Based in Queensland, Australia, Allan K. Johansen is a clinical research & development professional with more than 26 years of experience in the pharmaceutical industry, of which more than 18 years in senior clinical QA positions.
Allan left Roche as of 31 March 2011 (see below) to offer his GCP auditing & consulting services to the pharmaceutical community as independent GCP Auditor & Consultant, and has since conducted more than 40 audits as independent GCP auditor on behalf of American, Australian, British, Dutch, German and Swiss sponsor clients and QA partners. The majority of the audits have been audits of local Australian CROs and especially qualification and in-process of the four Australian not-for-profit CPUs, including FTIH studies.
Allan graduated as Doctor of Veterinary Medicine (DVM - Masters) from the Royal Danish Veterinary and Agricultural University (RVAU) in Copenhagen in 1976. The same year he obtained a postgraduate degree in Food Microbiology & Hygiene.
Between 1977– 1989, he worked with microbiology in various positions at the Danish Institute of Technology, BioSystems A/S and the Danish State Veterinary Service (Division of Food Control), respectively.
He joined the pharmaceutical industry in 1989, firstly with Ferrosan A/S, a then subsidiary of Novo Nordisk A/S, in the R&D Department as Medical Advisor for several OTCs and natural remedies, as well as Clinical Research Associate in Phase IV studies. In 1993 he moved to Novo Nordisk A/S, joining Health Care Regulatory Affairs as Regulatory Officer, responsible for the clinical sections of NDA submissions to the FDA. In 1996 he was asked to join another Novo Nordisk department, Medical Affairs Diabetes, as Medical Advisor and International Trial Manager of a major Phase IIIb program. Finally, still in Novo Nordisk, in July 1997 he accepted a position as International Clinical Auditor in the Clinical Quality Assurance department of Novo Nordisk A/S, Denmark.
He then joined Pharma Development Quality Roche in Aug 1999, setting up the local PDQ office in Dee Why, Australia, and has been Site Head of PDQ Dee Why (Asia-Pacific, India & South Africa) managing a growing staff of 8 QA professionals, as well as Sen. Team Leader, PDQ Auditing until 31 Mar 2011, when both positions were made redundant. View CV
Allan's audit experience includes 230+ audits (140 as lead) in 36 countries over 6 continents - including approx 140 audits in the Asia Pacific region (incl. Australia and NZ), in the areas of Investigator Sites (phases II to IV), Pharmacovigilance, CROs/CPUs/Vendors (qualification and in-process), IECs/IRBs and Sponsor Affiliate Study Management, and CSR, as well as preparing for regular authority inspections (EMA and FDA) as well as hosting foreign FDA investigator site inspections. View Audit Experience
Allan is an ISO 9001:2000 certified Lead QMS Auditor.
Allan has presented numerous times at international conferences including APEC, ARCS, DIA Annual US and Euro Meetings, EFGCP, internal workshops at WHO/TDR in Geneva and Bangkok, company Investigator’s Meetings etc.
Allan has also been involved as Facilitator and co-surveyor in a series of Surveys and Workshops on “Surveying and Evaluating Ethical Review Practices” under FERCAP (a WHO initiative), and has furthermore been conducting a series of audits on behalf of the WHO/TDR in mainly developing countries (Bangladesh, Ethiopia, Senegal, Uganda) as well as Thailand and South Africa, acting as External WHO QA Adviser/Mentor/Lead Auditor. He has furthermore been attached to Nagasaki University, Japan and Thammasat University, Thailand, respectively, as Visiting Lecturer at the annual “Diploma Course on Research & Development of Products to meet Public Needs” (supported by WHO/TDR). View Training/Presentations
Since 2014 Allan has been part of the international Expert Advisory Panel for Barnett’s “Good Clinical Practice: A Question & Answer Reference Guide” contributing two sections on ‘GCP and Clinical Research Standards’ in Australia and New Zealand, respectively (12th Edition May 2014, 13th Ed. May 2015, and forthcoming 14th Ed. May 2016, – under preparation; Barnett International, USA, edited by Michael Hamrell).
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