The Changing Face of Clinical Compliance: Regulatory, Technology, and Services SIAC Overview Track 11 Symposium 27 June 2012 1:30 – 3:00 PM Chairperson: Penelope Przekop, MSc

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Key Messages Face of clinical compliance is changing based on regulatory and technological advances. QA professionals are key to ensuring that industry continue to reflect current regulations and protect patient safety.

Presenters Regulatory Technology Services Carol Bognar, MSN, RN QA Consultant, Carol Bognar Consulting, LLC. Technology Shiela McLaughlin International Director, QA, DATATRAK International, Inc. Services Penelope Przekop, MSc Senior Director, Global QA & Training, Theradex Systems, Inc.

Carol Bognar QA Consultant Carol Bognar Consulting, LLC GCP Auditing Implications related to the FDA Guidance on Risk-Based Approach to Monitoring Carol Bognar QA Consultant Carol Bognar Consulting, LLC

Introduction Risk-based industry FDA Guidance risk-based monitoring EMA Reflection paper on risk-based quality management in clinical trials Clinical Trial Transformation Initiative (CTTI) Auditing Implications / Case Studies

FDA / EMA Draft EMA Reflection Paper on Risk-Based Quality Management in Clinical Trials (August 2011) Draft FDA Guidance for Industry – Oversight of Clinical Investigations – A risk-based approach to monitoring (August 2011)

QA Auditing Implications Will audits become obsolete in this new environment ? Will auditing change? Will auditors be required to change?

The Role of Quality Assurance in eClinical Environments – When to Dive in Shiela McLaughlin International Director Quality Assurance DATATRAK, International

Introduction Quality Assurance and the Software Development Lifecycle (SDLC) Auditing your software vendor eSource / eClinical, the FDA’s preferences

FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 2002) Guidance for Industry, Electronic Source Documentation in Clinical Investigations (December 2010)

A Whole New World: CRO Clinical Quality Assurance Penelope Przekop Sr. Director, Global QA & Training Theradex Systems, Inc.

Introduction Traditional CRO / Pharma relationships CRO vs. Pharma culture Regulatory trends Quality systems Outsourcing Assessing risk Relationship evolution

Quality Systems Key components in CROs and Pharma Processes Document Control Training Auditing CAPA Management Escalation Issues inherent in CRO culture Role of QA

CRO System Audits Identify process gaps Support organizational efficiency Ensure QC functions and steps exist Ensure right people are in right roles Provide audit / inspections readiness Drive pro-active risk-based approach