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Pharmacovigilance

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The competitiveness of drug development has been the impetus for new and accelerated regulatory pathways. While the growing patient-centric healthcare market coupled with a vested interest in safety information from a range of governmental and regulatory stakeholders has driven pharmacovigilance to reach a new paradigm in drug development. The consequence of which has led to tighter post-marketing surveillance systems on the global scale and a rapidly expanding volume of reported safety events impelling the industry to adopt new strategies to managing pharmacovigilance throughout the product lifecycle. In view of all these changes, it is timely to provide an overview on the concept of Pharmacovigilance, and here i3 Consult has published in this Slide Share, some key topics on Pharmacovigilance such as Signal Detection, Detection Management, Risk Management and Risk Reduction Strategies. At i3 Consult, our core team of experts & our 200,000+ network bring innovative ideas, cost effective solutions and game changing services to healthcare, pharma & life science, for more details, visit www.i3consult.com

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Pharmacovigilance

  1. 1. i3 ConsultIntegrated Intelligence for Healthcare Industries Pharmacovigilance Challenges & Opportunities
  2. 2. i3 Consult What is Pharmacovigilance? Some etymology;  Greek root “Pharmakon” means “Medicinal Substance”  Latin root “Vigilia” means “To keep watch over” A formal definition;  WHO: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
  3. 3. i3 ConsultEverything in Pharma Has a System According to the EMA: A pharmacovigilance system is defined as a system used by an organisation to fulfil its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of authorized medicinal products and detect any change to their risk-benefit balance [DIR Art 1(28d)]. A pharmacovigilance system, like any system, is characterised by its structures, processes and outcomes. For each specific pharmacovigilance process, including its necessary structures, a dedicated Module is included in good pharmacovigilance practices (GVP).
  4. 4. i3 Consult Wider Meaning of Pharmacovigilance  Apart from ethical drugs & OTCs, pharmacovigilance embraces any treatment intervention − Medical devices, vaccines, blood products, biological products e.g. mAbs, traditional medicines, herbals, nutriceuticals and complimentary medicines  Side Effects, Adverse Events, Side Effects & Drug-drug Interactions − Medicines may affect the patient/individual in unintended ways, such effects (side effects), even events/episodes (adverse events) may arise from multiple drugs being taken (drug-drug interactions), all posing a clinical risk
  5. 5. i3 Consult Pharmacovigilance Work Flow Data Acquisition ADR Clinical development Observational & Epidemiology Preclinical Detection Statistical treatment Data mining Disproportionality & Anomalies Quantitative Correlations Assessment Causality evaluation Signal assessment Benefit-Risk assessment Risk management Intervention Dear Dr. Letters RMPs License renewals Marketing authorisation annulments Label & product insert changes Safety reports
  6. 6. i3 ConsultDevelopmentStage Pre-clinical Clinical studies – Phase I to IV PostMarketing Marketing Authorisation Holders (MAH) Voluntary Reporting Data Analysis from MAH Communication Media PMS Misuse or errors E-monitoring of safety Data Sources
  7. 7. i3 ConsultSignal Detection  EMA & MAH both responsible for managing safety signals.  Safety signal may arise from simply patient/individual has a preexisting medical condition (other than the condition s/he is being treated for) or due to a drug- drug interaction, i.e. an adverse event is NOT always a consequence of the drug treatment.  Safety signal management requires establishing whether there is a causal relationship between the adverse event and the drug treatment.
  8. 8. i3 ConsultDetection Management  Differentiate between a true signal having a causal relationship with the drug treatment and that of background “noise” caused by media coverage or raised awareness due to socio-political or geographical trends.  Select suitable method of signal detection where there is collaboration between different MAHs.  Select detections of interests BUT provide a rationale for non-detections.  Prioritise these signal detections.  Standardise the signal evaluation so that reproducibility stems from different evaluators.  Contraction of time delay between occurrence of AE until data is processed is KEY.  Quality management system requires documentation in place, an audit trail & OJT training.
  9. 9. i3 ConsultRisk Management  Aims to maximise the margin of clinical benefit of the drug above the risk associated with that product  A Risk Management Plan (RMP) for the entire lifecycle of the drug must:  Identify what is known and unknown about the product's safety  Describe counter measures taken to minimise any risks associated with the product and an evaluation made of these interventions  Outline obligations conditional to marketing authorisation  Outline additional PMS measures on efficacy, safety etc.
  10. 10. i3 ConsultRisk Reduction Strategies  Choose the most amenable and effective risk reduction measure according to the severity and critical nature of the identified risk  Monitoring of specific sub-populations – expectant mothers, patients with underlying chronic conditions and children  Procedure stringency with patient ID ( DoB & addresses) and data protection laws (GDPR) so that signal detection can be accurately cross referenced  Make clear distinctions between RMP educational data and sales promotion data
  11. 11. i3Consult@i3Consult.com +33 788 914240 i3Consult.com @i3_Consult www.i3Consult.com I3 Consult i3 ConsultIntegrated Intelligence for Healthcare Industries

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