Gedanken eines Qualitätsgutachters Die Wahl der QUAL

Transcription

1 Gedanken eines Qualitätsgutachters Die Wahl der QUAL Dr. Peter Platzer Abteilungsleiter Arzneimittelqualität (QUAL) AGES Gespräch Österreich als RMS (Reference Member State) Wien, Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH

2 Your expectations regarding Quality Assessment? 2

3 Your expectations regarding Quality Assessment? High scientific quality / Competence Reliability of scientific assessment / Lasting decisions for European Procedures Pragmatic decisions / Well-considered questions Active participation within EU Reliability in timely manner / flexibility Direct and individual contact to assessors and, of course, all of that not too expensive 3

4 What we can provide 4

5 One umbrella Assessment of all applications for Marketing Authorisation, Variation and Renewal (CP, MRP, DCP, national; CEP) Assessment of human and veterinary dossiers Contribution to and cooperation with respective Working Parties, Groups of EMA and EDQM Triages Scientific Advice* Bioanalytics in BE-Studies Internal and external Training-Programs * Quality assessment also undertaken in other Department 5

6 Quality Assessment of Medicinal Products High degree of flexibility as each assessor can principally assess any complete quality dossier (no restrictions to indications, dosage forms, procedures, drug substance drug product, ) During assessment we take routinely into account procedures of identical/similar drug substances as well as previous assessments of the identical ASMF To avoid nice-to-know questions of CMS we proactively address these issues within our assessment reports (e.g. certificates of analyses of excipients, certain GMP issues, ) A flexible substitution system is in place guaranteeing continuous availability of quality assessors in case of absence Acknowledgement of CEPs (without any further questions) 6

7 Training/Expertise Recruitment of colleagues with experience in Regulatory Affairs/Assessment/Industry Twinning System: one experienced Assessor responsible for training of one Junior Assessor, change of teams after one year (Learning by Doing, Training on the Job) Internal Training System: Presentations of internal experienced Assessors and external experts Participation in international Conferences/Workshops Oral and written exam to obtain ESB, QM system Assessors are actively participating as lecturers in EU training sessions and also at universities 7

8 Harmonisation 4-eye-principle, peer review weekly internal meetings to discuss current questions/decisions/experiences Internal List of Harmonisation to ensure coherent desicions Periodical meetings assessors/inspectors/laboratory Active cooperation with/contribution to QWP/CEP Establishment of European Assessors Data Base QWP-List of Harmonisation Participation in EU-Jour fixe, Scientific Board 8

9 EU network and activities I EMA Delegate in QWP: Delegate in QWP core team: Delegate in BWP PMF DG: Delegate in BWP adhoc IWP: Delegate in Joint EMA-Ind TF: Susanne Stotter Susanne Stotter Martina Joseph Petra Falb Petra Falb 9

10 EU network and activities II EDQM Several Experts in CEP-procedure (chemical and TSE) Delegate in TAB (CEP): Peter Platzer Delegate in ad-hoc-committee: Peter Platzer Delegate in WP 12: Juliane Wögerer QWP-delegate in final products WG: Susanne Stotter 10

11 Statistics CEP Participation AT 11

12 EU discussions Redefinition Tendency: one-step synthesis have become very popular for industry in recent years Problem: all synthetic steps before starting material need NOT to comply with GMP principles and might not be followed via variations Discussions in QWP, TAB, Future: starting materials will have to be re-defined (update of restricted part of ASMF) Currently on-going discussion regarding retrospective application of redefinition 12

13 EU discussions ASMF I We have recognized that different versions of ASMFs are in use at the same time in different procedures We find different versions of Applicants Part in ASMF and dossier Identical ASMFs are evaluated by different authorities => No efficient approach of worksharing (compared to CEP) Initiatives by AT in CMDhand QWP 13

14 EU discussions ASMF II Initial discussions - Open CEP-procedure also for all ASMFs??? -> not possible - Reference to other procedures? - Discussion how to share ASMF-ARs Joint ASMF Working Group on procedures - European Numbering System for ASMFs - New Templates for ARs (ASMF-ARs splitted from general ARs) - European Database for ASMF-ARs - Worksharing Procedures Pilot phase will start on 1 st of December

15 Contact Who currently works on your dossier? Peter Platzer, Head of Department, New Applications / 36570, peter.platzer@ages.at Susanne Stotter, Deputy Head of Department, Lifecycle / 36571, susanne.stotter@ages.at Ulrike Heißenberger, Head of Group, Plasma Products& Vaccines / 36574, ulrike.heissenberger@ages.at In case of questions please contact assessor directly, for telefone number resp. refer to Ansprechpersonen.pdf at 15

16 TOP TEN objections 16

17 Some other Statistics Percentage of academic employees: 92% Percentage of female employees: 72% Percentage of employees from industry: 61% Average age of QUAL (Oktober 2013): 41,6 years 17

18 Thankyouverymuchforyour attention andlookingforwardto furthercooperationwithyou andages-mea asrms foryourproduct 18

19 Do you have any questions??? 19