Communication Plan

1.1 Introduction

The development of medicinal products requires strict adherence to quality standards such as Good Pharmacovigilance Practices, FDA guidelines etc. to ensure that the content of clinical trial data captured in the database is an accurate reflection of the source document. The guidelines state that organizations should have quality objectives and methods of monitoring the efficient operation of the quality system. Currently the global pharmacovigilance systems in many companies are facing compliance issues with data entry and the adverse event case processing that follows data entry. It is important to manage the quality of the adverse event cases that are entered into the safety database as a single error in the entry or a coding error can have a cascading effect on the overall quality review of the case.

1.2 Purpose

Adverse event case processing (AER) is a complex process in pharmacovigilance that requires an effective project management team. Multiple functions in pharmacovigilance cause a bottleneck in adhering to the timelines of submission to the regulatory authorities even after having strict adherences to Standard Operating Procedures (SOPs).

The challenge is to establish a robust quality management system (QMS) to align with industry recommended standards and guidelines for Good Pharmacovigilance Practices. The key project deliverables will be to develop processes that allow effective demonstration of accuracy and consistency of the most important function of the Pharmacovigilance (PV) system - Data Entry (DE) and AER that follows DE. The project management plan will also focus on outlining processes for tools within the QMS that can differentiate between significant and non-significant risks that will impact the quality of a clinical trial and patient data.

1.3 Scope

The scope of the project is to:

· develop a quality management system using quality control methods as performance indicators to monitor the efficiency of the PV system,

· minimize risks of non-compliance for the company

· meet global regulatory requirements

2. Project Overview

The basic need to develop a QMS within pharmacovigilance is to optimize the oversight and compliance of the process of receipt, review, assessment and reporting of adverse events to regulatory agencies from medicines and investigational drugs administered as part of post-marketing studies and different phases of clinical trials. A basic Plan-Do-Check-Act (PDCA) cycle will serve to design and build the processes, followed by training of staff on sub-processes, tools and metrics. A routine controls and measure check to review, improve and adopt any best practices will help increase effectiveness and efficacy of the system on a continuous basis.

Implementation of an effective quality management system is the most important goal of a pharmaceutical industry. Requirements to implement a quality management system in pharmacovigilance have been defined by the US FDA and the EMA in the GVP (Good Pharmacovigilance Practices). Companies outsource data entry operations in pharmacovigilance to international contract research organizations to reduce cost and save time. This hampers the quality of data due to errors in data entry given the huge volume of data present in clinical trials. Lack of governance over data handling and monitoring are known to affect the quality of information present in the database.

The project is to introduce within the Pharmacovigilance (PV) department a Quality Management System (QMS). This will be a set of procedures either in the form of Standard Operating Procedures (SOPs) or other work instructions (WI) to carry out different processes of adverse event case management. It will also include Key Performance Indicators (KPIs) to monitor the overall performance of the system. The aim of establishing a QMS will be to introduce to the staff and auditors a reference standard for use and review.

Non-compliance across a number of critical pharmacovigilance processes was one of the critical findings reported in the 2017/18 period of the Medicines & Healthcare products Regulatory Agency’s (MHRA) inspection. Late case submission of Individual Case Safety Reports (ICSRs) was one of them. A late submission of ICSRs to health authorities trickles down to the first step of adverse event reporting which starts from receiving the information about an adverse event. In order to comply with the regulatory requirements of having a QMS that will help identify non-compliance and effectively resolve it the project of establishing a QMS is being developed.

· To improve compliance and reduce quality costs by streamlining the adverse event assessment and reporting cycle.

· Develop defined processes, detailed activities and tasks for case processing.

· Assess the existing systems and operations within the organization to increase quality and compliance.

· Identify the key performance indicators for each of the processes starting from receipt of data to reporting of adverse events to regulatory authorities

· Identify actions and deliverables for each process

· Develop best practices through continuous improvement

Constraints:

· Outsourcing to a Contract Research Organization has the probability of compromising the quality of data entered in the safety database due to manual errors during data entry

· Insufficient guidelines around the expectations and requirements within a quality management system can be a challenge to build one

· Update to SOPs and WIs channeled without a defined QA&C process within pharmacovigilance

Assumptions:

· Triage of cases is evaluated into respective categories according to the industry defined standards of event seriousness

· 15 day “serious” reports that require submission to regulatory authorities have an additional review round before distribution

· Improve quality and compliance of adverse event reporting

· Achieve organizational goals

· Train all the employees on use of QMS

· Be a system to verify performance indicators to ensure organizational objective of compliance and continuous improvement.

Budget Summary:

1. QMS system software costs - $500K

· Software license - $200K

· System implementation -$200K

2. Functional budget - $500K

· Templates/Forms/CAPA - $200K

· Quality workflow and gap analysis - $100K

· Functional trainings - $200K

3. Resourcing - $500K

· IT programmers - $300K

· Quality specialists - $200K

Non-compliance across a number of critical pharmacovigilance processes was one of the critical findings reported in the 2017/18 period of the Medicines & Healthcare products Regulatory Agency’s (MHRA) inspection. Late case submission of Individual Case Safety Reports (ICSRs) was one of them. A late submission of ICSRs to health authorities trickles down to the first step of adverse event reporting which starts from receiving the information about an adverse event. In order to comply with the regulatory requirements of having a QMS that will help identify non-compliance and effectively resolve it the project of establishing a QMS is being developed.

3.Stakeholder Register