Report - HMA/EMEA Office of Training Steering Group

1. Report - HMA/EMEA Office of Training Steering Group Dr. Gro Ramsten Wesenberg Co-chair

2. The presentation • Overview –OTSG - first year of operation • Expert Group of Quality Assessors • Work report • Competence requirements and training needs for Quality Assessors document • Availability of scientific and regulatory training - 2011 • Proposal for an OTSG webpage

3. OTSG - terms of reference • manage the creation of the EU Office of training • provide strategic guidance to the subsequent operation of this office • identify, seek and obtain the resources necessary for the operation of the office • act as a link between the Office, HMA and EMA • act as a referral body to resolve issues related to the composition or operation of Expert Groups which cannot be resolved within the group itself or at the level of the Office.

4. OTSG - first year of operation • Members of OTSG: • Gro Ramsten Wesenberg, co-chair (NO) • David Mackay, co-chair (EMA) • Per Helboe (DK) • Christa Wirthumer-Hoche (AT) • Truus Janse de Hoog ( NL) • Gabriel Beechinor (IMB) • Usfeya Muazzam (BFARM) • Alar Irs (ET) • Renate McIntyre (IMB) • Nuala Harman, admin. support (IMB) • Iveta Karabozhilova, scientific support (EMA)

5. OTSG - first year of operation • 6 virtual meetings • Followed the action plan endorsed by HMA • Initiated a pilot study – quality of medicines • Survey of training availabilities for EMRN • Revision of webpage • Office only partly set up • Admin support from IMB • Scientific support from EMA

6. Expert group - quality assessors Mandate: • define and document the competence and knowledge requirements for quality assessors (basic and advanced), • define and document the training curricula required to meet the needs of quality assessors, • support the Training Office in preparation of a detailed inventory of training available to the network from EMA, NCAs and external suppliers of training,

7. Expert group - quality assessors Mandate cont’d: • define criteria for harmonised assessment of competence to be applied by the national agencies within the network, • assist the Office in a gap analysis to identify unmet needs in terms of training for quality assessors.

8. Expert group - quality assessors Composition: • Cornelia Nopitsch-Mai (DE) – Chair • Susanne Stotter (AT) • Diana van Riet (NL) • Gorm Jörgensen (DK) • Andrea Cseh-Palos (HU) • Malcolm Dash (UK) • Norbert Möller (DE, vet) • Piotr Kozarewicz and Ruben Pita (EMA) • Renate McIntyre (IMB) (learning and development)

9. Expert group - quality assessors Key criteria for roles: • Scientific knowledge and skills • Regulatory knowledge and experience • Challenge within the role • Decision making/level of responsibility • Social skills and attunement to internal and external context

10. Expert group - quality assessors • Report on competence requirements and training needs for Quality Assessors • Grades of quality assessors • Grade 1 - entry level • Grade 2 - career grade • Grade 3 – advanced expert • Work allocation per grade defined • Comments on the report highly appreciated • The OTSG thanks the expert group for excellent work

11. Training availabilities - 2011 • List enclosed in HMA-papers • Survey among NCAs • 52 % reponded • Online desk-based search of the internet • Not for profit orgnaisations • Universities • No quality assurance has been obtained

13. What are needed from HMA today? Most documents for information only, but: • Endorsement for the report of the first year of operation by the OTSG. • Any input from the HMA regarding • the report of the Expert Group of Quality Assessors • proposal for the OTSG webpage.

14. Thank you for your attention!