WORKING ING G GROUP 3& 3&5: 5: PUBLIC-PRIVATE - - PowerPoint PPT Presentation

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WORKING ING G GROUP 3& 3&5: 5: PUBLIC-PRIVATE - - PowerPoint PPT Presentation

Apr 16, 2023 373 likes •502 views

WORKING ING G GROUP 3& 3&5: 5: PUBLIC-PRIVATE PARTNERSHIP Susan Tansey / Pirkko Lepola Chair / Co-Chair WG 3&5 25/10/2017 Enpr-EMA CG TC / WG3+5 1 Enp npr-EM EMA WG 3 G 3&5 &5 Role: le: Facilitat ilitate

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SLIDE 1

WORKING ING G GROUP 3& 3&5: 5: PUBLIC-PRIVATE PARTNERSHIP

Susan Tansey / Pirkko Lepola Chair / Co-Chair WG 3&5

25/10/2017 Enpr-EMA CG TC / WG3+5 1

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SLIDE 2

Enp npr-EM EMA WG 3 G 3&5 &5

Role: le:

  • Facilitat

ilitate communication b betw tween een in industry an and netw tworks

  • Gathe

her e examples of

  • f good
  • od pra

ractice f from

  • m Networks

an and in industry w workin king wi with h En Enpr-EMA n net etworks ks

  • Develop
  • p p

prop

  • pos
  • sals t

to

  • disseminate examples of
  • f good
  • od

pr pract ctice ce t to En Enpr-EMA networks and d in industry

25/10/2017 Enpr-EMA CG TC / WG3+5 2

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SLIDE 3

En Enpr-EMA WG 3& G 3&5

25/10/2017 Enpr-EMA CG TC / WG3+5

Current W WG 3&5 m members: Martine Dehlinger-Kremer Stefanie Breitenstein Susan Tansey ( Acting Chair) Pirkko Lepola (Co-Chair) Jenny Preston Pamela Dicks Andrea Waβmuth Grünenthal Mark Sorrentino PRA Industr try y colla llaborators f for W WG 3&5 r recom

  • mmend

ndati tion

  • n:
  • Dr. Colin Hayward, Chief Medical Officer at Premier Research
  • Dr. Enrico Bosone - Director Patient Access Policy, EMEA Celgene
  • Dr. Chris Walker - Regulatory Affairs Executive Director Amgen

3

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SLIDE 4

Compl pleted t ed task 1 1.; Network & Industry survey; 12/2013 - 02/2014 Deliv iverable le 1 1: Public licatio ion: ‘ ‘Pharma maceutic ical I l Industry a and Pedia iatric ic Clin inic ical T l Trials ls n networks i in Europe- ho how d w do the they y commu mmunicate?’ , , Applied Clinica

cal Trials, s, Jan 08 2 2016. 6. Pirkk kko L Lepola, Susan Tanse sey, Pamela Dicks, ks, Jennifer P Prest ston, Marti tine Dehling nger er-Kre Kremer er

Tas ask 2.; 2.; Netwo work c rk consulta tation reco commendat ation; 1 12/ 2/20 2015 15 – 03/ 03/20 2017 Deliv iverable le 2 2: Con

  • nsultat

ation

  • n recommendat

ation

  • n doc
  • cument + diag

agram to

  • be

placed d on Enpr pr-EMA website e for r the e spons nsors a and nd CROs Os;

  • Distributed for consultations; 06/2016 – 08/2016
  • Final d

draft 0 04/20 2017; 7; ve version

  • n 1

10 . Enp Enpr-EMA WG 3 G 3&5 &5

25/10/2017 Enpr-EMA CG TC / WG3+5 4

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SLIDE 5

Version 10.0 – Consultation diagram

16/05/2017 Enpr-EMA Annual WS / WG3+5 5

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SLIDE 6

25/10/2017 Enpr-EMA CG TC / WG3+5 6

Version 10.0 – 1.st contact

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SLIDE 7

16/05/2017 Enpr-EMA Annual WS / WG3+5 7

Version 10.0 -1st contact (cont.)

Etc..

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SLIDE 8

Enpr-EMA A WG 3& 3&5 5

Next st steps; T Task sk 3 3.

pr propo

  • posal f

for

  • r Enp

Enpr-EM EMA C CG (as

as presented at at las ast W WS S May 2 2017):

): ■ Pilo ilot p perio iod - test est ph phase se - for

  • r usi

sing t these ese ser services FOR F R FRE REE (*!) !) ■ Sel elec ection of

  • f inter

erested c d com

  • mpa

panies f for

  • r pi

pilot ph phase se ( (e. e.g. 5 5-6) 6) ■ Se Select ction o

  • f

f interested n networks ( (e.g. 5 5-6) 6) ■ Max. 1

  • Max. 1-2 c

case ses / c / com

  • mpa

pany to be ser

  • be served

■ After er pi pilot ph phase se; su survey to

  • these

ese c com

  • mpa

panies; e evaluation a and d analysi sis o s of these s e servi vices es – did id t they brin ing a any v valu lue?-> > Po PoC ■ Pu Publ blication of

  • f the

e su survey r resu esults; c col

  • llected

ed e exper perien ence ■ Dec ecision of

  • f the

e con

  • ntinuation; wi

with th OR OR wi witho thout the t the fees

25/10/2017 Enpr-EMA CG TC / WG3+5 8

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SLIDE 9

Enp npr-EM EMA WG 3 G 3&5 &5

■ Str trongly relat elated ed t to 3 ongoin ing d develo elopmen ents – Fees for services

■ Discussed with the PDCO 8Nov2016

– IMI2 Call 10 project

■ WP1-4 – Governance, Innovation, Business Case

– Enpr-EMA Network Survey 2017

■ Identification of network services for 1-4 Consultation and New Network Categorization

– NEW link: WG Trial Preparedness

25/10/2017 Enpr-EMA CG TC / WG3+5 9

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SLIDE 10

Enpr-EMA A WG 3& 3&5 5

Next s t step eps; Task 3: 3: log logis istics

■ Selecti tion o

  • f n

networks prepared t to p parti ticipate i in Pilot t FOR FR FREE*

(*=no f fee b e by Enpr pr-EMA! ! – if t the r e req eques est requires es eg

  • eg. C

Consultation A Agree eemen ent, n net etwork e exper erts can d do that at b by the e network f fees es – we c cannot g guar arantee free ee ser ervices es – too broad l list o t of services / expertis tise f for s sele lectio tion)

– Circulat ation o

  • f q

questionnai aire – Su Survey ( (“Tick B Box

  • x”) to map e

each n network real practi tical c capabiliti ties a according t to the R Recommendat ation ( (timepoints ts 1.-4.) –list o

  • f s

services es –diffe ferent f from t the WG Networ

  • rk S

Survey ■ Selec ection o

  • f i

inter eres ested ed companies es for pilot p t phase – Approached ed b by P PRA – ? I IMI MI2 C Call 10 sponsors ■ Proposal t that e each n net etwork propose se their o

  • wn fee a

e and administ ster er it – Could v vary depen ending on c complexity o

  • f t

the PIP a and services es required ed/provided ed – Net etworks c s curren ently c charging f for similar s services es may b be a able to provide a e advice e regarding a appropriate e fees es ■ After p pilot p t phase; survey y to th these companies; e evaluation and a analysis o

  • f th

these ser services s – did t they y bring a any v y value ue?-> > PoC ■ Publication o

  • f t

the survey r resu sults; c collec ected ed e exper erien ence ■ Decision of t the c conti tinuati tion

25/10/2017 Enpr-EMA CG TC / WG3+5 10

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SLIDE 11

Enpr-EMA WG 3&5

■ Example of the ”Tick Box” -survey to selected networks (5-6)

25/10/2017 Enpr-EMA CG TC / WG3+5 11

These are the listed services under the 1.-4. timepoint s X

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SLIDE 12

Enpr-EMA WG 3&5

25/10/2017 Enpr-EMA CG TC / WG3+5 12

Etc..etc. Accross all timepoints 1.-4.

X X X