2 0 0 9 report on the interaction w ith Patients and Consum ers - - PowerPoint PPT Presentation

▶
2 0 0 9 report on the interaction w ith patients and
SMART_READER_LITE
LIVE PREVIEW

2 0 0 9 report on the interaction w ith Patients and Consum ers - - PowerPoint PPT Presentation

Mar 26, 2023 348 likes •502 views

2 0 0 9 report on the interaction w ith Patients and Consum ers Organisations PCWP plenary meeting 16 June 2010 An agency of the European Union Overview of PCOs evaluation So far, 58 PCOs have applied for eligibility: 28 positive, 22

slide-1
SLIDE 1

An agency of the European Union

2 0 0 9 report on the interaction w ith Patients’ and Consum ers’ Organisations

PCWP plenary meeting 16 June 2010

slide-2
SLIDE 2

2

Overview of PCOs evaluation

So far, 58 PCOs have applied for eligibility: 28 positive, 22 negative, 8 suspended/ withdrawn

Positive outcome Negative outcome Withdrawn/suspended

slide-3
SLIDE 3

3

Patients' and Consumers' Organisations working with EMA in 2007-2009

Nam e of the organisation Fulfilm ent of EMA eligibility criteria I nvolvem ent in 2 0 0 9 I nvolvem ent in 2 0 0 8 I nvolvem ent in 2 0 0 7 1 Alzheimer Europe (AE)

YES YES YES YES

2 European AIDS Treatment Group (EATG)

YES YES YES YES

3 European Cancer Patient Coalition (ECPC)

YES YES YES YES

4 European Federation of Allergy and Airways Diseases Patients' Associations (EFA)

YES YES

5 European Federation of Neurological Associations (EFNA)

YES YES YES YES

6 European Genetic Alliances' Network (EGAN)

YES YES YES YES

7 European Heart Network (EHN)

YES YES YES

8 European Multiple Sclerosis Platform (EMSP)

YES YES YES

9 European Myeloma Platform (EMP)

YES YES YES YES

10 European Older People's Platform (AGE)

YES YES

11 European Organisation for Rare Diseases (EURORDIS)

YES YES YES YES

12 European Parkinson's Disease Association (EPDA)

YES YES YES YES

13 European Patients' Forum (EPF)

YES YES YES YES

14 European Public Health Alliance (EPHA)

YES YES YES YES

15 Global Alliance for Mental Illness Advocacy Networks (GAMIAN-Europe)

YES YES

16 Health Action International (HAI)

YES YES YES YES

17 Insulin Dependent Diabetes Trust (IDDT)

YES YES YES YES

18 International Alliance of Patients' Organizations (IAPO)

YES YES YES YES

19 International Diabetes Federation (IDF)

YES YES YES YES

20 International Patient Organisation for Primary Immunodeficiencies (IPOPI)

YES YES YES YES

slide-4
SLIDE 4

4

Nam e of the organisation Fulfilm ent of EMA eligibility criteria I nvolvem ent in 2 0 0 9 I nvolvem ent in 2 0 0 8 I nvolvem ent in 2 0 0 7 21 Myeloma Euronet (ME)

YES YES YES YES

22 Rett Syndrome Europe (RSE)

YES YES YES

23 Thalassaemia International Federation (TIF)

YES YES YES

24 The European Consumers' Organisation (BEUC)

YES YES YES YES

25 The International Confederation of Childhood Cancer Parents Organisations (ICCCPO)

YES YES YES

26 Action Duchenne UK

NO YES

27 Charley's Fund, USA

NO YES

28 Cure Duchenne, USA

NO YES

29 Duchenne Ireland

NO YES

30 Duchenne Parent Project

NO YES

31 European Network of Fibromyalgia Associations (ENFA)

NO YES

32 Forschung und Therapie fuer SMA

NO YES

33 Gaucher Gesellschaft Deutschland E.V. (GGD E.V.)

NO YES

34 Muscular Dystrophy Association (MDA)

NO YES YES

35 Muscular Dystrophy Campaign, UK

NO YES

36 Parent Project Australia

NO YES

37 Parent Project Onlus Italy

NO YES

38 Thalidomide UK

NO YES YES

39 TREAT-NMD Neuromuscular Network

NO YES YES

40 United Parent Projects Muscular Dystrophy (UPPMD)

NO YES YES

41 Vaincre la Mucoviscidose

NO YES

slide-5
SLIDE 5

5

Patients and consumers have participated in EMA activities during 2009 as:

  • Members of committees/ working parties
  • Experts
  • Representatives of organisations
slide-6
SLIDE 6

6

Activities in which patients and consumers were involved as members of committees/ working parties

Members of the Management Board 2 Members and observers of the COMP 3 Members and alternates of the PDCO 3+ 3 Members and alternates of the CAT 2+ 2 PCWP 10+ 8 Observers at the HCP WG 2 Total 35

slide-7
SLIDE 7

7

Main activities in which patients and consumers were involved as experts

Working Group on Clinical Trials in third countries 6 SAG meetings 3 PhVWP consultations 3 SAWP discussions 3 Q&A preparation 2 Workshops 16 Review of EPAR summaries 36 Review of Package Leaflets 33 … Total 108

slide-8
SLIDE 8

8

Main activities in which patients and consumers were involved as representatives of organisations

Pilot phase observers at PhVWP 2 Meeting with EC on the pharma-package 9 PhVWP consultations 16 Input on EMA corporate identity 10 Meetings of ENCePP 1 Meetings of PROTECT 1 Workshops on Transparency Policy 9 EudraCT information day 3 CHMP consultations 3 … Total 70

slide-9
SLIDE 9

9

Involvement of patients and consumers in EMA activities in 2007-2009

20 40 60 80 100 120 Experts Representatives of organisations Members of committees/working parties 2007 2008 2009

slide-10
SLIDE 10

10

Patients and consumers involved in EMA activities in 2007-2009

20 40 60 80 100 120 2007 2008 2009 Experts Representatives of organisations Members of committees/working parties

slide-11
SLIDE 11

11

Total number of patients and consumers involved in EMA activities in 2007-2009

2007 2008 2009 50 100 150 200 250

slide-12
SLIDE 12

12

Review of EPAR summaries and Package Leaflets

10 20 30 40 50 60 70 80 2007 2008 2009 EPAR summaries Package Leaflets

slide-13
SLIDE 13

13

Conclusions

  • 2009 has seen a further increase in the level of involvement of

patients and consumers in EMA activities

  • Clear distinction of patients/ consumers involvement as:
  • Members
  • Experts
  • Representatives
  • Observers
  • 2009 report to be circulated to PCWP by the end of June 2010

for comments

slide-14
SLIDE 14

14

Next steps

  • The “Framework of interaction” between the EMA and PCOs will be

extensively revised during 2010:

  • PCOs representatives will continue to be involved in the preparation of

information oriented to patients and the general public

  • Further involvement:
  • Benefit/ risk assessment
  • Training
  • Role in scientific committees
  • Emerging safety issues
slide-15
SLIDE 15

15

Thank you for your attention