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If you are interested in our publications,
you are welcome to contact us for a copy.
 | Hattemer-Apostel R. Good Manufacturing Practice. In: Landau K, Pressel G, editors. Medizinisches Lexikon der beruflichen Belastungen und Gefährdungen. 2nd ed. Stuttgart: Alfons W. Gentner Verlag GmbH & Co. KG; 2009. p. 407-410 [ISBN 978-3-87247-715-6].
To order the book:
www.gentner.de
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Hattemer-Apostel R. Deficiencies Observed in Data Management Systems Audits-A Quantitative and Qualitative Analysis. Poster presentation at 2nd Global Quality Assurance Conference; 28-31 October 2008; Edinburgh, UK.
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Hattemer-Apostel R. SPAQA - Swiss Professional Association for Quality Assurance: A Small Organization, But Does Size Matter? Poster presentation at 2nd Global Quality Assurance Conference; 28-31 October 2008; Edinburgh, UK.
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Hattemer-Apostel R, Fischer S, Nowak H. Getting Better Clinical Trial Data – An Inverted Viewpoint. Drug Inf J. 2008;42(2)123:130.
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 | Hattemer-Apostel R, Reinhardt W. Audits in Data Management, Statistics and Medical Writing: Auditing Clinical Databases, Trial Reports and Related Systems. In: GCP Auditing-Methods and Experiences. 2nd ed. Aulendorf: ECV Editio Cantor Verlag; 2007. p. 188-205. [ISBN 978-3-87193-356-1]
To order the book:
www.ecv.de
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 | Hattemer-Apostel R. Quality Management in Clinical Research and the Value of Audits. In: GCP Auditing-Methods and Experiences. 2nd ed. Aulendorf: ECV Editio Cantor Verlag; 2007. p. 11-32. [ISBN 978-3-87193-356-1]
To order the book:
www.ecv.de
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 | Hattemer-Apostel R, Norton J. Audits of Early Phase Clinical Trials and Clinical Pharmacology Units. In: GCP Auditing-Methods and Experiences. 2nd ed. Aulendorf: ECV Editio Cantor Verlag; 2007. p. 146-163. [ISBN 978-3-87193-356-1]
To order the book:
www.ecv.de
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 | Hattemer-Apostel R. Quality Assurance, Quality Control and Audit. In: Edwards LD, Fletcher AJ, Fox WF, Stonier PD, editors. Principles and Practice of Pharmaceutical Medicine. 2nd ed. Chichester: John Wiley & Sons Ltd. p. 159-178 [ISBN 978-0-470-09313-9].
To order the book:
www.wiley.com/WileyCDA/WileyTitle/productCd-047009
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Hattemer-Apostel R, Nowak H, Fischer S. Monitoring und Datenmanagement aus der Sicht der Studienauswertung: Das Wesentliche im Blick. DZKF 2007;11(1/2):26-31.
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Hattemer-Apostel R, Broughton S. What's New?. Qual Assur J. 2006;10(4):290-314.
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Hattemer-Apostel R. Editorial: Does Quality Assurance need Quality Assurance?. Qual Assur J. 2006;10(4):245-246.
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Hattemer-Apostel, R. Quality Management in Clinical Research and the Value of Audits. Pharm. Ind. 2006;68(12):1369-1380.
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Hattemer-Apostel R. Calendar of Events. Qual Assur J. 2006;10(3):235-244.
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Hattemer-Apostel R, Broughton S. What's New?. Qual Assur J. 2006;10(3):213-234.
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Hattemer-Apostel R. The 2006 Quality Assurance Journal Best Article Award. Qual Assur J. 2006;10(2):154-155.
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Hattemer-Apostel R, Broughton S. What's New?. Qual Assur J. 2006;10(2):128-146.
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Hattemer-Apostel R. Editorial: Rethinking Procedures in Research. Qual Assur J. 2006;10(2):77-78.
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Hattemer-Apostel R. Analyzing GXP Approaches to Quality-A Scientific Exercise. Poster presentation at 22nd SQA Annual Meeting; 25-27 April 2006; Phoenix, AZ, USA.
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Hattemer-Apostel R. Website Review. Für: www.openminds.org. SPAQA Circle. 2006;(16):34.
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Hattemer-Apostel R. Buchrezension. Für: Schwarz JA. Leitfaden Klinische Prüfungen von Arzneimitteln und Medizinprodukten. SPAQA Circle. 2006;(16):33.
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Hattemer-Apostel R. Buchrezension. Für: Mayer AG, Söbbing T. Outsourcing leicht gemacht-Muss man denn alles selber machen?. SPAQA Circle. 2006;(16):32.
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Hattemer-Apostel R. Useful Links to FDA Websites. SPAQA Circle. 2006;(16):26-29.
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Hattemer-Apostel R. FDA Warning Letters in Good Laboratory Practice from 2004 and 2005. SPAQA Circle. 2006;(16):24-26.
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Hattemer-Apostel R. QM Toolbox: Risk Management. SPAQA Circle. 2006;(16):19-21.
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Jones AB, Hattemer-Apostel R, Colligon I. The Artful Science of Quality Assurance. Abstracts of the 22nd SQA Annual Meeting; 23-27 April 2006; Phoenix, AZ, USA. Qual Assur J. 2006;10(1 Suppl 1):S39-S40.
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Hattemer-Apostel R, Chase D. Conducting Clinical Trials in the European Union-Regulatory Developments and Impact on Quality Assurance. Abstracts of the 22nd SQA Annual Meeting; 23-27 April 2006; Phoenix, AZ, USA. Qual Assur J. 2006;10(1 Suppl 1):S17.
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Hattemer-Apostel R, Broughton S. What's New?. Qual Assur J. 2006;10(1):48-69.
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Hattemer-Apostel R. Editorial: Fraud and Misconduct-The Dark Side of Science. Qual Assur J. 2006;10(1):1-2.
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Hattemer-Apostel R, Broughton S. What's New?. Qual Assur J. 2005;9(4):314-332.
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Hattemer-Apostel R. Editorial: Quality Cross-Fertilization. Qual Assur J. 2005;9(4):263-264.
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Krempien W, Chase D, Schwarz G, Edelmann-Stergiou K, Eisfeld K, Hartlieb-Wallthor-Sano C, Hattemer-Apostel R, Pöhhacker R, Reinhardt W, Rittberger M, Stelzer HG, Weber S. Die Klinische Prüfung in Deutschland-Fragen und Antworten sowie Anmerkungen zum 12. bzw. 14. AMG-Änderungsgesetz vom 30. Juli 2004 bzw. 29. August 2005 und zur GCP-Verordnung vom 9. August 2004. Pharm. Ind. 2005;67(11):1261-1276.
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Hattemer-Apostel R, Broughton S. What's New?. Qual Assur J. 2005;9(3):238-256.
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Hattemer-Apostel R. Editorial: As Time Goes By. Qual Assur J. 2005;9(3):177-178.
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 | Hattemer-Apostel R. Quality Assurance and Clinical Research. In: Luscombe D, Stonier PD, editors. Clinical Research Manual, 2nd edition. Haslemere: Euromed Communications Ltd. 2005. p. 16.1–16.46 [ISSN 1355-4808].
To order the book:
www.euromed.uk.com/crm/crmhome.htm
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Hattemer-Apostel R. 1st Global Quality Assurance Conference - Bericht über die 1st Global Quality Assurance Conference (GQAC) "Committed to Quality in Research" vom 22. bis 24. Februar 2005 in Orlando (Florida, USA). Pharm. Ind. 2005;67(8):871-876.
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Hattemer-Apostel R. The 2005 Quality Assurance Journal Best Article Award. Qual Assur J. 2005;9(2):169-170.
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Hattemer-Apostel R, Broughton S. What's New?. Qual Assur J. 2005;9(2):152-168.
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Hattemer-Apostel R. Conducting Audits in Data Management and Statistics - Beyond Looking at Databases. Abstracts of the 1st Global Quality Assurance Conference and 21st SQA Annual Meeting; 20-24 February 2005; Orlando, FL, USA. Qual Assur J. 2005;9(1 Suppl 1):S38-S39.
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Hattemer-Apostel R. Challenges and Observations of Auditing Phase I/II Trials. Abstracts of the 1st Global Quality Assurance Conference and 21st SQA Annual Meeting; 20-24 February 2005; Orlando, FL, USA. Qual Assur J. 2005;9(1 Suppl 1):S34.
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Hattemer-Apostel R. Is QA Being Taken Seriously? - Thoughts on How to Raise Respect for QA. Abstracts of the 1st Global Quality Assurance Conference and 21st SQA Annual Meeting; 20-24 February 2005; Orlando, FL, USA. Qual Assur J. 2005;9(1 Suppl 1):S22.
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Hattemer-Apostel R, Broughton S. What's New?. Qual Assur J. 2005;9(1):61-75.
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Hattemer-Apostel R. Book Review. For: Emanuel EJ, Crouch RA, Arras JD, Moreno JD, Grady C, editors. Ethical and Regulatory Aspects of Clinical Research. Qual Assur J. 2005;9(1):50-52.
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Hattemer-Apostel R, Broughton S. What's New?. Qual Assur J. 2004;8(4):287-302.
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Hattemer-Apostel R. The 2004 Quality Assurance Journal Best Article Award. Qual Assur J. 2004;8(3):235-236.
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Hattemer-Apostel R, Broughton S. What’s New?. Qual Assur J. 2004;8(3):212–226.
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Hattemer-Apostel R. Editorial. Qual Assur J. 2004;8(3):151.
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Hattemer-Apostel R. 'GCP light' for academia? No double standards, please! [electronic response to Susan Mayor. Draft guidance on clinical trials recognises needs of non-commercial research]. BMJ. 2004;329:191. http://bmj.bmjjournals.com/cgi/eletters/ 329/7459/191-b#70641 [accessed 12 Aug 2004].
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Hattemer-Apostel R. What’s New?. Qual Assur J. 2004;8(2):129-142.
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Dent N, Hattemer-Apostel R. EQAS-The European Quality Assurance Society. Qual Assur J. 2004;8(2):116-117.
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Hattemer-Apostel R, Strack B, Edelstein R. The Quality Assurance Journal–An Information Source and Communication Tool for QA Professionals. Poster presentation at 20th Annual Society of Quality Assurance (SQA) Meeting; 27-29 April 2004; Reno, NV, USA.
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 | Hattemer-Apostel R. Quality Assurance and Clinical Research. In: Luscombe D, Stonier PD, editors. Clinical Research Manual. Haslemere: Euromed Communications Ltd. 2004. p. 17.1–17.46 [ISSN 1355-4808].
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Hattemer-Apostel R. Buchrezension. Für: Owen J. Das Lexikon des ganz normalen Management-Wahnsinns. SPAQA Circle. 2004;(15):15-17.
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Hattemer-Apostel R. QM Toolbox: Pareto’s 80:20 Rule. SPAQA Circle. 2004;(15):6-8.
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Hattemer-Apostel R, Broughton S. What’s New?. Qual Assur J. 2004;8(1):57-67.
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Hattemer-Apostel R. Editorial. Qual Assur J. 2004;8(1):1-2.
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Hattemer-Apostel R. Kryptische Abkürzungen–Was steckt hinter Good ... Practice?. SPAQA Circle. 2003;(14):12.
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Hattemer-Apostel R, Simon M. Dynamic Process Management Towards Sustained Compliance and Benefit in Clinical Reseach. Poster presentation at 21st ISDC International Systems Dynamics Conference; 21-24 July 2003; New York, NY, USA.
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Hattemer-Apostel R, Simon M. Dynamic Process Management Towards Sustained Compliance and Benefit in Clinical Research. Proceedings of the 21st ISDC International Systems Dynamics Conference; 21–24 July 2003; New York, NY, USA.
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 | Hattemer-Apostel R, Reinhardt W. Audits in Data Management, Statistics and Medical Writing: Auditing Clinical Databases, Trial Reports and Related Systems. In: GCP Auditing-Methods and Experiences. Aulendorf: ECV Editio Cantor Verlag; 2003. p. 110–126 [ISBN 3-87193-284-1].
To order the book:
www.ecv.de
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 | Hattemer-Apostel R. A Career in Clinical Quality Assurance. In: Stonier PD, editor. Careers with the Pharmaceutical Industry. 2nd ed. Chichester: John Wiley & Sons Ltd.; 2003. p. 187–202 [ISBN 0-470-84328-4].
To order the book:
www.wiley.com/WileyCDA/WileyTitle/productCd-047084
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Hattemer-Apostel R. Guest Editorial. Qual Assur J. 2002;6(4):217–218.
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Hattemer-Apostel R. Standard Operating Procedures–A Novel Perspective. Qual Assur J. 2001;5(4):207–219.
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Reinhardt W, Hattemer-Apostel R, Bless M. Audit 2000 / VII: Audits von Datenmanagement, biometrischem und integriertem Bericht / Teil II. Pharm. Ind. 2001;63(8):828–833.
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Reinhardt W, Hattemer-Apostel R, Bless M. Audit 2000 / VII: Audits von Datenmanagement, biometrischem und integriertem Bericht / Teil I. Pharm. Ind. 2001;63(7):694–700.
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Hattemer-Apostel R. GCP Auditors: Hard to Find–Hard to Develop–Hard to Keep, 3. Continuous Education and Further Development. Qual Assur J. 2001;5(1):3–11.
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Hattemer-Apostel R. GCP Auditors: Hard to Find–Hard to Develop–Hard to Keep, 2. Initial Training Requirements for Auditors. Qual Assur J. 2000;4(3):123–135.
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Hattemer-Apostel R. GCP Auditors: Hard to Find–Hard to Develop–Hard to Keep, 1. Criteria and Methods for Candidate Selection. Qual Assur J. 2000;4(1):3–8.
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Hattemer-Apostel R. Book Review. For: Kolman J, Meng P, Scott G. Good Clinical Practice: Standard Operating Procedures for Clinical Researchers. Pharm Technol Eur. 2000;12(2):50–51.
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Hattemer-Apostel R. Investigational Products at the Interface. Appl Clin Trials. 1999;8(10):12-17.
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Renneisen K, De Backer R, Hattemer-Apostel R, Helmrich C, Kobelt R, Norton J, Petersen C, Reiermann HJ. A Model Format and Structure of Investigator Site Audit Reports. Appl Clin Trials. 1999;8(6):46–52.
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