Update on public hearing PCWP/ HCPWP joint meeting Presented by - PowerPoint PPT Presentation

Update on public hearing PCWP/ HCPWP joint meeting Presented by Juan Garcia Burgos on 20 September 2017 Head of Public Engagement Department An agency of the European Union

A public hearing provides  An opportunity for the public to be heard by the PRAC leading to a more rounded understanding by PRAC of the issue  An opportunity for stakeholders groups to listen and to be heard by others  An opportunity to show a listening and engaged regulatory system 2

PRAC decision to hold public hearing Based on pre-defined criteria:  A public hearing is possible within the assessment timelines  A known high risk of neurodevelopmental disorders in children exposed in utero (30-40% ) and ongoing regulatory efforts to reduce this risk  Outcome expected to result in changes to existing RMMs  Input from patients/ carers and healthcare professionals will add value to the PRAC assessment  High level of public interest; seen in previous PhV referral, continued media reporting and patient organisations expressing concerns 3

1 Date & time Summary of issues & specific questions Application form Guidance & video Announcement on EMA website & twitter 4

1 st EMA Public Hearing: Valproate To be held during the October PRAC meeting Tuesday, 2 6 Septem ber 2 0 1 7

Susac & LoQ adopted by PRAC Question 1 Summary of What is your view of the risks of taking valproate safety during pregnancy, including its potential effect on the child? concerns Question 2 (Susac) & List What are your views on the measures currently in of questions place to reduce the risks of using valproate during pregnancy ? (LoQ) Question 3 What other measures should be taken to reduce the risks of using valproate during pregnancy? 6

Application form 7

Guidance for participants 8

Video 9

Announcement website & twitter 10

Dissemination W ide dissem ination to stakeholder groups:  Relevant patient, healthcare professional organisations and academia  Affected families and individuals previously in contact with the EMA  Organisations identified through the NUI  Twitter and media outreach  Early Notification System (ENS) 11

EMA website

2 Review applications Draw up list of speakers/ observers according to group & relevance Allocate time slots 13

Preparation Applications review :  Decide on speakers and observers  Ensure appropriate representation across all groups Num bers attending:  Ideally between 12-16 speakers  100 observers maximum  Depends on level of interest and relevant applications 14

Criteria for selection  Very focused contributions  Selection based on the relevance to the PRAC questions  Balanced representation based on: 3 4 1 2 Cont ntent nt Affilia liation Discip iplin ine Geo eogr graph phical di distr tributi bution 15

Participants United Denmark Kingdom 3 84 Sweden 1 46 Ireland 4 Germany 2 The Netherlands 2 Switzerland 2 Belgium 6 I srael United 1 States France Italy 5 4 7 Greece 1 16

Speakers United 32 Kingdom Sweden 1 8 / 17 speaker Ireland 2 requests 25 Belgium contributions 2 selected, grouped in France 2 1 6 General public (patient representatives, carers, families) speaker slots Healthcare professionals and academia Italy Pharmaceutical companies 1 17

Observers United Denmark 59 3 Kingdom 30 Ireland 2 Germany 2 The Netherlands 2 Switzerland 2 Belgium 4 I srael 1 United States Italy France 2 5 5 Greece 1 18

3 Chaired by PRAC chair Rapporteurs overview Speakers interventions Summary & wrap-up Broadcast live & recorded 19

Agenda Hearing duration: from 1 2 :4 5 to 1 8 :0 0 We Welcome & & Referral over erview ew, Speak akers rs Speak akers rs Wrap rap-up, s , summary ary Introdu duction public h hearing r g rules es inter in terven enti tions (7 min in inter terven enti tions (7 min of interven entions & and b background per intervention): per intervention): nex ext s t step teps information on - Patien ents, c carer ers & - Pharmaceu eutical Valpr proate e families es compa panies procedu edure - He Healthcare Coffee break professionals & & Academ demia 20

4 Broadcast available online Public summary to be published Outcome to be integrated into the assessment report Acknowledgement of the value of the contributions made by the public 21

Conclusion  A milestone in EU medicines regulation  A major step towards openness and transparency  Need to make it valuable: ─ For the assessment ─ For the public  Measure impact – ‘lessons learned’ exercise in 2017 22

Any questions? Further information Juan.Garcia@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