Annexes to the Stakeholder engagement annual report 2017
Annex I: Involvement in EMA activities (2009-2017)............................................................... 2 Annex II: Membership of patients and healthcare professionals in EMA Management Board and Scientific Committees.......................................................................................................... 4 Annex III: Membership of patients and healthcare professionals in EMA working parties .............. 5 Annex IV: Workshops attended by patients and healthcare professionals in 2017 ....................... 6 Annex V: Participation in EMA Workshops (2009-2017) ........................................................... 7 Annex VI: Patient and healthcare professional involvement in EMA activities (2009-2017) ........... 8 Annex VII: Documents reviewed (2007-2017) by patients and healthcare professionals .............. 9 Annex VIII: Eligible organisations working with EMA .............................................................. 11
Page 1 of 12
Annex I: Involvement in EMA activities (2009-2017) A: Patients and consumers
MB/ Committee/WP members
Individual experts
Representatives of their organisations
534 433
87 26 22 28
2007
33
108
47
2008
35
70
2009
46
86
2010
47
2011
345 277
242
240241
200 176
175
359 331
336
333
163 44
55
2012
Page 2 of 12
2013
55
2014
53
2015
60
2016
59
2017
B: Healthcare professionals
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Annex II: Membership of patients and healthcare professionals in EMA Management Board and Scientific Committees A: Membership of patients in EMA management board and scientific committees EMA Management Board and Scientific Committees
Members /alternates
Governance: Management Board (MB)
2
Scientific Committees: Committee for Orphan Medicinal Products (COMP)
3
Paediatric Committee (PDCO)
3/3
Committee for Advanced Therapies (CAT)
2/2
Pharmacovigilance and Risk Assessment Committee (PRAC)
1/1
TOTAL
17
B: Membership of healthcare professionals in EMA management board and scientific committees EMA Management Board and Scientific Committees
Pharmacovigilance and Risk Assessment Committee (PRAC)
1/1
TOTAL
14
Page 4 of 12
Annex III: Membership of patients and healthcare professionals in EMA working parties A: Patient and consumer membership of working parties Membership of working parties (WP)
Members /alternates (observers)
Patients and Consumers Working Party (PCWP) + co-chair
20+1 / 21
HealthCare Professionals Working Party (HCPWP)
2
TOTAL
40
B: Healthcare professional membership of working parties Membership of working parties (WP)
Members
HealthCare Professionals Working Party (HCPWP) + co-chair Patients and Consumers Working Party (PCWP)
19 / 22+1 1
TOTAL
43
Page 5 of 12
Annex IV: Workshops attended by patients and healthcare professionals in 2017 Month
Workshop
January
Multi-stakeholder paediatric oncology strategy workshop (cancers with
Patients
HCP
X
X
anaplastic lymphoma kinase aberrations) March
PCWP/HCPWP-Joint workshop on personalised medicines
X
X
March
Public-private collaborations & partnerships for vaccine benefit-risk
X
X
monitoring in Europe: the ADVANCE framework and governance principles March
Workshop on revising the guideline on strategies to identify and mitigate
X
risks for first-in-human clinical trials with investigational medicines March
Seventh Framework Programme (FP7) small-population research methods
X
X
X
X
projects and regulatory application workshop May
2017 annual workshop of the European network of paediatric research at the European Medicines Agency (Enpr-EMA)
May
First anniversary of PRIME: experience so far
X
June
Joint workshop addressing unmet needs of children with pulmonary arterial
X
X
hypertension (PAH) June
Cystic fibrosis workshop - Registries initiative
X
July
Multiple Sclerosis (MS) Registries – Workshop
X
September
Payer Community meeting
X
September
PCWP and HCWP joint meeting: info session on antimicrobial resistance
X
X
(AMR) September
Eleventh stakeholder forum on the pharmacovigilance legislation
X
X
September
Interested Parties meeting with the Biosimilar Medicinal Products Working
X
X
X X
X
X
X
X
X
X X X
X X X
Party October October
November November December December December
EU clinical trials portal and Union database meeting with Stakeholders Joint Drug Information Association (DIA) / European Forum for Good Clinical Practice (EFGCP) /European Medicines Agency (EMA) conference on how to optimise children's access to innovative medicines Second paediatric strategy forum on medicine development for mature B cell malignancies in children EMA/DIA information day on measuring the impact of pharmacovigilance activities Data anonymisation workshop A common data model in Europe? – Why? Which? How? Workshop on site and histology - Independent indications in oncology
Page 6 of 12
Annex V: Participation in EMA Workshops (2009-2017) A: Patients
142
138
115 104 87
44 18 3
5
2009
2010
2011
2012
2013
B: Healthcare professionals
Page 7 of 12
2014
2015
2016
2017
Annex VI: Patient and healthcare professional involvement in EMA activities (2009-2017) A: Patients
2009
2010
2011
2012
2013
2014
2015
2016
2017
131 104 76
3
13
13
19
28
82
37
SA/PA/HTA procedures
36 14
22
46 33
35 23
28
3
25 3
SAG/ad hoc expert meetings
B: Healthcare professionals
Page 8 of 12
8
7
13
24
10
Committee consultations
32
Annex VII: Documents reviewed (2007-2017) by patients and healthcare professionals
A: Patients
2007
2008
2009
2010 91
2011
80 70
2012
2013
2014
2015
2016
2017
95 80 71 58
48 47 27
32
38
36
35
39
14
36
39
39
41
39
33
27 11
9
24
44 29
24
19
10
2
Medicine overview
Package leaflet
Safety communication
Page 9 of 12
Herbal Summaries
34
B: Healthcare professionals
Page 10 of 12
Annex VIII: Eligible organisations working with EMA A: Patient and Consumer organisations
1
AGE Platform Europe (AGE)
2
Alzheimer Europe (AE)
3
Debra International
4
European AIDS Treatment Group (EATG)
5
European Cancer Patient Coalition (ECPC)
6
European Federation of Allergy and Airways Diseases Patients' Associations (EFA)
7
European Federation of Neurological Associations (EFNA)
8
European Foundation for the Care of Newborn Infants (EFCNI)
9
European Gaucher Alliance (EGA)
10
European Genetic Alliances' Network (EGAN)
11
European Haemophilia Consortium (EHC)
12
European Headache Alliance (EHA)
13
European Heart Network (EHN)
14
European Institute of Women’s Health (EIWH)
15
European Liver Patient Association (ELPA)
16
European Multiple Sclerosis Platform (EMSP)
17
European Network of Fibromyalgia Associations (ENFA)
18
European Organisation for Rare Diseases (EURORDIS)
19
European Parkinson's Disease Association (EPDA)
20
European Patients' Forum (EPF)
21
European Prostate Cancer Coalition (EUomo)
22
European Public Health Alliance (EPHA)
23
Fabry International Network (FIN)
24
Global Alliance for Mental Illness Advocacy Networks (GAMIAN-Europe)
25
Health Action International (HAI)
26
International Alliance of Patients' Organizations (IAPO)
27
International Bureau of Epilepsy (IBE)
28
International Diabetes Federation European Region (IDF Europe)
29
International Patient Organisation for Primary Immunodeficiencies (IPOPI)
30
Myeloma Patients Europe (MPE)
31
Pain Alliance Europe (PAE)
32
Spinal Muscular Atrophy Europe (SMAE)
33
Thalassaemia International Federation (TIF)
34
The European Consumers' Organisation (BEUC)
35
United Parent Projects Muscular Dystrophy (UPPMD)
Page 11 of 12
B: Healthcare professional organisations
1
European Academy of Allergy and Clinical Immunology (EAACI)
2
European Academy of Paediatrics (EAP)
3
European Academy of Neurology (EAN)
4
European Association for Clinical Pharmacology and Therapeutics (EACPT)
5
European Association of Hospital Pharmacists (EAHP)
6
European Association for the Study of Diabetes (EASD)
7
European Association of Urology (EAU)
8
European College of Neuropsychopharmacology (ECNP)
9
European Federation of Internal Medicine (EFIM)
10
European Forum for Primary Care (EFPC)
11
European Haematology Association (EHA)
12
European League Against Rheumatism (EULAR)
13
European Headache Federation (EHF)
14
European Renal Best Practice (ERBP)
15
European Respiratory Society (ERS)
16
European Society of Cardiology (ESC)
17
European Society of Endocrinology (ESE)
18
European Society for Medical Oncology (ESMO)
19
European Specialist Nurses Organisations (ESNO)
20
European Society of Oncology Pharmacy (ESOP)
21
European Society of Radiology (ESR)
22
European Union of General Practitioners / Family physicians (UEMO)
Annexes to the Stakeholder engagement annual report 2017
A: Membership of patients in EMA management board and scientific committees ... Stakeholders. X. X. October. Joint Drug Information Association (DIA) / European Forum for Good Clinical ... European Institute of Women's Health (EIWH). 15.
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