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

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 communication b betw tween een in industry an and netw tworks • Gathe her e examples of of good ood pra ractice f from om Networks an and in industry w workin king wi with h En Enpr-EMA n net etworks ks • Develop op p prop opos osals t to o disseminate examples of of good ood pr pract ctice ce t to En Enpr-EMA networks and d in industry 25/10/2017 Enpr-EMA CG TC / WG3+5 2

En Enpr-EMA WG 3& G 3&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 Wa βmuth Grünenthal Mark Sorrentino PRA Industr try y colla llaborators f for W WG 3&5 r recom ommend ndati tion on: 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 25/10/2017 Enpr-EMA CG TC / WG3+5 3

Enpr-EMA Enp WG 3 G 3&5 &5 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 onsultat ation on recommendat ation on doc ocument + diag agram to o 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 on 1 10 . 25/10/2017 Enpr-EMA CG TC / WG3+5 4

Version 10.0 – Consultation diagram 16/05/2017 Enpr-EMA Annual WS / WG3+5 5

Version 10.0 – 1.st contact 25/10/2017 Enpr-EMA CG TC / WG3+5 6

Version 10.0 -1st contact (cont.) Etc.. 16/05/2017 Enpr-EMA Annual WS / WG3+5 7

Enpr-EMA A WG 3& 3&5 5 Next st steps; T Task sk 3 3 . pr propo oposal f for or Enp Enpr-EM EMA C CG (as 2017 ): ): as presented at at las ast W WS S May 2 ■ Pilo ilot p perio iod - test est ph phase se - for or usi sing t these ese ser services FOR F R FRE REE (*!) !) ■ Sel elec ection of of inter erested c d com ompa panies f for or pi pilot ph phase se ( (e. e.g. 5 5-6) 6) ■ Se Select ction o of f interested n networks ( (e.g. 5 5-6) 6) ■ Max. 1 Max. 1-2 c case ses / c / com ompa pany to be ser o be served ■ After er pi pilot ph phase se; su survey to o these ese c com ompa 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 of the e su survey r resu esults; c col ollected ed e exper perien ence ■ Dec ecision of of the e con ontinuation; wi with th OR OR wi witho thout the t the fees 25/10/2017 Enpr-EMA CG TC / WG3+5 8

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

Enpr-EMA A WG 3& 3&5 5 Next s t step eps; Task 3: 3: log logis istics ■ Selecti tion o of 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 of q questionnai aire – Su Survey ( (“Tick B Box ox”) 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 of s services es –diffe ferent f from t the WG Networ ork S Survey ■ Selec ection o of 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 own fee a e and administ ster er it – Could v vary depen ending on c complexity o of 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 of th these ser services s – did t they y bring a any v y value ue?-> > PoC ■ Publication o of 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

Enpr-EMA WG 3&5 ■ Example of the ”Tick Box” -survey to selected networks (5-6) These are the listed services under the 1.-4. timepoint s X 25/10/2017 Enpr-EMA CG TC / WG3+5 11

Enpr-EMA WG 3&5 X X Etc..etc. X Accross all timepoints 1.-4. 25/10/2017 Enpr-EMA CG TC / WG3+5 12