GPvP Symposium 2014: Welcome and Updates. 14 March 2014 Rebecca Stanbrook, Group Manager Inspections (GCP/GPvP/GLP)

Transcription

1 GPvP Symposium 2014: Welcome and Updates 14 March 2014 Rebecca Stanbrook, Group Manager Inspections (GCP/GPvP/GLP)

2 Agenda Housekeeping The MHRA Welcome The Day Ahead The Technology 2

3 Housekeeping Restrooms - situated on the Lower Ground Floor Switch mobile phone off or to aeroplane mode. NOT TO SILENT Cloakroom situated on the Lower Ground Floor Emergency procedures - There is no scheduled fire alarm test today so if the alarm is raised please treat it as genuine and follow instruction from the venue staff. 3

4 Organisation MHRA - Regulates medicines and medical devices, ensuring that they work, and are acceptably safe; focusing on the core activities of product licensing, inspection and enforcement, and pharmacovigilance. Clinical Practice Research Datalink (CPRD) - Gives access to an unparalleled resource for conducting observational research and improving the efficiency of interventional research, across all areas of health, medicines and devices. National Institute for Biological Standards and Control (NIBSC) - World leaders in assuring the quality of biological medicines through product testing, developing standards and reference materials and carrying out applied research. Corporate divisions - Communications, human resources, operations and finance, information management, policy. 4

5 Our vision and values Vision - We protect and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. Values - Innovative - Proactive - Impartial - Evidence-based - Open - Trustworthy 5

6 Corporate Structure RALG Risk and audit liaison group Finance (FSC) Finance sub committee RegEx Regulatory excellence IMGB Information Management Governance Board OpEx Operational excellence IASG Information Assurance Steering Group Agency Board Corporate Executive Team Regulatory Group Audit & Risk Assurance Committee Regulatory Science Strategy Group NIBSC SMT NIBSC Centre Dev LD VRMM IE&S CPRD EC CPRD Centre PGU IMD Comms POL O&F HR Centre Director Responsible Officer Governance/Performance/ Strategy Division/Centre/Group 6

7 Divisions and centres Vigilance & Risk Management of Medicines Communications CPRD Centre Policy Operations & Finance NIBSC Centre MHRA Devices Human Resources Licensing Inspection, Enforcement & Standards Information Management 7

8 Bilateral links Russia Israel** India** Canada* USA* INTERNATI ONAL INFLUENCE China* Japan* Taiwan (ROC)* Singapore* Brazil* Ghana** New Zealand* Australia* Information exchange Source country BRICS country Other * Agreement/MOU ** Negotiating agreement/mou 8

9 The European regulatory network 28 member states in European Union (almost 500 million people) Legislation set up at European Union level Medical Devices: authorisation always for the whole EU Blood: site authorisations at national level, permitting distribution of blood components throughout Europe Medicines: authorisation at national, EU or in a number of countries European Medicines Agency (EMA) Heads of Medicines Agencies network (uniting 44 regulators) 9

10 Welcome and update (1) Service Provider Inspections Purple Guide GVP Updates and Union Procedures Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) 10

11 Welcome and update (2) Benchmarking of European Medicines Agencies (BEMA) Clinical Trials Regulation Transparency Risk based inspections database Stakeholder Engagement Meeting (StEM) 11

12 The Day Ahead 10:15-11:00 Updates on Union Procedures and GvP Modules Dr Anya Sookoo, MHRA 11:00-11:20 Refreshment break 11:20-12:10 Reference Safety Information and Pharmacovigilance Rebecca Webb, MHRA 12:10-12:50 The Pharmacovigilance Risk Assessment Committee Dr Julie Williams, MHRA 12:50-13:00 Panel Questions for the Morning Session Panel Lunch 12

13 The Day Ahead 14:00-14:40 PSMF in Practice - Your Questions Answered Jonathan Rowell, MHRA 14:40-15:10 Interventional Clinical Trials Pharmacovigilance Catharine Raitt, MHRA 15:10-15:30 Refreshment break 15:30-16:00 MHRA Pharmacovigilance Inspections: Practical Examples and Findings 2013/2014 Sophie Keddie, MHRA 16:00-16:30 Interactive Quiz Mandeep Rai, MHRA 16:30-16:45 Panel Questions for the Afternoon Session Panel 16:45-17:00 Closing Remarks Rebecca Stanbrook 13

14 On with the show 20

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