Facutly – 5th European Clinical Trials Inspection Readiness

Karim Benlachen
Trial Operations Team Manager, SANOFI R&D

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I hold a Ph.D. in Biology and Toxicology from the University of Bordeaux, France. I started my career in the Pharma industry in 1999 as a Clinical Research Associate and since then fulfilled a variety of positions at different companies acquiring large expertise in clinical trials management and Team management.

I joined Sanofi R&D as Global Study Manager in 2006 and have had several responsibilities since then as the Program Manager and Clinical Team Manager.

I have been involved in the submission dossier for several products in U.S., EU, and Japan and as Operational Team representative in the front room during two successful Sponsor FDA inspections in the US that occurred respectively in 2014 and 2016.

Most recently, I have been appointed as Director, Clinical Sciences & Operations on Multiple Sclerosis & Rare Diseases projects.

Dr. Andrew Bentley
Quality Assurance Manager, MINA THERAPEUTICS

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Andrew Bentley started his career in academic research, gaining a D.Phil. in neuroendocrinology at University of Sussex and conducting postdoctoral work at Oxford University. He has over three decades of experience in GxP environments, starting in GMP at Boots-Celltech Diagnostics, then moving on to work in GCP at three major global CROs. During this career he has implemented and integrated a number of quality management systems, conducted internal and external audits internationally, routinely hosted both sponsor audits and three MHRA GCP inspections, and guest lectured at Cranfield University. His experience and versatility often saw him drawn into major company initiatives. He recently transferred his expertise in quality management and risk management to a cutting-edge biotechnology company in London.

Marie Boireaud
Clinical Quality Assurance Auditor, PIERRE FABRE LAB

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Working within Pierre Fabre Research Institute since September 2016, Marie Boireaud holds the position of Quality Management officer and GCP auditor.
Marie ended her pharmaceutical studies in 2015. She was graduated in Pharmaceutical Industry and Quality Management System. She defended her PhD thesis in 2016, on “Maintenance and calibration of equipment used in a clinical trial: use of a risk-based approach”. After a quick internship in a GMP environment, she started working in Clinical Quality Assurance within GlaxoSmithKline France. Currently, her main responsibilities within Pierre Fabre Clinical Quality Assurance team is to manage Quality Management System, support clinical teams with regulation changes, and perform GCP audits.

Sally Digby
Senior Document Specialist, CHUGAI PHARMACEUTICAL CO LTD

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Has held various positions with Glaxo over 22 year, mainly working on the development of the CTMS system. Was also in charge of the archiving for the Clinical UK Division.

Then moved to GE Healthcare as a Principle CTA assisting Project Managers with the setup and management of the global studies.

I am now currently working at Chugai Pharma Europe as a Senior Document Specialist primarily assisting Project Managers with the documentation for their studies and working with Head Quarters in Japan on the implementation of our eTMF.

Keith Dorricott

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Keith Dorricott is Director, Dorricott Metrics &Process Improvement Ltd. and an Ambassador for the Metrics Champion Consortium (MCC). He has a background in manufacturing from Kodak Ltd. and has worked in quality, metrics, process improvement and operational roles over 11 years for two major CROs. He is a Master Black Belt in Lean Sigma quality and process improvement techniques and is an expert in root cause analysis developing a novel approach for clinical trials. He speaks regularly at conferences such as DIA on various topics and runs a number of different metric work groups for the MCC such as Vendor Oversight, Data Management / Biostatistics, Trial Master File, Site Selection and facilitates the Centralised Monitoring workgroup. He can be contacted via keith@dorricottmpi.com.

Martina Duevel
Senior Global Clinical Project Manager, BAYER PHARMACEUTICALS

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Martina Duevel has almost 20 years of pharma experience. In her current role as Systems Excellence Project Leader at Bayer she is responsible for eTMF Innovation and its integration into the R&D system landscape and involved in other projects driving digitization. In 2015 she lead the implementation of Bayer’s eTMF and subsequently headed the maturation program.

Martina has started her Industry career in Clinical Quality Assurance where she worked as an auditor for studies, vendors, and systems, as trainer of auditors and as internal GCP consultant for process changes, inspections, and SOP development. In 2008 she moved into Clinical Project Management were she was overseeing operations for clinical development projects in oncology and diagnostic imaging from early planning through submission and inspection. In 2014/15 she has led a group of clinical trial coordinators and clinical records coordinators managing study TMFs.

As background Martina has studied Biochemistry and earned a doctorate (Dr. rer. nat) from Free University Berlin and worked in several research institutions were she gained her first GxP experience. She is a certified Project Manager as well.

In her spare time she enjoys spending time with her family, singing in a choir, and gardening.

Barbara Hepworth-Jones
Director, Clinical Development Regulations and Advocacy, GLAXOSMITHKLINE

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Barbara Hepworth-Jones started in clinical research over 25 years ago, as a clinical trial monitor and study manager, before moving in to GCP training and quality, and inspection support. She has worked for several large pharmaceutical companies, most recently Roche and GlaxoSmithKline. Her current role is Director of Clinical Development Regulations and Advocacy within global Clinical Operations at GSK. This encompasses regulatory intelligence and its application to clinical research processes. She leads teams developing written standards and delivering GCP and inspection readiness training. Barbara is also an honorary lecturer at Kings College London.

Karen Hue

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Karen graduated with a B.Sc. in Applied Biology specialising in pharmacology followed later on with a diploma in total quality management. Her career started in toxicology in preclinical research followed by a short spell working in transplantation in Addenbrooke’s and Papworth Hospitals in Cambridge where she ran an investigator-led clinical trial focussing on population pharmacokinetics on a popular anti-rejection therapy. In 1991 she made the move to SmithKline Beecham in the Regulatory Compliance department and covered all types of auditing in clinical trials, including working on one of the first eCRFs. This led to a move to ADAMAS consulting and time spent covering auditing, inspections and gap analysis for many clients including CSV and of course the year 2000 projects. During this time Karen was a member of the RQA professional teaching team on the CSV courses and is a Fellow in RQA (FRQA). After leaving ADAMAS Karen became a consultant again focussing on CSV activities, inspection readiness and hosting as well as many gap analysis. In 2013 she went back to full-time employment in Optum Lifesciences and worked in the late phase and health economics area. After Optum Lifesciences was acquired by Mapi, Karen moved to Intercept Pharmaceuticals, a biotech company specialising in liver disease and then to Aimmune Therapeutics Inc, a company developing treatments for food allergies using biologic product candidates and a characterized oral desensitization immunotherapy (CODIT™) approach. During her career to-date, she has been involved in inspections from the FDA, Health Canada, the MHRA, Health Products Regulatory Authority (formerly the Irish Medicines Board) and the EMA, both for GCP and GvPV.

Bodo Lutz
Clinical Risk Management and Data Integrity, NOVARTIS CORPORATION

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Dr. Bodo Lutz is a trained environmental engineer and biologist by education. He received his Ph.D. from the Technical University of Munich, Germany.

Dr. Lutz is an assigned GCP/GcLP Data Integrity Officer for clinical development and as Clinical Quality Risk Manager is responsible for the audit program as part of the vendor and investigational site management process and for the internal self-inspection program related to the development of biopharmaceutical products within the global clinical Quality Assurance department.

Prior to this he held several positions in clinical quality assurance and management at CROs and biotech, medical device and pharmaceutical companies where he also conducted audits on internal processes and at service providers and investigational sites, and he provided consultancy to improve the cooperation of business partners in clinical research.

Before joining the pharmaceutical industry he worked in several scientific programs — e.g., HIV-infection and AIDS therapies improvements and human cancer research — and performed experimental studies to investigate degradation processes of genetically modified DNA and protein after ingestion.

Angelika Masuch
Head of Inspection Management, MERCK KGAA

Birthe Emilie Neilsen, Principal QA Specialist, LEO PHARMA

Birthe Nielsen
Associate Director, GCP QA, GENMAB

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Birthe has a background as MSc. in Pharmacy and has worked in the pharmaceutical industry for more than 25 years. She started her carreer as a research scientist working with development and validation of bio-analytical assays, but moved into the clinical research area in 1992, working with small and mid-size Danish Biotech and Pharma companies.

Since 1994 Birthe has been working as an auditor in the GCP, GLP, IT and Pharmacovigilance area and has in addition hosted local as well as FDA, MHRA and PMDA Inspections.

Birthe is currently a board member in the Danish Quality Group, DKG and has been active in the group since she joined the Quality Assurance work. In addition Birthe is member of the EF GCP Audit Working Party.

Geoff Taylor
Director, Clinical Quality Assurance, EISAI

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Geoff’s has over 35 years clinical research experience, starting as a CRA long before GCP was invented. For 15 years Geoff held Clinical Operations roles for Ciba-Geigy and Warner Lambert Parke-Davis. He then spent 10 years with PPD’s Quality Management group, including the period of the global introduction of the original ICH GCP. He performed multiple site and vendor audits across Europe and beyond, working on projects with many of the largest pharma companies. In 2003 he moved back “in-house”, first with Novartis and then, for the past 11 years, with Eisai as Director, Clinical Quality Assurance. In this role he manages all CQA activities across Europe, with additional interests in India and the Asia-Pacific region. He has introduced risk based concepts to the QA group and manages Quality Agreements with Eisai’s CRO partners. He is currently working to implement the new requirements of ICH GCP(R2) at Eisai.