Mircea Ciuca, MD Global Head Medical & Clinical Drug Safety

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1 Mircea Ciuca, MD Global Head Medical & Clinical Drug Safety

2 Disclaimer The views and opinions expressed in this presentation are solely those of the presenter and do not necessarily reflect those of Vifor, or any of its affiliated organizations.

3 Objectives Draft GVP Module IX (overview of changes) New terminology (EVDAS, ermr) MAH's obligations - access to EV, training, changes to current procedures

4 Introduction

5 Introduction Signal Management

6 Introduction

7 Introduction Benefit-risk management

8 MHRA GPvP Symposium 02 September 2016

9 Draft revision Module IX GVP First revision after 2012 implementation of new PV legislation Released for public consultation August 2016 Expected to be effective Q New elements introduced in the signal management process *Guideline on good pharmacovigilance practices (GVP). Module IX Signal management EMA/827661/2011 Rev 1* DRAFT for public consultation 04AUG2016

10 Draft revision Module IX GVP Revised definition and process for emerging safety issues, previously addressed in GVP Module VI Streamlined information on scientific aspects of signal management Statistical aspects now addressed in Addendum I Clarifications on terminology, roles and responsibilities, and processes Criteria for access by marketing authorisation holders to case narratives held in EudraVigilance Updated guidance on the periodicity of monitoring of EudraVigilance data Procedural options for signals validated by marketing authorisation holders *Guideline on good pharmacovigilance practices (GVP). Module IX Signal management EMA/827661/2011 Rev 1* DRAFT for public consultation 04AUG2016

11 Draft revision Module IX GVP Definitions Scientific aspects Steps in the process Timelines Communication *Guideline on good pharmacovigilance practices (GVP). Module IX Signal management EMA/827661/2011 Rev 1* DRAFT for public consultation 04AUG2016

12 GVP Module IX Signal management (rev1) IX.C.3.1 Emerging safety issues (definition) Module VI rev 1 - VI.C Module IX - rev1 IX.A.1 Terminology Events may occur, which do not fall within the definition of A safety issue considered by a marketing reportable valid ICSRs, and thus are not subject to the reporting authorisation holder in relation to an authorised requirements, even though they may lead to changes in the known medicinal product under its responsibility to risk-benefit balance of a medicinal product and/or impact on require urgent attention of the competent authority public health. Examples include: because of the potential major impact on the riskbenefit major safety findings from a newly completed non-clinical study; balance of the product and/or on patient or major safety concerns identified in the course of a noninterventional public health, that could warrant prompt regulatory post-authorisation study or of a clinical trial; action and communication to patients and signal of a possible teratogen effect or of significant hazard to healthcare professionals (see also GVP Module VI public health; and IX.C.3.1.). safety issues published in the scientific and medical literature; safety issues arising from the signal detection activity (see Module IX) or emerging from a new ICSR and which impact on the risk-benefit balance of the medicinal product and/or have implications for public health; safety issues related to the use outside the terms of the marketing authorisation; safety issues due to misinformation in the product information; marketing authorisation withdrawal, non-renewal, revocation or suspension outside the EU for safety-related reasons; urgent safety restrictions outside the EU; safety issues in relation to the supply of raw material; lack of supply of medicines. 06/03/

13 GVP Module IX Signal management (rev1) IX.C.3.1 Emerging safety issues (process) Module VI rev 1 - VI.C Reportable to : P-PV-emerging-safetyissue@ema.europa.eu Should be reported immediately when becoming aware of them. The document should indicate the points of concern and the actions proposed in relation to the marketing application/authorisation for the concerned medicinal product. Module IX. - rev 1 - C.3.1 Reportable to : P-PV-emerging-safety-issue@ema.europa.eu This should be reported within 2 working days of becoming aware of the issue. When notifying an emerging safety issue, the marketing authorisation holder should describe the safety concern, the source(s) of information, any planned or taken actions, and should provide any relevant documentation. In such instances, a standalone signal notification (see IX.C.3.4.) is not required. Upon being notified of an emerging safety issue, national competent authorities and/or the Agency as appropriate should promptly assess the urgency and potential impact of the issue and agree on appropriate next steps and the potential regulatory procedure to address the matter raised (see European Union Regulatory Incident Management Plan for Medicines for Human Use). In order to ensure its effectiveness, the system should not be saturated by the transmission of less urgent information. Marketing authorisation holders should only communicate as emerging safety issues those safety concerns which meet the definition provided in IX.A, i.e. whose urgency and seriousness cannot permit any delay in handling, for instance validated signals that cannot wait up to 30 days for confirmation by Member States. 06/03/

14 GVP Module IX Signal management (rev1) IX.A.1 Terminology Annex I Rev3 Signal Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action [IR 520/2012 Art 19(1)]. For the purpose of monitoring data in the EudraVigilance database, only signals related to an adverse reaction shall be considered [IR 520/2012 Art 19(1)]. For the purpose of Section 16.2 of the periodic benefitrisk evaluation report, signals relate to adverse effects (see Annex IV, ICH-E2C(R2) Guideline) Module IX - rev1 IX.A.1 Terminology Signal Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action [IR Art 19(1)]. New aspects of a known association may include changes in the frequency, duration, severity or outcome of the adverse event. For the purpose of monitoring data in the EudraVigilance database (also referred to as EudraVigilance ), only signals related to an adverse reaction shall be considered [IR Art 19(1)]. A signal often relates to all medicinal products containing the same active substance, including combination products. Certain signals may only be relevant for a particular medicinal product or in a specific indication, strength, pharmaceutical form or route of administration whereas some signals may apply to a whole class of medicinal products. 06/03/

15 GVP Module IX Signal management (rev1) IX.A.1 Terminology Amended definitions (vs GVP Annex I) - Signal management process - Signal validation New definitions (vs GVP Annex I) - Signal detection - Signal confirmation - Signal analysis and prioritisation by PRAC - Signal assessment by PRAC - Lead MS for signal assessment 06/03/

16 Draft revision Module IX GVP Definitions Scientific aspects Steps in the process Timelines Communication *Guideline on good pharmacovigilance practices (GVP). Module IX Signal management EMA/827661/2011 Rev 1* DRAFT for public consultation 04AUG2016

17 GVP Module IX Signal management (rev1) Addendum 1- Methodological Aspects of Signal Detection from Spontaneous Reports of Suspected Adverse Reactions 06/03/

18 GVP Module IX Signal management (rev1) Addendum 1 - General concept - Should allow routine signal detection - Based on the concept of Drug-Event Combinations (DECs) - Proposed statistical approach : Disproportionate reporting - Specific implementation in Eudravigilance is described in the Guidance «Screening for Adverse Drug Reactions in Eudravigilance» (available in Q4 2016) - The tools and their use will be described in separate user manuals (User Manual of the electronic Reaction Monitoring Report and EVDAS User Manual). 06/03/

19 GVP Module IX Signal management (rev1) Factors that may affect the performance of signal detection systems : * MedDRA hierarchy : Preferred Term (PT), has been shown to be a good choice in terms of sensitivity and positive predictive value, A subset of MedDRA terms judged to be important medical events (IMEs) is considered a useful tool in statistical signal detection, Other levels of MedDRA terms (HLT, SMQ) may be used for targeted monitoring of potential risks, Use of synonyms may be appropriate The definition of a synonym in this context is the pragmatic one that two PTs are considered synonyms if it is reasonable to suppose that a primary reporter of a suspected adverse reaction, presented with a single patient and without a specialist evaluation, would not necessarily be able to decide which term to use. 06/03/

20 GVP Module IX Signal management (rev1) Addendum 1 Methods aimed at specific groups of events Designated Medical Events It is recommended that these designated medical events (DME) are drawn to the attention of signal detection assessors irrespective of any other statistical methods used and that they are prioritised for clinical review. Serious events Due to their impact, serious events should be prioritised in Signal Detection. Complementary to the creation of a list of DMEs and in addition to the use of lists of IMEs, a simple approach to such prioritisation is to highlight new ICSRs in which a death is reported and to give separate counts of those ICSRs for each DEC. 06/03/

21 GVP Module IX Signal management (rev1) Addendum 1 Methods aimed at specific patients populations When ICSR databases are sufficiently large : - Paediatric populations - Geriatric populations Addendum 1 Methods aimed at underlying causal processes In addition to the description of the clinical manifestation of the suspected adverse reaction, ICSRs may include information on the potential causal mechanisms for the reaction. This applies to the situation of Abuse, misuse, overdose, medication error or occupational exposure. Thus, it is recommended that the numbers of ICSRs with the respective MedDRA codes should be displayed for each DEC in signal detection listings. 06/03/

22 Draft revision Module IX GVP Definitions Scientific aspects Steps in the process Timelines Communication *Guideline on good pharmacovigilance practices (GVP). Module IX Signal management EMA/827661/2011 Rev 1* DRAFT for public consultation 04AUG2016

23 GVP Module IX Signal management (rev1) IX.C.2.1 Principles for access (Eudravigilance Data) Prior to requesting access to case narratives, the following criteria should be met: The review of the electronic reaction monitoring report suggests a signal (see IX.A.); To the best of the marketing authorisation holder s knowledge, the signal is not addressed in the product information of any medicinal product authorised in the EU with the concerned active substance (see also IX.C.3.4.); Based on the information published on the European medicines webportal (see IX.C.8.), the signal was not recently addressed by (a) competent authority(ies) of (a) Member State(s) or by PRAC See European Medicines Agency Policy on Access to EudraVigilance data for Medicinal Products for Human Use EMA/759287/2009 rev 2 of 17 Dec /03/

24 GVP Module IX Signal management (rev1) IX.C.2.2 Periodicity of monitoring The appropriate frequency of monitoring of EudraVigilance data may vary with the accumulation of knowledge on the risk profile of a given active substance or medicinal product, taking into account, for example: time since first authorisation; patient exposure; potential risks and missing information documented in the RMP; PSUR submission frequency; any safety concern of interest in specific situations (e.g. vaccination campaigns). Thus : - A 2 weeks interval for products on additional monitoring list unless the sole reason for inclusion on the list is the request of a post-authorisation safety study (PASS), - A monthly monitoring of EudraVigilance data is routinely applied by the Agency for other active substances, - It is recommended that the interval between reviews of EudraVigilance data should not exceed 6 months. - Each organisation should document the frequency of their monitoring of 06/03/ EudraVigilance data

25 GVP Module IX Signal management (rev1) The evaluation of the evidence supporting a signal may involve several rounds of expert discussions and different levels of decisionmaking, within individual organisations. This may result in various decisions, such as: closing the signal, when the available data do not support a causal relationship (the signal may be re-opened at a later stage if new evidence arises) or when there is sufficient information on the association in the product information; monitoring the signal by reviewing new information from ICSRs or the scientific literature at appropriate time intervals to determine whether the new data are supportive of a causal relationship; proposing actions such as changes to the product information by means of a variation, if there is sufficient evidence of a causal relationship. 06/03/

26 GVP Module IX Signal management (rev1) IX.B.4 Signal prioritisation 2 new concepts added to help prioritisation : the expected extent of the regulatory intervention (e.g. addition of adverse reactions, warnings, contraindications, additional risk minimisation measures, suspension, revocation); whether the signal is likely to apply to other substances of the same class of medicinal products. 06/03/

27 GVP Module IX Signal management (rev1) IX.C.1 Roles and responsibilities 06/03/

28 GVP Module IX Signal management (rev1) IX.C.1 Roles and responsibilities PRAC List of signals 06/03/

29 New terminology EudraVigilance Data Analysis System (EVDAS) Module allowing data mining in Eudravigilance Electronic reaction monitoring report (ermr) Output from EVDAS European Pharmacovigilance Issues Tracking Tool (EPITT) Signal tracker

30 New terminology 9.jsp&mid=WC0b01ac05800b6f03

31 New terminology

32 New terminology

33 New terminology

34 New terminology 3. Drug info : this worksheet is automatically updated every 6 months. It is populated with the most used information related to a given active substance,

35 New terminology

36 MAH s obligations Access to Eudravigilance (new systems) Availability of dedicated resources Appropriate training of people involved in signal management 4200 MAHs (see EMA Annual activity report 2015) Adaptation of internal procedures Adaptation of SDEA with partners

37 MAH s obligations

38 Additonal resources The following documents provide additional guidance relevant to signal management: Report of CIOMS Working Group VIII on Practical Aspects of Signal Detection in Pharmacovigilance SCOPE Work Package 5 Signal Management - Best Practice Guidance EMA Questions & Answers on Signal Management Screening for Adverse Drug Reactions in EudraVigilance (Dec2016) IMI-PROTECT - Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (Sep2016) WEB-RADR - use of mobile technologies in pharmacovigilance to Recognise Adverse Drug Reactions (RADR).

39 Take home message Pharmacovigilance legislations are continuously evolving globally New methodologies are adopted Signal management has a great impact on continuous benefit-risk management Need for a cross-functional approach Robust process and documentation need to be in place Heavily scrutinized in audits/inspections

40

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