The EUQPPV Organisation: progress to date Objectives of this session

Transcription

1 The EUQPPV Organisation: progress to date Objectives of this session Review the history and progress to date of The EUQPPV Organisation. Present the current and planned future structure and governance of the organisation. Revisit and finalise objectives agreed at last years Forum. Obtain your input. Launch the organisation ASAP. 2 1

2 Background Annual EUQPPV forums since 2005 EUQPPV Organisation discussed at 2007 Forum Initial Organisation Team established from volunteers ou eesafter 2007 Forum ou First proposals presented to Forum Progress since 2008 Forum Nominated an expanded working group for The EUQPPV Organisation Analysed options for organisation support / cooperation with 3rd parties infrastructure fees governance Drilled down into Objectives We are ready to establish The Organisation 4 2

3 But what to call ourselves? 5 Members of The EUQPPV Organisation Working Group How were they chosen? Volunteers from last years DIA meeting Different countries/cultures represented Different types of Pharma company Different sizes of Pharma company Different lengths of EUQPPV experience Different backgrounds Acknowledgement: Karen Pattenden contributed significantly to the working group through last year 6 3

4 Name Background PV experience EU QPPV experience Conxita Barajas Spain Physician Currently small pharma. Large Pharma and Clinical research experience 13 years of PV experience 1 year Charlotte Barrett Life Small Pharma (Generics and Orphan) 10 years Scotland Sciences Large Pharma and merger experience Janet Hormbrey: Belgium/UK: 15 years Physician: PV experience Large Pharma Irina Baeumer 20 years in global research management and clinical development, all phases Physician Small and large Pharma 5 years Germany Experience in WHO research program 2 years of EUQPPV experience 12 years PV experience Jean-Paul Physician Small Orphan product company 7 years Dutertre Deirdre McCarthy : Ireland: Experience Life sciences: in France s Contract regional organisation PV France Experience with Irish medicines centers, as board, well as and large medium Pharma, sized phase Pharma 12 years PV experience, 1 studies 3 years EUQPPV experience 20 years PV experience, Elspeth McIntosh: Physician Large Pharma UK : Nurse: Small innovator/generic company 2 years Janet Hormbrey 20 years in global research Belgium/UK Experience with small management companies, biotech/biologicals, and clinical development, innovative and generic all phases Deirdre 14 years Life PV sciences experience, CRO, 10 Experience years EUQPPV with experience IMB and medium 3 years McCarthy sized Pharma Ireland 12 years PV experience, Elspeth Nurse Small innovator/generic company 10 years McIntosh Experience with small companies, UK biotech/biologicals, innovative and i 14 PV i 7 DIA to support The Organisation Provide infrastructure to The EUQPPV Organisation Differentiate The EUQPPV Organisation from topic SIACs Establish and maintain a Networking Platform / Web Office Continue to organize the annual EUQPPV forum Organize webinars or other communication venues Assist with recruitment of members ( advertising, mailing) Support advertizing of The EUQPPV Organisation DIA membership gives you membership of The EUQPPV Organisation You will hear later in this session from the DIA 8 4

5 EUQPPV Organisation Meetings One annual meeting In the future will encompasses the AGM Interim webcasts or webinars Ad hoc meetings 9 Current EUQPPV Organisation Oversight Advisors to Steering (Christine Bendall, Anya Sookoo + others) Steering (Val Simmons, Thomas Steinbach, Brian Edwards, Vicki Edwards, Janet Hormbrey & Steve Douglas) Organisation is supported by DIA who will provide meetings, admin facilities, webinars etc. EUQPPV Organisation Working Group (Lead Janet Hormbrey) Training and Curriculum Working Group (Lead Steve Douglas) EUQPPV Forum Organising Group 10 5

6 Current EUQPPV Organisation Oversight Advisors to Steering Steering EUQPPV Organisation Working Group Lead Janet Hormbrey, Conxita Barajas, Charlotte Barrett, Irina Baeumer, Jean-Paul Dutertre, Deirdre McCarthy, Elspeth McIntosh. Training and Curriculum Working Group EUQPPV Forum Organising Group 11 Current EUQPPV Organisation Oversight Advisors to Steering Steering EUQPPV Organisation Working Group Training and Curriculum Working Group Lead Steve Douglas, Janet Green, Sarah Daniels, Jean-Loup Thomas. EUQPPV Forum Organising Group 12 6

7 Current EUQPPV Organisation Oversight Advisors to Steering Steering EUQPPV Organisation Working Group Training and Curriculum Working Group EUQPPV Forum Organising Group Currently the Steering volunteers sought for next year. 13 The EUQPPV Organisation The draft plan for the first 5 years 7

8 First 6 months By Forum 2010 (Year 1) By Forum 2011 (Year 2) Define partnership with business partner First members enrolled First elections to Constitution, objectives and metrics to be agreed Website established (ongoing) Review/monitor business partnership LAUNCH THE ORGANISATION Establish on-line forums (ongoing) First benchmarking Send out call for members Launch webinars in conjunction with Training Group (ongoing) 15 By Forum 2012 (Year 3) By Forum 2013 (Year 4) By Forum 2014 (Year 5) First elected committee Elections Elections Formal review of organisation structure Decision on organisation structure at AGM Review and revision of constitution Establish mentoring programme (ongoing) Possible actions resulting from structure decision 16 8

9 The EUQPPV Organisation - Objectives Objective 1 To provide a unique specialist & focused forum for EUQPPVs to address issues relevant to the EUQPPV role Objective 2 To share and disseminate best practice & experience with respect to the EUQPPV role Explore the potential for mentoring /networking Provide opportunities for benchmarking Objective 3 To provide opportunities to EUQPPVs to Influence guidance and policies with respect to the EUQPPV role. To link with key industry associations regulatory bodies such that t the organisation s specialist/expert opinion is known, sought and recognised. e.g. To review current and planned regulations and guidance that have an impact on the EUQPPV role, to develop positions statements for the EUQPPV role Objective 4 Move towards developing minimum recommended standards Establishment of a recommended training curriculum 17 The EUQPPV Organisation Objective 1 To provide a unique specialist & focused forum for EUQPPVs to address issues relevant to the EUQPPV role 18 9

10 The EUQPPV Organisation Objective 2 To share and disseminate best practice & experience with respect to the EUQPPV role Explore the potential for mentoring /networking g Provide opportunities for benchmarking 19 The EUQPPV Organisation Objective 3 To provide opportunities to EUQPPVs to influence guidance and policies i with respect to the EUQPPV role. To link with key industry associations/ regulatory bodies such that the organisation s specialist/expert opinion is known, sought and recognised. e.g. To review current and planned regulations and guidance that have an impact on the EUQPPV role, to develop positions statements for the EUQPPV role 20 10

11 The EUQPPV Organisation Objective 4 Move towards developing minimum recommended standards Establishment of a recommended training curriculum 21 Next steps Your feedback and initial comments are welcome now If there is insufficient time today, questions received on comment cards will be addressed during tomorrow s surgery session. Additional comments would also be welcome during tomorrow s one on one session if preferred If you re an EUQPPV and a DIA Member that makes you a founding member of The EUQPPV Organisation! If you are not yet a DIA member you can apply for membership at this meeting. Leave us your business card/contact details for further information