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, while MedDRA is more extensive with over 72,000 terms organized into system organ classes. Both terminologies aim to standardize terminology for use by drug regulators and manufacturers, though MedDRA was developed further through international collaboration and is now the predominant global standard.
Establishment of Pharmacovigilance ProgrammeNipun Gupta
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Establishment of Pharmacovigilance ProgrammeNipun Gupta
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
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.
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
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
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.
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
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
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.
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.
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
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
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
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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.
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
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
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