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Galapagos Quality Strategy in Non-Regulated Research Frank Giots, Karen Schoonis Galapagos NV, Generaal de Wittelaan L11 A3, 2800 Mechelen, Belgium E-mail: frank.giots@glpg.com Introduction

Strategy & Approach

Methodology, Techniques & Tools

How does Quality spell in your Research organization? This question is often addressed to Quality Specialists supporting Research organizations in the Pharmaceutical Industry.

 Centralization: one global Quality project across all Research sites  Global Harmonization: aiming for standardized quality practices between all Research sites  Global Action Plan: remediation plan in response to QMS gap analysis to align with defined “Good Scientific Practices”  Pilot Projects: new process design and/or implementation focusing first at one Research site and subsequently having consolidated implementation across all Research sites  Subject Matter Experts: assignment of key experts in Research liaising with Quality with the aim of familiarizing with Research “Ways of Working”

Phased approach of Change Management, covering the following stages:  Diagnosis: analysis & evaluation of the situation before change in order to identify what must be kept, what should improve, and to allow an estimation of change impact  Design: conceptual phase of change development taking into account the expectations & requirements (technical, organizational and legal) for the future situation  Implementation: actual roll-out of designed processes, typically including an extensive learning phase (format dependent on complexity of the change) prior to release  Grow & Improve: every change will require adaptation to the new situation and eventually continuous re-evaluation of the situation must allow for further improvement

The answer is less straightforward as specific quality guidance on Research operations is limited in an area that is commonly considered non-regulated human medicinal product development.

Objective Starting from a complete revision of the current GLPG Research Quality Management System (QMS), a desired QMS is designed based upon: 1) GLPG Quality model described in our R&D Quality Policy 2) Benchmark analysis with common Industry guidelines for non-regulated Research in a Biotechnology company (see References) The future QMS will be defined as a GLPG Research Quality Framework reflecting applicable “Good Scientific Practices” and corresponding quality E2E processes. Such processes shall ensure validity & integrity of Research data and contribute to a smooth transition to the GLPG Development organization (anticipating compliance with GxP-regulated processes). Compliance with Research E2E quality processes (as described into GLPG procedures) will be verified through specific Quality Monitoring Programs resulting into continuous improvement of the actual QMS, where applicable.

Industry Benchmark Analysis Outcome: GLPG “Good Scientific Practices” (GSP)

Results Laboratory equipment management at GLPG Research has been entirely revised following explained change management methodology and today a newly designed E2E process is in place and in use following a specific implementation plan.

Global Action Plan A Quality & Compliance Global Action Plan is in place aiming for QMS remediation through revision and introduction of E2E quality processes in alignment with defined “Good Scientific Practices” and following Senior Management endorsement & agreed prioritization.

Conclusions References Guidelines for Quality in Non-Regulated Scientific Research, 2008 Handbook: Quality practices in basic biomedical research, 2006 Quality Assurance for Research and Development and Non-routine Analysis, 1998

Similar E2E process design, QMS improvement and phased implementation has been achieved for GLPG Research covering Research study design, conduct & reporting and chemical compound management. Other GSP key areas will follow, as agreed per Global Action Plan.

Using benchmark analysis with Industry guidelines, an adapted Quality Framework for GLPG Research has been defined & introduced. Based upon a change management methodology, QMS continuous improvement is sought and successful implementation will be monitored over time.