The updated whitepaper on ISO IDMP - learn what you need to know during this transition. And how Cunesoft's cune-IDMP can help your organization: https://cunesoft.com/en/products/idmp/
The presentation complemented a 60 minutes webinar on ISO IDMP provided by Cunesoft in May 2015. Benefits of a regulatory master data management system are being analyzed. The entire webinar was recorded. The latest information on IDMP can be accessed on our website: https://www.phlexglobal.com/idmp
The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57.
The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to use a "set of common global standards for data elements, formats, and terminologies for the unique identification and exchange of information on medicines."
Complying with IDMP represents a massive increase in scope and complexity, in addition to previous iterations. The EMA has divided the timeline for meeting the new requirements into several phases, making this a multi-year project.
Perficient’s expert in IDMP and the EudraVigilance Medicinal Product Dictionary, Mark Thackstone, reviewed everything you need to know in order to successfully comply with IDMP by the fast-approaching deadline:
-Latest information and timelines
-Steps to take meet regulatory requirements
-Challenges and factors to consider
-What IDMP means in the real world of a typical pharma company
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
Your next RIM solution - 3 key considerations for your moveV E R A
Considering to move to a new Regulatory Information Management system? Have a look at our pick of the 3 key considerations while moving to a new RIM system.
If you wish to receive more information - write us at info@cunesoft.com or visit our page https://cunesoft.com/en/products/rim/
The presentation complemented a 60 minutes webinar on ISO IDMP provided by Cunesoft in May 2015. Benefits of a regulatory master data management system are being analyzed. The entire webinar was recorded. The latest information on IDMP can be accessed on our website: https://www.phlexglobal.com/idmp
The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57.
The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to use a "set of common global standards for data elements, formats, and terminologies for the unique identification and exchange of information on medicines."
Complying with IDMP represents a massive increase in scope and complexity, in addition to previous iterations. The EMA has divided the timeline for meeting the new requirements into several phases, making this a multi-year project.
Perficient’s expert in IDMP and the EudraVigilance Medicinal Product Dictionary, Mark Thackstone, reviewed everything you need to know in order to successfully comply with IDMP by the fast-approaching deadline:
-Latest information and timelines
-Steps to take meet regulatory requirements
-Challenges and factors to consider
-What IDMP means in the real world of a typical pharma company
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
Your next RIM solution - 3 key considerations for your moveV E R A
Considering to move to a new Regulatory Information Management system? Have a look at our pick of the 3 key considerations while moving to a new RIM system.
If you wish to receive more information - write us at info@cunesoft.com or visit our page https://cunesoft.com/en/products/rim/
Regulatory Information Management - Everybody deserves the TruthV E R A
Learn why RIM is becoming software no.1 to life science companies and how cune-RIM can help you with increasing number of requirements from regulatory authorities, increasing submission complexity and burden, increasing costs and inefficient work. You grew out of spreadsheets long time ago - it's now time for Regulatory Information Management (RIM)! Watch our webinar recording here: https://cunesoft.com/en/downloads/webinar-library/ or visit cune-RIM page directly: https://cunesoft.com/en/products/rim/
Presented by Antoinette Azevedo, e-SubmissionsSolutions.com at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
Life sciences regulatory authorities in North America, Europe and Japan have been developing standards for drug and biologic registration submissions in electronic format for over ten years. The current version of the format—electronic Common Technical Document (eCTD)—has been the recommended format since 2005 and is on the way to becoming mandatory. This presentation will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review.
A California biotech submitted an eCTD to the US FDA in summer 2005. This company used commercial-off-the-shelf publishing software, experienced consultants, and in-house staff to compile this eCTD. This drug was the biotechs first candidate for commercialization. The biotech was partnered with big Pharma to assist with sales and marketing after the FDA authorized the drug for marketing. The biotech hired a sales force of nearly 200 in anticipation of FDA approval.
The FDA issued a refuse-to-file on this eCTD in fall 2005, due to problems with the PDF files and navigability of the content of the submission. The company’s market capitalization dropped 50% overnight. The company had to recompile the submission, by reworking the source files and rebuilding the XML backbone. The new version of the eCTD was resubmitted in early 2006. The FDA accepted the resubmission for review.
However, in May 2006 the FDA issued an approvable letter, that meant the drug could be approved in the future if certain conditions were met (meaning yet another delay in being able to market the product, plus additional expense to conduct further clinical studies). In June, 2006, the big pharma company terminated the partnership with the biotech. In July 2006, the biotech laid off their sales force. In August, 2006, the biotech laid off 100 more employees. In September 2006, the biotech had a meeting with FDA to discuss what additional studies and analysis was needed. Finally, in January 2007, the biotech announced plans to resubmit its NDA by end of second quarter 2007.
This presentation will describe:
* Regulatory and business drivers behind the eCTD format
* Technical components of an eCTD
* Practical implications of collecting documents and data over the discovery, development, application review, and post-marketing lifecycle phases of a drug or biological product
* Global picture for adoption of the eCTD format
* Future direction for the eCTD format
* Role of electronic document management in the eCTD lifecycle
* Top 12 Issues FDA Has with eCTD and how to avoid them
* Preparing submission-ready source documents and data for submission in eCTD
* Whether to purchase an eCTD publishing system or to outsource.
* How to prepare for the technical challenges of eCTD
get to know how to manage your regulatory information better with Cunesoft. cune-RIM is designed by industry's request - easy to use, reliable, Cunesoft. The brand we trust!
https://cunesoft.com/en/products/rim/
After adoption and success of E2B R2 for almost a decade finally change was brought to tear down and bring some more updates to the existing ICSR Elements Design.
Getting IDMP Ready via Modern Product Data ManagementCognizant
For life sciences and pharma companies, compliance with the identification of medicinal products (IDMP) mandate is best achieved by building on an existing IDMP-compliant data management platform that can integrate all product master data.
Regulatory Information Management - Everybody deserves the TruthV E R A
Learn why RIM is becoming software no.1 to life science companies and how cune-RIM can help you with increasing number of requirements from regulatory authorities, increasing submission complexity and burden, increasing costs and inefficient work. You grew out of spreadsheets long time ago - it's now time for Regulatory Information Management (RIM)! Watch our webinar recording here: https://cunesoft.com/en/downloads/webinar-library/ or visit cune-RIM page directly: https://cunesoft.com/en/products/rim/
Presented by Antoinette Azevedo, e-SubmissionsSolutions.com at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
Life sciences regulatory authorities in North America, Europe and Japan have been developing standards for drug and biologic registration submissions in electronic format for over ten years. The current version of the format—electronic Common Technical Document (eCTD)—has been the recommended format since 2005 and is on the way to becoming mandatory. This presentation will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review.
A California biotech submitted an eCTD to the US FDA in summer 2005. This company used commercial-off-the-shelf publishing software, experienced consultants, and in-house staff to compile this eCTD. This drug was the biotechs first candidate for commercialization. The biotech was partnered with big Pharma to assist with sales and marketing after the FDA authorized the drug for marketing. The biotech hired a sales force of nearly 200 in anticipation of FDA approval.
The FDA issued a refuse-to-file on this eCTD in fall 2005, due to problems with the PDF files and navigability of the content of the submission. The company’s market capitalization dropped 50% overnight. The company had to recompile the submission, by reworking the source files and rebuilding the XML backbone. The new version of the eCTD was resubmitted in early 2006. The FDA accepted the resubmission for review.
However, in May 2006 the FDA issued an approvable letter, that meant the drug could be approved in the future if certain conditions were met (meaning yet another delay in being able to market the product, plus additional expense to conduct further clinical studies). In June, 2006, the big pharma company terminated the partnership with the biotech. In July 2006, the biotech laid off their sales force. In August, 2006, the biotech laid off 100 more employees. In September 2006, the biotech had a meeting with FDA to discuss what additional studies and analysis was needed. Finally, in January 2007, the biotech announced plans to resubmit its NDA by end of second quarter 2007.
This presentation will describe:
* Regulatory and business drivers behind the eCTD format
* Technical components of an eCTD
* Practical implications of collecting documents and data over the discovery, development, application review, and post-marketing lifecycle phases of a drug or biological product
* Global picture for adoption of the eCTD format
* Future direction for the eCTD format
* Role of electronic document management in the eCTD lifecycle
* Top 12 Issues FDA Has with eCTD and how to avoid them
* Preparing submission-ready source documents and data for submission in eCTD
* Whether to purchase an eCTD publishing system or to outsource.
* How to prepare for the technical challenges of eCTD
get to know how to manage your regulatory information better with Cunesoft. cune-RIM is designed by industry's request - easy to use, reliable, Cunesoft. The brand we trust!
https://cunesoft.com/en/products/rim/
After adoption and success of E2B R2 for almost a decade finally change was brought to tear down and bring some more updates to the existing ICSR Elements Design.
Getting IDMP Ready via Modern Product Data ManagementCognizant
For life sciences and pharma companies, compliance with the identification of medicinal products (IDMP) mandate is best achieved by building on an existing IDMP-compliant data management platform that can integrate all product master data.
IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...Torben Haagh
ISO IDMP will be mandatory from July 1st 2016 and it will make a fundamental impact on the way the pharmaceutical industry is required to collect, manage and submit relevant data. Now is the last call for all marketing authorisation holders to (re)think their data submission policies and processes to make sure you close your IDMP implementation gaps in the next 12 month and have a clear vision of the next challenges lying ahead!
Don’t miss out on the opportunity to get your questions answered, to benchmark the stage of your preparation, to initiate partnerships and to take an active part in designing the RIM’s community future agenda! Join us this summer in Berlin and gain valuable, practical information:
# Learn how to assess and analyse data requirements for the IDMP standards by discussing possible interpretations with our expert from regulatory bodies on-site!
# Benchmark your own IDPM Implementation process with peers from both big and mid-size pharma
# Share insights how the IDMP standards are changing the interactions between IT-Systems, company departments, contract manufacturers and regulatory agencies
# Discuss and compare with your peers experiences with vendors and solution providers offering help to achieve your IDMP implementation goals!
For more information visit our website: http://bit.ly/EventWebsite
If you would like to be part of the conference, you can register now here: http://bit.ly/Register-Event
Rpm to transform healthcare services venkat k - mediumusmsystem
New-age theories such as the Internet of Medical Things (IoMT), Artificial Intelligence (AI), and Big Data analytics are starting up new cases for remote patient monitoring (RPM).
Market Research Reports, Inc. has announced the addition of “The Mobile Healthcare (mHealth) Bible: 2015 - 2020” research report to their offering. See more at- http://mrr.cm/ZuA
The word Lean comes from the ability to achieve more with less resource, by continuous elimination of waste. The lean manufacturing process is a comprehensive way to reduce waste of all types. It could be a waste of time or material, it is still waste.
Lean manufacturing is a manufacturing strategy that seeks to produce a high level of throughput with a minimum of inventory e.g. suppliers deliver small lots on a daily basis, and machines are not necessarily run at full capacity. One of the primary focuses of lean manufacturing is to eliminate waste; that is, anything that does not add value to the final product gets eliminated. A second major focus is to empower workers, and make production decisions at the lowest level possible.
ISO standards for identification of medical products (IDMP) are set to require pharmaceuticals companies to comply with medicinal identification standards. We explain how to get started and navigate a smooth IDMP transition.
Enterprise Firewall Market - Outlook (2017-21)ResearchFox
Businesses today, irrespective of their size are growing cautious and more serious about the data related threats or attacks. This has prompted them to implement firewall solutions that can negate any kind of network related attacks. Hence, the market for enterprise firewall solutions is expected to surge forward in the coming years. The market for Enterprise Firewall solution is catching up and this report provides deep insights on how the market is expected to fare in the next five years. It also presents interpretative and easy-to-understand facts on how the current Enterprise Firewall market is segmented based on the deployment type, the major verticals that have been implementing these, the end-user group of these firewall solutions and based on the geographic regions
Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory CompliancePerficient, Inc.
IDMP (Identification of Medicinal Products), which will soon be mandated by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), will enable stakeholders to obtain a comprehensive view of each individual product (e.g., ingredients, marketing and medicinal information, contacts), based on unique codes.
While the journey towards IDMP compliance can be incredibly challenging, industry-specific knowledge and systems play an integral role in meeting the new requirements.
In our webinar, we discussed how the Oracle IDMP Enterprise Foundation Suite can help you be ready in time.
Getting Started in Big Data-Fueled E-Commercejradisson
Presentation to Outdoor Industry at the European Outdoor Summit, 17 October 2013 in Stockholm.
Abstract from the event program:
"Everywhere you turn these days there is a story on the promise of Big Data. Fact is, there is a wave of innovation in Big Data technologies under way that will affect our business. But are we really having a clear idea on how to use it to create new business?
Here in Europe, we're selling against Amazon, Google and other algorithmic commpetitors using spreadsheets and other manual methods. Nobody is talking about concrete use-cases or generating any new business value from Big Data. Until now.... Listen to Jason Radisson, in charge of a complex and forward looking initiative from Sport Scheck to grasp the huge untapped potential of tomorrow's e-commerce consumers."
Take a quick look at the trends that will transform and rule Enterprise Resource Planning Software all through 2023 and may be beyond.
Table of content:
- What is ERP?
- How & Why is it evolving?
- ERP Trends for 2023
- ERP Stats and Growth
- Projections in 2023
- Conclusion
Read the presentation to get deeper insights.
Similar to The IDMP Challenge - Whitepaper on ISO IDMP by Cunesoft (20)
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.
ABDOMINAL TRAUMA in pediatrics part one.drhasanrajab
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
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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