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

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

3. OTSG - terms of reference l manage the creation of the EU Office of training l provide strategic guidance to the subsequent operation of this office l identify, seek and obtain the resources necessary for the operation of the office l act as a link between the Office, HMA and EMA l 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. 3

4. OTSG - first year of operation l 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) 4

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

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

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

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

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

10. Expert group - quality assessors l 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 l Work allocation per grade defined l Comments on the report highly appreciated l The OTSG thanks the expert group for excellent work 10

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

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

14. Thank you for your attention! 14