Transitioning from paper to eCTD for 2253 Submissions?
The updated 2253 draft guidelines for Ad Promo submissions, is an example of the FDA encouraging sponsors to adopt practices that will benefit industry as a whole.
A step in the right direction.
Submitting video, audio and images as DVD media by mail in an age of such impressive computing power at low cost is much too tedious for sponsor and Agency.
Modernization.
By updating the specification, updating the technology, and encouraging a rethinking of internal processes, the FDA is moving toward a more modern business reality.
Pyxa Solutions is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs.
Pyxa was founded in 2012 to provide our clients a refreshing consulting experience, through engagement with experienced industry leaders and consultants by delivery of high-quality deliverables and unique services. Pyxa is managed by a team of three seasoned partners with prior blended expertise in industry and management consulting.
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
FDA Data Integrity: Misconceptions of 21 CFR Part 11 EduQuest, Inc.
Martin Browning, co-author of FDA's 21 CFR Part 11 regulation for electronic records and signatures, explains FDA's expectations for data integrity and common industry misconceptions about how to comply with the rule.
PTC Successfully Submits Test Data to the FDA’s Global Unique Device Identifi...PTC
PTC (Nasdaq: PTC) announces it has successfully submitted UDI data to the preproduction version of the US Food and Drug Administration’s Global Unique Device Identifier Database (GUDID) through the Electronic Submission Gateway (ESG) in the required HL7 SPL format. The FDA’s UDI rule aims to dramatically reduce the instances of patient injury and death that result from the misidentification of medical devices.
Pyxa Solutions is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs.
Pyxa was founded in 2012 to provide our clients a refreshing consulting experience, through engagement with experienced industry leaders and consultants by delivery of high-quality deliverables and unique services. Pyxa is managed by a team of three seasoned partners with prior blended expertise in industry and management consulting.
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
FDA Data Integrity: Misconceptions of 21 CFR Part 11 EduQuest, Inc.
Martin Browning, co-author of FDA's 21 CFR Part 11 regulation for electronic records and signatures, explains FDA's expectations for data integrity and common industry misconceptions about how to comply with the rule.
PTC Successfully Submits Test Data to the FDA’s Global Unique Device Identifi...PTC
PTC (Nasdaq: PTC) announces it has successfully submitted UDI data to the preproduction version of the US Food and Drug Administration’s Global Unique Device Identifier Database (GUDID) through the Electronic Submission Gateway (ESG) in the required HL7 SPL format. The FDA’s UDI rule aims to dramatically reduce the instances of patient injury and death that result from the misidentification of medical devices.
How To Deliver Step Changes in Manufacturing Operations with Predictive Insig...Bigfinite
How To Deliver Step Changes in Manufacturing Operations with Predictive Insights using AI/ML and Pharma 4.0 Principles at ManuPharma 2019 in Frankfurt, Germany by Toni Manzano
How to Prepare for the New EU In Vitro Diagnostics RegulationsGreenlight Guru
Agreement was reached on the eagerly awaited new EU In Vitro Diagnostic Regulations (IVDR) earlier this year.
The IVDR will significantly change the way IVDs bear the CE mark, and it will include a completely new risk-based classification system.
Now 80% of all IVDs will need to be certified by a notified body under the IVDR where as before, only 20% needed to under the IVD Directive.
The new IVDR is expected to be formally published in late 2016 or early 2017, and there will be a five-year transition period to be compliant.
Many forward thinking IVD companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
This presentation includes:
-Why the European regulations are changing
-What does the new regulation mean for IVD manufactures
-How to classify your IVD using the new risk-based classification system
-How to evaluate your existing clinical evidence to know if new studies will be needed to support your CE mark
-An overview of all the most significant changes brought by the IVDR
-What IVD manufactures can do to start preparing now
Watch the presentation here: https://www.greenlight.guru/webinar/eu-in-vitro-diagnostic-regulations-ivdr
How to Review, Cleanse, and Transform Clinical Data in Oracle InFormPerficient, Inc.
When it comes to clinical trials, the consequences of bad data can be severe. Research and development becomes complicated and lives can be put at risk. The need for clinical data to be clean is critical for comprehensive reporting and analysis, ultimately enabling safer drugs and devices to be brought to market faster.
During our 30-minute, no-nonsense webinar, we discussed why and how organizations can leverage Oracle Health Sciences Data Management Workbench (DMW) to revitalize the clinical trial data captured in Oracle Health Sciences InForm.
Minimize the Impact of E2B(R3) on Drug Safety Operations with Argus SafetyPerficient, Inc.
The electronic transmission of adverse event information to stakeholders, using the International Conference on Harmonization (ICH) E2B standard, is an essential component of global drug safety and pharmacovigilance operations.
E2B(R3), the latest version of the ISO ICSR standard, presents a number of challenges that need to be addressed before life sciences companies can implement the essential technology and processes required to perform day-to-day activities and comply with the new regulatory guidelines.
Our webinar delivered insight into the impact of the requirements on your drug safety business processes (e.g., CIOMS reporting, Line Listings, PSURS/DSURS, Signal Generation), as well as to how Oracle's Argus Safety can help you meet the E2B(R3) requirements.
PTC announces the availability of the latest release of PTC Windchill® produc...PTC
NEEDHAM, MA - September 17, 2013 - PTC (Nasdaq: PMTC) today announced the availability of the latest release of PTC Windchill® product lifecycle management (PLM) software. PTC Windchill 10.2 adds capabilities to help manufacturers improve productivity and streamline compliance with new government regulations.
PTC Expands Regulatory Compliance Capabilities, Broadens Support for Product Quality Processes, and Enhances Collaboration between Hardware and Software Development Teams
Latest release of PTC Windchill reduces effort needed to comply with new FDA and SEC regulations; enhances integration with PTC Integrity
PTC Expands Regulatory Compliance Capabilities, Broadens Support for Product Quality Processes, and Enhances Collaboration between Hardware and Software Development Teams
Latest release of PTC Windchill reduces effort needed to comply with new FDA and SEC regulations; enhances integration with PTC Integrity
PTC Expands Regulatory Compliance Capabilities, Broadens Support for Product Quality Processes, and Enhances Collaboration between Hardware and Software Development Teams
Latest release of PTC Windchill reduces effort needed to comply with new FDA and SEC regulations; enhances integration with PTC Integrity
Implementing a Global Unique Device Identification (UDI) Solution: Regional U...Greenlight Guru
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates.
This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
FDA's Case for Quality: What, Why, and How? Changing the Regulatory ParadigmGreenlight Guru
Top-quality medical devices help the FDA better protect and promote public health. And one of the top priorities for FDA's medical devices center is a focus on quality.
The FDA launched the Case for Quality in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders.
This program allows the FDA to recognize device manufacturers that are capable of consistently producing high-quality devices and continuously improving.
Greenlight Guru is partnering with FDA CDRH to help spread the word and promote the Case for Quality initiative and its benefits to the medical device industry. This is the first of four presentations, learn about the others at greenlight.guru.
Key points in this presentation:
-Learn about CfQ – What it is, why we are doing it, and how we are engaging
-Introduce pilot programs – Provide summary detail on various pilots at CDRH and associated with CfQ
-Regulatory paradigm – How is FDA rethinking the regulatory engagement
Watch this presentation, by Franciso Vicenty, the Case for Quality Manager of the FDA, here: https://www.greenlight.guru/webinar/fda-case-for-quality
Building a link between ectd and xevmpdQdossier B.V.
Describing the role of XEVMPD/ IDMP in context of the regulatory environment and explaining the link with information managed within the eCTD and under GMP.
After 10 years of eCTD the standard is fit for rejuvenation. Although eCTD has brought many benefits there is still significant room for improvement. This presentation covers different areas: continuous challenges associated with eCTD, Regulatory guidelines and eCTD viewing
Prioritizing Documentation for MDR Transition PlanningGreenlight Guru
This session will discuss the one year delay of the MDR date of application as well as some strategies to employ during the MDR Transition. In addition, some approaches for determining documents to prioritize for the transition will be discussed.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)Greenlight Guru
What should the medical device industry expect in 2018?
Great question.
From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals.
This presentation covers:
- Why you should expect it to be harder for devices to get to market and stay there in the EU
- How to avoid the mad dash to update ISO 13485 certification before the deadline
- Where the latest revision of ISO 14971 is and when to expect the next update
- About Health Canada and their MDSAP deadline
- Why companies are shifting from being compliance-focused to quality-focused
Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions
Current labs can greatly benefit from a digital transformation.
FAIR data principles are crucial in this process.
Laying a solid data governance foundation is an invaluable long-term move.
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Somos Expertos en Marketing Estratégico Agropecuario.Nos importan las personas. Tenemos grandes ideas. Todos somos parte de un equipo, encargado de encontrar la solución adecuada para nuestros clientes. No vivimos detrás de un título. No vivimos detrás de una descripción de trabajo. Compartimos una visión. Mostramos el camino. Superamos las barreras. Encontramos las respuestas. Entre sonidos y ruidos, creamos una sola voz.
Somos una suma de talentos y actitudes profesionales potenciados por claves de negocios adquiridas, transformadas en experiencias, habilidades e inteligencia estratégica, con el objetivo de impulsar el crecimiento mirando siempre a los ojos.
How To Deliver Step Changes in Manufacturing Operations with Predictive Insig...Bigfinite
How To Deliver Step Changes in Manufacturing Operations with Predictive Insights using AI/ML and Pharma 4.0 Principles at ManuPharma 2019 in Frankfurt, Germany by Toni Manzano
How to Prepare for the New EU In Vitro Diagnostics RegulationsGreenlight Guru
Agreement was reached on the eagerly awaited new EU In Vitro Diagnostic Regulations (IVDR) earlier this year.
The IVDR will significantly change the way IVDs bear the CE mark, and it will include a completely new risk-based classification system.
Now 80% of all IVDs will need to be certified by a notified body under the IVDR where as before, only 20% needed to under the IVD Directive.
The new IVDR is expected to be formally published in late 2016 or early 2017, and there will be a five-year transition period to be compliant.
Many forward thinking IVD companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
This presentation includes:
-Why the European regulations are changing
-What does the new regulation mean for IVD manufactures
-How to classify your IVD using the new risk-based classification system
-How to evaluate your existing clinical evidence to know if new studies will be needed to support your CE mark
-An overview of all the most significant changes brought by the IVDR
-What IVD manufactures can do to start preparing now
Watch the presentation here: https://www.greenlight.guru/webinar/eu-in-vitro-diagnostic-regulations-ivdr
How to Review, Cleanse, and Transform Clinical Data in Oracle InFormPerficient, Inc.
When it comes to clinical trials, the consequences of bad data can be severe. Research and development becomes complicated and lives can be put at risk. The need for clinical data to be clean is critical for comprehensive reporting and analysis, ultimately enabling safer drugs and devices to be brought to market faster.
During our 30-minute, no-nonsense webinar, we discussed why and how organizations can leverage Oracle Health Sciences Data Management Workbench (DMW) to revitalize the clinical trial data captured in Oracle Health Sciences InForm.
Minimize the Impact of E2B(R3) on Drug Safety Operations with Argus SafetyPerficient, Inc.
The electronic transmission of adverse event information to stakeholders, using the International Conference on Harmonization (ICH) E2B standard, is an essential component of global drug safety and pharmacovigilance operations.
E2B(R3), the latest version of the ISO ICSR standard, presents a number of challenges that need to be addressed before life sciences companies can implement the essential technology and processes required to perform day-to-day activities and comply with the new regulatory guidelines.
Our webinar delivered insight into the impact of the requirements on your drug safety business processes (e.g., CIOMS reporting, Line Listings, PSURS/DSURS, Signal Generation), as well as to how Oracle's Argus Safety can help you meet the E2B(R3) requirements.
PTC announces the availability of the latest release of PTC Windchill® produc...PTC
NEEDHAM, MA - September 17, 2013 - PTC (Nasdaq: PMTC) today announced the availability of the latest release of PTC Windchill® product lifecycle management (PLM) software. PTC Windchill 10.2 adds capabilities to help manufacturers improve productivity and streamline compliance with new government regulations.
PTC Expands Regulatory Compliance Capabilities, Broadens Support for Product Quality Processes, and Enhances Collaboration between Hardware and Software Development Teams
Latest release of PTC Windchill reduces effort needed to comply with new FDA and SEC regulations; enhances integration with PTC Integrity
PTC Expands Regulatory Compliance Capabilities, Broadens Support for Product Quality Processes, and Enhances Collaboration between Hardware and Software Development Teams
Latest release of PTC Windchill reduces effort needed to comply with new FDA and SEC regulations; enhances integration with PTC Integrity
PTC Expands Regulatory Compliance Capabilities, Broadens Support for Product Quality Processes, and Enhances Collaboration between Hardware and Software Development Teams
Latest release of PTC Windchill reduces effort needed to comply with new FDA and SEC regulations; enhances integration with PTC Integrity
Implementing a Global Unique Device Identification (UDI) Solution: Regional U...Greenlight Guru
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates.
This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
FDA's Case for Quality: What, Why, and How? Changing the Regulatory ParadigmGreenlight Guru
Top-quality medical devices help the FDA better protect and promote public health. And one of the top priorities for FDA's medical devices center is a focus on quality.
The FDA launched the Case for Quality in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders.
This program allows the FDA to recognize device manufacturers that are capable of consistently producing high-quality devices and continuously improving.
Greenlight Guru is partnering with FDA CDRH to help spread the word and promote the Case for Quality initiative and its benefits to the medical device industry. This is the first of four presentations, learn about the others at greenlight.guru.
Key points in this presentation:
-Learn about CfQ – What it is, why we are doing it, and how we are engaging
-Introduce pilot programs – Provide summary detail on various pilots at CDRH and associated with CfQ
-Regulatory paradigm – How is FDA rethinking the regulatory engagement
Watch this presentation, by Franciso Vicenty, the Case for Quality Manager of the FDA, here: https://www.greenlight.guru/webinar/fda-case-for-quality
Building a link between ectd and xevmpdQdossier B.V.
Describing the role of XEVMPD/ IDMP in context of the regulatory environment and explaining the link with information managed within the eCTD and under GMP.
After 10 years of eCTD the standard is fit for rejuvenation. Although eCTD has brought many benefits there is still significant room for improvement. This presentation covers different areas: continuous challenges associated with eCTD, Regulatory guidelines and eCTD viewing
Prioritizing Documentation for MDR Transition PlanningGreenlight Guru
This session will discuss the one year delay of the MDR date of application as well as some strategies to employ during the MDR Transition. In addition, some approaches for determining documents to prioritize for the transition will be discussed.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)Greenlight Guru
What should the medical device industry expect in 2018?
Great question.
From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals.
This presentation covers:
- Why you should expect it to be harder for devices to get to market and stay there in the EU
- How to avoid the mad dash to update ISO 13485 certification before the deadline
- Where the latest revision of ISO 14971 is and when to expect the next update
- About Health Canada and their MDSAP deadline
- Why companies are shifting from being compliance-focused to quality-focused
Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions
Current labs can greatly benefit from a digital transformation.
FAIR data principles are crucial in this process.
Laying a solid data governance foundation is an invaluable long-term move.
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Somos Expertos en Marketing Estratégico Agropecuario.Nos importan las personas. Tenemos grandes ideas. Todos somos parte de un equipo, encargado de encontrar la solución adecuada para nuestros clientes. No vivimos detrás de un título. No vivimos detrás de una descripción de trabajo. Compartimos una visión. Mostramos el camino. Superamos las barreras. Encontramos las respuestas. Entre sonidos y ruidos, creamos una sola voz.
Somos una suma de talentos y actitudes profesionales potenciados por claves de negocios adquiridas, transformadas en experiencias, habilidades e inteligencia estratégica, con el objetivo de impulsar el crecimiento mirando siempre a los ojos.
Es de vital importancia para la protección y la integración Mundial contra el
Nuevo Orden Mundial, El “CODEX ALIMENTARIUS!” y demás agendas luciferinas para el resto del mundo y los países en vías de desarrollo!!!....
Distrifood Interview - Enorme kans voor supers in vers-bewerktWouter de Heij
Meer over de toekomst van de supermarkt:
- http://wdeheij.blogspot.nl/2013/03/the-future-of-supermarkets-niks-geen.html
En waarom nieuwe conserveertechnologie het verschil gaat maken:
http://wdeheij.blogspot.nl/2013/03/houdbaarheid-en-mild-conserveren-een.html?q=supermarkt en dus chemie geen toekomst heeft:
http://www.foodlog.nl/artikel/chemische-conseveringsmiddelen/
Waarom RFEM de optimale rekensoftware is voor uw ingenieursJo Gijbels
De rekensoftware RFEM is t.o.v. andere rekensoftware:
1 Gebruiksvriendelijker
2 Produceert sneller resultaten
3 Maakt sneller een rapport van de berekening
4 Gemaakt met Duitse topkwaliteit en wereldwijd gebruikt
5 Lagere onderhoudskosten door vele licenties
6 Ondersteuning via Webinars, Social Media, Blogs
7 Heeft vele extra mogelijkheden t.o.v. andere rekensoftware
With over 20 years of success, Cinetransformer is a unique, world-class experiential mobile events & marketing company and a designer/manufacturer of specialty and custom vehicles.
Cinetransformer creates and operates mobile events of virtually any kind, engaging the senses like no other marketing medium can. The result? Powerful emotional connections and memorable experiences that generate audience excitement and buzz!.
"Convention of Security Presidential homage Zero"
Before the eminent risk of attacks terrorist and of death, against the person of the President or a leader political in the world; and the danger that implies the submission and delivery of power total in the hands of a single person, something as important as it is the representation of the President of the Republic or the nation and the insecure Social and policy that this represents...
Life is long, and so is our travel bucket list. We've got plenty of destinations on our agenda, but in addition to the "wheres," there are many activities we hope to take part in when we travel. Read on for 18 travel goals we think everyone should have on their list, from wandering through ancient ruins to speaking a foreign language.
Learn more in Upstart University course "Choosing Your Production Method" >> (http://bit.ly/2croGyL)
Aeroponics is an exciting plant production technique growing in popularity. However, it does have some less than favorable elements. Find out why clogging is such an issue in aeroponics, how it impacts labor, and how to find more information in this presentation.
PhillyCooke eCTD Submissions for Ad-PromoDale Cooke
This presentation was initially delivered at the NJ/NY RAPS chapter on November 19, 2015. It reviews the FDA guidance on providing ad-promo submissions in electronic and print formats, explains the complex nature of the guidance and its scope, and includes the latest from FDA on how the guidance is being implemented.
QMSR Harmonization - The Good the Bad and the UglyGreenlight Guru
Learn about the proposed QMSR rule, intended benefits of MDSAP for the regulatory authorities, benefits for the manufacturer, and similarities between ISO 13485 and FDA Regulations, and more!
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Watch the recording of this presentation here: https://bit.ly/3zTOpe4
Detailed description:
SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits.
In this webinar, you will learn:
• Regulatory overview of remote audits
• The technologies needed to support the audit process
• What types of inspections are possible with the use of these technologies
• How audits may look in the future
Presented by:
Daniel Buescher, Product Manager - Digital Solutions
The Future of Pharma- and Biopharmaceutical AuditsMilliporeSigma
Watch the recording of this presentation here: https://bit.ly/3zTOpe4
Detailed description:
SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits.
In this webinar, you will learn:
• Regulatory overview of remote audits
• The technologies needed to support the audit process
• What types of inspections are possible with the use of these technologies
• How audits may look in the future
Presented by:
Daniel Buescher, Product Manager - Digital Solutions
This webinar is focused on the current state of UDI regulations, the best approaches to medical device UDI Compliance in the cloud and how to gain business benefits by implementing KPIT's UDI Cloud Solution. This is a must-watch session for medical device companies who are preparing for UDI compliance or the ones who have already implemented however looking for a long-term solution.
DevOps vs GDPR: How to Comply and Stay AgileBen Saunders
A joint webinar between Contino and Delphix explaining how DevOps, Cloud and Data Virtualization can be used to accelerate application delivery, yet still allow organisations to remain GDPR compliant.
Qumas Collaboration to Innovation Quality QMS PIMS 2014GBX Summits
Qumas Collaboration to Innovation Quality QMS PIMS 2014
How Enterprise Quality Management can protect your customers, keep you compliant, and have a positive effect on your bottom line.
www.pims.gb.com
www.gbx.uk.com
The FDA’s 510(k) process for medical devices is doing a lot of rounds in the news lately. This includes the FDA Commissioner Dr. Scott Gottlieb’s announcement on the renovation to the 510(k) program and two new pilot programs initiated by FDA: the Quality in 510(k) (“Quik”) Review and the Special 510(k) pilot programs. In this week’s blog, we are shedding some light on what you should expect from the Quik 510(k) and the Special 510(k) programs...
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
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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.
2. 2
The
Industry
is
shiAing..
10/6/16
M1
ini*a*ve
The
updated
2253
dra7
guidelines
for
AdPromo
submissions
is
an
example
of
the
FDA
encouraging
sponsors
to
adopt
prac*ces
that
will
benefit
industry
as
a
whole.
A
step
in
the
right
direc*on
SubmiJng
video,
audio
and
images
as
DVD
media
by
mail
in
an
age
of
such
impressive
compu*ng
power
at
low
cost
is
much
too
tedious
for
sponsor
and
Agency.
Moderniza*on
By
upda*ng
the
specifica*on,
upda*ng
the
technology,
and
encouraging
a
rethinking
of
internal
processes,
the
FDA
is
moving
toward
a
more
modern
business
reality.
A
“MORE
MODERN
BUSINESS”
REALITY
FOR
2253’S
..are
you
shiAing
with
it?
3. 3
10/6/16
Quan*fying
the
shi7
in
2253
submissions
from
paper
to
eCTD
Since
the
Office
of
Prescrip*on
Drug
Promo*on
(OPDP)
started
accep*ng
electronic
submissions
in
June
2015
through
the
middle
of
February
2016
(in
the
first
8.5
months),
it
has
received
400
AdPromo
submissions
containing
more
than
1,000
promo*onal
pieces*.
Since
then
(in
the
3
months
that
followed)
these
numbers
have
doubled**.
As
of
now
(end
of
April
2016),
approximately
a
couple
dozen
companies
have
already
made
the
transi*on**.
**Source: Confidential to Pyxa Solutions LLC
** NOTE: The “couple dozen companies” is inclusive of partnerships and subsidiaries.
*Source: presentation from Roberta Szydlo from the ODPD during the DIA Marketing Pharmaceuticals 2016 conference
4. 4
10/6/16
Why
some
Companies
are
deciding
to
shi7
to
eCTD
before
the
dra7
guidance
is
final
and
before
the
mandated
deadline
Proac*vely
shiAing
from
paper
to
eCTD
for
2253
Submissions
Strategic
Considera*ons
Opera*onal
Considera*ons
FDA
Considera*ons
Compliance
Considera*ons
5. 5
10/6/16
Strategic
Considera*ons
Why
companies
are
shi7ing
now…
Reviewers
like
it!
An
overwhelming
#
of
reviewers
in
OPDP
that
review
2253’s
and
associated
promo*onal
materials
like
to
receive
it
in
eCTD
format
Improves
manageability
The
granular
format
of
eCTD
AdPromo
submissions
improves
manageability
and
helps
companies
more
clearly
and
succinctly
organize
their
informa*on
Open
Dialogue
w/
Agency
The
agency
is
seeking
open
dialogue
and
is
providing
some
leeway
for
companies.
They
want
companies
to
no*fy
them
of
formats
that
fall
outside
the
guidance
Influence
Change
Commen*ng
period
is
over,
however
FDA
is
s*ll
taking
comments
on
board
and
may
update
the
guidance
with
clearer
statements
to
remove
ambiguity
Save
*me
and
effort
The
ability
to
submit
grouped
submissions
will
save
*me
and
effort
by
allowing
one
submission
to
mul*ple
applica*ons
that
share
the
same
informa*on.
Beher
insight!
With
AdPromo
being
eCTD,
companies
can
easily
link
to
the
various
applica*ons
in
order
to
have
beher
oversight
and
improved
decision
making.
6. 6
10/6/16
Opera*onal
Considera*ons
Why
companies
are
shi7ing
now…
Submit
high
volume
2253s
Opportunity
for
companies
to
develop
streamlined
processes
to
submit
high
volume
2253s
electronically
over
the
electronic
submission
gateway
(ESG)
Lifecycle
Opera*ons
Take
advantage
of
the
convenience
and
visibility
afforded
when
performing
Lifecycle
opera*ons
in
eCTD.
(e.g.
If
part
of
the
original
submission
is
rejected,
the
sponsor
may
file
an
amendment
with
only
the
missing
or
rejected
component,
instead
of
submiJng
the
en*re
2253)
Reduced
Manual
Effort
Preparing
Ad
Promo
submissions
would
not
require
as
much
manual
effort.
There
would
be
no
coun*ng
of
hard
paper
copies
and
burning
media
to
discs.
Faster
Publishing-‐Review
Publishing
is
faster
and
cheaper.
Submission
through
the
gateway
allows
reviewers
to
assess
submission
rapidly.
This
process
is
faster
then
Paper.
7. 7
10/6/16
FDA
Considera*ons
Why
companies
are
shi7ing
now…
Alignment
with
Submission
Process
Alignment with submission process for
other submissions in CDER
Improve
processing
efficiency
Due to extensive metadata collection
allows submission information to be
automatically populated into tracking
software to improve processing
efficiency
BeVer
Insights
Electronic search and filtering
capabilities. FDA has more insight, the
FDA can now do searches of the
submission to extract the information
they need.
Faster
and
More
Efficient
Faster and more efficient delivery to the
reviewer - With the new Module 1, the
ability to accept Form 2253
submissions in eCTD format via the
ESG
Ability
to
receive
high
volume
2253’s
Opportunity for streamlined processes
and ability to receive high volume
2253s from companies electronically
over the electronic submission
gateway (ESG)
Availability
for
All
Reviewers
Submission is available for all staff to
see, therefore secondary review and
consultation of other offices is more
efficient
Product
Applica*on
Info
Quickly
Available
Product application information is in
one location, will be quickly available
for all reviewers as needed.
Ability to receive eCTD 2253 and
non-2253 submissions over same
electronic submission gateway (ESG)
Receive
all
Submissions
through
ESG
8. 8
10/6/16
Compliance
Requirements:
FDA
Guidance
&
Landscape
Indicated
by
the
use
of
the
words
MUST
and
REQUIRED,
this
document
is
NOT
subject
to
the
usual
restricAons
in
FDA’s
good
guidance
pracAce
(GCP)
regulaAons
FDA
is
not
including
this
standard
language
in
this
guidance
because
it
is
not
an
accurate
descrip*on
of
all
the
effects
of
this
guidance.
This
guidance
contains
both
binding
and
non-‐
binding
provisions.
Insofar
as
this
guidance
specifies
the
format
for
electronic
submissions
pursuant
to
sec*on
745A
of
the
FD&C
Act
it
will
have
binding
effect.
FDA
Guidance's
ordinarily
contain
standard
language
explaining
that
guidance's
should
be
reviewed
only
as
recommenda*ons
unless
specific
regulatory
or
statutory
requirements
are
cited.
In
sec*on
745A
of
the
FD&C
Act,
congress
granted
explicit
statutory
authoriza*on
to
FDA
to
specify
in
guidance
the
format
for
the
electronic
submissions
required
under
that
sec*on.
9. 9
10/6/16
Compliance
Requirements:
Upcoming
Requirements
In
OPDP’s
draL
guidance,
FDA
is
proposing
pharmaceuAcal
companies
submit
promoAonal
materials
for
human
prescripAon
drugs
to
OPDP
using
its
electronic
common
technical
document
(eCTD)
format.
OPDP
has
tradi*onally
required
companies
to
submit
promo*onal
materials
to
it
for
review
using
Form
FDA
2253—a
paper-‐
based
form.
FDA
explains
"As
of
that
date,
paper
hard
copies
will
no
longer
be
accepted
for
such
submissions”.
In
the
mean*me,
firms
are
"strongly
encouraged"
by
FDA
to
begin
submigng
promo*onal
materials
using
the
eCTD
immediately.
This
requirement
is
changing,
eCTD
submissions
for
2253
will
be
required
two
years
aAer
the
guidance
document
is
finalized.
10. 10
10/6/16
Compliance
Requirements:
Risk
of
Non-‐Compliance
FDA
explains
"As
of
that
date,
paper
hard
copies
will
no
longer
be
accepted
for
such
submissions”.
Not
a
point
for
nego*a*on
with
the
FDA.
Companies
who
do
not
comply
with
the
upcoming
eCTD
requirements
for
submiJng
their
2253s
will
find
themselves
in
a
posi*on
where
their
submissions
will
be
rejected
or
returned
with
comments
(as
would
any
submission
made
to
the
FDA
that
does
not
follow
the
regula*ons).
This
will
result
in
delays
with
FDA
review
and
therefore
use
of
the
materials
in
the
field.
11. 11
10/6/16
Value
Proposi*on
Once
the
guidance
is
final,
there
will
be
NO
other
op*on
but
to
implement
the
eCTD
process
Advance
planning
allows
all
risks
to
be
mi*gated
and
resources
to
be
addressed
prior
to
required
“go-‐
live”
date
Good
Standing:
Following
FDA’s
strong
recommenda*on
to
begin
submiJng
promo*onal
materials
using
the
eCTD
immediately
Documents
available,
easily
accessible,
traceable
and
reportable
(throughout
the
lifecycle)
Preparing for and implementing (pilot or full go-live) a
2253 eCTD process before it is mandated by FDA
Implemen*ng
the
eCTD
Process
in
advance
will
ensure
the
process
is
implemented
effec*vely
and
efficiently
prior
to
mandated
deadline
12. 12
10/6/16
Risks
that
can
be
avoided
Vendors
not
providing
materials
in
the
correct
format
–
Regulatory
can
take
this
on
Mis-‐
management
of
life
cycling
of
the
pieces
(and
maintenance
of
lifecycle)
Poor
*meline
management
to
ensure
pieces
are
ready
for
use
Under
es*ma*on
of
resources
/
skills
when
managing
electronic
submissions
As
part
of
the
end-‐to-‐end
eCTD
process
ensure
measures
are
put
in
place
to
manage
revised
pieces
or
discon*nua*on
of
a
piece.
As
part
of
the
end-‐to-‐end
eCTD
process
ensure
format
and
standards
for
promo*onal
pieces
are
established
and
communicated
to
vendors
–
HAVE
A
BACK
UP
-‐
if
you
can
not
get
vendors
to
take
this
on
effec*vely
and
efficiently.
As
part
of
the
end-‐to-‐end
eCTD
process
ensure
*melines
are
clearly
communicated
to
all
func*ons
involved
in
the
process
and
the
turn-‐around
*me
for
“re-‐work”
is
understood
so
that
submissions
are
not
delayed
.
As
part
of
the
end-‐to-‐end
eCTD
process
ensure
resources
(people
and
tools)
are
in
place
to
accommodate
the
required
changes
from
paper
to
eCTD.
ConsideraAon:
Eliminate
large
scale
risk
by
implemenAng
a
small
scale
pilot
(for
one
or
more
“not
so
acAve/criAcal”
products
to
ensure
the
process
is
streamlined
and
miAgaAon
plans
are
considered
prior
to
full
scale
implementaAon
13. 13
10/6/16
Industry
Best
Prac*ce
–
How
Pyxa
Can
Support
✓
✓
Establish
a
vendor
guide
to
ensure
all
Vendors
providing
promo*onal
materials
are
following
the
required
format
/
standards
(ONLY
if
Vendors
will
be
managing
this
for
you)
Incorporate
language
in
Vendor
agreements
to
ensure
vendors
are
contractually
obligated
to
abide
by
the
templates
/
standards
guide
provided
to
them
(embed
in
the
process)
-‐
(ONLY
if
Vendors
will
be
managing
this
for
you)
✓
Ensure
Regulatory
QC
performed
on
materials
received
from
Commercial
is
inclusive
of
checks
for
submission
readiness
(built
within
a
checklist
to
ensure
consistency
with
each
review)
✓ Establish
internal
standards
(e.g.
leaf
*tles
and
file
names;
placement
loca*on
etc.)
–
as
applicable
✓ Establish
a
lifecycle
management
approach
to
maintaining
promo*onal
pieces
Establish
an
end-‐to-‐end
cross-‐funcAonal
2253
eCTD
process
to
ensure
consistent
and
efficient
transiAon
to
meet
the
upcoming
requirements
✓ Implement
a
pilot
(Test
Submission)
to
fine-‐tune
processes
before
full
implementa*on
✓
Determine
if
Vendors
will
provide
promo*onal
materials
in
the
required
format
or
if
Regulatory
Opera*ons
will
re-‐format
pieces
to
the
necessary
standards