WHO-ART and MedDRA are medical terminologies used for adverse event reporting. WHO-ART has a 4-level hierarchical structure with over 6,000 terms developed in multiple languages. MedDRA is an internationally standardized terminology developed by ICH with over 72,000 terms managed by the MSSO. Both terminologies aim to facilitate adverse event reporting, analysis and communication.
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
Defined daily dose-DDD
B Pharm, Pharm D and medicine syllabus
Useful for examination and regulatory function information
Useful for Pharmacovigilance interview and medical coding also.
Good Luck and all the best!!!
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
Defined daily dose-DDD
B Pharm, Pharm D and medicine syllabus
Useful for examination and regulatory function information
Useful for Pharmacovigilance interview and medical coding also.
Good Luck and all the best!!!
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilis...Dr.Amreen Saba Attariya
detailed information about Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilisation, DU90%, WHO Collaborting Centre for drug statistic methodology, DDD/1000inhabitants/day, DDD/100beddays, DDD/1000inhabitants/year, Pediatric DDD, ATC & DDD in drug utilisation research, Electronic Prescribing, Guidelines for ATC classification & DDD assignment 2016
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
Pharmacovigilance Reporting and Communication: Collaboration between Stakehol...ClinosolIndia
Effective reporting and communication in pharmacovigilance play a vital role in ensuring the safety of medications and protecting public health. This paper explores the importance of collaboration between various stakeholders in the field of pharmacovigilance for efficient reporting and communication processes.
Pharmacovigilance reporting involves the collection, analysis, and evaluation of adverse drug reactions (ADRs) and other drug-related incidents. Prompt and accurate reporting of ADRs is crucial for detecting potential safety issues, identifying patterns or trends, and taking necessary actions to mitigate risks. However, the success of reporting relies on effective collaboration between healthcare professionals, regulatory agencies, pharmaceutical companies, and patients.
The paper highlights the role of healthcare professionals in recognizing and reporting ADRs. It emphasizes the importance of their active participation in pharmacovigilance activities, including the proper documentation and reporting of suspected adverse events. Additionally, the paper discusses the significance of education and training programs to enhance healthcare professionals' awareness and knowledge of pharmacovigilance principles and reporting systems.
Anatomical Therapeutic Chemical Classification System and Defined Daily Doses...Balwant Meshram
The Anatomical Therapeutic Chemical (ATC) classification system and the Defined Daily Dose (DDD) is the WHO recommended measuring unit which is being used for drug utilization studies. This system is internationally accepted and the users are also increasing. While measuring the drug use, the classification system and unit of measurement, both are important.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilis...Dr.Amreen Saba Attariya
detailed information about Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilisation, DU90%, WHO Collaborting Centre for drug statistic methodology, DDD/1000inhabitants/day, DDD/100beddays, DDD/1000inhabitants/year, Pediatric DDD, ATC & DDD in drug utilisation research, Electronic Prescribing, Guidelines for ATC classification & DDD assignment 2016
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
Pharmacovigilance Reporting and Communication: Collaboration between Stakehol...ClinosolIndia
Effective reporting and communication in pharmacovigilance play a vital role in ensuring the safety of medications and protecting public health. This paper explores the importance of collaboration between various stakeholders in the field of pharmacovigilance for efficient reporting and communication processes.
Pharmacovigilance reporting involves the collection, analysis, and evaluation of adverse drug reactions (ADRs) and other drug-related incidents. Prompt and accurate reporting of ADRs is crucial for detecting potential safety issues, identifying patterns or trends, and taking necessary actions to mitigate risks. However, the success of reporting relies on effective collaboration between healthcare professionals, regulatory agencies, pharmaceutical companies, and patients.
The paper highlights the role of healthcare professionals in recognizing and reporting ADRs. It emphasizes the importance of their active participation in pharmacovigilance activities, including the proper documentation and reporting of suspected adverse events. Additionally, the paper discusses the significance of education and training programs to enhance healthcare professionals' awareness and knowledge of pharmacovigilance principles and reporting systems.
Anatomical Therapeutic Chemical Classification System and Defined Daily Doses...Balwant Meshram
The Anatomical Therapeutic Chemical (ATC) classification system and the Defined Daily Dose (DDD) is the WHO recommended measuring unit which is being used for drug utilization studies. This system is internationally accepted and the users are also increasing. While measuring the drug use, the classification system and unit of measurement, both are important.
This presentation was presented as a term presentation in the course of Business Ethics, Iqra University.
This presentation is about a tragedy which made 20 thousand babies to born with birth defects.
If you find any correction or have any complains regarding this presentation kindly email me on my mailing account.
P.S You can also take help from the report of this presentation in my documents area with the same name.
PharmaCoNER: Pharmacological Substances, Compounds and proteins Named Entity ...Martin Krallinger
PharmaCoNER: Pharmacological Substances, Compounds and proteins Named Entity Recognition track
Talk at: BioNLP-OST Workshop, November 4, SkyCity RM 2, Hong Kong EMNLP2019
One of the biomedical entity types of relevance for medicine or biosciences are chem-
ical compounds and drugs. The correct detection these entities is critical for other text
mining applications building on them, such as adverse drug-reaction detection, medication-related fake news or drug-target extraction.
Although a significant effort was made to detect mentions of drugs/chemicals in English texts, so far only very limited attempts were made to recognize them in medical documents in other languages. Taking into account the growing amount of medical publications and clinical records written in Spanish, we have organized the first shared task on detecting drug and chemical entities in Spanish medical documents. Additionally, we included a clinical concept-indexing sub-track asking teams to return SNOMED-CT identifiers related to drugs/chemicals for a collection of documents. For this task, named PharmaCoNER, we generated annotation guidelines together with a corpus of 1,000 manually annotated clinical case studies. A total of 22 teams participated in the sub-track 1, (77 system runs), and 7 teams in the sub-track 2 (19 system runs). Top scoring teams used sophisticated deep learning approaches yielding very competitive results with F-measures above 0.91. These results indicate that there is a real interest in promoting biomedical text mining efforts beyond English. We foresee that the PharmaCoNER annotation guidelines, corpus and participant systems will foster the development of new resources for clinical and biomedical text mining systems of Spanish medical data.
MedDRA - the Medical Dictionary for Regulatory Activities - is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines). Coding these data to a standard set of MedDRA terms allows health authorities and the biopharmaceutical industry to more readily exchange and analyze data related to the safe use of medical products.
OpenMRS Concept Management Tutorial presented on 9 Dec 2015 at the OpenMRS Worldwide Summit in Singapore. Presented by Andy Kanter and Ellen Ball. 4 hour presentation.
SNOMED CT and other healthcare terminology standards: competition or cooperat...THL
SNOMED CT and other healthcare terminology standards: competition or cooperation? SNOMED CT in relation to LOINC, ICD, ICPC and other terminologies.
Robert Hausam, Hausam Consulting LLC
SNOMED CT 2019 -seminaari (29.3.2019
How to Submit Non-Clinical Data to CBER Using SEND : Understanding New FDA Re...MMS Holdings
What You Will Learn
The FDA’s CBER will begin requiring electronic submissions of nonclinical data to be submitted using the 3.1 and 3.1.1 versions of CDISC SENDIG on March 15th, 2023. With these requirements taking effect soon, Sponsors need to understand how to meet the new rules and regulations provided by SEND, as failing to meet them could result in FDA refusal.
In this webinar, a cross-functional team of statistical programmers and regulatory experts will share actionable insights to help study teams prepare for the new requirements.
Attendees will learn how to:
Understand nonclinical study data submissions to CDER and CBER
Differentiate biologics from drug submission in non-clinical studies
Prepare for this change to ensure a successful submission.
Solve the challenges of a SEND package
Ensure compliance with both SEND 3.1 and 3.1.1 for submission of nonclinical data to CDER and CBERHo
Separate SEND IG DART 1.1 from SEND IG
Manage legacy studies and studies that already meet requirements
Differentiate between submission packages
Use the FDA’s data standard catalog, technical conformance guide and controlled terminology
Who Will Benefit from Attending?
Regulatory Affairs and Submissions Professionals
Pharmaceutical Data and Programming Professionals
Nonclinical/Preclinical Development Professionals
HXR 2016: Data Insights: Mining, Modeling, and Visualizations- Niraj KatwalaHxRefactored
Data is useless if it fails to inform, which is precisely what data experts are furiously working on: turning raw informatics into meaningful narratives that begin to shift our standards. From the individual to the population level, data is leading both policy and better decision making in the clinical sphere.
The Current Regulatory Environment and Auditing Urine Drug TestingPYA, P.C.
PYA Consulting Seniors Jennifer Bridgeforth and Jennifer Kastner also presented “The Current Regulatory Environment and Auditing Urine Drug Testing.” Attendees:
Learned the history of urine drug test (UDT) billing changes.
Understood current requirements of UDT coding and documentation.
Learned common compliance issues.
Became familiar with best practice recommendations.
Daedalus develops technology to extract the meaning and structure all types of multimedia content. In the field of Healthcare or e-Health, Daedalus' semantic technology allows to exploit automatically the information featured in the Electronic Health Record (EHR).
This presentation covers Daedalus experience in:
• Online health content monitoring
• Semantic enrichment (tagging) of medical records
• Anonymization of medical records
• Multimedia search in medical records
• Detection of interactions between drugs
• Text analytics and data analytics in the health sector
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.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler Community Health Nursing A Canadian Perspective, 5th Edition TEST BANK by Stamler Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Study Guide Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Studocu Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Course Hero Community Health Nursing A Canadian Perspective, 5th Edition Answers Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Course hero Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Studocu Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Study Guide Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Ebook Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Questions Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Studocu Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Stuvia
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.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
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
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
3. Features
• Four-level hierarchical structure
• About 6000 terms
• Developed in English with French, Chinese,
Spanish and Portuguese translations
• Used by drug regulatory agencies and
pharmaceutical manufacturers in many countries
3
5. Structure – 2015Q1
• 23 SOCs – body organ groups
• 339 HLTs – for grouping preferred terms
• 2123 PTs – principal terms for describing ADR
• 3925 ITs – synonyms to preferred terms
5
6. Definitions and uses
• System-organ classes
High level terms same organ system
at the output side
• High level terms
PTs qualitatively similar
at the output side,
e.g. Thrombophlebitis and Thrombophlebitis superficial
represent two different preferred terms but are grouped
under Thrombophlebitis as a high level term.
6
7. 7
• Preferred terms
used to describe adverse drug reactions.
at the input side
• Included terms
terms closely related to Preferred terms.
used to assist in finding the corresponding PT
8. Record number system
• PTs
a record number (Arecno) – eg: 0363
sequence number (Seq) - eg: 001.
• Included terms get
• the same record number as their corresponding Preferred
terms,
• but with a higher sequence number.
• High level term link (HL LINK)
8
10. Critical Terms
• indicated by asterisk.
• serious disease states,
• particularly important to follow up.
• If a PT is indicated as a Critical Term, its linked ITs are
also regarded as Critical Terms.
10
13. Future of WHO-ART
• UMC collaboration with terminology MedDRA towards
having one global terminology solution.
• the final version, 2015Q1 would continue to fulfil its
purpose until a new terminology solution is available.
13
15. What is MedDRA?
Med = Medical
D = Dictionary for
R = Regulatory
A = Activities
15
16. Key Features of MedDRA
• Standardized terminology
• International scope – currently available in 11
languages including English, Spanish, French,
Chinese, and Japanese
• Developed by International Conference on
Harmonization (ICH)
• Managed by Maintenance and Support Services
Organization (MSSO) and updated bi-annually with
input from users
16
17. Key Features of MedDRA (cont)
• Structure facilitates data entry, analysis, reporting, and
electronic communication
• Large terminology with > 72,000 terms at lowest level -
allows greater specificity
• Approx. 20,000 Preferred Terms, each representing a
unique medical concept
17
18. Scope of MedDRA
18
Medical conditions
Indications
Investigations (tests, results)
Medical and surgical procedures
Medical, social, family history
Medication errors
Product quality issues
Device-related issues
Pharmacogenetic terms
Toxicologic issues
Standardized queries
Not a drug
dictionary
Not an equipment, device,
diagnostic product dictionary
Clinical trial study
design terms
Patient
demographic
terms
Frequency
qualifiers
Numerical values
for
results
Severity descriptors
IN
OUT
19. MedDRA Definition
MedDRA is a clinically-validated international medical
terminology used by regulatory authorities and the
regulated biopharmaceutical industry.
19
20. MedDRA Hierarchy
20
System Organ Class (SOC)
High Level Group Term (HLGT)
High Level Term (HLT)
Preferred Term (PT)
Lowest Level Term (LLT)
21. System Organ Classes
21
• Blood and lymphatic system disorders
• Cardiac disorders
• Congenital, familial and genetic disorders
• Ear and labyrinth disorders
• Endocrine disorders
• Eye disorders
• Gastrointestinal disorders
• General disorders and administration site
conditions
• Hepatobiliary disorders
• Immune system disorders
• Infections and infestations
• Injury, poisoning and procedural
complications
• Investigations
• Metabolism and nutrition disorders
• Musculoskeletal and connective tissue
disorders
• Neoplasms benign, malignant and unspecified
(incl cysts and polyps)
• Nervous system disorders
• Pregnancy, puerperium and perinatal
conditions
• Psychiatric disorders
• Renal and urinary disorders
• Reproductive system and breast disorders
• Respiratory, thoracic and mediastinal
disorders
• Skin and subcutaneous tissue disorders
• Social circumstances
• Surgical and medical procedures
• Vascular disorders
23. Non-Current Terms
• at the LLT level
• very vague, ambiguous, out-dated, truncated, or
misspelled
• Terms derived from other terminologies that do not fit
MedDRA rules
• Not recommended for continued use
• Retained within the terminology to preserve historical
data for retrieval and analysis
23
24. MedDRA Codes
• Each MedDRA term assigned an 8-digit numeric code
• New terms
• Renaming
• When terms are renamed, the code number is reused for the
renamed term
• for spelling errors, hyphenation, and parenthesis changes
• When HLT or HLGT terms are removed from the
terminology, they are deleted
24
28. Multi-Axial Terminology (cont)
• Allows terms to be grouped by different classifications
• Allows retrieval and presentation via different data sets
• Allows an automatic assignment of predefined term
groupings
28
29. Primary SOC allocation
• PTs are assigned to a prime manifestation site SOC
• Eg: Congenital anomalies have SOC Congenital,familial
and genetic disorders
29
30. What is new in MedDRA?
• New MedDRA versions are released in March and
September each year.
• The Current version of MedDRA is version 18.0.
31. Regulatory Status
• US FDA
• Used in several databases including FAERS (drugs and biologics),
VAERS (vaccines), and CAERS (foods, dietary supplements,
cosmetics)
• Recommended terminology for adverse event reporting in several
Proposed Rules
• Not mandatory
• Japanese Ministry of Health, Labour and Welfare
• Mandatory use in electronic reporting
MSSO-DI-6225-17.0.0
31
32. Regulatory Status (cont)
•European Union
• Mandatory
• EudraVigilance database
• Good pharmacovigilance practices (GVP) specifically
mention MedDRA
UMC
Using Meddra
MSSO-DI-6225-17.0.0
32
Editor's Notes
e.g. in full regulatory process:
Clinical studies
- Reports of spontaneous adverse reactions and events
- Regulatory submissions
- Regulated product information