Pharmacovigilance Inspections
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Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
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Pharmacovigilance Inspections
- 1. Pharmacovigilance System Inspections Raj Bhogal Head of Inspection Management R&D Quality, Takeda 1
- 2. Disclaimer “The views and opinions expressed in this presentation are those of the author and do not necessarily represent official policy or position of Takeda” 2
- 3. Agenda • Importance of Pharmacovigilance • Pharmacovigilance Inspection Management • PV System Legislation Updates • Regulatory Agency Trends & Inspection Findings • Consequences of Poor Inspections 3
- 4. Importance of Pharmacovigilance • Pharmacovigilance is the science and activities relating to the – Detection – Assessment – Understanding and – Prevention of adverse effects or any other medicine-related problem. 4
- 5. PV in Product LifeCycle • Before a medicine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials – where patients are selected carefully and followed up very closely under controlled conditions. – This means that at the time of a medicine's authorisation, it has been tested in a relatively small number of selected patients for a limited length of time. • After authorisation the medicine may be used in a large number of patients, for a long period of time and with other medicines. – Certain side effects may emerge in such circumstances. • It is therefore essential that the safety of all medicines is monitored throughout their use in healthcare practice. 5
- 6. Objectives of PV System Inspections • To determine that the marketing authorisation holder has the following in place to meet their pharmacovigilance obligations – Personnel – systems – facilities • To identify, record and address non-compliance – which may pose a risk to public health • To use the inspection results – For enforcement action basis, where considered necessary 6
- 7. Risk Based Approach 7 INSPECTIONS Inspection related Product related MAH related PV system related Inspection History across GxP & CAPAs management requirement for risk-minimization activities Mergers acquisitions number of products change in the QPPV or local PV contact person changes to PSMF changes to Organisation and management
- 8. PV System Element Ownership Research Non-clinical studies and Literature Owned by Global Safety Team Owned by other R&D functions Safety Review Team Company Core Data Sheet Aggregate reports Risk Management Plan Investigator Brochure/ Informed Consent Ad Hoc Communication Global Safety Individual Case Safety Reports Tech Op Quality Complaints Epidemiology Population data Epi Studies Regulatory Affairs HA Requests Clinical Clinical trials Registries Local Label Labelling Committee Commercial Patient Support Programs/MR Product Council Medical Affairs Medical Info Literature Quality Management System Procedural documents Training Deviations CAPA process Audits Metrics Inspection management Owned by commercial Owned by Tech Ops/Mfg
- 9. How do you decide support model? • Determined by the following – Country of inspection – Inspectorate/Regulatory Authority experience – Announced or unannounced – Inspection Duration – Previous inspection experience and any previous inspection findings and severity across GxPs – Language of inspection conduct – Scope of inspection (R&D, Tech Ops, Commercial) & MAH entities – Size of site (incl. Quality personnel) & PV System related activities – Subject matter experts location – Scope of PV system related changes – Risk areas 9
- 10. Inspection Management 10 Lead Inspection Readiness Activities Host Inspections or oversee if delegated Share Lessons learnt and findings with R&D stakeholders and LOCs Coordinate Responses & CAPAs Review evidence of CAPA completion Perform CAPA Effectiveness Checks
- 11. Inspection Readiness – Who? • All Company Employees • All Agents of Company – Contractors & temporary employees – CROs – Distributors, Vendors and Other External Service Providers • Anyone who may receive Safety Information/AEs in the normal course of their daily work 11
- 12. Inspection Readiness Step 1 Step 2 Step 3 Step 4 Step4Step3Step2Step1 People Integrity Excellence Sharing Industry Findings Sharing previous audit/ Inspection findings, reports and responses Understand the Inspection process, legislation Complete trainings Update CVs and JDs Review Inspection Readiness checklist Attend the Inspection Kick off meeting Identify SMEs Interview Prep Run through the Inspection logistics Write Position Statements Identify CAPAs Highlight areas of non Compliance or risk to Management and Quality Print the prep documentation Review processes & documentation Work in cross functional Teams to prepare Document Deviations Review the inspection Readiness checklist Create a collaboration site Logistics planning
- 13. Where are Authorities actively inspecting? Australia Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Croatia Denmark Europe France Indonesia Japan Jordan Moldova Netherlands Poland Portuguese Saudi Arabia Slovenia Sweden Switzerland UK USA EVOLVING… Arab GVPs China, India, Australia Singapore, Malaysia, Vietnam, Egypt • Implementation and adoption of EU GVP like legislation • Implementation of Compliance Questionnaires • Focus on QMS • Focus on Contact person responsible for pharmacovigilance • Implementation of ISO, ICH E2B(R3), EVDAS • FDA unannounced • focus on ICSR, QMS, Deviations and CAPA • European Authorities • Concept of supersite/volume of requests • Health Canada • unexpected lack of effect, QMS and training • SwissMedic • Swiss PV requirements, causality assessment
- 14. GVP - MHRA Findings Source: MHRA Symposium May 2018 & https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/761289/GPvP_Metrics_2017-18_.pdf 14 April 2016 – March 2017 April 2017 – March 2018 Critical Reference Safety Information on decrease Increase in relation to signal management and supervision and oversight of the PV system Major Quality Management Ongoing safety evaluation and RSI supervision and oversight of the PV system Critical & Majors Risk Management Quality Management System Ongoing Safety Evaluation
- 15. GVP - TGA Findings Source: https://www.tga.gov.au/sites/default/files/pharmacovigilance-inspection-program-metrics-report-sep-2017-dec-2018.pdf 15
- 16. GCP – MHRA Critical Findings • “The MHRA approved Reference Safety Information (RSI) in effect at the time of occurrence of a Serious Adverse Event (SAE) was not being used for expectedness assessments as required by CT-3 guidance.” Source: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/706356/GCP_INSPECTIONS_ METRICS_2016-2017__final_11-05-18_.pdf 16
- 17. Consequences of Poor Inspections • Failure to demonstrate remediation of major findings results in critical findings • Initiates ANNUAL inspections – major resource consumption • Remediation efforts become greater and more costly • Regulatory Agency meetings • Could negatively impact current approvals and future filings • Require a response from industry within a specific timeframe • FDA 483 letters • Enforcement Actions – Administrative: license suspension or revocation – Legal: seizure, injunction, consent decree, prosecution • Infringement notices e.g., MHRA & Injunction letters published e.g., ANSM 17
- 18. Questions 18