Angelini Pharmacovigilance

Dr. João Guimarães, Medical Director and Director of Regulatory Affairs of Angelini

Executive Summary

Angelini Farmacêutica is a subsidiary of Angelini, a medium-sized Italian international group, centered in the creation, distribution and commercialization of pharmaceutical and parapharmaceutical products. The Portuguese operation is committed to streamlining the marketing of products in the areas of health and well-being.

Angelini Linha Infantil, operates with its own structure in Italy, Spain and Portugal having secured an alliance with CSC Pharmaceuticals for Western European markets and a stake in Elder Pharma, an important Indian company. It specializes in pain therapy, in neurological physiotherapy, in gynecology, on antibiotic therapy and colds.

Its products are represented in more than 60 countries through a network of licensed partners and strategic agreements with local businesses target markets.

From prescription to generics, self-medication, parapharmaceuticals, physiotherapy and healing and personal hygiene products, Angelini’s offer is one of the most complete and qualified in the well-being market.

• It is one of the 5 leaders in Italy (by volume)
• It is the 22nd pharmaceutical company in the Portuguese market (by volume);
• It holds the 51st position in the Spanish pharmaceutical market (by volume);
• Angelini – Farma Lepori was recognized with the EFQM Excellence Award for its quality management system in Spain
• Angelini is the market leader in Italy, with a joint venture with Procter & Gamble in baby diapers and sanitary towels segment.

Situation

Due to its direct impact on public health, the pharmaceutical market is an area where regulation and supervision of products is crucial, demanding and monitored. There are a number of regulatory and health authorities who supervise and enforce the compliance of presence and performance rules in the pharmaceutical market. Globally there are FDA (Food and Drug Administration in the United States), Health Canada, Therapeutical Products Directorate and the EMEA (European Agency for the Evaluation of Medicinal Products of the European Community.) In Portugal, INFARMED is responsible for evaluating and inspecting the pharmaceutical activity, ensuring and communicating the results of surveillance of medicines and health products to the EMEA.

Based on the highest accuracy and quality which has always been associated with the culture and history of this pharmaceutical, there was the need to implement a solution that not only met all the standards required by the competent authorities, but also correspond to the internal objectives of the Pharmaceutical Quality and Safety Pharmacology areas.

It was essential to implement a solution (web-accessible) that would operate a pharmacovigilance system in the context of adverse reactions and medication (RAM), with its delivery to INFARMED in electronic format, and a second that would managed the «register of samples».

Within the Pharmacovigilance, the need derived from the requirement to manage Periodic Safety Update Reports (PSURs) and reporting Adverse Drug Reactions (ADR). The management of the RMA is made under the ICH E2B M Standard, in order to generate and import XML files in accordance, to be sent to INFARMED.

As regards the registration of samples. It was crucial to obtain the computer record, in real time, of the samples given to doctors by medical sales representatives (MSR). If needed to identify a sample or a lot, it would be necessary to quickly locate it and remove it from the market.

Solution

It was urgent to find a solution of rapid implementation and with ongoing adaptive capacity to the dynamics of Angelini’s business.
It was in this context that Infosistema formed a strategic partnership with Outsystems to respond to the problem.
As an Outsystems Gold partner, Infosistema demonstrated its vast expertise and certification in this technology to large clients, among which included the INFARMED itself.

Outsystemas affirmed itself as an undisputed and differentiating technology platform, which will allow companies to not only create and modify applications in an exceptionally short time, but also operate them at much lower costs. The applications could be easily changed throughout their life cycle, with very low risk. The platform flexibility assured the alignment of systems with business needs, making the IT departments in extremely agile solutions delivery centers.

With the OutSystems Hub Edition platform, Angelini could create and modify applications very quickly, significantly reducing its time-to-market.

Infosistema and Outsystems accompanied Angelini during the identification phase of its needs and the design of the solution, in order to guarantee services, perform tests, train users and perform initial monitoring.

The solutions were developed based on Outsystems technology and implemented by Infosistema in six weeks.

Technology Used

The OutSystems Hub Edition platform allows you to develop collaborative applications, which can be integrated with existing systems. It also offers new user interfaces, accessible from personal computers (by Internet browser or email) and mobile devices (SMS, WAP, i-mode, PDA, etc.). This platform supports the entire life cycle of applications, ensuring a rapid creation and modifications in real time, to meet new business needs and processes.

Pharmacovigilance Solution:

This module includes the implementation of the records management process of RAM and consists of:

• Form creation/editing RAM
• RAM search form
• Generating process and data import (in XML) for electronic transmission of RAM according to standards ICH (E2B, M1 and M2)
• RPS management form including its generation based on XML model.

Software and Services

Server

• Microsoft Windows Server 2003
• Microsoft SQL Server 2000
• Internet Information Services 6.0
• Outsystems Hub Edition Platform

Client Machines

• Internet Explorer 6.0

Hardware

Server:

• Pentium IV 3.2 GHz Processor
• Memory 2048 MB
• SCSI 74 Gb Disk
• 1Gb Ethernet Interface

Sample Records Solution:

Includes the implementation of the Sample Records process and consists of:

• Import Excel File Form with delivery data to Medical Sales Representatives (MSR).
• Registration form of deliveries made to doctors.
• Deliveries search form.
• Delivery statistics per interval, with dates and the respective lots

(As a sidenote, all Products, Doctors and Delegates data are external data of existing MySQL databases.)

Pre-built modules used:

Enterprise Manager: is the central node in the architecture of the solutions developed in OutSystems technology. It provides an integrated back-office for all OutSystems applications and external, which gives it a business vision providing an entrepreneurial vision.

Benefits

These are the benefits of implementing the Pharmacovigilance solutions and Registration of Samples:

• Reducing the time of introduction into the market solution;
• Increasing productivity, improving quality and reducing costs;
• Flexibility and fast introduction of new features;
• Seamless integration and compatibility with existing systems;
• Extensible and safe solution.

These benefits have the following features:

• Central database, with full and structured information;
• Low implementation costs and high return on investment;
• Maximum Performance in operating the systems;
• Specialized and certified resources on OutSystems technology;
• Certification of quality management system based on ISO 9001:2000.

There are, however, other direct benefits with an impact on business:

• Compliance with the standards required by the regulatory authority;
• Improved internal database;
• Control of identifiers generated for numbering of RAM;
• On-line monitoring of sample records delivered to the MSR;
• On-line monitoring of samples delivered to doctors, including lots;
• Possibility of using the delivery statistics for planning to deliver reinforcements to the MSR

OutSystems

OutSystems is a software company that provides the All-in-one Agile Suite. Market leader, this is the first solution that responds to the full life cycle of delivering and managing web business applications, based on flexible methodologies.

Main technological differentiators

With OutSystems Hub Edition it is now possible to:

• Rapid creation of applications and reduce the cost of maintenance of the applications in production;
• Unifying applications platform that enables Angelini to generate significant economies of scale;
• Monitoring of innovation on the web, through the creation of new applications and the rapid recombination of existing information across multiple systems;
• Creating a platform where Angelini can create, if necessary, its own applications in a simple way and without requiring in-depth knowledge of technology;
• Use of new forms of interaction with existing systems through email, mobile and WebServices;
• Image of permanent innovation and dynamism;
• Flexibility and fast introduction of new solutions;
• Simplified modification of applications in the production stage;
• Service-oriented architecture, which allows the evolution of automatic services published by Angelini to other systems;
• Ability to operate all platform-compatible mobile channels, namely: SMS, MMS, WAP 2.0, XHTML and PDA (WiFi or Browser);
• Autonomy of the proposed solution in regards to OutSystems since the entire environment is open and shared with Angelini;
• Infosistema/OutSystems professional service experience, which guarantees the quality of interaction required with the Angelini team and bridges possible setbacks in the integration of external systems;
• Rapidly modifiable solution to reflect feedback from users and changes to basic services;
• Maintenance of applications achievable by teams with drastically different know-how from the one currently required in the development of collaborative applications.

Future

Infrastructure designed to enable the growth of the system

The OutSystems Hub Edition platform allows the maximization of the platform in future projects, with financial and operational benefits to Angelini. For example, in the future, you can share the base hardware and software, opening the door to a unified management of projects awarded at different times and by different companies.

OutSystems technology substantially reduces maintenance costs and makes the infrastructure of different projects more profitable.

Flexibility to adapt to diffuse requirements

The flexibility provided by OutSystems Hub Edition platform solves a major problem in the creation and maintenance of software systems: the difficulty in establishing an iterative process that allows permanent changes, through user feedback on business requirements. These requirements are usually diffuse and changeable. Consequently, the ease of modification is a powerful asset.

When combined with the proposed method, the OutSystems Hub Edition platform creates a software which is flexible and adaptable to the creation and maintenance cycle, without increasing the risks associated with the project. In terms of technology, it is precisely here that we find many of OutSystem’s and its patents differentiating features (currently pending).