A national agencys views Sabine Straus Sabine Straus MD PhD - PowerPoint PPT Presentation

The new pharmacovigilance legislation A national agency’s views Sabine Straus Sabine Straus MD PhD Medicines Evaluation Board September 27, 2013 0 London 27-09-2013

• Introduction • Challenges for a NCA • Some lessons learned • Closing remarks 1 London 27-09-2013

Prioritised implementation* Firstly, public health activities Secondly, transparency and com m unication activities Thirdly, sim plification and efficiency activities * agreed by EMA Management Board London 27-09-2013

3 London 27-09-2013 Dr Peter Arlett, nov 12, 2012

Actions taken at national level • I nternal • External – Steering group – Stakeholder meetings – Working groups – Patient/ HCP organisations meetings – Review/ update SOPs – Training • Support – dedicated website 4 London 27-09-2013

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Signal detection • Introduction Referrals • Challenges for a NCA Risk Management Plans • Some lessons learned • Closing remarks 7 London 27-09-2013

Implementing Regulation No 520/ 2012 CHAPTER III provides details on operational aspects for minimum requirements for the monitoring of data in the EV: ⇒ EV monitoring Art 18 General Requirements ⇒ Signals Art 19 Identification of changed risks and new risks ⇒ Validation Art 20 Methodology for determining the evidentiary value of a signal ⇒ Stakeholders Art 21 Signal Management ⇒ Public list of Art 22 Work-sharing for signal management substances ⇒ eRMR Art 23 Signal detection support ⇒ EPITT & locally Art 24 Signal detection audit trail 8 8 London 27-09-2013

Signal Management Process IR art 21 MAH PRAC MSs MSs Agency Agency Analysis, Signal Confirm atio Recom m endation Validation prioritizatio Assessm ent detection n for action n 9 London 27-09-2013

Signal detection Referrals In practice Risk Management Plans Transparancy 10 London 27-09-2013

I n practice at MEB Tracking & audittrail non-validated signals IR Art 24(1)] 11 London 27-09-2013

Electronic Reaction Monitoring Report (eRMR) Excel based summary data • Contain all Drug Event Combinations for a substance • Counts against different criteria, eg - literature - parent-child - fatal - source (Patient, Health Care Professional, Study..) - route of administration - pediatric, geriatric - abuse, medication error • PRR based disproportionality • Highlighted Signals of Disproportionate Reporting 12 London 27-09-2013

Electronic Reaction Monitoring Report (eRMR) 13 13 London 27-09-2013

Periodicity EudraVigilance monitoring Frequency proportionate to: • identified risk • potential risks • need for additional information Baseline periodicity: once monthly 2 week frequency: • products under additional monitoring • products with need for additional information More frequent in specific situations e.g. Pandemic situation, targeted safety issues 14 London 27-09-2013

EV Monitoring at Medicines Evaluation Board consistent, timely, traceable Week 1 e-RMR ? meeting ? Week 2 consult NL-PRAC meeting validation delegates 15 15 London 27-09-2013

Signal confirm ation I X.C.1 . Roles and responsibilities E-mail: “Signal from … to …” 16 London 27-09-2013

Signals: Data and PRAC Outcomes • Period: September 2012 - August 2013 Num ber of signals 92 1 Data source Outcom e 51 EudraVigilance 44 labelling changes 19 national review 12 no regulatory action 8 referral evaluation 2 9 literature 4 FDA/ PMDA 1 update RMP 4 historical (PhVWP) 27 assessment ongoing 5 studies 1 54 for CAPs (59% ), 29 for NAPs (31% ), 9 for both (10% ) • • 2 6 referrals ongoing, 2 concluded: restriction of use (codeine) and suspension of MA (HES) 17

Signal detection • Introduction Referrals • Challenges for a NCA Risk Management Plans • Some lessons learned • Closing remarks Referral Procedures: Art 2 0 , Art 3 1 and Urgent Union Procedure ( 1 0 7 i) , 18 London 27-09-2013

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Time (hours) Activity EU referral National actions Management 22 60 Case management 124,75 72,5 Assessment 564 58,5 PRAC 113 9 CMD-h 18,5 0 Policy advise 0 25,75 Public relations 48,5 416,5 Total 8 9 0 ,7 5 6 4 2 ,2 5 20 London 27-09-2013

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Signal detection • Introduction Referrals • Challenges for a NCA Risk Management Plans • Some lessons learned • Closing remarks 22 London 27-09-2013

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DUAL Rapporteurship CHMP PRAC rapporteur rapporteur CHMP PRAC Co- Co- rapporteur rapporteur CHMP PRAC Peer Concerned CHMP Concerned 24 London 27-09-2013

RMP assessment principles (1/ 2) • Both CHMP and PRAC Rapporteurs start assessing the dossier at Day 0 • CHMP Rapporteur’s draft AR circulated first • PRAC Rapporteur considers CHMP draft AR and circulates the draft RMP AR • Peer review and MS comments (PRAC + CHMP) • PRAC RMP AR updated (AR template designed for the process; one single document concept) 25 London 27-09-2013

PRAC – CHMP interaction timeline Opinion D181: MAH sends responses to LOI D182-3: PRAC Rapporteur circulates the RMP AR D189: CHMP Rapporteur circulates the draft CHMP AR + D196: PRAC adopts the final PRAC Assessment Overview and Advice D210: CHMP adopts RMP PRAC TC* the CHMP AR and Opinion <1 week <1 week Member States 2 weeks comments D210 +7 +14 +21 D181 Opinion PRAC week CHMP week * I f there is disagreement between PRAC and CHMP on the RMP assessment and recommendations 26 London 27-09-2013

• Introduction • Challenges for a NCA • Some lessons learned • Closing remarks 27 London 27-09-2013

Science/Quality – Procedures Transparancy -communication Workload 28 London 27-09-2013

The new EU PV Legislation: Finding the right balance between procedures and contents 29 London 27-09-2013

Transparancy -communication DIA Amsterdam 2013: Transparancy is there , but has communication improved 30 London 27-09-2013

Challenges for the MEB - W orkload 31 London 27-09-2013

• Introduction • Challenges for a NCA • Some lessons learned • Closing remarks 32 London 27-09-2013

The ultim ate test for pharm acovigilance system s is the dem onstration of public health benefit w ith the em erging pharm acovigilance tools and new legislative provisions, w e should be able not only to refine benefit– risk assessm ents, but also to m axim ize the public health benefit of new m edical treatm ents. 33 London 27-09-2013

Closing rem arks 34 London 27-09-2013