Leitlinienentwicklung: Perspektiven der internationalen Zusammenarbeit Hans C. Korting, München

Leitlinienentwicklung:
Perspektiven der internationalen Zusammenarbeit
Hans C. Korting, München
Dermatologische
Qualitätssicherung
Dermatologische
Qualitätssicherung
Leitlinien und Empfehlungen
6. Auflage 2009
Leitlinien und
Empfehlungen
Herausgegeben von
H. C. Korting • R. Callies • M. Reusch M. Schlaeger W. Sterry
1. Auflage 2000
Herausgegebenvon
Korting H.C., Callies R.,
Reusch M., Schlaeger M..
Schöpf E.. Sterry W.
Berufsverband
Dewuher Bermaiolopen
B
V
D
D
ABW .Wissenschaftsverlag
EDF Guidelines
for Dermatology
in Europe
Dermatologische
Qualitätssicherung
Edited by
W. Sterry • C. Griffes • H. C. Korting
Leitlinien und Empfehlungen
6. Auflage 2009
Herausgegeben von
H. C. Korting • R. Callies M. Reusch M. Schlaeger • W. Sterry
European
Forum
ABW • Wissenschaftsverlag
ABW • Wissenschaftsverlag
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SOP for creation of European Dermatology Guidelines
Step Responsible
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
Task
EDF Guidelines Decision of topic of specific guideline
Committee
(EDF-GC)
EDF Board
Confirmation of the choice and level of guideline (S1, S2 or S3) plus
suggestion to the Guideline Committee of potential chairmen and
subcommittee members.
EDF Guidelines Foundation of subcommittee for specific guidelines. Nomination of
Committee
EDF members (50 %) as well as identification of possible EADV
members (25 % of members for the subcommittee) who could work
within the subcommittee. Chairman of EDF guideline committee
asks EADV president for approval.
Finally nomination of a chairperson of the subcommittee by the
group.
EDF-GSubC
Development of a business plan (see attachment)
EDF Board
Confirmation of business plan and signature of the contract for
financial support of guideline
EDF Guidelines Identify all existing guidelines for the specific guideline (active
Subcommittee process: literature survey plus contact to Dermatological Societies)
(EDF-GSubC)
EDF Guidelines Select the guidelines with highest quality. Criteria for selection:
Subcommittee 1. Availability of strength of evidence
2. Availability of strength of recommendation
3. Evidence of mechanics of literature review (adhere to the
recommendations of the Cochrane collaboration. These
standards should assure high quality for the systematic literature
search as well as for the critical appraisal of the papers. For
further information see
http://www.cochrane.org/crgprocedures/chapter4/1.htm and
documents available at EDF Guidelines Secretariat (Mrs. Janine
Schweiger, janine.schweiger@charite.de)
EDF Guidelines Identification/nomination of additional 50 % EDF members for the
Subcommittee EDF-GSubC from amongst the authors of the best guidelines
Chairperson of Consider involvement of other disciplines and patients´
Subcommittee organisations
EDF Guidelines Meet
Subcommittee 1. to decide the author of the first draft (normally the chairperson of
the subcommittee) and to discuss the present guidelines, their
strengths and weaknesses
2. 6 months later to discuss the draft (consensus conference)
Chairperson of Circulate the guideline draft to national dermatological societies for
Subcommittee comments
Guidelines
Circulate final version for approval among members of the guideline
Subcommittee subcommittee
Chairperson of Deliver final version for comments to
Subcommittee EDF guideline committee chairperson, who forwards it to EADV
Board and to UEMS
EDF Guidelines Review and comment guideline
Committee
EDF GC
Send guideline for official approval to UEMS (formal approval)
chairperson
EDF secretary Distribute guideline for in advance information to EDF members and
National Dermatological Societies (actual list of societies and their
presidents at EDF guidelines secretariat)
Months
duration

0,5
at EDF
Meeting
1
1
1
1
0,5
1
6
2
1
2
1
2
1
Step Responsible
Task
Months
Duration
1
EDF Guidelines
Committee
(EDF-GC)
Decision of specific guideline
Ø
2
EDF Board
Confirmation of the choice and level of guideline (S1,
S2 or S3) plus suggestion to the Guideline
Committee of potential chairmen and subcommittee
members
0,5
3
EDF Guidelines
Committee
Foundation of subcommittee for specific guidelines.
Nomination of EDF members (50%) as well as
identification of possible EADV members (25% of
members for the subcommittee) who could work
within the subcommittee. Chairman of EDF guideline
committee asks EADV president for approval.
Finally nomination of a chairperson of the
subcommittee by the group.
at EDF
Meeting
4
EDF-GSubC
Development of a business plan (see attachment)
1
5
EDF Board
Confirmation of business plan and signature of the
contract for financial support of guideline
1
Step Responsible
Task
Months
Duration
6
EDF Guidelines
Subcommittee
(EDF-GSubC)
Identify all existing guidelines for the specific
guideline (active process: literature survey plus
contact to Dermatological Societies)
1
7
EDF Guidelines
Subcommittee
Select the guidelines with highest quality. Criteria for
selection:
1. Availability of strength of evidence
2. Availability of strength of recommendation
3. Evidence of mechanics of literature review
(adhere to the recommendations of the
Cochrane collaboration. These standards should
assure high quality for the systematic literature
search as well as for the critical appraisal of the
papers. For further information see
http://www.cochrane.org/
crgprocedures/chapter4/1htm and documents
available at EDF Guidelines Secretariat (Mrs.
Janine Schweiger, janine.schweiger@charite.de)
1
8
EDF Guidelines
Subcommittee
Identification/nomination of additional 50% EDF
members for the EDF-GSubC from amongst the
authors of the best guidelines
0,5
Step Responsible
Task
Months
Duration
9
Chairperson of
Subcommittee
Consider involvement of other disciplines and
patients‘ organisations
1
10
EDF Guidelines
Subcommittee
Meet
1. To decide the author of the first draft (normally
the chairperson of the subcommittee) and to
discuss the present guidelines, their strengths
and weaknesses
2. 6 months later to discuss the draft (consensus
conference)
6
11
Chairperson of
Subcommittee
Circulate the guideline draft to national
dermatological societies for comments
2
12
Guidelines
Subcommittee
Circulate final version for approval among members
of the guideline subcommittee
1
13
Chairperson of
Subcommittee
Deliver final version for comments to EDF guideline
committee chairperson, who forwards it to EADV
Board and UEMS
2
Step Responsible
Task
Months
Duration
14
EDF Guidelines
Committee
Review and comment guideline
1
15
EDF GC
chairperson
Send guideline for official approval to UEMS (formal
approval)
2
16
EDF secretary
Distribute guideline for in advance information to
EDF members and National Dermatological Societies
(actual list of societies and their presidents at EDF
guidelines secretariat)
1
EDF guidelines published as book in 2009
Guidelines
Responsible
authors
Expiry date
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
Melanoma (S1 – S2)
Garbe
5/2012
Cutaneous malignant
lymphoma
Whittaker
8/2011
Basal cell carcinoma
Stockfleth
8/2008
Actinic keratosis (S2)
Stockfleth, Kerl
5/2009
Chronic urticaria
Zuberbier
8/2012
Venous leg ulcers (S3)
Neumann
3/2011
Immunoglobulines (S1)
Enk
8/2011
Psoriasis (S3)
Rzany
11/2012
Photodermatoses
Murphy
12/2012
Physical and cholinergic
urticaria
Maurer
12/2012
Dermatopathology
Kerl, Sterry
9/2012
EUROPEAN JOURNAL OF CANCER 46 (2050)
2 7 0-2 8 3
avallabie at www.sciencedirect.corn
••••
dir
IM.
•;'ScienceDirect
ELSEVIER
iournal horriepage:www.erconline..com
Current Perspective
Diagnosis and treatment of melanoma: European
consensus-based interdisciplinary guideline
Claus Garbe
Ketty Peris b'rn, Axel Hauschild
Philippe Saiag
Mark Middieton ", Alain Spatz I'', Jean-Jacques Grob g>', Josep Maluehy
Julia Newton-Bishop
Alexander Stratigos iJniHubert Pehamberger
Alexander Eggerrnont
Center for DellYtat0Oncoiogy, Department of Dermatoiogy, Lieber meisterstr. 25, 72076 Tübingen, Germany
EJC
JEADV
OCTOBER 2009, VOLUME 23, SUPPLEMENT 2.
Ettropean S3-Guidelines on the systemic treatment of psoriasis vulgaris
D Pathirana, AD Ormerod, P Saiag, C Smith, PI Spuls, A Nast, J Barker, JD Bos,
G-R Burmester, Chimenti, L Dubertret, B Eberlein, R Erdmann, J Ferguson,
G Girolomoni, P Gisondi, A Giunta, C Griffiths, H Hönigsmann, M Hussain, R Jobling,
Maronen, L Kemeny, I Kopp, C Leonardi, M Maccarone, A Menter, U Mro-wietz,
L Naldi, T Nijsten, J-P Ortonne, H-D Orzecho wski, T Rantanen, K Reich, N Reytan,
H Richards, HB Thio, P van de Kerkhof, B Rzany
Einführung
D01:10.111 /j.1610-0379.2006.136172.x
Leitlinie
53-Leitlinie zur Therapie der Psoriasis vulgaris
Alexander Nast I, Ina B. Kopp, Matthias Augustin3, Kirstin-Benita Bande'', Wolf-Henning Boehncke5,
Markus Follrnann6, Markus Friedrich', Matthias Huber, Christina Ka h11,Joachim Klaus'', Joachim Koza9,
Inga Kreiselmaler'°, Johannes Mohrl 1, Ulrich Mrowietzl°, Hans-Michael Ockenfels12, Hans-Dieter
Orzechowskia, Jörg Prinz' 3,Kristian Reich14,Thomas Rosenbach', Stefanie Rosumeck 1, Martin
Schlaeger16, Gerhard Schmid-Ott17, Michael Sebastian ',Volker Streit19,Tobias Weberschock', Berthold
Rzany'
(1) Division of Evidence Based Medicine (dEBM), Klinik für Dermatologie,Venerologie und Allergologie,Charite Universitätsmedizin Berlin
Psoriasis-Leitliniengruppe der WG • Journal compilation Blac Wen Verlag. Berlin •JDCG • 1860-602£290515uppl 2 -51
JDDG Supplement 2.2006 (Band 4)
Si
Deutschsprachige Autoren der nationalen sowie
europäischen S3-Leitlinie zur Psoriasistherapie in
alphabetischer Reihung (I)
Deutsche Leitlinie
Europäische Leitlinie
Augustin M
Burmester G-R
Banditt K-B
Eberlein B
Boehncke W-H
Erdmann R
Follmann M
Hönigsmann H
Friedrich M
Kopp I
Kahl C
Mrowietz U
Klaus J
Kopp I
Koza J
Kreiselmeier I
Mohr J
Mrowietz U
Blau: Autoren beider Leitlinien
Deutschsprachige Autoren der nationalen sowie
europäischen S3-Leitlinie zur Psoriasistherapie in
alphabetischer Reihung (II)
Deutsche Leitlinie
Europäische Leitlinie
Nast A
Nast A
Ockenfels H-M
Orzechowski H-D
Orzechowski H-D
Reich K
Prinz J
Rzany B
Reich K
Rosenbach T
Rosumeck S
Rzany B
Schlaeger M
Schmidt-Ott G
Sebastian M
Streit V
Weberschock T
Status on New European Guidelines (I)
Guidelines
Responsible
authors
1
Acne
Gollnick/Rzany
Androgenetic alopecia (S1
- diagnosis)
Blume-Peytavi
Androgenetic alopecia (S3
- therapy)
Blume-Peytavi
Atopic eczema
Ring
Autoimmune bullous skin
diseases
Hertl/Feliciani
Dermatofibrosarcoma
protuberans
Garbe
Extracorporeal
Photopheresis
Knobler
Gonorrhea
Neumann
2
3
4
5
6
7
8
9
10
11
12
14
15
Due
date
Not approved by UEMS
14.10
Herpes
Hidradenitis suppurativa
HPV-vaccination
13
Gross
Lichen planus
finished
In progress according to schedule
overdue
Status on New European Guidelines (II)
Guidelines
Responsible
authors
Step according to the EDF Guidelines SOP
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Due
date
Lichen sclerosus
Lupus erythematosus
Merkel cell carcinoma
Garbe
Psoriasis with arthritic
involvement
Rzany
Pruritus (S1 – S2)
Ständer
Squamous cell carcinoma
Garbe
Syphilis
Hegyi
Topical steroids in
pregnancy
Wojnarowska
Vitiligo
Taieb/Picardo
14.10
27.10
-
finished
In progress according to schedule
overdue
Europäische Leitlinien: Besondere Vorkommnisse im
Kontext der Psoriasis-Leitlinie (I)
• 2/2009: Übersendung des Leitlinientexts durch den EDFLeitlinienbeauftragten an die Präsidenten von EADV
(Prof. Giannetti) und UEMS (Prof. Gollnick)
• 5/2009: Zustimmung durch die UEMS nach Modifikation
(keine Stellungnahme seitens der EADV)
• 8/2009: Elektronische Veröffentlichung der Leitlinie
Europäische Leitlinien: Besondere Vorkommnisse im
Kontext der Psoriasis-Leitlinie (II)
• 9/2009: E-Mail von Co-Autor Prof. Giunta:
– „I‘m really sorry to arise these issues after the online
publication, but …“
– „Regarding the new S3 Guidelines, I noticed 3 inaccuracies
that I do believe it is mandatory to change in the chapter
we wrote on Etanercept.“
• 10/2009: Revision der Leitlinie im Sinne eines Erratum
Darstellung des Ablaufs in Anlehnung an die des EDF-Leitlinienbeauftragen Prof. Sterry
14TH MEETING OF THE
European
Dermatology
Forum
JANUARY 21-22, 2011
LUZERN, SWITZERLAND
Meeting Program
Friday, January 21, 2011
11.00 - 12.30
EDF warking groups
Guidelines
Education
Genodermatoses Database
Room
Meeting
Saturday, January 22, 2011
Room
8.00 - 9.00
Liaison rneeting
9.00
Reports of the European sister societies
Chairpersons: Peter Fritsch, Annamari Feanki
-
10.00
1)
2)
3)
4)
EADV
ESDR
UE1v15
ILDS
Disc LASS ion
Frank Powell
Vincent Piguet
Magdalena Czarnecka-Oieteracz
Jean-Hilaire Saurat
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Guideline for the Management of Pelitic Inflammatory Disease
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CONCEPT VERSION
EUROPEAN GUIDELINES
ON THE DIAGNOSIS AND TREATMENT OF PELVIC GIRDLE PAIN.
COST ACTION B13
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The guidelines are devekiped within the frarnework of the COST ACTION 813 'Low bac*
pain: guidehnes for its rnanagement", issued by the European Commission, Research
Direetorate-General, Department of Policy, Coordination an d.Strategy
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the requiremenzs contained in the referenced EU leg'slaban are not applkcable to the evaluatien ofpreschphon meckines by the TGA.
The Ausbalian legislative requirements applying 4a prescription medicines are contained in the Therapeutm: Guuds Art 1939 and the
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Guideiirles adopted In the last 4 menths
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SafetyStudles for the Condu ct of Human CIMlull Trials and Mar*etlosi
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Human Chnical Trials and Marketing Autherization for Pharmaceuticals
Step 1.
NOTE FOR GUIDANCE ON NON-CLIMCAL SAFE TY S TUDIE S FOR THE C:ONDUCT
OF HUMAN CLIVICAL TRIALS AND MARKETING AUTHORIZATION FOR
FHARMA CEU TICAL S
(CPMPICH286195)
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TRANSMISSION TO INTERESTED PARTIES
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December 2009
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The Co mrrittee for Medio nal Products for Human use i.CHMP) prepares scientifl r guid el in es. in consultati an with the competent
authorities of the EU Member states, to help apolicants prepare niarketino authorisation apulication5 for medicinal products for
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QuariLy
human u SE
Guidelines sre irrtended to pnn•icte a hasis for practical harmonisation of the manner in or hich the Eu member states and the
European Medicines AciQncy Interpret and .3poly the detailed recitiirero ents for the demon stration of Quality, safet9 and f5cacy
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For the assurance of qualrty oF medianal pro duuts, guidelinue are tomplementary Instruments to European Pharm.scupsela
rnonographs and chaptera.
5inike • . —
Extras •
European Guideline for the Management of Peh-k Infiammator5 Dkease
Date: August 2OO
Proposed Date for Review: December 20,09
Adithorz:
Prof Ionothan Ross B DiB }.0 FRCP(Ed) FRCP (Loni)
Whittall Street Chic
Whittall Street
BimiioghamB4 6DH
Lid
TeL 0121 237 5721 Fax 0121 237 5729 email: jemathau_rusehohtpct.nlis.ul:
Prof Philippe Tucllin MD. FACOG
Clinique Universitaire de Gynecologie-Obetetrique
Maternite Regionale de Nancy_
France
email:p judlin'c4naternite chu-nancy fr
Dr. Li3beth Mim 1D Dr.
Department of Ohstetricl and Gynecology 537
avidovre Hospital
Kettegaards Alle 22
DK 2650Hvidovre
Denmark
email: Lisbeth_Nilas@hh_hosp.dk
RD Traimmit Goillaktqc - Ezropa 2411.61:5 - 233 miELDT updx--;,thic
pap 1
Eur J Nuel Med Mol bnagirig (2008) 35..251—R85
IDOL 10.1007/e3259-007-0694-9
G [ADE LINE S
EANIWESC guidelines for radionuclide irnaging
of cardiac function
B. Hesse • T. B. Lindhardt • W. Acampa •
C. Anagnostopoulos • J. Ballinger • J. J. Bai •
L. Ed enbrandt • A. Flotat s • C. Germane •
T. Cmeiner Stopar • P. Franken • A. Kelion • A. Kjaer •
D. Le Culudee • M. Ljungberg • A. F. Alaenhaut •
C. Marcassa • 1 Marting • F. MeKiddie •
W. M. Sehaefer • L. Stegger • R. Underwood
B. Hesse (21) • K Kjaer • J. tvlarving
L) partinent of Clinical Phy5,iology and. Nuclear Medieine,
University Hospital of Copenhagen,
Rigshospitalet,
Copenhageri, Derrrnark
bbessi.,•grh_hocip_dk
Preamtile
The European guidelines for radionuelidc imaging of
eardiac function hark bcen cicvcdopc..d und er the auspices
of the European Council an Nuelca.r Cardiology (the johlt
grou.p of the Cardiovascular Committee of the Eu.mpean
Association of Nuclear Medieine and af the Working Group
an Nuelear Cardiology of the European Society af
Cardiology). The aim of the authors has bin to present
the state-of-the-art applications and protocols approved by
experts in the Field and to disseminato this information to
the Europcan nucica.r cardiology corntriunity_ Ihr guidelines ate dcsigncd t0 a.ssist physicians and other healtheare
Seh.aefer
Nuelear Medicine Department, University Hospital,
Aachen University of Teehnology,
Aachen, Germany
L. Stegger
Department of Nuelear Medieine, University Hospital [Münster,
M ün
Cürmany
Undc....rwol.).d.
Department of Nuelear Modieine, Royal Brompton Hospital,
London, UK
Future tasks in European guideline management:
relevant alternatives
• Guideline development coordination with corresponding
bodies of EDF addressing the various medical specialties
collaborating with UEMS, possibly forming a new
European umbrella organisation,
• Guideline development coordination by various national
umbrella
organisations
such
as
AWMF,
possibly forming a new European umbrella organisation
URIS -European Unron of fledlcalSanclalisb -riorosned bY Mal Internee Soll »web -Windoes Internet Enpiorer
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EUROPEAN UNION OF MEDICAL SPECIALISTE
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UEMS Secricas
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The UEMS Section ef Dermato Vererecegy
EACCME
UEFA S News
Puhncarfons
Ha mepAge Sei ion
Enationed Assocranons
Preideng Seeden
L ink3
Pirofeeloir Magdalena Czarnecka-Operacz, NID,PhD
PL - PCIZNAN
mczaine2Ounloedunl
ecrerary SBzuen
Prof..Faber5 TEIILEN
Beertsenhoven 4
NL - 6321 PR WIRE
9 -mail psteesdel.azm
Merrilzkers 1 :,dir
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Corne
Wekorne to oUr Web5itC
Dear colleagues.
Lookng back at my first months
ran dedare that 1 am veri praud to he
the neer Chau- of G-I-N.
We expenenced a farrtasbt tongress
In thE wonderful E.eth n.2 of Chicago,
with alrflOgt 450 celeauues trOrn 31
countries anpund the world. Hioh
Guideline ad aptation surre.,
TrIQ .9th
G•I - N coniererue wiII take plane in seou.i.
South Korea dWorld. Design Capital 2010) an
Abstract submissions and treck-.
28-31.augrat 2011.
G-]-N Strategy 2010-2013
The soererfit tammittee of the 20 11 tonterente i 3
working an the preparation of stimulating plenars
"Penary Sessions I-V"
s essions around the them e;
-
Mark
LInkIng evidenterFxdIcy, and practice."
your calendars:
Ae.orE
: 6 5eke =
Dee =
G-I-N: Allgemeiner Ansatz
• Introduction
The Guidelines International network, G-I-N, is a global
network, founded in 2002. It has grown to comprise 94
organisations and 77 individual members representing
46 countries from all continents. The network supports
evidence-based health care and improved health
outcomes by reducing inappropriate variation throughout
the world.
• G-I-N mission…
... to lead, strengthen and support collaboration and
work within the guideline development, adaptation and
implementation community
G-I-N: Hauptziele
• Providing a network and partnerships for guideline
organisations, implementers, end-users, researchers,
students and other stakeholders
• Assisting members in reducing duplication of effort and
improving the efficiency and effectiveness of evidencebased guideline development, adaptation, dissemination
and implementation
• Promoting best practice through the development of
opportunities for learning and building capacity, and the
establishment of high quality standards of guideline
development,
adaptation,
dissemination
and
implementation.
J
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A I •• "
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AGREE
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AGREE: Rolle und Steuergremium
• What is AGREE?
AGREE is an international collaboration of researchers
and policy makers who seek to improve the quality and
effectiveness of clinical practice guidlines by establishing
a shared framework for their development, reporting and
assessment.
• Who are the participants?
The collaboration has the participation of a core of
European countries: Denmark, Finland, France,
Germany, Italy, the Netherlands, Spain, Switzerland and
the United Kingdom as well as Canada, New Zealand and
the USA (See list of AGREE members).
Global medical guidelines: a relevant option?
• Guidelines by WHO as examples,
• Guideline by CIOMS as another example.
Global medical guidelines by WHO
wower .cems.ch -W1ndoffl
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•••••
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httpliciame.rhe
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COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES
ein World Health Organization CH-1211 Geneva 27 (Swilzerlandl
-
OI
MS
New
Horne
Ab mit
Publications
Activ ines
UPDATES
erarikaiCormarderationg for Derehumerri. arra' Appdrtibrr txf a
roebilit ibr modiceal Prodarr Kisk dieflaggeweg t'The plan Is to
develop a pragmatic conseoso 5 iluidelipe5 to be used fty induer? and
regukbars.
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dick Here
CiOMS Furrn 1
LATEST PUBLICATIONS
KEIN C10115 Woi. king Group 1X
Ne are olea seid to announce the lauoch of C]OMS working Group IX,an
News
ermldal
frwevem. Firm.
PradtkalAspectscif Signal
DetectIonlnPha rrnacov igiance
Report of CIOMS sivoddrig Graue
The Report of CICK's :5 Woeldne Group :.;111 atme prenaray to
pro.vide a cetr9tahenäce
eFotdrosecan~devne
deine horrw
soenetest eheir Omaneonichelee esrrteess and prace ree:and to
paCtiCal advice.
Read ra c re
dick Here
FATIEL 131.512/551041
k .15 mith gxeot pleo5ure !Irak CIOMS can ontiounce to vier tnenibet5 the
specken in the CIOMS lincraalionall'ancl Disansire inmemory oE
Protze 5 of Zkrigniess.BEITAM7751:j nn tbe topic: Time berptemerizrziiim of
etkimm' priaciA-5 iuleedicinefrorR behilf to bedsiük. Hon.dzo
pirrmidan rue hieegrate rime Iren ranze of kis pudern with wienre
(reszarcir and erimirs)
Ilae pole' diseassionw2be held in the tnetoory of Professor Zt.eniets!
3einkolvild etw:L .4,e take place an Tuesele. :Cos ealer 2010 frotn
08:45 to 13.43 in roma M303 at W1-10 Headquarters in Geneva
SPLIKEP2
Irgi.tiLahüdlei
111k:ei {luideline,
kir Eperlernloiteral
Studie:
International EthicAl
Guidefnes for Epithemiological Stiches
The Guid e 'Ines set forth Ethicol g tido n ce nn how
suiderniologists - Eis well asthose e•ho sponsu, revIew, or
carticipate in the 511Jdle3ther. chnduct -Ehould identlf and
respond to the ethicad issues that are raised by the prooess
of prcducing this information.
Read ro o re ......1=1 Here
Council for International Organizations of Medical
Sciences
• The Council for International Organizations of Medical
Sciences (CIOMS) is an international, nongovernmental,
not-for-profit organization established jointly by WHO and
UNESCO in 1949.
• CIOMS serves the scientific interests of the international
biomedical community in general and has been active in
promulgating guidelines for the ethical conduct of research,
among other activities. CIOMS promulgated guidelines in
1993 entitled International Ethical Guidelines for Biomedical
Research Involving Human Subjects. These 15 guidelines
address issues including informed consent, standards for
external review, recruitment of participants, and more. The
Guidelines are general instructions and principles of ethical
biomedical research.
http://wikidoc.org/
0
• ealt
International Ethical
Guidelines for Biomedical
Research Involving
Human Subjetts
II>
Prepared by the Council for International Organizations of
Medical Sciences (CIOMS) in collaboration with the
World Healt h Organization (WHO)
CI
MS
Geneva
2032
CIOMS Guidelines
• The
CIOMS
Guidelines,
formally
known
as
International Ethical Guidelines for Biomedical Research
Involving Human Subjects, is a set of ethical principles
regarding human experimentation.
• Created in 1993 by the Council for International
Organizations of Medical Sciences (CIOMS) and updated
in 2002, these 21 guidelines (15 in the original report)
address issues including informed consent, standards for
external review, recruitment of participants, and more.
The Guidelines are general instructions and principles of
ethical biomedical research
http://wikidoc.org/
Global medical guideline by CIOMS
Organisational aspects of global medical guidelines:
a global scenario
• International League of Dermatological Societies (ILDS)
joins CIOMS,
• CIOMS coordinates global guideline work,
• CIOMS collaborates with the World Health Organization
(WHO) acting as a clearing house based on the AGREE
instrument.
Global medical guidelines: the complexity challenge
• Problem: management of diseases may have to be
different in highly developed and emerging/developing
countries,
• Solution: for every major disease management is defined
reflecting the current situation in the health care system:
the "two velocities approach“.
The evolving medical guidelines scheme: a trias
• National guidelines,
• Supra-national guidelines, if considered helpful (EU,
NAFTA?, and others),
• Global guidelines