Framework for interaction between EMA and healthcare professionals - PowerPoint PPT Presentation

Framework for interaction between EMA and healthcare professionals Revision principles HCPWP plenary meeting Presented by Rosa Giuliani and Sergio Bonini on 15 June 2016 HCPWP topic group on academia, learned societies and healthcare professionals co-leaders An agency of the European Union

Collaboration of EMA with healthcare professionals 2 0 1 1 2 0 0 8 Framework of interaction Healthcare 2 0 0 6 with professionals Healthcare rep. in EMA Working Professionals Scientific group with 2 0 0 5 Committee Healthcare Professionals Doctors’ created rep. in Management 1 9 9 5 Board EMA created http: / / www.ema.europa.eu/ docs/ en_GB/ docum ent_library/ Other/ 2011/ 12/ WC500119625.pdf 1

As is… Support the Agency in order Contribute to a more efficient to access the best possible Enhance healthcare professional and targeted com m unication independent expertise organisations’ understanding to healthcare professionals, of the role of the EU medicines and obtain information on the to support their role in the safe current use of medicines in Regulatory Network and rational use of medicines real clinical practice Network of European healthcare professional organisations 2

Collaboration of EMA with healthcare professionals 2 0 1 2 2 0 1 1 Eligibility status 2 0 0 8 Framework of granted to interaction Healthcare healthcare 2 0 0 6 with professionals professional Healthcare organisations rep. in EMA Working Professionals (HCPOs) Scientific group with 2 0 0 5 Committee Healthcare Professionals Doctors’ created rep. in Management 1 9 9 5 Board EMA created 3

EMA network of European healthcare professional organisations 30 eligible organisations by May 2016 4

Collaboration of EMA with healthcare professionals 2 0 1 3 2 0 1 2 Healthcare 2 0 1 1 Professionals Eligibility Working Party status 2 0 0 8 Framework of granted to (HCPWP) interaction Healthcare healthcare created 2 0 0 6 with professionals professional Healthcare organisations rep. in EMA Working Professionals (HCPOs) Scientific group with 2 0 0 5 Committee Healthcare Professionals Doctors’ created rep. in Management 1 9 9 5 Board EMA created 5

Healthcare Professionals Working Party (HCPWP) Platform for dialogue and exchange on relevant issues concerning medicines; The HCPWP provides recommendations to the EMA and its Human Scientific Committees on all matters of direct or indirect interest to healthcare professionals 6

Collaboration of EMA with healthcare professionals 2 0 1 5 2 0 1 4 2 0 1 3 Creation of HCPWP 2 0 1 2 1 st Annual Healthcare dedicated report 2 0 1 1 Professionals Eligibility topic group Working Party status to reflect on 2 0 0 8 Framework of granted to (HCPWP) EMA interaction Healthcare healthcare created interaction 2 0 0 6 with professionals professional with Healthcare organisations rep. in EMA Working academia, Professionals (HCPOs) Scientific group with learned 2 0 0 5 Committee Healthcare societies Professionals and HCPOs Doctors’ created rep. in Management 1 9 9 5 Board EMA created 7

General objectives of the Topic Group • Reflect on the need to review the EMA framework of interactions with HCPs • Support the development of the • The 2011 Framework EMA framework for collaboration document should be up-dated with Academia to adapt to a more relevant role of HCPs in drug • Identify current practice with development and monitoring involvement in regulatory activities • HCPs should significantly • Discuss areas for improvement and contribute to the drafting of foreseeable changes an updated version 8

Collaboration of EMA with healthcare professionals 2 0 1 6 … 2 0 1 5 Revision 2 0 1 4 2 0 1 3 Creation of of HCPWP 2 0 1 2 1 st Annual Framework Healthcare dedicated report of 2 0 1 1 Professionals Eligibility topic group interaction Working Party status to reflect on 2 0 0 8 Framework of granted to (HCPWP) EMA interaction Healthcare healthcare created interaction 2 0 0 6 with professionals professional with Healthcare organisations rep. in EMA Working academia, Professionals (HCPOs) Scientific group with learned 2 0 0 5 Committee Healthcare societies Professionals and HCPOs Doctors’ created rep. in Management 1 9 9 5 Board EMA Ongoing… created Systematic inclusion of clinical practice input into EMA regulatory output 9

Involvement in core activities * * WP – working parties 10

Scanning the horizon… what lays ahead

Medicines Where do the regulatory and clinical contexts information come together? Risk management and communication Benefits/ risks balance 12

> > > > 50 Shades of grey… . CARDIO- HTA & Regulatory CANCER VASCULAR Reimbursement approval DISEASE HCPs/ Academia organizations may contribute to clear grey areas (sometimes we create them..) Timely Clinically Development Robust Regulatory Meaningful Of innovative evidence approval benefit “options”

EFFICACY EFFECTIVENESS EFFICIENCY Does it work Does it work Does it contribute to more in clinical TRIALS? in clinical PRACTICE? efficient use of resources? HCPs Real-world data B/R HTA assessment (registries, post-A S&E studies, National  HTAN EMA observational trials…) 14

Promotion of platforms/ forums for interaction and collaboration 15

Guiding principles for the revision • EU Medicines Agencies Network Strategy to 2020 Alignment with regulators’ • EMA priorities strategic objectives • EMA Multi-annual programme • Framework for stakeholder relations management Consistency and • Framework of collaboration with academia (focus on research, complementarity amongst education and training) • Further strengthening link with patients (should we identify specific stakeholders areas of focus e.g. health literacy?) • Focus on health care (should we define the full spectrum e.g. from Inclusion of healthcare primary care to highly specialised care?) professionals’ fields of • Aspects deriving from HCPs’ role: not only prescribers but partners in the development and monitoring of medicines activity and areas of • How much detail should be included in relation to areas of interest? interest (e.g. collection of data (eHealth and registries); personalised medicine; ... • As the foundation is now set, should we consider additional levels of Continuous improvement granularity for interaction? (e.g. on the basis of maturity of on the basis of acquired interaction; response/ engagement capacity; level of interest) • Where to direct efforts? ‘Expansion’/ ‘diversification’ / ‘integration’ / experience ‘specialisation’ (e.g. per types of activity; therapeutic areas; … ) 16

Annexes to the framework document • Action plan with outline of specific actions and estimated timeframes for completion – will be detailed in annex I • EMA activities where healthcare professionals are involved and modalities of interaction – will be described in annex II Eligibility criteria – outside scope of revision of the framework • Criteria to be fulfilled by healthcare professionals' organisations involved in European Medicines Agency (EMA) activities • Evaluation of financial information from patients’, consumers’ and healthcare professionals’ organisations for assessment of EMA ‘eligibility’ 17

http: / / www.ema.europa.eu/ ema/ index.jsp?curl= pages/ partners_and_networks/ general/ general_content_000233.jsp&mid= WC0b01ac05800aa3c8 18

Thank you for your attention Further information HCPsecretariat@ema.europa.eu European Medicines Agency 30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone + 44 (0)20 3660 6000 Facsim ile + 44 (0)20 3660 5555 Send a question via our w ebsite www.ema.europa.eu/ contact Follow us on @EMA_ New s