EMAs 1 st public hearing (Valproate) PCWP meeting with all eligible - PowerPoint PPT Presentation

EMA’s 1 st public hearing (Valproate) PCWP meeting with all eligible patient/ consumer organisations Presented by Nathalie Bere Public Engagement Department An agency of the European Union

Key principles PRAC can hold Public is invited Any m em ber of the public hearings to express its view s public can apply to attend as a speaker or an observer If the number of requests In the context of Guided by a pre-defined is greater than can safety referral set of questions reasonably be procedures (Article 20 accommodated only the of Regulation (EC) most appropriate 726/ 2004, Article 31 or applications will be 107i of Directive selected based on PRAC 2001/ 83/ EC) questions and focus of the hearing 2

Public hearings complement EMA’s existing channels for engaging w ith patients and healthcare professionals in the assessment of medicines, such as written consultations and participation in EMA expert meetings during safety reviews 3

Aims of a public hearing I ncrease transparency By opening up the scientific evaluation Em pow er citizens By giving them a voice in the evaluation of TRUST medicines Engagem ent Helps them to understand how regulators work Adds value Help us in ensuring safety of medicines 4

Key characteristics PRAC considers need to hold a public hearing based on: 1 2 3 4 5 Feasibility in Nature and Therapeutic Potential Level of public light of extent of effect of impact of interest urgency of safety concern medicine and regulatory matter availability of actions alternatives 5

CONDUCTED I N ENGLI SH If speakers unable to present in English, EMA can provide translation 6

1 st EMA Public Hearing: Valproate Tuesday, 2 6 Septem ber 2 0 1 7

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 9

1 Date & time Summary of issues & specific questions Application form Guidance & video Announcement on EMA website & twitter 11

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? 12

Application form 13

Guidance for participants 14

Video 15

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) 16

2 Review applications Draw up list of speakers/ observers according to group & relevance Allocate time slots 17

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 18

Criteria for selection  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 distr di tributi bution 19

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 20

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 21

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 22

3 Chaired by PRAC chair Broadcast live & recorded 23

Agenda Hearing duration: from 1 2 :4 5 to 1 8 :0 0 We Welcome & & Referra rral over erview ew Speak akers rs Speak akers rs Wrap rap-up, s , summary ary Introdu duction and background inter in terven enti tions inter in terven enti tions of interven entions & information on (7 min each): (7 min each): nex ext s t step teps Valpr proate e - Patien ents, c carer ers & - Pharmaceu eutical procedu edure families es compa panies - He Healthcare Coffee break professionals & & Academ demia 24

4 Broadcast and Public summary published Outcome will be integrated into the assessment report Acknowledgement of the value of the contributions made by the public 25

Conclusions  A milestone in EU medicines regulation  ‘Lessons learned’ exercise to be carried out Initial feedback very positive : – Well conducted with optimal timing – Relevant and valuable contributions – Better understanding of issues and options – Lessons learnt report to be presented and published 26

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Any questions? 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