Managing Food Incidents Incident Management in the Food Standards Agency. Colin Houston Head of Incidents Unit

Size: px
Start display at page:

Download "Managing Food Incidents Incident Management in the Food Standards Agency. Colin Houston Head of Incidents Unit"

Transcription

1 EMERGENZE IN SICUREZZA ALIMENTARE: PROCEDURE E GESTIONE FOOD SAFETY EMERGENCY: PROCEDURES AND MANAGEMENT Cremona, 6-8 Giugno 2011 Managing Food Incidents Incident Management in the Food Standards Agency Colin Houston Head of Incidents Unit

2 Overview of Presentation What is an incident? Role of the Agency and the Incidents Unit Types and frequency of incidents How do we manage incidents? How do we classify an incident? What action do we take? How do we learn from experience?

3 What is an incident? An incident is any event where, based on the information available, there are concerns about actual or suspected threats to the safety or quality of food that could require intervention to protect consumers interests.

4 Role of the Agency Agency is the Lead Government Department for widespread contamination of food Agency also has a key supporting role, providing food safety and standards advice in relation to a range of other incidents

5 Role of the Incidents Unit Role covers incident response, food fraud and emergency planning Incidents Branch First contact point for incidents in England (24/7 response) Local variations in devolved countries Lead administrative role during incidents Maintain an official audit trail, using a dedicated Incidents Database Contact local authorities Support to Operational and Strategic Incident Management Teams Arranges issue of food alerts and allergy alerts Alerts EC via Rapid Alert System for Food and Feed (RASFF)

6 Types of Incidents (clockwise from top left food borne illness, chemical fires, illegal colours, on-farm)

7 Frequency of Incidents in 2010 In 2010 we investigated 1,505 incidents in the UK. Where needed, action was taken to ensure consumers were protected from eating unsafe food. The major categories of incident in 2010 were: environmental contamination 23% microbiological contamination 18% natural chemical contamination (mycotoxins, algal toxins and others) 15% on-farm incidents 8% physical contamination 8%

8 How do we manage incidents? We follow a set Protocol, which covers, inter alia: - notification procedures; - incident classification levels; - roles and responsibilities; - management structure during Low, Medium and High incidents - Meetings with external stakeholders Scoping Group and Stakeholder meetings - out-of-hours procedures - closure and review procedures Protocol is regularly reviewed and revised version published in May Rolling training programme for Agency staff on protocol and database (300+ staff trained)

9 How do we classify an incident? We classify all incidents using a combination of the severity of the incident and the complexity of the investigation. A number of parameters contribute to these high-level criteria. But the overall assessment or output is simply high, medium or low.

10 How do we classify an incident? Severity Extent of health effects Numbers and/or groups of consumers affected Public health risk assessment Perceived risk by consumers Perceived risk by the media Complexity Numbers of reports received Numbers of products/locations Number of agencies involved Traceability

11 How do we classify an incident? Each heading contains a range of scores and is weighted to produce a final score that equates to high, medium or low. The system enables rapid and consistent categorisation of incidents, once notified, and as they develop. This allows incidents to be effectively scoped, resourced and managed. The system is not designed as a risk assessment tool, but a means to aid us in planning and management decisions.

12 How do we classify an incident? Low These are minor incidents, with localised effects and few, if any, food safety implications. Examples of such incidents include barn fires, vehicles in rivers, or minor oil spills. Medium These include incidents involving evidence of illness, impact on vulnerable groups (babies, pregnant women or the elderly) and breaches of statutory limits (for example, for mycotoxins). In some cases the public or the media are likely to express some concerns. High These are severe incidents with the potential to cause serious illness or deaths. They are complex, with a large number of products affected and a high level of resources required to manage. They are widespread and likely to generate a high level of concern among the public and the media.

13 Risk Assessment We have a wide range of scientific and policy experts at our disposal during incidents. These experts provide advice on risks to human health, risk to the food chain and applicable legislation during incidents. This advice is used to formulate risk management options and determine a risk management strategy during each incident. We also have access to various independent scientific committees that comprise individuals with recognised expertise within their field. These committees provide independent, expert advice to the Agency on research and policy when requested.

14 Risk Management Risk assessment is used to inform the risk management options during each incident. The Agency will liaise with the relevant local authorities, industry, other government departments and agencies in order to arrive at an appropriate risk management strategy. The strategy will take into account:- risk assessment risk communication proportionality legislation the precautionary approach Once a strategy is decided upon by ourselves in consultation with key external stakeholders, it will be disseminated to teams within the Agency, local authorities, industry and others as appropriate.

15 How do we manage incidents? I n c id e n t N o tific a tio n In c id e n ts B r a n c h In fo r m a tio n flo w O th e r D e p a r tm e n ts / A g e n c ie s In d u s tr y L o c a l A u th o ritie s P o lic y D iv is io n ( R is k A s s e s s m e n t) C o m m u n ic a tio n s L e g a l R is k M a n a g e m e n t O p tio n s S tr a te g y A c t io n W ith d r a w a l o r r e c a ll M o n ito rin g a n d s a m p lin g C o m m u n ic a tio n G u id a n c e o r a d v ic e R e s tric tio n s

16 ROLES & RESPONSIBILITIES Where a member of staff has been assigned a specific role (Incident Manager, Investigating Officer, Official Note Taker etc) that individual must ensure at the outset that they have identified a suitable deputy, who can effectively carry out that function in their absence, and updated the Incident Manager accordingly. The Incidents Branch act as the first point of contact with external stakeholders for incidents and maintain the official audit trail for the investigation by co-ordinating the logging, collation and distribution of information required during the investigation.

17 ROLES & RESPONSIBILITIES Where there has been known distribution of potentially contaminated products, the Branch will contact the relevant local authorities (LAs) to trace this material and report back its findings to the Operational Incident Management Team. The Branch shall also arrange Operational Incident Management Team meetings, draft notes of meetings, co-ordinate the production of briefing for Directors, Ministers and provide any other administrative support to the Operational Incident Management Team deemed necessary. The Incidents Branch arrange the issue of food alerts and product recall/withdrawal information notices to LAs, other Government departments, trade organisations etc. Incidents Branch acts as UK contact point for the Rapid Alert System for Food and Feed (RASFF) and is responsible for issuing RASFF notifications to the Commission.

18 ROLES & RESPONSIBILITIES For high level incidents, the Incidents Branch has suitable business continuity plans in place to ensure that it can continue to operate effectively in the event of an IT failure or similar serious business disruption. During High level incidents, it is often appropriate to set up a dedicated briefing cell to carry out the information management and/or briefing function.

19 Incident Manager For each incident an Incident Manager is identified. This would normally be the Head of the Incidents Unit or their appointed deputy. To cope with the intense demands of the role, for high level incidents at least two Incident Managers will be required. Where two (or more) incident managers will be undertaking this role, a meeting between them will be required at the outset to agree on the allocation of tasks. The Incident Manager is accountable to Directors and the Chief Executive for the strategic management of the incident, for decisions taken by the operational incident management team and for the outcome of the incident investigation.

20 Incident Manager The Incident Manager will be responsible for setting and maintaining the pace of the incident (including the frequency and timing of Operational Incident Management Team meetings) and for ensuring that the Strategic Director, Strategic Incident Management Team and other interested parties (e.g. Ministers) receive timely briefing on the progress of incident investigations. The Incident Manager will agree at the outset, following consultation with other Operational Incident Management Team group members, the key determinants of the incident management process. These include: the scope and severity of the event the time-scale for resolution the availability of resources identifying those responsible for delivering work-streams identifying those responsible for initiating and maintaining contact with stakeholders.

21 Incident Manager The Incident Manager shall ensure that the standard agenda is followed as a minimum during Operational Incident Management Team meetings. Incident Managers are also responsible for clearing final notes of Operational Incident Management Team meetings and ensuring that the content reflects the conclusions of the meeting. The level of direct involvement of the Incident Manager in the operational management process will vary depending on the nature and severity of the incident. Each Incident Manager must identify a deputy with the authority and responsibility to take decisions in their absence. In cases where the Incident Manager changes during the investigation, it is vital that there is a seamless handover. Consequently, the new Incident Manager must be fully briefed by his/her predecessor. Where appropriate, the Incident Manager shall decide whether any further accommodation or resource issues need to be addressed, for example, when planning for activity out of normal office hours.

22 INVESTIGATING OFFICER The Investigating Officer is the main contact within the Incidents Branch leading the incident. The Head of Incidents Unit or deputy will determine who takes on this role, taking into account officials workloads at the time. The Investigating Officer will ensure that the incident is dealt with in a timely manner, key stakeholders (internal and external) are updated on developments and that all staff dealing with the incident follow the protocol.

23 INVESTIGATING OFFICER An Investigating Officer s tasks will include: information gathering (liaising with a range of external stakeholders including FBOs, LAs and OGDs) seeking legal advice, where the legal position is unclear arranging and attending Operational Incident Management Team meetings taking notes of meetings co-ordinating briefing drafting food alerts, allergy alerts and product withdrawal/recall information notices preparing RASFF notifications logging data on the Incidents Database answering calls and correspondence regarding the incident. Including Ministers Correspondence cases, Freedom of Information requests and Parliamentary Questions

24 PRESS OFFICER The Press Officer s role will be to deal with any queries from the media regarding the incident. All calls from journalists must be forwarded to the Communications Division press officer for his/her attention. The Agency s press officer will also attend Operational Incident Management Team meetings and draft news stories as appropriate. The Press Officer will aim, wherever possible, to issue web stories or press releases regarding incidents at set times during the day. However, in many incidents this may prove to be difficult given the pressures, often from the media to distribute information as quickly as possible. Where this is the case the press office will aim to ensure that the release of information is as close to one of the set times as possible. The press office is also mindful of deadlines, particularly for printed media, and will aim to have information in the public domain before the end of the day.

25 LEGAL ADVISER The Agency s Legal Adviser advise on any legal aspects of the incident (e.g. where clarification is required re: legal basis for our actions) and, where necessary, attend operational incident management team meetings. Where legal advice is being sought, the Incidents Branch must ensure that this is made explicitly clear in the to Legal Services (preferably in the title). The Legal Adviser will also lead on the production of Orders under the Food and Environmental Protection Act (FEPA) or other legislation required to be introduced as part of the incident response..

26 OFFICIAL NOTE TAKER Every incident involving an Operational Incident Management Team will have an official note taker assigned to it, taken from within the Incidents Branch. The note taker will attend all Operational Incident Management Team meetings and, where appropriate, Strategic Incident Management Team meetings relating to that incident. The note taker will produce a summary of the meeting, which will be circulated to all attendees and, where appropriate, Directors within one hour of the meeting. The summary shall in each case identify roles and responsibilities (e.g. Incident Manager), the legal basis, risk assessment and action points agreed, the individuals tasked with carrying them out and the time-scales for action. The Incident Manager will clear this summary note and, where there are significant legal issues, the note will also be cleared by the Legal Adviser. The note taker will also prepare a formal note of the meeting, which will be commented on by attendees and cleared by the Chair.

27 TECHNICAL SUPPORT OFFICER Every incident will have a technical support officer assigned to it, taken from within the Incidents Branch. This official will be responsible for all video/tele-conferencing arrangements relating to Operational, Strategic, Scoping Group and Stakeholder meetings held during that particular incident.

28 OPERATIONAL INCIDENT MANAGEMENT TEAM The Incidents Manager will ensure that the Incidents Branch identifies the members of an Operational Incident Management Team (OIMT) to progress the incident investigation. The Group will consist of representatives from the Incidents Branch, all of the relevant Policy Divisions, Communications Division, Legal Services, representatives for devolved administrations and any other relevant Agency officials, as appropriate. For incidents with a European dimension, EU and International Strategy team representatives need to be involved at an early stage and be included within the Operational Incident Management Team.

29 OPERATIONAL INCIDENT MANAGEMENT TEAM The OIMT will take tactical level decisions, discharge actions needed to collect information and formulate proposals for risk management options or strategic decisions for the Incident Manager to endorse. The OIMT should critically review precedents for action or inaction to establish whether they continue to be appropriate. It should also consider the consequences of action or inaction and these deliberations must be recorded as part of the official record. This should be an ongoing part of the incident investigation. The Group will, at the outset, document the legal basis for action or inaction, the factors relied on and the weight given to each factor. It will also clarify the role of enforcement authorities, recognising the authorities other statutory responsibilities and the need to prioritise resources.

30 STRATEGIC INCIDENT MANAGEMENT TEAM The purpose of the Strategic Incident Management Team is to set the overall strategy for responding to a high level incident. As part of this function, the team should consider and agree an appropriate communications strategy. The overall strategy will then be passed to the Operational Incident Management Team for implementation, who will regularly report back on progress. Once the strategy is set, the Strategic Incident Management Team will ensure that the strategy is effectively implemented by directing and supporting the Operational Incident Management Team.

31 STRATEGIC INCIDENT MANAGEMENT TEAM SIMT meetings can also be used as a clearing house where key documents need to be cleared urgently (e.g. news story or Ministerial submission). These meetings will normally be chaired by the Strategic Director. Other potential members include the Chief Executive, Chief Scientist, Incident Manager, Director of Communications, Director of Legal Services, Head of EU and International Strategy, Strategic Adviser, Directors in devolved offices and senior representatives from relevant policy divisions. The Incidents Branch will always seek to ensure that Agency officials with suitable expertise are available, as required, for SIMT meetings. The Strategic Director will ultimately determine who attends each meeting. The frequency and number of these strategic meetings will depend largely on the scale of the incident and the degree of Agency involvement.

32 What will we do with the information once received? We will use the information received to inform our risk assessment, which, in turn will be taken into account when considering our risk management and risk communication options. Dialogue between industry, us and local authorities is encouraged at all stages to ensure our risk management advice is proportionate and practical. We may, in the light of the information received, issue a food alert to local authorities, who enforce food law. These alerts are used during incidents where, for example, the distribution of a product is wide and will potentially involve many local authorities.

33 Food Alerts Two types of Food Alert Drafted carefully to avoid mistakes and ambiguity 3 drafts of each Food Alert Circulated for comment to LA / Company Cleared by Senior Management Press release / news story on web Procedures for 'Product Withdrawal Information Notice' or a 'Product Recall Information Notice' began 2 June 2010

34 How do we learn from experience? All incidents dealt with by the Incidents Branch are reviewed Ad-hoc incident review meetings Quarterly Review Meetings Findings from ad-hoc review meetings to Incident Review Group Protocol updated, where necessary

35 Thank you

Food Standards Scotland. Incident Management Plan for Non-routine Incidents.

Food Standards Scotland. Incident Management Plan for Non-routine Incidents. Food Standards Scotland Incident Management Plan for Non-routine Incidents. May 2015 v 1.0 DOCUMENT CONTROL This Food Standards Scotland (FSS) Incident Management Plan, and its associated internally held

More information

Incident Management in the Food Standards Agency. The Role of External Communications. Colin Houston Head of Incidents Unit

Incident Management in the Food Standards Agency. The Role of External Communications. Colin Houston Head of Incidents Unit Incident Management in the Food Standards Agency The Role of External Communications Colin Houston Head of Incidents Unit How to report an incident Businesses and local and port health authorities can

More information

Business Continuity Policy

Business Continuity Policy Business Continuity Policy Page 1 of 15 Business Continuity Policy First published: Amendment record Version Date Reviewer Comment 1.0 07/01/2014 Debbie Campbell 2.0 11/07/14 Vicky Ryan Updated to include

More information

Information Governance Policy

Information Governance Policy Information Governance Policy Version: 4 Bodies consulted: Caldicott Guardian, IM&T Directors Approved by: MT Date Approved: 27/10/2015 Lead Manager: Governance Manager Responsible Director: SIRO Date

More information

Information Governance Policy

Information Governance Policy Author: Susan Hall, Information Governance Manager Owner: Fiona Jamieson, Assistant Director of Healthcare Governance Publisher: Compliance Unit Date of first issue: February 2005 Version: 5 Date of version

More information

Risk Management Policy

Risk Management Policy Principles Through a process of Risk Management, the University seeks to reduce the frequency and impact of Adverse Events that may affect the achievement of its objectives. In particular, Risk Management

More information

South West Lincolnshire NHS Clinical Commissioning Group Business Continuity Policy

South West Lincolnshire NHS Clinical Commissioning Group Business Continuity Policy South West Lincolnshire NHS Clinical Commissioning Group Business Continuity Policy Reference No: CG 01 Version: Version 1 Approval date 18 December 2013 Date ratified: 18 December 2013 Name of Author

More information

Business Continuity Policy

Business Continuity Policy Page 1 of 16 Business Continuity Policy Issue Date: Aug 2013 Document Number: 00241 Prepared by: Business Management and Continuity Senior Manager Next Review Date: April 2014 Page 2 of 16 NHS England

More information

Type of change. V02 Review Feb 13. V02.1 Update Jun 14 Section 6 NPSAS Alerts

Type of change. V02 Review Feb 13. V02.1 Update Jun 14 Section 6 NPSAS Alerts Document Title Reference Number Lead Officer Author(s) (name and designation) Ratified By Central Alerting System (CAS) Policy NTW(O)17 Medical Director Tony Gray Head of Safety and Patient Experience

More information

WORK HEALTH AND SAFETY

WORK HEALTH AND SAFETY WORK HEALTH AND SAFETY SCOPE POLICY Work Health and Safety System Work Health and Safety Objectives Roles and Responsibilities Executive Responsibilities Manager Responsibilities Worker Responsibilities

More information

Information Integrity & Data Management

Information Integrity & Data Management Group Standard Information Integrity & Data Management Serco recognises its responsibility to ensure that any information and data produced meets customer, legislative and regulatory requirements and is

More information

The Risk Management strategy sets out the framework that the Council has established.

The Risk Management strategy sets out the framework that the Council has established. Derbyshire County Council Management Policy Statement The Authority adopts a proactive approach to Management to achieve Best Value and continuous improvement and is committed to the effective management

More information

JOB DESCRIPTION. T&T Security and Resilience Manager. Technology and Telecommunications. Bedford, Chelmsford or Norwich

JOB DESCRIPTION. T&T Security and Resilience Manager. Technology and Telecommunications. Bedford, Chelmsford or Norwich JOB DESCRIPTION PART A: JOB DETAILS JOB TITLE: AFC BAND: T&T Security and Resilience Manager 8a HOURS: 37.5 DIRECTORATE: DEPARTMENT: REPORTING TO: BASE: IM&T Technology and Telecommunications Head of T&T

More information

Information Governance Strategy

Information Governance Strategy Information Governance Strategy ONCE PRINTED OFF, THIS IS AN UNCONTROLLED DOCUMENT. PLEASE CHECK THE INTRANET FOR THE MOST UP TO DATE COPY Target Audience: All staff employed or working on behalf of the

More information

Information Governance Strategy and Policy. OFFICIAL Ownership: Information Governance Group Date Issued: 15/01/2015 Version: 2.

Information Governance Strategy and Policy. OFFICIAL Ownership: Information Governance Group Date Issued: 15/01/2015 Version: 2. Information Governance Strategy and Policy Ownership: Information Governance Group Date Issued: 15/01/2015 Version: 2.0 Status: Final Revision and Signoff Sheet Change Record Date Author Version Comments

More information

List of Contents Section 10, Nuclear Safety and Radiation Protection Legislation Page

List of Contents Section 10, Nuclear Safety and Radiation Protection Legislation Page List of Contents Section 10, Nuclear Safety and Radiation Protection Legislation Page Overview 1 The Radiation Protection (Medical Exposures) Directive 11 The Public Information (Radiological Emergency)

More information

Memorandum of Understanding between the Financial Conduct Authority and the Bank of England, including the Prudential Regulation Authority

Memorandum of Understanding between the Financial Conduct Authority and the Bank of England, including the Prudential Regulation Authority Memorandum of Understanding between the Financial Conduct Authority and the Bank of England, including the Prudential Regulation Authority Purpose and scope 1. This Memorandum of Understanding (MoU) sets

More information

LEEDS BECKETT UNIVERSITY. Information Security Policy. 1.0 Introduction

LEEDS BECKETT UNIVERSITY. Information Security Policy. 1.0 Introduction LEEDS BECKETT UNIVERSITY Information Security Policy 1.0 Introduction 1.1 Information in all of its forms is crucial to the effective functioning and good governance of our University. We are committed

More information

Making Experiences Count Procedure

Making Experiences Count Procedure Making Experiences Count Procedure When a mistake happens, it is important to acknowledge it, put things right quickly and learn from the experience. Listening, Responding, Improving A guide to better

More information

Data Quality Arrangements in the Screening Division Public Health Wales NHS Trust. Issued: August 2012 Document reference: 348A2012

Data Quality Arrangements in the Screening Division Public Health Wales NHS Trust. Issued: August 2012 Document reference: 348A2012 Data Quality Arrangements in the Screening Division Public Health Wales NHS Trust Issued: August 2012 Document reference: 348A2012 Status of report This document has been prepared for the internal use

More information

Version No: 2 Date: 27 July 2015. Data Quality Policy. Assistant Chief Executive. Planning & Performance. Data Quality Policy

Version No: 2 Date: 27 July 2015. Data Quality Policy. Assistant Chief Executive. Planning & Performance. Data Quality Policy Version No: 2 Date: 27 July 2015 Data Quality Policy Assistant Chief Executive Planning & Performance Data Quality Policy Contents 1. Summary Statement 2. Context 3. Purpose 4. Scope 5. Detail of the policy

More information

HEALTH SYSTEM. Introduction. The. jurisdictions and we. Health Protection. Health Improvement. Health Services. Academic Public

HEALTH SYSTEM. Introduction. The. jurisdictions and we. Health Protection. Health Improvement. Health Services. Academic Public FUNCTIONS OF THE LOCAL PUBLIC HEALTH SYSTEM Introduction This document sets out the local PH function in England. It was originally drafted by a working group led by Maggie Rae, FPH Local Board Member

More information

NHS Lancashire North CCG Business Continuity Management Policy and Plan

NHS Lancashire North CCG Business Continuity Management Policy and Plan Agenda Item 12.0. NHS Lancashire North CCG Business Continuity Management Policy and Plan Version 2 Page 1 of 25 Version Control Version Reason for update 1.0 Draft for consideration by Executive Committee

More information

DEPARTMENT FOR BUSINESS INNOVATION AND SKILLS (BIS) ENGLAND ILLEGAL MONEY LENDING PROJECT

DEPARTMENT FOR BUSINESS INNOVATION AND SKILLS (BIS) ENGLAND ILLEGAL MONEY LENDING PROJECT DEPARTMENT FOR BUSINESS INNOVATION AND SKILLS (BIS) ENGLAND ILLEGAL MONEY LENDING PROJECT PROTOCOL FOR ENGLAND ILLEGAL MONEY LENDING SECTION INVESTIGATIONS Interpretation For the purposes of this Protocol

More information

Business Plan 2012/13

Business Plan 2012/13 Business Plan 2012/13 Contents Introduction 3 About the NFA..4 Priorities for 2012/13 4 Resources.6 Reporting Arrangements.6 Objective 1 7 To raise the profile and awareness of fraud among individuals,

More information

BUSINESS CONTINUITY POLICY

BUSINESS CONTINUITY POLICY BUSINESS CONTINUITY POLICY Last Review Date Approving Body n/a Audit Committee Date of Approval 9 th January 2014 Date of Implementation 1 st February 2014 Next Review Date February 2017 Review Responsibility

More information

Process for advising on the feasibility of implementing a patient access scheme

Process for advising on the feasibility of implementing a patient access scheme Process for advising on the feasibility of implementing a patient access scheme INTERIM September 2009 Patient Access Schemes Liaison Unit at NICE P001_PASLU_Process_Guide_V1.3 Page 1 of 21 Contents (to

More information

Data Quality Policy. Appendix A. 1. Why do we need a Data Quality Policy?... 2. 2 Scope of this Policy... 2. 3 Principles of data quality...

Data Quality Policy. Appendix A. 1. Why do we need a Data Quality Policy?... 2. 2 Scope of this Policy... 2. 3 Principles of data quality... Data Quality Policy Appendix A Updated August 2011 Contents 1. Why do we need a Data Quality Policy?... 2 2 Scope of this Policy... 2 3 Principles of data quality... 3 4 Applying the policy... 4 5. Roles

More information

Decision Support Tool for NHS Continuing Healthcare User Notes

Decision Support Tool for NHS Continuing Healthcare User Notes Decision Support Tool for NHS Continuing Healthcare User Notes July 2009 1 Decision Support Tool for NHS Continuing Healthcare We have developed the Decision Support Tool (DST) to support practitioners

More information

Information Governance Strategy

Information Governance Strategy Information Governance Strategy THCCGCG9 Version: 01 The information governance strategy outlines the CCG governance aims and the key objectives of its governance policies. The Chief officer has the overarching

More information

Clinical trials regulation

Clinical trials regulation Clinical trials regulation The Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use and Repealing Directive 2001/20/EC an update

More information

MEMBERS CONSIDER THE RISK STRATEGY AND RECOMMEND APPROVAL TO COUNCIL.

MEMBERS CONSIDER THE RISK STRATEGY AND RECOMMEND APPROVAL TO COUNCIL. Agenda item: 8 Committee: Audit & Standards Committee Date of meeting: 19 th September 2011 Subject: Risk Management Strategy Lead Officer: Head of Finance Portfolio Holder: Resources - Councillor T Oliver

More information

AUDIT & PERFORMANCE REVIEW COMMITTEE ON 26 TH SEPTEMBER 2007

AUDIT & PERFORMANCE REVIEW COMMITTEE ON 26 TH SEPTEMBER 2007 PAGE: 1 REPORT TO: SUBJECT: BY: AUDIT & PERFORMANCE REVIEW COMMITTEE ON 26 TH SEPTEMBER 2007 ASSET MANAGEMENT CHIEF FINANCIAL OFFICER 1. REASON FOR REPORT 1.1 To provide the Audit and Performance Review

More information

Auditing data protection a guide to ICO data protection audits

Auditing data protection a guide to ICO data protection audits Auditing data protection a guide to ICO data protection audits Contents Executive summary 3 1. Audit programme development 5 Audit planning and risk assessment 2. Audit approach 6 Gathering evidence Audit

More information

1.1 Terms of Reference Y P N Comments/Areas for Improvement

1.1 Terms of Reference Y P N Comments/Areas for Improvement 1 Scope of Internal Audit 1.1 Terms of Reference Y P N Comments/Areas for Improvement 1.1.1 Do Terms of Reference: a) Establish the responsibilities and objectives of IA? b) Establish the organisational

More information

Business Continuity Policy

Business Continuity Policy Business Continuity Policy Summary: This policy sets out the structure for ensuring that the PCT has effective Business Continuity Plans in place in order to maintain its essential business functions during

More information

www.lawsociety.org.uk/lexcel Lexcel England and Wales v6 Standard for legal practices Excellence in legal practice management and client care

www.lawsociety.org.uk/lexcel Lexcel England and Wales v6 Standard for legal practices Excellence in legal practice management and client care www.lawsociety.org.uk/lexcel Lexcel England and Wales v6 Standard for legal practices Excellence in legal practice management and client care Lexcel England and Wales v6 Contents About Lexcel... 3 Glossary

More information

Recorded Crime in Scotland. Scottish Government

Recorded Crime in Scotland. Scottish Government Recorded Crime in Scotland Scottish Government Assessment Report 2 June 2009 Recorded Crime in Scotland June 2009 Crown Copyright 2009 The text in this document may be reproduced free of charge in any

More information

CONFIGURATION COMMITTEE. Terms of Reference

CONFIGURATION COMMITTEE. Terms of Reference SWBTB (8/13) 166 (g) CONFIGURATION COMMITTEE Terms of Reference 1. CONSTITUTION 1.1 The Board hereby resolves to establish a Committee of the Board to be known as the Configuration Committee (The Committee).

More information

Healthcare Governance Alert and Guidance Review Procedure

Healthcare Governance Alert and Guidance Review Procedure Healthcare Governance Alert and Guidance Review Procedure Healthcare Governance Alert and Guidance Review Procedure Page: Page 1 of 20 Recommended by Approved by Quality Directorate/Medical Directorate

More information

Information Governance Strategy

Information Governance Strategy Information Governance Strategy Document Status Draft Version: V2.1 DOCUMENT CHANGE HISTORY Initiated by Date Author Information Governance Requirements September 2007 Information Governance Group Version

More information

Business Continuity Management Policy and Plan

Business Continuity Management Policy and Plan Business Continuity Management Policy and Plan 1 Page No: Contents 1.0 Introduction 3 2.0 Purpose 3 3.0 Definitions 4 4.0 Roles, Duties & Responsibilities 4 4.1 Legal And Statutory Duties, Responsibilities

More information

Policies, Procedures, Guidelines and Protocols

Policies, Procedures, Guidelines and Protocols Policies, Procedures, Guidelines and Protocols Document Details Title Complaints and Compliments Policy Trust Ref No 1353-29025 Local Ref (optional) N/A Main points the document This policy and procedure

More information

Securing safe, clean drinking water for all

Securing safe, clean drinking water for all Securing safe, clean drinking water for all Enforcement policy Introduction The Drinking Water Inspectorate (DWI) is the independent regulator of drinking water in England and Wales set up in 1990 by Parliament

More information

Risk Management Strategy

Risk Management Strategy Risk Management Strategy Version: 8 Approved by: Quality and Governance Committee Date approved: 31 July 2014 Ratified by: Trust Board of Directors Date ratified: Name of originator/author: Head of Patient

More information

Freedom of Information PM&C Business Rules

Freedom of Information PM&C Business Rules Freedom of Information PM&C Business Rules Key FOI process milestones Time (in working days) Milestones Stage 1 Day 0 Request submitted Days 0-1 Determine validity, identify decision maker and initial

More information

Councillor role descriptions

Councillor role descriptions Councillor role descriptions All Councillors:- Community Leader Champion your division Deal with casework Represent the community within the Council and other agencies Campaign on local issues Keep in

More information

Aberdeen City Council IT Security (Network and perimeter)

Aberdeen City Council IT Security (Network and perimeter) Aberdeen City Council IT Security (Network and perimeter) Internal Audit Report 2014/2015 for Aberdeen City Council August 2014 Internal Audit KPIs Target Dates Actual Dates Red/Amber/Green Commentary

More information

BUSINESS CONTINUITY PLAN 1 DRAFTED BY: INTEGRATED GOVERNANCE MANAGER 2 ACCOUNTABLE DIRECTOR: DIRECTOR OF QUALITY AND SAFETY 3 APPLIES TO: ALL STAFF

BUSINESS CONTINUITY PLAN 1 DRAFTED BY: INTEGRATED GOVERNANCE MANAGER 2 ACCOUNTABLE DIRECTOR: DIRECTOR OF QUALITY AND SAFETY 3 APPLIES TO: ALL STAFF BUSINESS CONTINUITY PLAN 1 DRAFTED BY: INTEGRATED GOVERNANCE MANAGER 2 ACCOUNTABLE DIRECTOR: DIRECTOR OF QUALITY AND SAFETY 3 APPLIES TO: ALL STAFF 4 COMMITTEE & DATE APPROVED: GOVERNING BODY, 5 MARCH

More information

CHAPTER 1 COMPUTER SECURITY INCIDENT RESPONSE TEAM (CSIRT)

CHAPTER 1 COMPUTER SECURITY INCIDENT RESPONSE TEAM (CSIRT) CHAPTER 1 COMPUTER SECURITY INCIDENT RESPONSE TEAM (CSIRT) PURPOSE: The purpose of this procedure is to establish the roles, responsibilities, and communication procedures for the Computer Security Incident

More information

Request for feedback on the revised Code of Governance for NHS Foundation Trusts

Request for feedback on the revised Code of Governance for NHS Foundation Trusts Request for feedback on the revised Code of Governance for NHS Foundation Trusts Introduction 8 November 2013 One of Monitor s key objectives is to make sure that public providers are well led. To this

More information

Terms of Reference - Board Risk Committee

Terms of Reference - Board Risk Committee Terms of Reference - Board Risk Committee The Board Risk Committee is authorised by the Board to oversee the Group s risk management arrangements. It ensures that the overarching risk appetite is appropriate

More information

TRUST SECURITY MANAGEMENT POLICY

TRUST SECURITY MANAGEMENT POLICY TRUST SECURITY MANAGEMENT POLICY EXECUTIVE SUMMARY The Board recognises that security management is an integral part of good, effective and efficient risk management practise and to be effective should

More information

Northern Ireland Blood Transfusion Service

Northern Ireland Blood Transfusion Service Northern Ireland Blood Transfusion Service Risk Management Strategy Northern Ireland Blood Transfusion Service Lisburn Road Belfast BT9 7TS Telephone No. 028 9032 1414 www.nibts.org Page 1 of 12 CONTENTS

More information

EVERCHINA INT L HOLDINGS COMPANY LIMITED (the Company ) Audit Committee

EVERCHINA INT L HOLDINGS COMPANY LIMITED (the Company ) Audit Committee EVERCHINA INT L HOLDINGS COMPANY LIMITED (the Company ) Audit Committee Terms of Reference (Amended & adopted by the Board on 8 January 2016) Constitution The board (the Board ) of directors (the Directors

More information

CONSULTATION PAPER CP 41 CORPORATE GOVERNANCE REQUIREMENTS FOR CREDIT INSTITUTIONS AND INSURANCE UNDERTAKINGS

CONSULTATION PAPER CP 41 CORPORATE GOVERNANCE REQUIREMENTS FOR CREDIT INSTITUTIONS AND INSURANCE UNDERTAKINGS CONSULTATION PAPER CP 41 CORPORATE GOVERNANCE REQUIREMENTS FOR CREDIT INSTITUTIONS AND INSURANCE UNDERTAKINGS 2 PROPOSAL 1.1 It is now widely recognised that one of the causes of the international financial

More information

How To Ensure That Sovini Is A Successful Business

How To Ensure That Sovini Is A Successful Business Group Risk Management Policy Originator: Approval date: Policy and Strategy Team Sovini Board PCHA Board OVH Board/EMT 6 th December 2013 31 st October 2013 14 th October 2013 Review date: December 2014

More information

DRAFT REVISED MoU 15.10.15

DRAFT REVISED MoU 15.10.15 DRAFT REVISED MoU 15.10.15 Memorandum of Understanding on resolution planning and financial crisis management 1. This memorandum has been prepared and published in line with the provisions of Section 65

More information

Lexcel England and Wales v6 Standard for in-house legal departments Excellence in legal practice management and client care

Lexcel England and Wales v6 Standard for in-house legal departments Excellence in legal practice management and client care www.lawsociety.org.uk/lexcel Lexcel England and Wales v6 Standard for in-house legal departments Excellence in legal practice management and client care Lexcel England and Wales v6 Contents About Lexcel...

More information

Complaints Policy. Controlled Document Number: Version Number: 6 Controlled Document Sponsor: Controlled Document Lead: Approved By:

Complaints Policy. Controlled Document Number: Version Number: 6 Controlled Document Sponsor: Controlled Document Lead: Approved By: Complaints Policy CONTROLLED DOCUMENT CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Version Number: 6 Controlled Document Sponsor: Controlled Document Lead: Approved By: Policy Governance

More information

E Lighting Group Holdings Limited 壹 照 明 集 團 控 股 有 限 公 司 (incorporated in the Cayman Islands with limited liability) Stock Code : 8222

E Lighting Group Holdings Limited 壹 照 明 集 團 控 股 有 限 公 司 (incorporated in the Cayman Islands with limited liability) Stock Code : 8222 1. ORGANIZATION E Lighting Group Holdings Limited 壹 照 明 集 團 控 股 有 限 公 司 (incorporated in the Cayman Islands with limited liability) Stock Code : 8222 TERMS OF REFERENCE OF AUDIT COMMITTEE The board (the

More information

General Register Office for Scotland information about Scotland s people. Paper NHSCR GB 1/08. NHSCR Scotland Information Governance Standards

General Register Office for Scotland information about Scotland s people. Paper NHSCR GB 1/08. NHSCR Scotland Information Governance Standards General Register Office for Scotland information about Scotland s people Paper NHSCR GB 1/08 NHSCR Scotland Information Governance s This is a draft on which the Board s comments would be welcome. Contents

More information

JOB DESCRIPTION. Corporate Governance Manager. 45 hours per week. Director of Compliance & Governance. London with national responsibilities

JOB DESCRIPTION. Corporate Governance Manager. 45 hours per week. Director of Compliance & Governance. London with national responsibilities JOB DESCRIPTION POST: SALARY: HOURS: REPORTS TO: LOCATION: Corporate Governance Manager 40,000 per annum 45 hours per week Director of Compliance & Governance London with national responsibilities JOB

More information

INFORMATION GOVERNANCE POLICY & FRAMEWORK

INFORMATION GOVERNANCE POLICY & FRAMEWORK INFORMATION GOVERNANCE POLICY & FRAMEWORK Version 1.2 Committee Approved by Audit Committee Date Approved 5 March 2015 Author: Responsible Lead: Associate IG Specialist, YHCS Corporate & Governance Manger

More information

Align Technology. Data Protection Binding Corporate Rules Processor Policy. 2014 Align Technology, Inc. All rights reserved.

Align Technology. Data Protection Binding Corporate Rules Processor Policy. 2014 Align Technology, Inc. All rights reserved. Align Technology Data Protection Binding Corporate Rules Processor Policy Confidential Contents INTRODUCTION TO THIS POLICY 3 PART I: BACKGROUND AND ACTIONS 4 PART II: PROCESSOR OBLIGATIONS 6 PART III:

More information

KEELE UNIVERSITY IT INFORMATION SECURITY POLICY

KEELE UNIVERSITY IT INFORMATION SECURITY POLICY Contents 1. Introduction 2. Objectives 3. Scope 4. Policy Statement 5. Legal and Contractual Requirements 6. Responsibilities 7. Policy Awareness and Disciplinary Procedures 8. Maintenance 9. Physical

More information

EXPLANATORY MEMORANDUM & REGULATORY IMPACT ASSESSMENT FRAMEWORK

EXPLANATORY MEMORANDUM & REGULATORY IMPACT ASSESSMENT FRAMEWORK EXPLANATORY MEMORANDUM & REGULATORY IMPACT ASSESSMENT FRAMEWORK PART 1 - EXPLANATORY MEMORANDUM to the Fire and Rescue Services (Emergencies) (Wales) Order 2007 This Explanatory Memorandum has been prepared

More information

13 ENVIRONMENTAL AND SOCIAL MANAGEMENT SYSTEM

13 ENVIRONMENTAL AND SOCIAL MANAGEMENT SYSTEM 13 ENVIRONMENTAL AND SOCIAL MANAGEMENT SYSTEM This ESIA has identified impacts (both positive and negative) to the physical, natural and socio-economic environments, as well as to community and worker

More information

Lancashire County Council Information Governance Framework

Lancashire County Council Information Governance Framework Appendix 'A' Lancashire County Council Information Governance Framework Introduction Information Governance provides a framework for bringing together all of the requirements, standards and best practice

More information

CONTRACTS STANDING ORDERS (CSOs) 2015 / 2016 CSO 2015-6 1

CONTRACTS STANDING ORDERS (CSOs) 2015 / 2016 CSO 2015-6 1 CONTRACTS STANDING ORDERS (CSOs) 2015 / 2016 CSO 2015-6 1 PART 3G Contracts Standing Orders 2015/16 Definitions Aggregation is the combining together of the total contract value from separate contracts

More information

Recommendations. That the Cabinet approve the withdrawal of the existing policy and its replacement with the revised document.

Recommendations. That the Cabinet approve the withdrawal of the existing policy and its replacement with the revised document. Report to: Cabinet Date: 14 th October 2004. Report: of Head of Corporate Personnel Services Report Title: USE of INTERNET POLICY Summary of Report. The use of the Internet is growing rapidly. Over the

More information

F I N A N C I A L R E G U L A T I O N S

F I N A N C I A L R E G U L A T I O N S F I N A N C I A L R E G U L A T I O N S South Downs National Park Authority March 2014 Page 0 of 17 F I N A N C I A L R E G U L A T I O N S Contents Page 1 INTRODUCTION Purpose of Financial Regulations

More information

Attendance Management Policy 1

Attendance Management Policy 1 Scope: All Staff Effective Date: Aug 2009 Responsible Dept: Human Resources Equality Impact Assessment: Completed April 2012 Last updated by/date: May 2012 Next review date: May 2015 Associated links &

More information

Data Breach Management Policy and Procedures for Education and Training Boards

Data Breach Management Policy and Procedures for Education and Training Boards Data Breach Management Policy and Procedures for Education and Training Boards POLICY on DATA BREACHES in SCHOOLS/COLLEGES and OTHER EDUCATION and ADMINISTRATIVE CENTRES UNDER the REMIT of TIPPERARY EDUCATION

More information

Job Description. Management Assistants, Team Administrators and Business Support Apprentice. Head of Integrated Governance

Job Description. Management Assistants, Team Administrators and Business Support Apprentice. Head of Integrated Governance Job Description Job Title: Reference No: Organisation: Department: Business Support Manager NHS Vale of York Clinical Commissioning Group Corporate and Governance Base: West Offices, Station Rise, York,

More information

EU Directive on Network and Information Security SWD(2013) 31 & SWD(2013) 32. A call for views and evidence

EU Directive on Network and Information Security SWD(2013) 31 & SWD(2013) 32. A call for views and evidence EU Directive on Network and Information Security SWD(2013) 31 & SWD(2013) 32 A call for views and evidence 22 nd May 2013 Contents Contents... 2 Overview: The EU Directive on Network and Information Security...

More information

INFORMATION GOVERNANCE OPERATING POLICY & FRAMEWORK

INFORMATION GOVERNANCE OPERATING POLICY & FRAMEWORK INFORMATION GOVERNANCE OPERATING POLICY & FRAMEWORK Log / Control Sheet Responsible Officer: Chief Finance Officer Clinical Lead: Dr J Parker, Caldicott Guardian Author: Associate IG Specialist, Yorkshire

More information

Chair Cabinet Committee on State Sector Reform and Expenditure Control

Chair Cabinet Committee on State Sector Reform and Expenditure Control Office of the Minister of State Services Chair Cabinet Committee on State Sector Reform and Expenditure Control REPORT OF THE GOVERNMENT CHIEF INFORMATION OFFICER ON THE REVIEW OF PUBLICLY ACCESSIBLE INFORMATION

More information

Framework for an Aviation Security Management System (SeMS)

Framework for an Aviation Security Management System (SeMS) Framework for an Aviation Security Management System (SeMS) CAP 1223 Civil Aviation Authority 2014 All rights reserved. Copies of this publication may be reproduced for personal use, or for use within

More information

Business Plan 2016-2017

Business Plan 2016-2017 Business Plan 2016-2017 March 2016 Contents Introduction... 3 About us... 5 Role of Registrar... 5 Objectives for 2016-17... 5 Work programme for 2016/17... 6 Activity 1 Continue to operate an accessible,

More information

Version: 3.0. Effective From: 19/06/2014

Version: 3.0. Effective From: 19/06/2014 Policy No: RM66 Version: 3.0 Name of Policy: Business Continuity Planning Policy Effective From: 19/06/2014 Date Ratified 05/06/2014 Ratified Business Service Development Committee Review Date 01/06/2016

More information

1.0 Policy Statement / Intentions (FOIA - Open)

1.0 Policy Statement / Intentions (FOIA - Open) Force Policy & Procedure Reference Number Business Continuity Management D269 Policy Version Date 23 July 2015 Review Date 23 July 2016 Policy Ownership Portfolio Holder Links or overlaps with other policies

More information

Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015

Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015 Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015 *QP Code of Practice 2008 updated Aug15 Page 1 of 13 Code of Practice for Qualified Persons 1. INTRODUCTION 2.

More information

Job Description. Industry business analyst. Salary Band: Purpose of Job

Job Description. Industry business analyst. Salary Band: Purpose of Job Job Description Job Title: Industry business analyst Division/Company: Industry Policy/Payments UK Reporting To: Director of Industry Policy Salary and: C Purpose of Job To provide thought leadership and

More information

National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP)

National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP) National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP) Operating Manual Please check the CRN Website for the latest version. Version: 6.0 Status: Consultation in

More information

Who s next after TalkTalk?

Who s next after TalkTalk? Who s next after TalkTalk? Frequently Asked Questions on Cyber Risk Fraud threat to millions of TalkTalk customers TalkTalk cyber-attack: website hit by significant breach These are just two of the many

More information

The City of Nottingham and Nottinghamshire Economic Prosperity Committee. Constitution (terms of reference, membership and procedure rules)

The City of Nottingham and Nottinghamshire Economic Prosperity Committee. Constitution (terms of reference, membership and procedure rules) Appendix A The City of Nottingham and Nottinghamshire Economic Prosperity Committee Constitution (terms of reference, membership and procedure rules) 1. Purpose To bring together local authority partners

More information

Memorandum of Understanding. Department of Justice and Attorney-General. Department of Transport and Main Roads. between the.

Memorandum of Understanding. Department of Justice and Attorney-General. Department of Transport and Main Roads. between the. Memorandum of Understanding between the Department of Justice and Attorney-General and the Department of Transport and Main Roads June 2010 Table of contents Part 1 - Introduction... 3 Legislative scope...

More information

A Framework of Quality Assurance for Responsible Officers and Revalidation

A Framework of Quality Assurance for Responsible Officers and Revalidation A Framework of Quality Assurance for Responsible Officers and Revalidation Supporting responsible officers and designated bodies in providing assurance that they are discharging their statutory responsibilities.

More information

Caedmon College Whitby

Caedmon College Whitby Caedmon College Whitby Data Protection and Information Security Policy College Governance Status This policy was re-issued in June 2014 and was adopted by the Governing Body on 26 June 2014. It will be

More information

FRAMEWORK FOR IMPLEMENTING PERFORMANCE MANAGEMENT

FRAMEWORK FOR IMPLEMENTING PERFORMANCE MANAGEMENT FRAMEWORK FOR IMPLEMENTING PERFORMANCE MANAGEMENT As amended on 26 May 2014 Framework for implementing performance management Adopted by the Mayoral Committee on 15 May 2013. Amendments adopted by the

More information

Information Governance Strategy

Information Governance Strategy Information Governance Strategy To whom this document applies: All Trust staff, including agency and contractors Procedural Documents Approval Committee Issue Date: January 2010 Version 1 Document reference:

More information

Information Governance Plan

Information Governance Plan Information Governance Plan 2013 2015 1. Overview 1.1 Information is a vital asset, both in terms of the clinical management of individual patients and the efficient organisation of services and resources.

More information

Bridge Parish Council Community Emergency Plan

Bridge Parish Council Community Emergency Plan BRIDGE Parish Council Caring for the village Bridge Parish Council Community Emergency Plan IF YOU ARE IN IMMEDIATE DANGER CALL 999 October 2014 All enquiries relating to this document should be sent to:

More information

Royal College of Music

Royal College of Music Royal College of Music Code of Practice on the selection of staff February 2014 Document record Document title REF 2014 Code of Practice on the selection of staff Version 4 Person responsible Director

More information

ISO 20000-1:2005 Requirements Summary

ISO 20000-1:2005 Requirements Summary Contents 3. Requirements for a Management System... 3 3.1 Management Responsibility... 3 3.2 Documentation Requirements... 3 3.3 Competence, Awareness, and Training... 4 4. Planning and Implementing Service

More information

BIRMINGHAM CITY UNIVERSITY ACADEMIES TRUST SICK PAY AND ABSENCE MANAGEMENT SCHEME

BIRMINGHAM CITY UNIVERSITY ACADEMIES TRUST SICK PAY AND ABSENCE MANAGEMENT SCHEME BIRMINGHAM CITY UNIVERSITY ACADEMIES TRUST SICK PAY AND ABSENCE MANAGEMENT SCHEME 1. Introduction 1.1. BCUAT wants to ensure that employees who are absent from work due to ill-health or injury receive

More information

GUIDANCE FOR THE HANDLING OF BANDING APPEALS BY HOST ORGANISATIONS AND LEAD EMPLOYERS IN THE NORTH WESTERN DEANERY

GUIDANCE FOR THE HANDLING OF BANDING APPEALS BY HOST ORGANISATIONS AND LEAD EMPLOYERS IN THE NORTH WESTERN DEANERY GUIDANCE FOR THE HANDLING OF BANDING APPEALS BY HOST ORGANISATIONS AND LEAD EMPLOYERS IN THE NORTH WESTERN DEANERY In line with the obligations of Host Organisations as stated in the Service Level Agreement

More information

Houses of Parliament. Health and Safety Policy Supplement (PS1) Accident and Incident Reporting

Houses of Parliament. Health and Safety Policy Supplement (PS1) Accident and Incident Reporting Health and Safety Policy Supplement (PS1) Accident and Incident Reporting This policy supplement has been prepared by the Parliamentary Safety Risk Management team and endorsed by the Director General

More information

Guideline on good pharmacovigilance practices (GVP)

Guideline on good pharmacovigilance practices (GVP) 1 2 20 February 2012 EMA/541760/2011 3 4 Guideline on good pharmacovigilance practices (GVP) Module I Pharmacovigilance systems and their quality systems Draft finalised by the Agency in collaboration

More information