About Kim

Mr. Kim Nitahara is the co-founder and Chief Executive Officer of META Solutions. Since its inception in 1987, the company has performed needs analyses, technical consulting, computer system consulting, and computer software validation services for more than two hundred pharmaceutical and biotechnology companies throughout North America, Europe, and Asia.

Kim was the Director of Business Development at Medical Development Systems, Inc. where he was responsible for the development and implementation of the Marketing Plan for a software product designed for the management of clinical trials data and supporting activities (CLINTROL). Kim has held the position of R&D Administrator at Berlex Laboratories, Inc., a subsidiary of Schering AG, where he was responsible for the development and implementation of computerized systems for project management of pharmaceutical R&D activities and systems for the automated indexing and retrieval of research documentation. While he was at Berlex, he also served as the Toxicology & Preclinical Development Coordinator, and was a Regulatory Compliance Associate and Manager of the GLP Quality Assurance Unit in the Drug Regulatory Affairs Department. Kim also gained significant experience in preclinical toxicology safety evaluation testing and GLP quality assurance monitoring and auditing during his employment at Bio/dynamics, Inc., a large contract toxicology firm.

Kim has extensive experience in pharmaceutical computer systems design and development, and is considered to be an authority on electronic document management, imaging technology, electronic submissions and computer system validation. He was a co-author of the FDA/industry/academia “Red Apple Workshop” collaboration on “Computerized Data Systems for Nonclinical Safety Assessments: Current Concepts and Quality Assurance”. Kim was the founder and Editor of a monthly publication entitled, “The Compliance Advisor” which includes detailed reviews of actual FDA inspection results and provides practical advice on how a company should prepare for a regulatory inspection.

Kim was been internationally recognized as a presenter or chairman of more than 70 industry meetings and workshops sponsored by such industry organizations as the Drug Information Association, (DIA), Society of Quality Assurance (SQA), Society of Clinical Data Management (SCDM), and the Pharmaceutical Manufacturers Association (PMA; now PhRMA). At the DIA Annual Meeting in 1995, Kim received the Outstanding Service Award for his years of service to the DIA. His professional affiliations include the Regulatory Affairs Professionals Society (RAPS), the Drug Information Association (DIA), the Society of Quality Assurance (SQA), the Association for Information and Image Management (AIIM), and the Society of Toxicology, Mid-Atlantic Chapter (MAST). He was the National Secretary of the Society of Quality Assurance and a member of its Board of Directors from 1989 to 1994.

Kim has a Masters of Business Administration from Fairleigh Dickinson University and a Bachelor of Arts from Rutgers University. He also received the designation of “Master of Information Technologies” from the Association for Information and Image Management International.

Publications

Nitahara, K., Participant Author and Member, Editorial Board, “Computerized Systems Used in Nonclinical Safety Assessment: Current Concepts in Validation and Compliance” (“Red Apple II Conference”), Drug Information Association, 2008.
Fitzmartin, R. and Nitahara, K., “A Survey of Industry Best Practice Metrics in Clinical Data Management and Biostatistics,” Drug Information Journal, Volume 35, Issue 3, pp. 671 – 679, 2001.
Nitahara, K., “August 20, 1997: A Day to Remember?” The Compliance Advisor, January 1998.
Nitahara, K., “Shall We Dance?: Computer Systems Validation Paralysis.” The Compliance Advisor, July 1997.
Nitahara, K., “Practical Implementation of Computers in the GLP Environment.” The Compliance Advisor, March, April, May 1997.
Nitahara, K., “Systems Validation–A Strategic Lesson.” Insight Newsletter, Fraser Williams Scientific, Issue 12, Spring 1997.
Nitahara, K., “Documentation Deficit Disorder: Software Specifications.” The Compliance Advisor, March, April 1996.
Nitahara, K., “Good Automated Laboratory Practices and Other Standards: Validation of Computer Systems in the PC Environment.” Quality Assurance: Good Practice, Regulation and Law, Academic Press, Inc.: Volume 2, Numbers 1/2, March/June 1993.
Nitahara, K., “CANDA – An Introduction, Overview and Future Visions.” Quality Assurance: Good Practice, Regulation and Law, Academic Press, Inc.: Volume 2, Numbers 1/2, March/June 1993.
Nitahara, K., “The Integration of Imaging Technologies with Existing R&D Information Management Systems.” LRS Optical Disk News, January 1991.
Buonomo, J. and Nitahara, K., “Processing Pharmaceutical R&D Information Using Optical Disk Technologies.” LRS Optical Disk News, September 1988.
Nitahara, K., “Reducing the Paper Bottleneck in New Drug Development.” LRS Optical Disk News, June 1988.
Co-author, “Computerized Data Systems for Nonclinical Safety Assessment: Current Concepts and Quality Assurance.” Drug Information Association, September 1988.
Nitahara, K., “The ONDA: Streamlining the NDA Review Process.” LRS Optical Disk News, March 1988.
Blaser, C., Nitahara, K. and Buonomo, J., “Computerized Monitoring and Remote Study Management.” submitted for publication in Drug Information Association Journal.
Buonomo, J. and Nitahara, K., “Collection of Clinical Trials Data Using Optical Disk Technology.” submitted for publication in Drug Information Association Journal.

Presentations

“GxP Regulatory Compliance Challenges for Global Data and Document Management,” Speaker; Global Regulatory Compliance Challenges Symposium, Society for Quality Assurance, Philadelphia, PA, October 27, 2009.
“eData Vendor Impact on Validation Risk and Complexity,” Speaker; 45th Annual Meeting, Drug Information Association, San Diego, CA, June 25, 2009.
“Regulatory Agency Expectations for Process Management & Control in Clinical Trials – CAPA Program Management, Continuous Improvement, and Agency Expectations for GCP Quality Management,” Speaker; Gaithersburg, MD, May 7, 2009.
“Assuring Regulatory Compliance of Commercial Off-the-Shelf Products for Electronic Document Management,” Speaker; 25th Annual Meeting, Society of Quality Assurance, San Diego, CA, April 21, 2009.
“FDA Update,” Session Co-Chair with FDA CDER Representative; 24th Annual Clinical Data Management Conference, Drug Information Association, Philadelphia, PA, March 9-11, 2009.
“Validation of Computerized Systems for Regulated Electronic Records, Documents and Submissions,” Instructor; and “Regulatory Town Hall Q&A,” Session Co-Chair with FDA CDER Representative; 22nd Annual Electronic Document Management Conference, Drug Information Association, Philadelphia, PA, February 10-13, 2009.
“Application of Corrective and Preventive Action (CAPA) Concepts in Clinical Trials,” Speaker; Gaithersburg, MD, January 29, 2009.
“Publishing for eHealth and eScience: An FDA Update,” Session Chairperson; 23rd Annual Clinical Data Management Conference, Drug Information Association, Washington, DC, March 16-18, 2008.
“Managing Documents and Records – The Never-Ending Process,” Program Co-Chair; “Validation of Computerized Systems for Regulated Electronic Records, Documents, and Submissions,” Tutorial Instructor; “Regulatory Town Hall Q&A,” Session Co-Chairperson; “Regulatory Compliance and Computerized Systems Validation,” Session Chairperson; and “Regulatory Compliance Requirements for Electronic Document and Submission Management Systems,” Tutorial Instructor; 21st Annual Electronic Document Management Conference, Drug Information Association, Philadelphia, PA, February 5-8, 2008.
“Archiving of Electronic GXP Data,” Speaker; Bay Area Compliance Discussion Group (BACDG), Palo Alto, CA, January 31, 2008.
“Data Integrity and Validation of Computerized Systems in Clinical Trials,” Speaker; “Inspection of Computerized Systems and Clinical Trials Data Management,” Speaker; “Key Tips for Audits and Inspection of e-Clinical Trials,” Speaker; and “Lessons Learned from Global Audits of Clinical Trials and Clinical Laboratories,” Speaker; Sino-US Advanced Auditing Workshop, Chinese State Food and Drug Administration (SFDA), Sanya, Hainan, China, December 19, 2007.
“Regulatory Compliance of Laboratory Systems – Update and Industry Status,” and Speaker; “Regulatory Expectations for Clinical Laboratory Systems,” Speaker; Rochester, MN, September 20, 2007.
“Good Documentation Practices for the FDA-Regulated R&D Environment,” Tutorial Instructor; University of Pennsylvania, Philadelphia, PA, March 30, 2007.
“Moving Down the e-Highway: The FDA Update/Town Hall Session,” Session Co-Chairperson with FDA CDER Representative, 22nd Annual DIA Clinical Data Management Conference, Drug Information Association, Orlando, FL, March 19, 2007.
“Reconnecting the Process to the Delivery of Safe and Effective Medical Products,” Program Committee Member; “Regulatory Compliance Requirements for Electronic Records, Documents, and Submissions: Predicate Rule and Part 11 System Design and Validation Considerations,” Tutorial Instructor; “Introduction to Drugs, Biologics, and Medical Devices: Regulatory, Process, and Technology Needs and Solutions for Information Management,” Tutorial Instructor, “Regulatory Compliance and Validation: Current Topics, Issues, and Trends,” Session Chairperson; “Regulatory Town Hall Q&A,” Session Co-Chair with FDA CDER Representative, 20th Annual DIA Electronic Document Management Conference, Drug Information Association, Philadelphia, PA, February 6-9, 2007.
“An Overview of the 21 CFR 11 Regulations and Guidance: Practical Considerations in Planning and Achieving Regulatory Compliance of Electronic Records, Signatures and Systems,” Tutorial Instructor, 42nd Annual Meeting, Drug Information Association, Philadelphia, PA, June 17-18, 2006.
“Leveraging Electronic Health Records Using Lean/Quality Management Principles,” Presenter, DIA Health Information Technology Conference, “R&D Meets HIT: Using Electronic Health Records to Streamline Clinical Trials Operations,” Drug Information Association, Philadelphia, PA, March 29, 2006.
“FDA Clinical Data Standards Update,” Session Co-Chairperson with FDA Representative, 21st Annual DIA Clinical Data Management Conference, Drug Information Association, Philadelphia, PA, March 27, 2006.
“Transitions: Standards, eContent Life Cycle Management and Beyond,” Program Committee Member, “Regulatory Compliance Requirements for Electronic Records, Documents, and Submissions; Predicate Rule and Part 11 System Design and Validation Considerations,” Tutorial Instructor; “Best Practices in Regulatory Compliance and Validation of Electronic Document and Submission Publishing and Management Systems,” Session Chair, “Regulatory Updates,” and “FDA Town Hall Q&A,” Session Co-Chair with FDA CDER Representative, 19th Annual DIA Electronic Document Management Conference, Drug Information Association, Philadelphia, PA, February 7-10, 2006.
“Best Practices for Computer System Validation and Electronic Records and Electronic Signatures Compliance,” Speaker, 2nd Annual FDA Information Management Summit; “Delivering the Right Data, The Right Way,” FDAnews, Bethesda, MD, December 1, 2005.
“Good Documentation Practices for GLPs and Research in the Penn Library for Preclinical Cardiology,” Tutorial Instructor, University of Pennsylvania, Philadelphia, PA, November 8, 2005.
“An Overview of the 21 CFR 11 Regulations and Guidance: What has Changed and What is Now Required?” Tutorial Instructor, 41st Annual Meeting, Drug Information Association, Philadelphia, PA, June 26, 2005.
“Development and Application of Risk-Based Approaches to 21 CFR 11 Compliance of Computerized Systems Used in Clinical Trials,” Tutorial Instructor, “Data Standards Submission: An FDA Update,” Session Co-Chairperson with FDA CDER Representative, 20th Annual DIA Clinical Data Management Conference, Drug Information Association, Arlington, VA, April 3-6, 2005.
“Beyond Vision… Addressing Reality,” Program Committee; “Validation and Compliance Issues of Electronic Documents and Submissions,” Tutorial Instructor; “FDA Updates,” and “EDM Summit,” Session Co-Chairperson with FDA CDER Representative, 18th Annual DIA Electronic Document Management Conference, Drug Information Association, Philadelphia, PA, February 15-18, 2005.
“21 CFR 11 Application to USAMRMC,” Presenter, “Setting Standards and Translating Theory into Practice,” USAMRMC Regulatory Affairs Investigator Training Conference, Fort Detrick, MD, September 13-15, 2004.
“An Overview of the 21 CFR 11 Regulations and Guidance: What Has Changed and What is Now Required?” Tutorial Instructor and “Risk-Based Approaches to Regulatory Compliance with 21 CFR 11 and Computer System Validation Requirements: How, What, When, Where and Why?” Tutorial Instructor, 40th Annual Meeting, Drug Information Association, Washington, D.C., June 12, 2004.
“Development and Application of Risk-Based Approaches to 21 CFR 11 Compliance of Computerized Systems Used in Clinical Trials,” Tutorial Instructor, “FDA: An Update on Current Initiatives and Directions,” Session Co-Chairperson with FDA CDER Representative; 19th Annual DIA Clinical Data Management Symposium and Exhibition, Drug Information Association, Philadelphia, PA, March 21-23, 2004.
“Risk-based Requirements Definition and Validation for Regulated Document Management Systems,” Tutorial Instructor, “Regulatory Update: FDA Electronic Common Technical Document (eCTD)” and “FDA/CDER Initiatives,” Session Co-Chairperson with FDA CDER Representative; “Practical Scope and Application of 21 CFR Part 11 on Electronic Documents, Signatures and Submissions,” Session Chairperson, 17th Annual DIA Document Management Meeting, Drug Information Association, Philadelphia, PA, February 17-20, 2004.
“How to Develop a Risk-Based Approach to 21 CFR 11 Compliance of Computerized Systems Used in Clinical Trials in Japan,” Speaker, 7th Annual Clinical Data Management Workshop in Japan, Drug Information Association, Tokyo, Japan, January 30, 2004.
“Re-Positioning 21 CFR Part 11: Understanding the Purpose and Impact of 21 CFR Part 11 Regulations and Related FDA Guidance on Computerized Systems, Electronic Records and Electronic Signatures,” Seminar Instructor, tpi consulting Seminar, Arlesheim, Switzerland, September 24, 2003.
“21 CFR 11 and the New Scope Guidance: The Impact of FDA’s Changing Strategy,” Program Committee; “An Overview of FDA Predicate Regulations and Guidance for Industry, and the Impact of the 21 CFR 11 Scope and Application Guidance,” Speaker; “Legacy Systems and Remediation Approaches,” Panelist; DIA 21 CFR 11 Conference, Drug Information Association, Philadelphia, PA, May 13, 2003.
“Impact of Recent Changes to Regulatory Compliance Requirements and Expectations for Electronic Records and Electronic Submissions,” Speaker, “Barnett International Electronic Regulatory Submissions” Conference, Barnett International Conference Group, Philadelphia, PA, May 12-13, 2003.
“The Optimized Clinical Data Management Process,” Program Committee; Data Standards, Session Chairperson, “Technology Enablers,” Session Chairperson; “The Optimal CDM Process,” Panel Member, Drug Information Association Conference, Philadelphia, PA, May 5-6, 2003.
“Adopting Global Standards,” Program Committee; “Practical Implementation of 21 CFR Part 11 and Validation Regulatory Compliance Requirements for Clinical Computer Systems,” Tutorial Instructor; “e-Data and the FDA: An Update on Current Initiatives and Directions,” Session Co-Chairperson with FDA CDER Representative; “21 CFR 11 Best Practices,” Roundtable Discussion Leader; “Data Security and Confidentiality” and “Systems Validation,” Session Chairperson, 18th Annual DIA Clinical Data Management Symposium and Exhibition, Drug Information Association, Philadelphia, PA, March 30 – April 2, 2003.
“Auditing Electronic GCP Systems”(Presenter), Clinical Research Association of Canada (May 2003)“Understanding the Purpose and Impact of 21 CFR Part 11” (Workshop Leader), 27th Annual Meeting; Association of Clinical Research Professionals (April 2003)
“Understanding the Purpose and Impact of 21 CFR Part 11 Regulations and Related FDA Guidance on Computerized Systems, Electronic Records and Electronic Signatures,” Seminar Instructor, tpi Consulting and META Solutions Seminar, Arlesheim, Switzerland, March 12-13, 2003.
“Electronic Document Management: Are We Done Yet? A Collaborative Systems and Process Evolution,” Program Committee; Document Management Essentials 101: From Authoring to Publishing, Tutorial Instructor; FDA Overview, Updates and Panel Discussion and On-going Projects, Session Co-Chairperson with FDA CDER Representative; Compliance, Session Chairperson, 16th Annual DIA Document Management Meeting, Drug Information Association, Philadelphia, PA, February 11-14, 2003.
“HIPAA Privacy, Security and Medical Research: Can They Co-Exist?” (Presenter), Audio Training Session (with A. Shuren, MSN, JD and S. Goldman, MD) – Regulatory Affairs Professional Society (January 2003)
“An Introduction to Electronic Document Management and Electronic Submissions: Technologies, Techniques and Trends” (Tutorial Instructor), 38th Annual Meeting, Drug Information Association, Chicago, IL, June 17, 2002.
“An Overview of the Electronic Records: Electronic Signatures Regulations and Analysis of Related FDA-483 Computer Systems and Validation Observations” (Tutorial Instructor), 38th Annual Meeting, Drug Information Association, Chicago, IL, June 17, 2002.
“Overview of FDA Regulations and Guidance on Electronic Regulatory Submissions: From CANDAs to the CTD”, “Electronic Regulatory Submissions” Conference, Barnett International, Philadelphia, PA, June 6, 2002.
“Applying 21 CFR 11 and Other Regulatory Compliance Requirements to Data Warehouses” (Workshop Leader), “2nd Annual Data Warehousing in Drug Development” Conference, Institute for International Research (IIR), Philadelphia, PA, May 20, 2002.
“Assuring 21 CFR 11 Compliance at Clinical Sites: What is Expected vs. What is Practical?”, “21 CFR Part 11 in the Clinical Environment” Conference, Institute for International Research (IIR), Philadelphia, PA, April 26, 2002.
“Validation of Clinical Computer Systems” (Tutorial Instructor), 17th Annual DIA Clinical Data Management Meeting, Drug Information Association, North Charleston, SC, March 17, 2002.
“Clinical Data Management 2002: Strategies for the Transformation of Clinical Data Management Over the Next Decade”, 17th Annual DIA Clinical Data Management Meeting (Program Committee), “FDA Update: Guidance, Current Practice, Initiatives and Future Directions” (Session Co-Chairperson with FDA CDER Representative), “Clinical Systems Validation” (Session Chairperson), and “Warehousing and Reporting” (Session Chairperson), Drug Information Association, North Charleston, SC, March 17-20, 2002.
“Application of 21 CFR Part 11 Regulations and New Guidance on Electronic Document and Submission Management Systems” (Tutorial Instructor), 15th Annual DIA Document Management Meeting, Drug Information Association, Philadelphia, PA, February 12, 2002.
“Strategic Document Management: Meeting the Challenges and Building Value”, 15th Annual DIA Document Management Conference (Program Committee) and “FDA Electronic Submission Initiatives Update” and “FDA Panel Discussion and Q&A” (Session CO-Chairperson with FDA CDER Representative), Drug Information Association, Philadelphia, PA, February 12-15, 2002.
“Current Issues in Interpreting the Rule: Understanding FDA’s Current Enforcement Practices” (Speaker), “FDA’s 21 CFR Part 11: Electronic Signatures & Records in Clinical Systems” 2nd Annual Conference, Barnett International, Philadelphia, PA, November 29, 2001.
“Considerations in GLP Telemetry Studies: What to Expect from Your FDA GLP Telemetry Audit” (Speaker for DSI International Workshop), Safety Pharmacology Society Meeting, Chicago, IL, November 27, 2001.
“Improving Performance of a 21 CFR Part 11 Audit Using Actual FDA Inspection Results and 483’s” (Speaker), “Pharmaceutical and Biotech GCP Quality and Compliance” Conference, Barnett International, Philadelphia, PA, October 12, 2001.
“Implementation of Metrics and Best Practices in the Industry: Case Studies” (Session Chairperson), “Metrics and Best Practices in Clinical Data Management” Conference, Drug Information Association, Philadelphia, PA, October 11, 2001.
Defining and Using Metrics to Control and Improve Clinical Data Management” (Speaker), 10th Annual Conference: “The Elements of Change in Clinical Research”, Society of Clinical Research Associates, Newport Beach, CA, September 14, 2001.
“Planning and Conducting an Audit of a Vendor or Service Provider” (Workshop Leader), 4th Annual 21 CFR Part 11 Conference: “Electronic Signatures & Records; Strategic Implementation, Compliance and Validation”, Barnett International, Philadelphia, PA, September 10, 2001.
“An Introduction to Electronic Document Management in the Pharmaceutical R&D Process” (Tutorial Instructor), 37th Annual Meeting, Drug Information Association, Denver, CO, July 8, 2001.
“An Overview of the Electronic Records; Electronic Signatures Regulations and Their Impact on Pharmaceutical R&D Computer Systems” (Tutorial Instructor), 37th Annual Meeting, Drug Information Association, Denver, CO, July 7, 2001.
“Practical Implementation of 21 CFR Part 11 Using the FDA Guidance on Clinical Systems Used in Clinical Trials” (Speaker) and “Performing 21 CFR 11 Audits of Vendor-Supplied Software and Services” (Speaker), 4th Annual “Regulatory Compliance and Advanced Management Strategies for Computer and Software Validation for Pharmaceutical, Biotech and Medical Device Companies” Conference, Barnett International Conference Group, Washington, D.C., May 7-8, 2001.
“An Overview of 21 CFR Part 11 Regulations and the FDA Guidance on Computerized Systems Used in Clinical Trials”(Tutorial Instructor), 16th Annual DIA Clinical Data Management Meeting (Program Committed), Drug Information Association, Atlantic City, March 12-15, 2001.
“Clinical Data Management: Innovative Technologies and Strategies for the Global Management of Clinical Data”, 16th Annual DIA Clinical Data Management Meeting (Program Committee), Drug Information Association, Atlantic City, NJ, March 12-15, 2001.
“Electronic Document Management: Collaboration Across the Virtual Community”, 14th Annual DIA Document Management Conference (Program Committee), Drug Information Association, Philadelphia, PA, February 13-15, 2001.
“Performing Audits of Vendor-Supplied Software and Services” (Speaker),” Electronic Signatures and Records in Clinical Systems” Conference, Barnett International, Tysons Corner, VA, December 1, 2000.
“Regulatory Requirements for Computer Software Validation” (Speaker), 1st Annual Worldwide eConference, eResearch Technology, Aventura, FL, October 2, 2000.
“A Strategic Approach to Prepare for Compliance with Electronic Signatures/Electronic Records (21 CFR 11) Regulations” (Speaker), Pharmaceutical Education and Research Institute (PERI), Inc. ” Electronic Records and Signatures Workshop”, Washington, DC, September 18, 2000.
“Defining and Using Metrics to Control and Improve Clinical Data Management”(Speaker and CO-Chairperson), 3rd Annual “Validating Clinical Data Management” Workshop, Institute for International Research (IIR), Philadelphia, PA, July 28, 2000.
“An Introduction to Electronic Document Management the Pharmaceutical R&D Process” (Tutorial Instructor), DIA Annual Meeting, Drug Information Association, San Diego, CA, June 11, 2000.
“An Overview of the Electronic Records; Electronic Signatures Regulations and Their Impact on Pharmaceutical R&D Computer Systems” (Tutorial Instructor), DIA Annual Meeting, Drug Information Association, San Diego, CA, June 11, 2000.
“The FDA Inspection Process: Anticipating Inspector Needs and Expectations” (Co-Presented with Steve Wilson, US Food and Drug Administration), Society for Clinical Trials (SCT) 21st Annual Meeting, Toronto, Canada, April 17-19, 2000.
“A Survey of Compliance with 21 CFR Part 11 in the Pharmaceutical, Biotechnology and CRO Industries”(Speaker), Society for Clinical Trials (SCT) 21st Annual meeting, Toronto, Canada, April 17-19, 2000.
“Preparing for Regulatory Inspections of Computer and Software Validation Practices” (Speaker), 3rd Annual “Regulatory Compliance and Advanced Management Strategies for Computer and Software Validation for Pharmaceutical, Biotech and Medical Device Companies” Conference, Barnett International Conference Group, London, UK, March 27-28, 2000.
“Innovative Technologies and Strategies for the Global Management of Clinical Data”, 15th Annual DIA Clinical Data Management Meeting (Program Committee), Philadelphia, PA, March 14-17, 2000.
“Preparing for Regulatory Inspections of Computer and Software Validation Practices” (Speaker), 3rd Annual “Regulatory Compliance and Advanced Management Strategies for Computer and Software Validation for Pharmaceutical, Biotech and Medical Device Companies” Conference, Barnett International Conference Group, Washington, DC, February 17-18, 2000.
“Electronic Document Management 2000: Integrating Technology and People”, 13th Annual DIA Document Management Conference (Program Committee), Philadelphia, PA, February 13-16, 2000.
“Understanding 21 CFR 11 Regulations for Electronic Records and Signatures: Strategies for Compliance of Clinical Systems”, 2nd Annual “Validating Clinical Data and Database” Conference (Speaker), Institute for International Research, Orlando, FL, December 9-10, 1999.
“Application of CFR 11 in FDA Audits o Clinical Data”, DIA Workshop “The FDA Guidance on Computerized Systems Used in Clinical Trials” (Speaker), Washington, DC December 2-3, 1999.
“Electronic Document Management and Knowledge Management: Systems and Workflow Process”, 35th Annual Meeting of the DIA (Session Chair), June 27 to July 1, 1999.
“A Strategic Approach to Preparing for Compliance with 21 CFR Part 11 Regulations”, Pharmaceutical Education and Research Institute (PERI), Inc. “Electronic Records and Signatures Workshop”, May 11, 1999.
“Innovative Technologies and Strategies for the Global Management of Clinical Information”, 14th Annual DIA Data Management Symposium and Exhibition (Program Committee), April 6-9, 1999.
“Preparing for Regulatory Inspections of Computer and Software Validation Practices”, Barnett International 2nd Annual Computer and Software Validation Meeting “Regulatory Compliance & Advanced Management Strategies for Computer & Software Validation for Pharmaceutical, Biotech and Medical Device Companies”, February 19, 1999.
Preconference Tutorial “An Introduction to Electronic Document Management in the Biopharmaceutical Industry”, 12th Annual DIA Document Management Conference: “Electronic Document Management: Practical Learnings” (Program Committee), February 7-10, 1999.
“A Strategic Approach to Preparing for Compliance with 21 CFR Part 11 Regulations”, Barnett International Conference “Electronic Signatures/Records: Strategies for Implementation and Compliance”, November 12-13, 1998.
“A Strategic Approach to Prepare for Compliance with Electronic Signatures/Electronic Records (21 CFR 11) Regulations”, Barnett Parexel Conference “Audits and Inspections”, November 5-6, 1998.
“ProVision: An Internet Data Mart Approach to Improve Clinical Study Management”, DIA Workshop “Improvement of Clinical Study Management Through Sophisticated Service Support”, October 5, 1998.
“Developing and Implementing Strategies for Clinical Computer Systems Validation and Compliance with FDA’s Electronic Signatures Regulations”, Society for Clinical Data Management (SCDM) 1998 Annual Fall Conference “Marrying Process Changes to New Technologies”, September 27-30, 1998.
“An Overview of the Applicability, Content and Impact of FDA’s New Electronic Records; Electronic Signatures Regulations”, Northern NJ Chapter of the Association of Clinical Research Professionals (ACRP) Chapter Meeting, July 13, 1998.
“Electronic Document Management Systems and Technologies” and “Electronic Document Management and Workflow” (Sessions Chairperson), DIA Annual Meeting “Thinking Globally: Product Development, Registration and Marketing in the New Millennium”, Drug Information Association, June 7-11, 1998.
“An Overview of the New Electronic Records; Electronic Signatures Regulations and Their Impact on Pharmaceutical R&D Computer Systems” (Tutorial Instructor), DIA Annual Meeting, Drug Information Association, June 7, 1998.
“An Introduction to Electronic Document Management in the Pharmaceutical R&D Process” (Tutorial Instructor), DIA Annual Meeting, Drug Information Association, June 9, 1996, June 22, 1997 and June 7, 1998.
“The Importance of Computer System Validation Principles in Globally-Distributed Clinical Systems” (Len Grunbaum), Drug Information Association, March 23-25, 1998.
“Computer Systems Validation Principles as a Way to Conduct Business” (Len Grunbaum), Drug Information Association, April 15, 1998.“Strategies for Clinical Trials Information Management” (Track Chairperson), Clinical Data Management Symposium and Exhibition “Innovative Technologies and Strategies for the Global Management of Clinical Information”, Drug Information Association, March 23-25, 1998.
“Validating Clinical Computer Systems: Practical Application of the Electronic Signature; Electronic Records Regulations”, Barnett Parexel Conference “Audits & Inspections: Accelerate Drug Approval through GCP Compliance”, February 12, 1998.
“Corporate Knowledge: Recognize It, Package It, Store It, Review It, Distribute It, Use It and Save It via the Document”, February 8-11, 1998.
“Document Content – Structuring the Message” and “Electronic Records and Signatures – Explanation of the Guidelines and Your Options” (Sessions Chair), DIA Document Management Workshop“Practical Implementation of Computer Systems in the GLP Environment: With Special Update on Electronic Signatures Rule”, META Solutions Seminar “Advanced GLP Concepts: Strategies for Compliance” (Seminar Co-Director and Sponsor), December 8-10, 1997.
“Implementation and Validation of Electronic Submissions”, Society for Clinical Data Management Annual Fall Conference “Clinical Data Integrity: Assuring the Quality”, Society for Clinical Data Management, October 14, 1997.
“Practical Approaches to Validating Clinical Computer Systems”, The National Managed Health Care Congress Conference “Electronic Document Management Systems Post-Conference Workshop”, July 23, 1997.
“The Use of IT in Re-Engineering & Refocusing Pharmaceutical R&D”, International Business Communications Conference “Pharmatics ‘97: Revolutionary Pharmaceutical IT Strategies for the 21st Century”, July 22,1997.
“Using the Intranet for Knowledge Management Purposes to Achieve Competitive Advantage” (Workshop Leader), Institute for International Research Conference “Knowledge Management: Gain and Sustain the Competitive Edge in the Global Bio/Rx Industry”, July 21, 1997.
“Clinical Trials Program Management” (Session Chairperson), Clinical Data Management Symposium and Exhibition “Innovative Technologies and Strategies for the Global Management of Clinical Information”, Drug Information Association, March 18, 1997.
“Validating Clinical Computer Systems” (Co-Instructor), Barnett International Pre-Conference Workshop for “Audits and Inspections ‘97: Accelerate Approval Through GCP Compliance” Conference, March 3, 1997.
“Managing Electronic Document Workflow and Collaboration” (Session Chair), DIA Document Management Workshop “Moving Beyond Paper in a Global Environment”, February 10-13, 1997.
“Intranet 101: Practical Applications of Inter/Intranet Technologies for Drug Development” (Tutorial Instructor), Institute for International Research Conference “Bio/Pharmaceutical Intranet Cyberstrategies ‘97”, January 13, 1997.
“Practical Implementation of Computer Systems in the GLP Environment”, Practical Implementation of the GLPs: A Recipe for Compliance” (Seminar CO-Director and Sponsor), November 4-6, 1996.
“Practical Implementation of the Good Automated Laboratory Practices (GALPs): Issues and Experiences” (Session Co-Chairman), SQA Annual Meeting, October 14, 1996.
“A Contract Research Organization Perspective on Electronic Submissions”, DIA Annual Meeting “Optimizing Pharmaceutical Development: The Global Experience”, Drug Information Association, June 24, 1996.
“Introduction to the Internet and Intranet Applications in the Pharmaceutical Industry” (Tutorial Instructor), DIA Annual Meeting, Drug Information Association, June 22, 1996.
“Re-Engineering Pharmaceutical R&D Using Document Management and Imaging Technologies” (Session Chairperson), DIA Annual Meeting, Drug Information Association, June 11, 1996.
“Internet and Intranet: Uses, Benefits and Concerns in the Drug Development Process”, DIA Annual Meeting, Drug Information Association, June 11, 1996.
“The ABC’s of CANDA’s: Approval Acceleration, Business Benefits and Computerization” (Tutorial Instructor), DIA Annual Meeting, Drug Information Association, June 5, 1994, June 25, 1995 and June 9, 1996.
“Imaging and Workflow Technologies” (Session Chairperson), DIA Workshop on Pharmaceutical Document Management, Drug Information Association, February 14, 1996.
“Practical Approaches to Validating Clinical Computer Systems” (CO-Instructor), Time- and Cost-Efficient Strategies for Assuring
“Electronic Signatures and Identification” (Session Chairperson), DIA Annual Meeting, Drug Information Association, June 27, 1995.
“Imaging and Workflow Technology” (Session Chairperson), DIA Annual Meeting, Drug Information Association, June 27, 1995.
“The Roles of CROs, Vendors and Consultants in the CANDA Development Process”, DIA Annual Meeting, Drug Information Association, June 26, 1995.
“Imaging 101” and “Imaging 102” (Course Presenter), DIA Annual Meeting, Drug Information Association, July 11, 1993 and June 25, 1995.
“Information Technology for Clinical Trials: To Build or To Buy”, Information Technology ‘95 Conference, Barnett International Corporation, June 8, 1995.
“Electronic Document Management: An Overview of Current Technologies and Their Potential Application in Re-engineering Clinical Processes”, Information Technology ‘95 Conference, Barnett International Corporation, May 15, 1995.
“A Methodology for Choosing and Implementing a System Development Standard: Developing User Requirements and Obtaining Buy-In” (presented with Len Grunbaum), Managing Quality System Standards: What Are They and How Are They Applied to Computer System Validation, DIA Workshop, Drug Information Association, May 9, 1995.
“Integration of Data Review by In-House and FDA Reviewers Using a Common CANDA System”, CANDA Conference, International Business Communications, April 10, 1995.
“Practical Experiences with the Validation of Clinical Computer Systems”, Worldwide Issues and Solutions for Clinical Data Management, DIA Workshop, Drug Information Association, March 26, 1995.
“Imaging and Workflow Technologies” (Session Chairperson), Pharmaceutical Document Management: The World’s View, DIA Workshop, Drug Information Association, February 15, 1995 (planned).
“Maximizing the Efficiency of CANDA Development”, Project Scheduling in Pharmaceutical Development-Resources, DIA Workshop, Drug Information Association, October 14, 1994.
“Computer Validation: Panel Discussion” (Panel Member), SQA Annual Meeting, Society of Quality Assurance, October 10, 1994.
“Future State of Computer Technology”, Computer Validation Training Seminar, Society of Quality Assurance, July 27, 1994.
“Integrating Images with the Data: A Basic CANDA Requirement”, Third Annual CANDA/CAPLA Technology Conference, Institute for International Research, July 19, 1994.
“Systematic Approaches to Assure Data Quality” (Session Chairperson), DIA Annual Meeting, Drug Information Association, June 9, 1994.
“Opportunities for Workflow Re-Engineering Using Document Management and Imaging Technologies” (Session Chairperson), DIA Annual Meeting, Drug Information Association, June 8, 1994.
“This Old CANDA: Re-Using SAS Datasets and Programs to Build a Better CANDA”, DIA Annual Meeting, Drug Information Association, June 7, 1994.
“CANDA: Overview of Benefits, Pitfalls and Technologies”, PSG Update 1994, Pharmaceutical Sciences Group of Canada, May 3, 1994.
“Imaging Technologies” (Session Chairperson), DIA Document Management and Imaging Workshop, Drug Information Association, February 15, 1994.
“The Design and Development of a SAS-Based CANDA and In-house Medical Review System”, DIA Annual Meeting, July 14, 1993.
“The Latest Perspectives on Cost Justification and Specification of Imaging Systems” (Session Chairperson), DIA Annual Meeting, Drug Information Association, July 13, 1993.
“Data Management”, DIA Comprehensive Drug Safety Surveillance Training Course (Course CO-Instructor), Drug Information Association, January 11-12, 1993 and June 2-3, 1993.
“The Design and Development of a SAS-Based CANDA and In-house Medical Review System” (Co-Author with Linda Riebel), PharmaSUG Annual Meeting, SAS Pharmaceutical Users Group, June 1993.
“Panel Discussion on Electronic Alternatives to Identification/Signature; Integration and Control of Technology” (Session Chairperson), DIA Clinical Computer System Validation Workshop, Drug Information Association, May 12, 1993.
“A Practical Approach to the Validation of Clinical Computer Systems”, DIA Clinical Computer System Validation Workshop, Drug Information Association, May 11, 1993.
“Computer Validation: Industry Perspective” (Speaker and Panelist), PMA Bioresearch Monitoring Subcommittee Annual Meeting, Pharmaceutical Manufacturers Association, May 5, 1993.
“Computers, CANDAs and Compliance: Impact and Involvement of Regulatory Affairs”, Presentation at Glaxo, Inc., March 9, 1993.
“Imaging Technologies” (Session Chairperson), DIA Document Management and Imaging Workshop, Drug Information Association, February 23, 1993.
“CANDA Project Planning”, Project Scheduling Solutions in Pharmaceutical Development, DIA Workshop, Drug Information Association, November 19, 1992.
“Validation of Purchased Software and Add-On Programs”, SQA Annual Meeting, Society of Quality Assurance, October 1, 1992.
“CANDA: Introduction, Overview and Future Visions”, SQA Annual Meeting, Society of Quality Assurance, October 1, 1992.
“The Three R’s of Computer System Validation: Regulation, Rationality and Reality” (Course Instructor), DIA Annual Meeting, Drug Information Association, June 7, 1992.“Imaging 101” (Course Presenter), DIA Annual Meeting, Drug Information Association, June 16, 1991.
“Accelerating the Research Cycle: Applying Information Technology from Compound to Market” (AGS Seminar Presenter and Panelist), October 23, 1990.
“Design and Development of a Distributed Clinical Data Management Environment Using Workstation Technologies” (co-author with Joseph Buonomo), DIA Workshop, Drug Information Association, September 25, 1990.
“Imaging Technology – Future Trends” (Session Chairman), DIA Annual Meeting, Drug Information Association, June 5, 1990.
“Managing Regulatory Submissions and Correspondence in the 1990’s: Applying Computing and Imaging Technologies in Regulatory Affairs”, PMA Information Management Subsection 20th Annual Meeting, Pharmaceutical Manufacturers Association, April 23, 1990.
“CANDA in the 1990’s: Integrating Advanced Computer and Imaging Technologies”, April 5, 1990.
“The Application of Innovative Technologies in Pharmaceutical R&D: A Survey of Needs”, DIA Workshop, Drug Information Association, September 28, 1989.
“The Application of Innovative Technologies in Pharmaceutical R&D: New Technologies – Storage Devices and Peripherals” (Session Chairperson), DIA Workshop, Drug Information Association, September 28, 1989.
“Application of Optical Disk Technologies: User and Vendor Perspectives” (Session Moderator), DIA Annual Meeting, Drug Information Association, June 19, 1989.
“Submitting a New Drug Application on Optical Disk: Methods and Potential Benefits.” PMA/FDA Jointly Sponsored Meeting on Computer-Assisted NDA Reviews, June 14, 1988.
“Application of Advanced Technology in Clinical Data Management.” with Richard Chamberlain, Ph.D. in “Future Trends in Clinical Data Management”, CLIN-REG Conference and Exposition ’88, February 29, 1988.
“Expert Systems in Quality Assurance.” Poster Presentation, SQA Annual Meeting, Society of Quality Assurance, October 29, 1987.
Publications
Nitahara, K., Participant Author and Member, Editorial Board, “Computerized Systems Used in Nonclinical Safety Assessment: Current Concepts in Validation and Compliance” (“Red Apple II Conference”), Drug Information Association, 2008.
Fitzmartin, R. and Nitahara, K., “A Survey of Industry Best Practice Metrics in Clinical Data Management and Biostatistics,” Drug Information Journal, Volume 35, Issue 3, pp. 671 – 679, 2001.
Nitahara, K., “August 20, 1997: A Day to Remember?” The Compliance Advisor, January 1998.
Nitahara, K., “Shall We Dance?: Computer Systems Validation Paralysis.” The Compliance Advisor, July 1997.
Nitahara, K., “Practical Implementation of Computers in the GLP Environment.” The Compliance Advisor, March, April, May 1997.
Nitahara, K., “Systems Validation–A Strategic Lesson.” Insight Newsletter, Fraser Williams Scientific, Issue 12, Spring 1997.
Nitahara, K., “Documentation Deficit Disorder: Software Specifications.” The Compliance Advisor, March, April 1996.
Nitahara, K., “Good Automated Laboratory Practices and Other Standards: Validation of Computer Systems in the PC Environment.” Quality Assurance: Good Practice, Regulation and Law, Academic Press, Inc.: Volume 2, Numbers 1/2, March/June 1993.
Nitahara, K., “CANDA – An Introduction, Overview and Future Visions.” Quality Assurance: Good Practice, Regulation and Law, Academic Press, Inc.: Volume 2, Numbers 1/2, March/June 1993.
Nitahara, K., “The Integration of Imaging Technologies with Existing R&D Information Management Systems.” LRS Optical Disk News, January 1991.
Buonomo, J. and Nitahara, K., “Processing Pharmaceutical R&D Information Using Optical Disk Technologies.” LRS Optical Disk News, September 1988.
Nitahara, K., “Reducing the Paper Bottleneck in New Drug Development.” LRS Optical Disk News, June 1988.
Co-author, “Computerized Data Systems for Nonclinical Safety Assessment: Current Concepts and Quality Assurance.” Drug Information Association, September 1988.
Nitahara, K., “The ONDA: Streamlining the NDA Review Process.” LRS Optical Disk News, March 1988.
Blaser, C., Nitahara, K. and Buonomo, J., “Computerized Monitoring and Remote Study Management.” submitted for publication in Drug Information Association Journal.
Buonomo, J. and Nitahara, K., “Collection of Clinical Trials Data Using Optical Disk Technology.” submitted for publication in Drug Information Association Journal.