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Who is Who and What is What in EU Pharmacovigilance Vicki Edwards QPPV and Head of Affiliate Vigilance Excellence AbbVie.

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Presentation on theme: "Who is Who and What is What in EU Pharmacovigilance Vicki Edwards QPPV and Head of Affiliate Vigilance Excellence AbbVie."— Presentation transcript:

1 Who is Who and What is What in EU Pharmacovigilance Vicki Edwards QPPV and Head of Affiliate Vigilance Excellence AbbVie

2 Overview European Commission European Medicines Agency (EMA) CHMP PRAC Competent Authorities of Member States (CAs) Marketing Authorisation Holder (MAH) CIOMS ICH DipPharmMed – Module 9- April 20112Who’sWho

3 3 Pharmaceutical industry under the responsibility of DG SANCO (Directorate-General for Health and Consumer Affairs) Competent Authority for Centrally Authorised Products Drafts proposals for new European Laws Presents to the European Parliament & Council Implements the decisions of Parliament & Council  Enforcement of implementation of Decisions by Member States and MAHs  Manages the day to day business of the EU  Runs the programmes of the EU  Spends the EUs funds….. European Commission Who’sWhoDipPharmMed – Module 9- April 2011

4 Who’sWho The EU Decision-Making Process The EU’s decision-making process involves three main institutions  The European Parliament (EP), which represents the EU’s citizens and is directly elected by them.European Parliament (EP)  The Council of the European Union, which represents the individual Member States.Council of the European Union  The European Commission, which seeks to uphold the interests of the Union as a whole.European Commission This ‘institutional triangle’ produces the policies and laws that apply throughout the EU. In principle, it is the Commission that proposes new laws, but it is the Parliament and Council that adopt them. European Commission (EC) Council of the European Union European Parliament (EP) 4

5 DipPharmMed – Module 9- April 2011 Who’sWho European Medicines Agency Protection and promotion of public health through evaluation and supervision of medicines Responsible for scientific evaluation of applications for MA for medicinal products (Centralised procedure)  Opinion presented to Commission for decision Utilises scientific resources of 30 EU and EEA-EFTA countries 5

6 DipPharmMed – Module 9- April 2011 Who’sWho Role of the EMA Monitors the safety of medicines through the EU PV network Takes appropriate action in the event of change to benefit : risk profile of a product Provides scientific advice to academia and the Pharmaceutical Industry Provides guidelines on quality, safety and efficacy 6

7 7 Coordination of the supervision of products authorized in the EU Monitor legal obligations of MAH Transmission of Serious ADRs reports between Member States and to Rapporteur Identify safety signals, in agreement with Rapporteur Communication of Safety Issues (all parties) Communication of Opinions to the European Commission Communication with the MAH in consultation with Rapporteur Development and maintenance of Eudravigilance database Role of the EMA Who’sWhoDipPharmMed – Module 9- April 2011

8 Who’sWho Committee for Medicinal Products for Human Use (CHMP) Prepares EMA’s opinions on all questions concerning medicinal products Centrally approved products  Assessment of MAAs and maintenance including modifications and extensions (variations) MRP & decentralised products  Provides arbitration in event of Member State disagreement Monitoring of safety of products through EU network of national medicines agencies 8

9 Co-ordination Group for mutual recognition and decentralised procedures – Human (CMDh) Examines any question related to marketing authorisations of a medicinal product in two or more member states New applications Variations Renewals PV activities DipPharmMed – Module 9- April 2011 Who’sWho 9

10 New Pharmacovigilance Risk Assessment Committee PRAC Regulation (EU) No 1235/2010 the Mandate shall cover: All aspects of the risk management of the use of medicinal products including the detection, assessment, minimisation and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product, the design and evaluation of post-authorisation safety studies and pharmacovigilance audit

11 PRAC Membership Appointed by each Member State 1 member + alternate 27 + EEA countries non-voting members Appointed by the European Commission (public call for expressions of interest): 1 patient organisations rep + alternate 1 healthcare professionals rep + alternate 6 members to ensure relevant expertise available

12 Identified PRAC Activities (1/2) Activity Involvement Risk Management Systems Agreement on RMPs + Monitoring their effectiveness Periodic Safety Update Reports PSURs List of harmonised submission frequencies and substances, assessment + recommendation Eudravigilance + Periodic Safety Update Reports repository Functional specifications, any substantial changes Medicines subject to additional monitoring Addition to/removal from list extension of timeframe, symbol Signal detection Initial analysis + prioritisation assessment + recommendations

13 Identified PRAC Activities (2/2) Activity Involvement Urgent Safety Procedures for the EU Assessment, public hearings, recommendations Post Authorisation Safety Studies Consultations on requests (pre and post MA), assessment of protocols (incl. amendments + Recommendations, assessment of results + Recommendations Literature Adverse Drug Reactions monitoring Consultation on list of active substances and medical literature subject to monitoring Safety announcements Advice

14 PRAC Agenda Issues – All items Proposed PRAC Statistics14

15 Signal Overview PRAC outcomes/Signals with NAPs15 NAP (#19)Signal PhWP Follow-up PRAC Recommendation PRAC discussion RoxithromycinRhabdomyolysis secondary to interaction with statins Variation (3) Sep 12/ Feb13 RoxithromycinHearing disorders Sep 12/ Feb13 NicardipineThrombocytopenia Dec 12 (Nov) CodeineDrug toxicity in CYP2D6 ultra-rapid metabolisers Referral (5) Oct 12 Short-acting beta agonistsMaternal cardiovascular events following use in tocolysisX Oct 12 Hydroxyethyl starch (blood plasma substitutes) Effect on renal function and mortality in septic patients X Oct 12 DomperidoneCardiotoxicityX Feb 13 ThiocolchicosideGenotoxic potential Feb 13 Vitamin K antagonistsInteraction with Goji berries (Lycium barbarum) Cumulative review (7) Oct 12 Trazodone Risk Minimisation for trazodone associated postural hypotension and somnolence Oct 12 MirtazapinePancreatitis Oct 12 Tiotropium bromideAnaphylactic reaction Jan 13 Tiotropium bromide soft mist formulation (RESPIMAT) Increased mortality from cardiovascular disease and all cause mortality Jan 13 TramadolHypoglycaemia Feb 13 Zolpidem Next-morning impaired mental alertness, including impaired driving ability Feb 13 Anticholinergic drugs for inhaled use Increased incidence of myocardial infarction and stroke in patients with chronic obstructive pulmonary disease (COPD)X No MAH action (4) Oct 12 FluoroquinolonesRetinal detachmentX Oct 12 Human albumin solutions Increased risk of death in patients with severe traumatic brain injury and in patients with burnsX Oct 12 Influenza vaccineExtensive limb swelling (ELS) Oct 12/Nov 12 CAP&NAP (#3) SomatropinConvulsions SMQ Narrow Cumulative review Sep 12 Olmesartan Increased risk of fatal cardiovascular events in patients with type 2 diabetes at increased cardiovascular riskXVariation Oct 12 Hormonal contraceptivesEmbolic and thrombotic events Referral Dec 12 (Nov)/Jan 13/Feb 13

16 16 Roles and Responsibilities of the Competent Authorities Establish national pharmacovigilance systems Responsible for PV for all products authorised nationally, including mutual recognition products Responsible for monitoring centrally authorised products Ensure data are shared between MS’s and EMA via EudraVigilance network Inform the Commission, CHMP, EMA and MAH of any relevant actions Provide serious ADR cases to EMA and MAH Implement Commission Decision Power to suspend a product in urgent circumstances Who’sWhoDipPharmMed – Module 9- April 2011

17 PRAC and the other Groups/Committees Drug Information Association Coordination Group CG Member States European Commission PRAC Recommendations CHMP

18 PRAC output with formal decision making phase – at least one CAP DipPharmMed – Module 9- April 2011 Who’sWho 18 Referrals Art.107 & Art.31 & Art 20 PSUR Single AssessmentPASS Results PRAC Recommendation & Assessment Report Publication on EMA website (Art.26 Regulation) CHMP In line with PRAC No Public justification European Commission Decision-making phase Commission decision Publication on EMA website (Art.26 Regulation) MAH MS

19 PRAC output with formal decision making phase – NAPs only DipPharmMed – Module 9- April 2011 Who’sWho 19 Referrals Art.107 & Art.31 PSUR Single AssessmentPASS Results PRAC Recommendation & Assessment Report Publication on EMA website (Art.26 Regulation) CMDh Agreement by Consensus YesNo In line with PRAC Yes No Yes CMDh consensus and timetable PRAC AR ± scientific grounds for disagreement CMDh consensus and timetable PRAC AR ± scientific grounds for disagreement MS Publication on EMA website (Art.26 Regulation) MAH Publication on EMA website (Art.26 Regulation) MAH MS EC Commission decision

20 20 Roles and Responsibilities of the MAH Ensure an appropriate system of pharmacovigilance and risk management  Provide description at application of MA (DDPS)  Assure responsibility and liability for marketed products  Ensure appropriate action can be taken, when necessary Immediately notify the Competent Authorities of any change in the balance of risks and benefits of their products Appoint a Qualified Person Responsible for Pharmacovigilance (QPPV)  Submit proof that the services of the QPPV are available at application of MA  MAH should adequately support the QPPV  Ensure mechanisms are to keep QPPV fully informed  Ensure that the QPPV has sufficient authority Who’sWhoDipPharmMed – Module 9- April 2011

21 Council for International Organisations of Medical Sciences (CIOMS) DipPharmMed – Module 9- April 2011 Who’sWho 21

22 22 What is CIOMS International, non-governmental, non-profit organisation Established in 1949 by WHO and UNESCO A forum to consider and prepare advice on contentious issues in research ethics and safety of pharmaceuticals for WHO, public health authorities, academia, pharmaceutical industry and others Comprises various working groups Modus operandi = Think Tank (practical solutions) Think beyond local practices and regulations => optimise drug safety procedures internationally Do not develop regulations but intended to inform and encourage those with rule-making responsibilities DipPharmMed – Module 9- April 2011 Who’sWho

23 23 CIOMS Safety Working Groups I CIOMS I (1990)International Expedited Reporting CIOMS IA (1992)Report unpublished: Concept of Global Safety Database and comprehensive set of data fields and electronic specification CIOMS II (1992) CIOMS III (1995) (First Edition) International Reporting of Periodic Drug Safety Update Summaries (PSUR) Guidelines for Preparing Core Clinical Safety Information on Drugs( Core Data Sheet) CIOMS IV (1998)Benefit – Risk Balance for Marketed Drugs: Evaluating Safety Signals DipPharmMed – Module 9- April 2011 Who’sWho

24 24 CIOMS Safety Working Groups II CIOMS III/V (1999)Second Edition of CIOMS III : Including New Proposals for Investigator Brochures (DCSI) CIOMS V (2001)Current Challenges in Pharmacovigilance : Pragmatic Approaches CIOMS VI (2005) CIOMS VII ( 2007) CIOMS VIII (2010) CIOMS IX (in progress) Management of Safety Information from CTs The Development Safety Update Report (DSUR): Harmonizing the Format and Content for Periodic Safety Reporting During Clinical Trials Points to Consider in the Application of Signal Detection and Management in Pharmacovigilance Practical Considerations for Development & Application of a Toolkit for Risk Management DipPharmMed – Module 9- April 2011 Who’sWho

25 DipPharmMed – Module 9- April 2011 Who’sWho International Conference on Harmonisation ICH – Basic Principles Development of scientific consensus through discussions between regulatory & industry experts. Regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. Wide consultation of the draft consensus document, through normal regulatory channels, before a harmonised text is adopted. Commitment by regulatory parties to implement the ICH harmonised texts. 25

26 DipPharmMed – Module 9- April 2011 Who’sWho 26 ICH Process Technical discussions in GPS/development of consensus Consensus achieved with release for consultation Formal consultation outside ICH ICH guideline finalized Implementation in ICH regions Step 2 Step 3 Step 4 Step 5 Step 1

27 27 CIOMS, ICH and International Regulation CIOMS IBasis for ICHE2A and international regulatory standards and definitions, including CIOMS I form CIOMS IABasis for ICH E2B (Standards for electronic submission) CIOMS IIBasis for ICH E2C, European, Japanese and US standards for PSURs – Recently updated CIOMS IIIConcept of CDS/CSI included in ICH E2C CIOMS IVNot formally incorporated into regulation but standard requested by EU authorities CIOMS VBasis for ICH E2D; incorporation into Volume 9a (EU) CIOMS VIIBasis for ICH E2F (DSUR) DipPhaMed – Module 9- April 2011 Who’sWho

28 DipPharmMed – Module 9- April 2011 Who’sWho Any Questions?


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