Quality in pharmacovigilance systems

Transcription

1 Quality in pharmacovigilance systems June 20 th, 2014 Lisa Stagi, Medical Compliance Leader Roche Spa Quality systems in pharmacovigilance: legal requirements Regulation 1235/2010 e Directive 2010/84 Legal basis Regulation 520/2012 Minimum requirements for quality systems for carrying out the pharmacovigilance activities GVP Modulo I PV Systems and their Quality Systems 1

2 Quality systems in pharmacovigilance: legal requirements Consistency with principles in ISO standards ISO 9000 standard for quality management systems implementation defines: - How an organization manages process in a quality framework - How to manage compliance to defined requirements - How to manage customer satisfaction - A set to aim at continuous improvement (ISO 9004) What is quality and quality management system? 2

3 Definition of Quality Management Quality is: The degree to which a set of inherent characteristics fulfills requirements According to the ISO 9000 standard A Quality Management system is defined as: The organizational structure, responsibilities, procedures, processes and resources for implementing quality management According to US FDA 21 CFR 820 Definition of Quality Management System (QMS) Framework and mindset at same time It is a framework that sets out the structure, responsibilities and procedures that help us identify, measure, control and enhance core business processes The goal of a QMS is to maintain compliance and improve business performance. It is composed by different elements interconnected QMS is the difference between excellence and disaster 3

4 A mature GVP QMS includes 5 elements... Implemented both at a Global level and at Affiliate level Communication links between Global and local functions The cycle assures continuous improvement 7 QMS Framework Strategy & Governance Strategic direction and principles that demonstrates Roche s commitment to operate in a compliant way and is dedicated to continuous improvement Organisational Effectiveness Organisation that is structured in a clear way and is well resourced with people that are capable and trained to perform their activities Processes and Procedures Policies, SOPs, work instructions, processes and training materials that enables the business to be correctly skilled and compliant Records Objective evidence and associated network of IT systems, documentation and tools to collect, process, manage and store all data associated with GCP/GVP Continuous Improvement Process by which Roche continually improves the effectiveness of our procedures and overarching QMS 8 4

5 QMS Core Documents GCP/ GVP QMS Manual The fundamental document that summarises the content of the QMS framework Strategy & Governance Organisation Effectiveness Regular management reviews to assess Quality performance Clearly defined roles, job descriptions and training documented for all individuals GCP/ GVP Quality Plan Operational tool designed to oversee the implementation of the Quality Manual (updated annually) Processes & Procedures Record Continuous Improvement Standardized and simplified processes and SOPs across the organisation GVP documents stored in structured and easily accessible compliant systems Opportunities for improvement are identified through regular review of metrics & targets (KPI management and monitoring) 9 Strategy & Governan ce Regular management reviews to assess Quality System performance in order to provide management with adequate information Periodic assignment and review of quality objectives Governance model maps and charters 10 5

6 Organisatio n Effectivene ss Clearly defined roles, job descriptions and training documented for all individuals - QPPV with sufficient authority to affect the operation in the quality system and the activity of pharmacovigilance - organization chart and clear definition of roles and responsibilities (function in charge of PV system implementation and oversight, execution, audit activities) - job descriptions with description of main role responsibilities, including QPPV - defined procedures to be followed in case of emergency (back up) 11 Organisatio n Effectivene ss Clearly defined roles, job descriptions and training documented for all individuals - staff competent, qualified and trained, (documented way) including QPPV - initial and continuing training, documented - reliable and updated training records - Training efficacy 12 6

7 The marketing authorization holder has the responsibility to ensure that in relation to outsourced activities is applied to an effective system of quality Organisatio n Effectivene ss importance of procedures on vendors management and vendor continuous oversight, in order to assure a fully compliant system: - Pharmacovigilance agreements in place - KPI defined to have oversight of vendor activities - Audit plan 13 Process es & Procedu res Standardized and simplified processes and SOPs across the organization - continuous monitoring of pharmacovigilance data - Risk minimization and risk prevention, managing new risks or changes to existing risks - the scientific assessment of the risks of medicines - transmission to the EudraVigilance database of accurate and verifiable data on serious and non-serious adverse reactions, according to the timing defined by regulation - SOPs to guarantee the quality, integrity and completeness of the information provided on risks of medicines - To avoid double reporting - For validation of the signals 14 7

8 Standardized and simplified processes and SOPs across the organization Process es & Procedu res - effective communication with the competent Authorities - Business Continuity Plan - Managing the PSFM - Management of PSUR - Corrective and preventive actions - Post-authorization safety studies - the updating of product information - Safety management during clinical trials - Adequate provision of information relevant to safety to health professionals and patients 15 GCP / GVP documents are stored in structured and easily accessible compliant systems Record - Recording all the information of PV, handled and stored in such a way they can be reported, interpreted and verified thoroughly - Pharmacovigilance data and documents relating to individual medicines authorized preserved as required - Records management system for all documents used for pharmacovigilance activities in order to: Find these documents Track how and when were examined / made decisions on safety issues - Tracking and follow-up of adverse reaction reports - Keeping the elements of the PSFM according to law requirements 16 8

9 Continuous Improveme nt Opportunities for improvement are identified through regular review of metrics & targets (KPI management and monitoring) Periodic review of Quality Plans Implement Quality Monitoring ( routine sourvellaince of activities performed through Quality Control and Quality Assurance activities) 17 Quality Control activities Continuo us Improve ment - Double check activities and quality control plan for more relevant processes (IRT collection, RMP ) - Monitoring of process performance through KPI, regularly collected and reviewed -KPI identified based on the main attributes of processes (in terms of accuracy, consistency, completeness and medical adherence) dashboard developed to be considered by senior management. - KPI out of control subject to CAPA (Corrective & Preventative) management 18 9

10 Quality Assurance activities Continuo us Improve ment Audit - Periodic audits based on risk and process analysis, with a defined audit plan to ensure compliance with quality system requirements described to determine the effectiveness outsourced activities covered by audit plan - Audits carried out by people who do not have responsibility or implications Independent auditors required (Quality Assurance function) - Documented reports and follow up 19 Quality Assurance activities Continuo us Improve ment CAPA management - Defined SOPs to track, manage and periodically review corrective and preventative actions, to be reported to senior management in management review - Deviation management 20 10

11 Quality is not an act, it s a habit Aristotile Our approach to QMS Fully engrained quality in the organization Systems & Processes GxP Process Business Process Capabilities Skills Knowledge Experience Education Training Mindset Accountability Proactive Thinking Commitment Robust business processes & systems Process capability/ KPIs Leadership & business acumen Qualified Staff Compliance sustainability & proactive risk management Quality owned by all 11

12 Most importantly: Keep it Simple! 23 Grazie per l attenzione 12