Sustaining and Improving Compliance in Operation (Track 3)

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Sustaining and Improving Compliance in Operation

Organisations maintain control of their processes, products and systems throughout their operations. Pharmacovigilance systems monitor, analyse and report the product safety and must be effectively managed to ensure the integrity of analysis and reporting of safety data. Clear ownership of data and clarity or roles and responsibilities are essential to effective system governance and change management. Product security is assured throughout the supply chain with the deployment of Track and Trace platforms that enable detection of counterfeit products. Technologies, implementation considerations, benefits and risks of implementing product safety and security solutions are shared through practical technology demonstrations and case studies. Compliance metrics, essential to measuring systems compliance and effectiveness and efficiency of compliance processes, are shared and further developed through interactive sessions to enable cost-effective, resource-efficient validation and operational compliance.

Please click here ( 152 KB) to view the Agenda

This track will cover:

  • Metrics and How they Can be Used to Aid in Compliance
  • Configuration and Change Control for Pharmacovigilance Systems
  • Managing Outsource Suppliers
  • Track and Trace


  • Winnie Cappucci, Senior Consultant, USA
  • Chris Reid, Director, Integrity Solutions Ltd., United Kingdom

Some of the sessions will include: 

A General Framework for Developing Effective Metrics for IT and Software Organisations
Dr. Radouane Oudrhiri, Systonomy Limited, United Kingdom

Measurements and quantitative methods are considered as key tools for any effective management and decision-support process. However, implementing a set of useful metrics is a complex task and has been a challenge for many IT and software organisations. Many metrics programmes fail, do not accomplish their goals or become inefficient to maintain. This workshop will present a solid yet a pragmatic framework for developing a set of useful metrics and KPI’s, to support IT and software organisations in improving their process performance, achieving efficient compliance and tracking their daily management activities.

At the conclusion of this session, participants will be able to:

  • Understand the general measurement framework and underlying concept
  • Understand the concept of goal-oriented measurement
  • Categorise metrics by type: e.g. effectiveness and efficiency
  • Use a set of typical metrics for IT processes
  • Use a set of examples of analytical tools for interpreting the metrics
  • Apply the framework and the associated approach to develop a set of metrics for pre-selected processes

Serialised Marking, Verification and Data Capture
Axel Jung, Product Manager, Track and Trace Systems, Laetus GmbH, Germany
James Freer, Technical Sales Manager, HAPA, Switzerland

Track and Trace is the marriage of marking, verification, data storage and retrieval. What you print and how you print it has an influence on overall track and trace effectiveness, production efficiency, packaging costs, product perception and brand impact. This presentation looks at the key factors that affect printing technology choice and their impact on track and trace implementation.

Track and Trace - EFPIA
Stefan Artlich, Director, Bayer, Germany

To fight the alarming increase of falsified medicinal products detected, the European Parliament and the Council of the European Union released the Directive 2011/62/EU in 2011. In anticipation of this law-making process, EFPIA, the European Federation of Pharmaceutical Industries and Associations, has developed the Point-of-Dispense Verification model that was very successfully operated in a pilot project in Sweden in 2009/2010. Subsequently, EFPIA has engaged with the relevant European stakeholders such as pharmacists, wholesalers, and parallel distributors to extend the proven concept to what is now called the ‘European Stakeholder Model’ (ESM). Stefan will tell us about both the technical and organisational setup of the ESM and the recent developments in terms of implementation in response to the EU’s Falsified Medicines Directive.

Implementation and Change Control for Pharmacovigilance
Andy Cochrane, Novartis, United Kingdom

The implementation, validation and operational change management of a computerised pharmacovigilance system can be time consuming and expensive. In this session we will show you that an efficient implementation approach will lead to effective change management, focused validation and better documentation.

Building a Global Serialisation Infrastructure for the Complete Supply Chain
Dr. Jyrki Syväri, Corporate Director Supply Chain Integrity, Boehringer Ingelheim GmbH, Germany

This presentation will give an overview on why and how Boehringer Ingelheim is preparing for serialisation and potential aggregation. Main reasons for this preparation are:

  • Identification of counterfeits
  • Reduction of dispensing and dosing errors
  • More effective and efficient product recalls

Additionally, regulatory requirements are coming up in the different parts of the world that demand serialisation.

    • Plenary Session

      • Track Reviews
      • Compliance Round Table
      • Question and Answer Panel

        Track Leaders and Speakers
        Special Guest Sion Wyn, Director, Conformity Ltd, UK