How to Create Controlled Vocabularies for Competitive IntelligenceIntelCollab.com
The document describes an upcoming webinar on creating controlled vocabularies for competitive intelligence. The webinar will feature two speakers, Justin Soles and Lisa Coady, and will cover topics such as what a controlled vocabulary is, how it can help competitive intelligence work, and best practices for developing one. Attendees are encouraged to ask questions during the webinar.
What is Lean Authoring?
Why Lean Authoring?
Advantages of Lean Authoring
How to apply Lean Authoring
Lean Authoring General
Lean Authoring Module 3
Real life examples
The document discusses challenges related to IDMP compliance, including information stored across different systems and formats, duplication of data, lack of integration between processes. It then outlines potential solutions to these challenges like entity extraction to transform unstructured data, master data management to connect siloed structured data, reference data management to handle semantic issues, and linked data approaches to publish structured, interconnected data using common standards and identifiers. The value of these solutions beyond mere compliance is also discussed in terms of transparency, risk reduction, efficiency and collaboration.
ICIC 2014 Semantic Integration of Pharmaceutical Content : Blueprint and Exam...Dr. Haxel Consult
This document provides an overview of TEMIS' Luxid Navigator software for semantic integration and analysis of pharmaceutical content. It discusses how Luxid Navigator aggregates content from multiple sources, extracts and normalizes key information, and presents it in an intuitive web application. Examples are provided of modules for experts/publications, clinical trials, news and adverse events. The goals of Luxid Navigator are to streamline competitive intelligence efforts and provide a holistic view of information on topics of interest.
ICIC 2014 Finding Answers in the Data – The Future Role of Text and Data Mini...Dr. Haxel Consult
Vast amounts of new information and data are generated every day through scientific research. More and more of this data is stored in rapidly growing, but siloed databases, creating “Big Data” challenges. New technologies such as text and data mining make it possible to efficiently search and improve knowledge by applying analytics across these data sources. Research-intensive companies in the pharmaceutical and chemical industry are exploring the use of text and data mining (TDM) techniques to glean new insights from patents, clinical data, scientific literature, and other data sources. These insights are seen as critical to accelerating the process of drug and product discovery. As these researchers leverage TDM techniques, obtaining easy, centralized access to TDM-ready full-text content from multiple publishers becomes more and more important. What will be the future role of TDM in 2014 and beyond? What are the major TDM trends and what solutions are companies looking for to accelerate their R&D; efforts? Based on the experience gathered in a text and data mining pilot program successfully run by RightsDirect’s parent company Copyright Clearance Center (CCC) in 2013, RightsDirect’s General Manager Kim Zwollo will give an overview of current market needs, options and trends in Text and Data Mining. Using CCC’s TDM solution as an example, the presentation outlines critical success factors in technology and business models that need to be part of a comprehensive approach to text and data mining.
Maintenance organization roles for enabling Operational ExcellenceMarcelo Costa
This document discusses the roles of maintenance in enabling operational excellence at pharmaceutical companies. It outlines how adopting a total productive maintenance (TPM) approach and focusing on planned maintenance, autonomous maintenance, and focused improvement can help reduce downtime and costs. Some key achievements discussed include implementing OEE metrics, developing energy management programs, and improving maintenance key performance indicators over time through the TPM approach. Challenges that can arise include lack of data accuracy, weak root cause analysis practices, and ensuring maintenance remains focused on business results and continuous improvement.
Turacoz is an ISO certified medical writing, training and consultancy company that works with medical device, pharmaceutical and biotech companies. It provides a range of services including regulatory affairs support, scientific communications, medical education and commercial/marketing solutions. Turacoz has over 100 employees across several international offices and has worked with over 35 industry clients and 82 research institutes globally. It aims to create sustainable business through high quality, on-time project delivery and a focus on client satisfaction.
This document provides information about four pre-conference workshops at the 7th DIA China Annual Meeting from May 24-27, 2015 in Shanghai, China. The workshops cover topics including essential biostatistics concepts, completing CDISC-compliant CRF annotation, exploring medical communications services, and using lean approaches for authoring regulatory documents. Each half-day or full-day workshop includes sessions on the workshop topic led by industry experts and provides training and discussion for clinical research professionals.
How to Create Controlled Vocabularies for Competitive IntelligenceIntelCollab.com
The document describes an upcoming webinar on creating controlled vocabularies for competitive intelligence. The webinar will feature two speakers, Justin Soles and Lisa Coady, and will cover topics such as what a controlled vocabulary is, how it can help competitive intelligence work, and best practices for developing one. Attendees are encouraged to ask questions during the webinar.
What is Lean Authoring?
Why Lean Authoring?
Advantages of Lean Authoring
How to apply Lean Authoring
Lean Authoring General
Lean Authoring Module 3
Real life examples
The document discusses challenges related to IDMP compliance, including information stored across different systems and formats, duplication of data, lack of integration between processes. It then outlines potential solutions to these challenges like entity extraction to transform unstructured data, master data management to connect siloed structured data, reference data management to handle semantic issues, and linked data approaches to publish structured, interconnected data using common standards and identifiers. The value of these solutions beyond mere compliance is also discussed in terms of transparency, risk reduction, efficiency and collaboration.
ICIC 2014 Semantic Integration of Pharmaceutical Content : Blueprint and Exam...Dr. Haxel Consult
This document provides an overview of TEMIS' Luxid Navigator software for semantic integration and analysis of pharmaceutical content. It discusses how Luxid Navigator aggregates content from multiple sources, extracts and normalizes key information, and presents it in an intuitive web application. Examples are provided of modules for experts/publications, clinical trials, news and adverse events. The goals of Luxid Navigator are to streamline competitive intelligence efforts and provide a holistic view of information on topics of interest.
ICIC 2014 Finding Answers in the Data – The Future Role of Text and Data Mini...Dr. Haxel Consult
Vast amounts of new information and data are generated every day through scientific research. More and more of this data is stored in rapidly growing, but siloed databases, creating “Big Data” challenges. New technologies such as text and data mining make it possible to efficiently search and improve knowledge by applying analytics across these data sources. Research-intensive companies in the pharmaceutical and chemical industry are exploring the use of text and data mining (TDM) techniques to glean new insights from patents, clinical data, scientific literature, and other data sources. These insights are seen as critical to accelerating the process of drug and product discovery. As these researchers leverage TDM techniques, obtaining easy, centralized access to TDM-ready full-text content from multiple publishers becomes more and more important. What will be the future role of TDM in 2014 and beyond? What are the major TDM trends and what solutions are companies looking for to accelerate their R&D; efforts? Based on the experience gathered in a text and data mining pilot program successfully run by RightsDirect’s parent company Copyright Clearance Center (CCC) in 2013, RightsDirect’s General Manager Kim Zwollo will give an overview of current market needs, options and trends in Text and Data Mining. Using CCC’s TDM solution as an example, the presentation outlines critical success factors in technology and business models that need to be part of a comprehensive approach to text and data mining.
Maintenance organization roles for enabling Operational ExcellenceMarcelo Costa
This document discusses the roles of maintenance in enabling operational excellence at pharmaceutical companies. It outlines how adopting a total productive maintenance (TPM) approach and focusing on planned maintenance, autonomous maintenance, and focused improvement can help reduce downtime and costs. Some key achievements discussed include implementing OEE metrics, developing energy management programs, and improving maintenance key performance indicators over time through the TPM approach. Challenges that can arise include lack of data accuracy, weak root cause analysis practices, and ensuring maintenance remains focused on business results and continuous improvement.
Turacoz is an ISO certified medical writing, training and consultancy company that works with medical device, pharmaceutical and biotech companies. It provides a range of services including regulatory affairs support, scientific communications, medical education and commercial/marketing solutions. Turacoz has over 100 employees across several international offices and has worked with over 35 industry clients and 82 research institutes globally. It aims to create sustainable business through high quality, on-time project delivery and a focus on client satisfaction.
This document provides information about four pre-conference workshops at the 7th DIA China Annual Meeting from May 24-27, 2015 in Shanghai, China. The workshops cover topics including essential biostatistics concepts, completing CDISC-compliant CRF annotation, exploring medical communications services, and using lean approaches for authoring regulatory documents. Each half-day or full-day workshop includes sessions on the workshop topic led by industry experts and provides training and discussion for clinical research professionals.
Clinical data transparency - EMA Policy 0070Qdossier B.V.
This document provides an overview of EMA Policy 0070 on the publication of clinical data for medicinal products. It discusses the redaction of personal protected data and commercially confidential information from clinical reports. It also outlines the technical requirements and submissions process for proposed and final redaction packages.
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
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
Practical XEVMPD experience; once upon a time there was a perfectly clean dat...Qdossier B.V.
This document discusses challenges with inconsistent drug product data across different databases, regions, and disciplines. It notes inconsistencies in substance naming, active ingredients listed as excipients, and differences in listed excipients between countries for the same product. Maintaining consistent data in the XEVMPD format is challenging due to issues like using controlled vocabularies versus SmPC data and different MA numbers used across countries. Lessons learned include that inconsistencies across systems and SmPCs become visible when consolidating data, and defining consistent metadata elements and values across disciplines is important to achieve consistent records.
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.
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
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- 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
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
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.
Clinical data transparency - EMA Policy 0070Qdossier B.V.
This document provides an overview of EMA Policy 0070 on the publication of clinical data for medicinal products. It discusses the redaction of personal protected data and commercially confidential information from clinical reports. It also outlines the technical requirements and submissions process for proposed and final redaction packages.
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
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
Practical XEVMPD experience; once upon a time there was a perfectly clean dat...Qdossier B.V.
This document discusses challenges with inconsistent drug product data across different databases, regions, and disciplines. It notes inconsistencies in substance naming, active ingredients listed as excipients, and differences in listed excipients between countries for the same product. Maintaining consistent data in the XEVMPD format is challenging due to issues like using controlled vocabularies versus SmPC data and different MA numbers used across countries. Lessons learned include that inconsistencies across systems and SmPCs become visible when consolidating data, and defining consistent metadata elements and values across disciplines is important to achieve consistent records.
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.
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
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- 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
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
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.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the 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 lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
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. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Mastering Controlled Vocabularies (CVs) to faciliate succesful Regulatory Information Management (RIM)
1. Mastering Controlled Vocabularies to
facilitate successful Regulatory
Information Management
Michiel Stam
Regulatory Operations Consultant
Qdossier B.V.
2. Agenda
Introduction RIM & Controlled
Vocabularies (CVs)
Controlled Vocabulary Challenges
Context of Use
Mapping terminology
Mastering Vocabularies (example)
Developing a CV or Taxonomy
Conclusions
23/05/2014 Mastering CVs to facilitate sucesssful RIM 2
4. Regulatory Information Management
“the collection and management of information from one
or more sources…
…and the distribution of that information to one or more
1
audiences
23/05/2014 Mastering CVs to facilitate sucesssful RIM 4
5. Controlled Vocabularies (I)
“provide a interpretive layer of semantics between
underlying database and term entered by user to better
represent the original intention of the terms”
1
23/05/2014 Mastering CVs to facilitate sucesssful RIM 5
6. Controlled Vocabularies (II)
Translation: converting natural language into
vocabulary fit for indexing and retrieval
• commonly understood language to enable
communication and knowledge exchange among
stakeholders
Consistency: promote uniformity in format
and use of terms
Indication of relationships: semantic
relationships across terms
• Solve the problems of Ambiguity (e.g. homographs and
synonyms)
Retrievability: optimize searches
23/05/2014 Mastering CVs to facilitate sucesssful RIM 6
7. Structure: CVs, taxonomies and thesauri
represent increasing levels of complexity
Use terms
from list only
Parent-child
relations
Relationships
beyond
Customized parent-child
semantic
relationships
23/05/2014 Mastering CVs to facilitate sucesssful RIM 7
9. Vocabulary challenges – Synonyms (I)
Extended
release tablet
Prolonged
release tablet
23/05/2014 Mastering CVs to facilitate sucesssful RIM 9
10. Vocabulary challenges – Synonyms (II)
10
Saline
Sodium
Chloride
Salt
NaCl
= Different spelling, same meaning
23/05/2014 Mastering CVs to facilitate sucesssful RIM 10
11. Vocabulary challenges – Homographs
Coenzyme
Certificate of
Analyses
Abbreviation “COA”?
Clinical
Outcome
Assessment
= Same spelling, different meaning
23/05/2014 Mastering CVs to facilitate sucesssful RIM 11
12. Vocabulary challenges - difference in detail
Arginine
glutamate
Arginine
L-Arginine
Arginine
monoglutamate
23/05/2014 Mastering CVs to facilitate sucesssful RIM 12
13. Challenges of managing semantics –
Personal preferences
23/05/2014
13
Mastering CVs to facilitate sucesssful RIM
15. Other challenges managing terminologies
Spelling variations (and word ordering)
• WATER FOR INJECTION
• WATER FOR INJECTIONS
• WATER-FOR-INJECTION
• WATER-FOR-INJECTIONS
Data granularity
Transformation of data
23/05/2014 Mastering CVs to facilitate sucesssful RIM 15
16. Data granularity challenges (II)
XEVPRM
Product Strength name: 4.2% w/v
Product Generic name: Sodium Bicarbonate
Product Form name: Intravenous Infusion
Product Company name: Q-pharma
Product Short name: N/A
Product Reference name: BP
23/05/2014 Mastering CVs to facilitate sucesssful RIM 16
17. Data granularity challenges (IV)
IDMP
Scientific name part
Invented name part Sodium Bicarbonate
Intended Use part
Strength part: 4.2% w/v
Pharmaceutical dose form part Intravenous Infusion
Formulation part
Target Population part
Container or Pack part
Device part
Trademark or Company Name part Q-pharma
Time/Period part
Flavour part
23/05/2014 Mastering CVs to facilitate sucesssful RIM 17
18. Challenges when transforming data
SmPC:
“Prevention and treatment of nausea and vomiting
induced by cytotoxic chemotherapy and radiotherapy”
MedDRA:
• Prophylaxis of nausea and vomiting (LTT)
• Chemo induced not available
• Prophylaxis against radiation induced nausea and vomiting
(LLT)
• Nausea post chemotherapy (LLT)
• Nausea post radiotherapy not available
• Vomiting post chemotherapy (LLT)
• Vomiting post radiotherapy (LLT)
23/05/2014 Mastering CVs to facilitate sucesssful RIM 18
32. EUTCT - Controlled Term Lists
23/05/2014 Mastering CVs to facilitate sucesssful RIM 32
33. EUTCT – Authorisation Status
23/05/2014 Mastering CVs to facilitate sucesssful RIM 33
34. EUTCT – Expired due to Sunset Clause
23/05/2014 Mastering CVs to facilitate sucesssful RIM 34
35. U.S. National Library of Medicine - Medical
Subject Headings (MeSH)
for indexing journal articles and books in
the life sciences; and serves as a
thesaurus that facilitates searching (since
1963..)
23/05/2014 Mastering CVs to facilitate sucesssful RIM 35
36. MeSH – Medical Subject Headings Browser
23/05/2014 Mastering CVs to facilitate sucesssful RIM 36
37. Thesaurus principles
• Broader and narrower terms
• Preferred term and definition
• Aliases
• Translations
• Reference sources
• Relationships with other
terms
• Unique identifier
23/05/2014 37
Mastering CVs to facilitate sucesssful RIM
40. 40
ISO 11239 Controlled Vocabularies
Pharmaceutical dose form CV examples
23/05/2014 Mastering CVs to facilitate sucesssful RIM
41. Managing different vocabularies for different
audiences
ISO
IDMP
Local implementation A
Local implementation B
Local implementation C
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Mastering CVs to facilitate sucesssful RIM
42. ICD-10 and MedDRA mapping
Both terminologies used for adverse event
coding
•MeDRA Medical Dictionary for Regulatory
Activities – Indications and reactions
• E.g. SPC indication to MedDRA in XEVMPD
• ICD-10 International Classification of Diseases
and Related Health Problems
• E.g. SPC indication to ICD-10 in E-prescription system
Greece
23/05/2014 Mastering CVs to facilitate sucesssful RIM 42
43. MedDRA <> ICD-10 “Complete confidence”
Perfect match
23/05/2014 Mastering CVs to facilitate sucesssful RIM 43
44. MedDRA <> ICD-10 “Relative confidence”
No loss of information, slightly broader
term
23/05/2014 Mastering CVs to facilitate sucesssful RIM 44
45. MedDRA <> ICD-10 “out of scope”
No match possible
23/05/2014 Mastering CVs to facilitate sucesssful RIM 45
47. Vocabulary standards
ANSI/NISO Z39.19-2005 Guidelines for
the Construction, Format and
Management of Monolingual CVs
• http://www.niso.org/apps/group_public/download.
php/12591/z39-19-2005r2010.pdf
New ISO 25964 thesaurus standard
• http://www.niso.org/schemas/iso25964/
23/05/2014 Mastering CVs to facilitate sucesssful RIM 47
48. Important basic ISO standards
Importanc
e
Standard Identifier Standard Name Topics Related Standards
639 Codes for the representation of names of languages
[3 Parts]
Language Codes
Very 704 Terminology work — Principles and methods Definitions,
Objects,
Concepts
/IEC 11179-4 Information
technology — Metadata
registries () — Part 4:
Formulation of data
definitions
860 Terminology work – Harmonization of concepts and
terms
Concepts,
Terms
Very 1087-1 Terminology work — Vocabulary — Part 1: Theory
and application
Objects,
Concepts,
Definitions,
Designations
/IEC 2382 Information technology — Vocabulary [Many Parts] Vocabulary
2788 Documentation - Guidelines for the establishment
and development of monolingual thesauri
Thesaurus,
Terms
3166-1 Codes for the representation of names of countries and
their subdivisions - Part 1: Country codes
Country Codes
5964 Documentation - Guidelines for the establishment and
development of multilingual thesauri
Thesaurus,
Terms
Very TR 9007 Information processing systems - Concepts and
terminology for the conceptual schema and the
information base
Conceptual
Schema
/IEC 9834 Information technology - Open Systems Interconnection
- Procedures for the Operation of Registration
Authorities [Many Parts]
Identifiers
Very /IEC TR 10032 Information technology — Reference Model for Data
Management
Database
/IEC 11179-1 Information technology — Metadata registries () — Part
1: Framework
Registry for data
elements and their
components
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49. Developing a CV
Scope
Build
Publish
Review
Maintain
• In Scope < > Out of scope
• Scope Notes restricted to selected
meanings within domain
• Reference sources (e.g. databases,
external vocabularies)
• avoid duplicating existing CVs
• Maintenance plan (rules for creation,
status change, relationships and
restructuring)
• Define structure of CV
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50. Developing a CV
Scope
Build
Publish
Review
Maintain
• Collecting terms
• top-down (BT > NT)
• bottom up (NT > BT)
• deductive method
• machine assisted (e.g.
queries, frequency of use)
• Organizing terms (parent-child,
preferred and non-preferred,
abbreviations etc)
• Granularity of terms
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51. Grammar and spelling
Verbs expressed as infinitives should be
avoided, e.g.;
• Analyses rather then analyze
• Publishing rather then publish
British English or American English
spelling?
Abbreviations used as terms only if well
established
• e.g. eCTD rather electronic Common Technical
Document
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52. Developing a CV
Scope
Build
Publish
Review
Maintain
• Export terms in machine-readable
language, e.g.:
• Web Ontology Language
(OWL)
• Simple Knowledge
Organization System (SKOS)
• RDF-S
• XML
• User documentation
• Type of display
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54. Developing a CV
Scope
Build
Publish
Review
Maintain
• SME review process
• form, completeness,
consistency
• Technical validation
• RDF/SKOS/XML files
• Error checking
• (potential) duplicates
• Usability test
• retrievability
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55. Developing a CV
Scope
Build
Publish
Review
Maintain
• Policy and procedures on periodic
review (addition, modification and
deletion of terms)
• Term request form
• Term status
Candidate/ Provisional (terms
not admitted until review)
Approved
Not valid
• Versioning & History
Create date and modified date
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57. Conclusions
Semantic challenges can impact
information retrievability
Controlled Vocabularies help to
understand original intention of information
No one-size fits all; vocabularies differ per
audience
Leverage from existing standards; do not
copy
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59. Scope notes
Used to restrict or expand usage of a term
To distinguish between terms with
overlapping meanings
To provide other advice on term usage to
indexer or searcher
Must state the chosen meaning of a term
May state other meanings of a term
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60. Use of Qualifiers
Use compound terms rather then
qualifiers, if available in language
• e.g. clinical study <> study (clinical)
Consider reuse CV across other domains
• e.g. sequence > ectd sequence vs. dna
sequence
Standardize Qualifiers
• e.g. use of clinical study and clinical trial
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