June 24-28 | Philadelphia, PA Pennsylvania Convention Center 48th Annual Meeting June 24-28 | Philadelphia, PA Pennsylvania Convention Center www.diahome.org/DIA2012 TRACK 11: COMPLIANCE TO GOOD CLINICAL PRACTICE (GCP), GOOD LABORATORY PRACTICE (GLP), AND QUALITY ASSURANCE (QA) Describe how to avoid GCP/GLP noncompliance through innovation and collaboration in a period of increasing complexity and globalization in

Format of Offerings FORUM: A 90-minute blended presentation and panel discussion that includes panelists who represent diverse work settings such as regulatory, academia, patients, and industry. Forums provide ample opportunity for active participation by attendees. SESSION: A 90-minute standard lecture-style offering that includes speakers who represent diverse work settings. Session chairs facilitate a formal question-and answer period. SIAC SHOWCASE: A 60-minute presentation on a wide variety of topics developed by DIA Special Interest Area Communities. SYMPOSIUM: A 90-minute offering consisting of several shorter presentations such as case studies and presentations from multiple perspectives. TUTORIAL: Full- and half-day preconference tutorials are led by subject matter experts who will provide in-depth instruction on some of today’s hottest topics. Each preconference tutorial is designed to increase your knowledge in specific subject areas while allowing for small group interaction. WORKSHOP: A 90-minute conceptual presentation delivered in an interactive/simulation or role-playing format. Workshops feature learning in the form of activities or demonstrations. http://www.diahome.org/en/Flagship-Meetings/DIA2012/Meeting-Program/About-our-Offerings.aspx

Large Pool of Excellent Abstracts 71 Abstracts for Various Offerings - Sessions, Presentations, Workshops and Forums for GCP, GLP and QA Track. Other Tracks also have offerings related to GCP, QA and Compliance 11 Offerings Selected and several additional abstracts accommodated within these – Many include FDA and EMA speakers sharing their perspectives Tutorials Related to GCP/QA– Half and Full Day (Under Various Tracks) GCP and QA SIAC Showcase (Track 19P) – Leslie Ball, FDA and Fergus Sweeny, EMA - This showcase will bring together regulatory authority compliance experts from FDA and EMA who will share their perspective on inspections, international efforts in GCP collaborations, and common areas of GCP noncompliance. – Tuesday June 26, 3:30 PM to 4:30 PM GCP and QA SAIC Meeting – All are invited. Update will be provided by GCP and QA SIAC Chair, Leslie Sam, Eli Lilly and some of the Core Committee members on accomplishments for the year and plans for remainder of 2012 including an update on the White paper on Protocol Deviations - Tuesday June 26, 4:30 PM – 5:30 PM

Session Title Session Summary Good Clinical Practice (GCP) through Good Documentation Practices (GDPs), Wednesday 3:30 PM, Paul Swidersky, WORKSHOP The requirements for providing credibility to clinical study data require that each site assure full reconstructibility of the data that is generated by each of its personnel. Good Documentation Practices (GDPs) require attributes of data that will be defined and explained. They include not only recording the data directly and promptly, but assuring legibility, attributability, and durability. The reconstructibility of records will be shown to include linking study-specific data to site-specific records, such as which equipment was used for each subject, temperature logs, calibration records, qualification and training records, and addressing data recording issues in the subject’s diary. Proper correction techniques will be described for manual data entries. Examples will illustrate gaps that auditors routinely identify in clinical data. **Due to workshop format, seating will be limited and will be available on a first come, first served basis. The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded. The Role of Corrective and Preventive Action (CAPA) in GCP/GLP Audit Quality Management Systems, Thursday 9:00 AM, Michael R. Hamrell, PhD,RAC, SYMPOSIUM Corrective and Preventive Action (CAPA) have become an integral part of a GCP Quality Management System approach. A formal program for CAPA is becoming an integral means for meeting FDA and global regulatory expectations for clinical trial quality. The relationship between documentation, deviations and corrective actions is becoming more clear with each 483 letter issued by the FDA. The ability to effectively manage your SOPs, track training and associate them to CAPA resolution is vital. Good Laboratory Practice (GLP): Design and Inspection Readiness, Monday 1:30 PM, David Brodish, MA, SYMPOSIUM This symposium reviews the different types of regulations and standards for the design of laboratory services for both research and health care delivery. These include GLP, GCLP, ISO 15189, ISO 17025 and others. The basics of each standard are highlighted showing key considerations for human and laboratory animal research. A scalable training program is described, that matches a series of one hour live and web-based tutorials with the regulations, standards, guidance, advisories, and compliance program guidance from a variety of regulatory agencies. The fulfillment of training requirements, leads to a well prepared organization that can withstand regulatory scrutiny. In this regard, the speakers will review GLP inspection readiness, including what documentation is expected to be readily available and how to avoid inspection findings.

Session Title Session Summary Conducting Clinical Trials in Developing Countries: Challenges in Meeting Good Clinical Practice (GCP) Compliance, Monday 3:30 PM, Sherri A Hubby, SYMPOSIUM With the challenges in recruitment and placing more global studies in developing countries, regulatory agencies have raised concerns over ethical and data quality standards. Cultural diversity, variability in ethical review, difficulty in recruiting investigators with GCP experience and different regulatory standards in non ICH countries constitute major challenges to pharmaceutical industries and marketing authorization agencies related to compliance with GCP and ethical standards. This symposium covers local laws, specific customs within developing regions such as Asia, Africa, and South America and examples of effective methods for dealing with and managing the trial requirements, managing risks and providing solutions for developing local partners and cooperative efforts with foreign regulators and IRBs. Quality by Design: Is Your Clinical Trial Fit for Purpose?, Monday 1:30 PM, Regina Freunscht, SESSION This session facilitates the development of a systematic, prioritized, risk-based approach to quality management of clinical trials that supports the principles of GCP and complements existing quality practices, requirements, and standards. Defining Quality in Clinical Trials, Monday 10:00 AM, John Poland, PhD, SESSION Latest progress in FDA and EMA initiatives on developing a new approach to quality in clinical trials, together with current expectations and practical examples from recent experience, will be analyzed and discussed. What Should You Put in a Clinical Quality Assurance (CQA) Agreement, Tuesday 1:30 PM, Neil McCullough, PhD, MSc, SESSION This session will focus on how to properly develop, organize, and initiate a Clinical Quality Assurance (CQA). Discussions will include examples of content categories, content, and experiences from speakers who have developed and implemented a CQA. Building Quality into Clinical Trials: Regulatory Perspectives and Practical Considerations, Monday 3:30 PM, Winifred Ann Meeker-O'Connell, MS, SESSION Current models for clinical trial oversight have become outmoded in a global, complex environment. This session describes recent efforts to foster new models that employ risk-based approaches and that build quality into clinical trials.

Session Title Session Summary FDA and European Medicines Agency Collaboration: GCP Inspections and Beyond, Wednesday 8:00 AM, Leslie Ball, MD, SESSION This session will discuss the progress of the FDA and EMA GCP initiative, present areas of current focus, and preview future collaborations on inspections as well as GCP policy and guidance. Misconduct and Management of Serious or Continued Noncompliance: What Are the Differences and Similarities?, Tuesday 10:00 AM, Deborah A. Waltz, MS, SESSION This session will provide regulatory perspective on new enforcement directives which place greater emphasis on accountability for compliance for all parties involved in the research enterprise. The Changing Face of Clinical Compliance: Regulatory, Technology, and Services, Wednesday 1:30 PM, Penelope Przekop, MSc, SYMPOSIUM The face of clinical compliance is changing based on regulatory and technological advances. Long accepted industry standard practices require change. These changes are impacting pharmaceutical companies as well as their service providers. Quality professionals are key partners for ensuring that appropriate industry changes continue to reflect current regulations and protect patient safety. This symposium features clinical quality assurance experts who will address one of these key aspects of our changing environment: regulatory, technology, and service. Meet the Regulators: Helping You Ensure GCP Compliance by Knowing the Most Frequent and Serious Findings, Tuesday 3:30 PM, Munish Mehra, PhD, SIAC Showcase This showcase will bring together regulatory authority compliance experts from FDA and EMA who will share their perspective on inspections and common areas of GCP noncompliance. Developed by the Good Clinical Practice and Quality Assurance (GCP) SIAC.