, and what lies ahead.
Enhance Learning Efficiency in LIfe Sciences with Industry-Leading Learning C...Veeva Systems
See how an end-to-end solution enables customers to modernize training while streamlining resources and improving learning outcomes. Join us to learn how combining best-in-class training content and LMS technology improves efficiency and brings strategic value to your organization.
Join this session to learn:
How adding a standard GxP content library to your LMS increases training efficiency
The best place to start with eLearning content
Scaling your use of a GxP training library based on organizational maturity
Partnering with Veeva for your ongoing learning strategy needs
Moving to unified PV: Transforming Safety with End-to-end PV SolutionsVeeva Systems
New technologies and approaches to safety and pharmacovigilance are enabling end-to-end processes for greater collaboration and oversight.
During Pharmacovigilance World 2021, Jen Markey, VP Vault Safety Strategy Europe, shared how you can leverage a unified PV solution to improve outsourcing, streamline safety, and make compliance easier.
For more information visit:
www.veeva.com/eu/products/vault-safety
Reimagine patient safety 2030 governance through a unified safety platformVeeva Systems
Technology disruptions and healthcare transformation are shifting the roles of QPPV's and senior safety leaders to a more predictive, preventative and participatory safety ecosystem.
During the DIA QPPV Forum, Sharmila Sabaratnam, Senior Director Vault Safety Strategy, shared how you can improve collaboration, benefit-risk data flow and quality and generate insights to maximise patient outcome and minimise avoidable harm through medical governance oversight.
For more information visit:
www.veeva.com/eu/products/vault-safety
Reshaping Global ICSR Reporting to Deliver Real-time Visibility and OversightVeeva Systems
Learn how you can reshape global ICSR reporting to deliver real-time visibility and oversight.
In this presentation we discuss:
- Challenges and approaches to safety data management and ICRS reporting
- How technology is making it easier to comply with global and regional requirements
- Considerations for incorporating affiliates into one pharmacovigilance solution
- Strategies for adopting a single multi-lingual safety solution
View the on-demand webinar here: https://bit.ly/35Pfyik
Tufts Research: EDC Trends, Insights, and OpportunitiesVeeva Systems
Watch the video here: https://bit.ly/3yIrVu0
New Tufts research on the eClinical landscape
Learn how seemingly minor decisions in one functional group can significantly impact overall clinical trial timelines. Specifically, those who never release the database before first patient, first visit (FPFV) take more than three weeks longer to lock the database than those who always release before FPFV. Other key findings include:
* Types and volume of data companies manage in EDC
* The biggest causes of database build delays
* How sponsor and CRO cycle times compare for database build, data entry, and database lock
Who Will Benefit:
* Data Management
* eClinical
* Clinical Operations
* Biometrics
* Clinical Development
* R&D IT
Tufts Research: Strategies from Data Management Leaders to Speed Clinical TrialsVeeva Systems
Watch the video here: https://bit.ly/3wChmGQ
Learn how top pharmas and CROs plan to speed database build and data collection, as well as their top challenges and future priorities. In this webinar you'll gain insights into:
* Taking an agile approach to database build
* Reducing UAT timelines with a risk-based approach
* Driving innovation at your organization
This in-depth research from Tufts follows their industry-wide eClinical Landscape Study, examining the major cause of database build delays and their impact on trial cycle times.
Meet Your Presenters:
Ken Getz
Director of Sponsored Programs, Tufts CSDD
Richard Young
Vice President, Vault EDC, Veeva Systems
Webinar: Rethinking the Life Sciences Training Technology EcosystemVeeva Systems
Watch the full webinar here: https://go.veeva.com/training-ecosystem-2021
As a training steward, you are required to select the right systems to enable an effective and efficient training program for your organization. But the task is easier said than done due to an increasingly complex technology landscape.
Join Kent Malmros, Sr. Director of Veeva Vault Training, to learn about different training technologies available today and how they fit together to create an optimal learning environment for both administrators and learners. You will also learn about technologies you won't need, reducing the cost and complexity of your training environment.
In this one hour webinar, you will learn:
Key definitions and descriptions of modern training technology categories
How to prioritize acquiring new job technologies and eliminating legacy solutions
Best practices for effectively connecting systems and processes to ensure faster time to qualification and competency
We will also have a deep dive discussion into:
Authoring tools
Document and Content Management Systems
Learning Management Systems
Gamification Frameworks
Learning Experience Platforms
PICI’s Best Practices for Building Oncology Studies in an EDCVeeva Systems
Watch the video here: https://bit.ly/3vrYslR
The Parker Institute for Cancer Immunotherapy (PICI) runs complex clinical trials that depend on an electronic data capture (EDC) system that is adaptive, flexible and innovating at the same pace as their patient-centric mission.
Learn why their legacy EDC system workarounds and custom functions no longer sustained their business, which motivated them to take a new approach. In this webinar, Toby Odenheim, the Director of Technology and Governance, will share how PICI decided to adopt a new EDC system that streamlines the build process for oncology trials and how they better equip their clinical programmers and data managers. PICI’s lead study builder, Gary Smith, will provide a hands-on perspective and share strategies to handle the key challenges that oncology teams face with EDC systems, including:
* Umbrella trials that evaluate multiple therapies
* Adaptive trial branching and routing
* Having an unknown number of treatment cycles
* Amendments and other unplanned changes
Who Will Benefit:
* Data managers
* Database Programmers
* Clinical Programmers
* Clinical programmers in charge of building studies
* Clinical leaders in charge of selecting EDC systems
* EDC Programmers
Meet Your Presenters:
Toby Odenheim
Director, Technology and Governance, Parker Institute for Cancer Immunotherapy
In his current role as director of technology and governance at PICI, Toby Odenheim, MBA, leads an array of technology and process improvement initiatives aimed at accelerating the development of innovative cancer immunotherapy treatments. Core areas of oversight include management of clinical and pharmacovigilance systems, including CTMS, eTMF, IRT, EDC, ePRO, medical coding, safety, and business intelligence systems.
Prior to joining PICI, Odenheim was the founder and principal at Odin Life Sciences Consulting, where he guided companies in the selection, implementation, and validation of best-of-breed clinical technologies. Toby Odenheim has held management positions at Gilead, Synteract, ClinicalSoft, and Pfizer. He holds an undergraduate degree in biology, an MBA, and professional certifications in finance, Oracle database administration, and relational database design.
Gary Smith
Senior EDC Programmer/Analyst, Parker Institute for Cancer Immunotherapy
Gary has over twenty years of experience in clinical programming and is a subject matter expert on study design, configuration, and testing with off-the-shelf EDC systems including Veeva Vault CDMS, Medidata Rave, and Oracle Clinical. Gary has deep expertise in building oncology studies, specifically platform studies, and is currently responsible for all aspects of EDC design and study builds in immuno-oncology studies with the Parker Institute for Cancer Immunotherapy. Gary has developed global libraries for five different companies, spanning medical device and pharmaceutical industries.
Veeva Systems Webinar: Driving Continuous Quality ImprovementsVeeva Systems
Watch the on-demand webinar here: https://go.veeva.com/driving-continuous-quality-improvements/on-demand
Building a strong foundation to drive continuous quality improvements requires connecting people, processes, and technology. Life sciences companies transforming quality management with this holistic approach have increased quality management efficiency by up to 50% and reduced paperwork by 90%.
Watch the webinar and learn how you can create such a foundation for your organization on an intelligent, data-driven, end-to-end digital platform. You will also hear real-world use cases of applying advanced technologies like AI to enable proactive quality management across all operational areas.
You will hear:
- Opportunities and recommendations to unify and streamline quality systems and processes
- Areas where modern-era technologies like cloud and AI can increase efficiency, optimize cost, and bring products to patients faster
- Real-world examples of how leading organizations are transforming quality management to drive continuous quality improvements.
Immunomedics: Transforming TMF OperationsVeeva Systems
Immunomedics discusses how they achieved best-in-class TMF management and outlines steps for improving cross-functional ownership and collaboration with CRO partners.
To learn more best practices and see how organizations like Allakos, Daiichi Sankyo, and GBT maintain inspection readiness, visit this resources page: https://bit.ly/Inspection-Readiness
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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