Faculty – 3rd European Clinical Trials Inspection Readiness Summit

Dorte Frejwald Christiansen
Principal Consultant, NNIT

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Dorte Frejwald Christiansen is working as Principal Consultant at NNIT A/S, where her main focus is on the Trial Master File, both seen from technical and process perspectives. Dorte has several years of hands-on experience with trial master files and has gained her process insight from working in trial management on large multinational trials. Dorte has a broad project experience, working both with TMF process optimisation, change management and eTMF system implementation. Furthermore, Dorte is involved in the TMF Reference Model working group, Inspection Readiness. Supplementing her process knowledge, Dorte also has hands-on experience with several eTMF systems and takes a keen interest in bridging the business requirements with the supporting IT system.

Karen Edelmann-Stergiou
Global Senior Inspection and Regulatory Manager, BOEHRINGER INGELHEIM

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Karen holds currently a position of Global Senior Inspection and Regulatory Manager by Boehringer Ingelheim Pharma GmbH. From 2008, when she joined Boehringer Ingelheim, she gained extensive experience in managing global quality in clinical trials, with increasing responsibilities in clinical development projects. She established and led GCP Quality Assurance unit for Bioanalytics, Biomarker and Pharmacogenetic Laboratories, and became an expert for Translational Medicine and Pharmacovigilance. Before joining Boehringer Ingelheim, she held the positions in Clinical research Organization and in pharma. Karen holds a master degree in Veterinary Medicine.

Celia Gibson, Senior QA Manager, ZIGZAG ASSOCIATES

Celia Gibson
GCP Quality Assurance Manager, RENEURON

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Celia Gibson was born in South Africa, where she gained her bachelor’s and post-graduate degrees and worked until 15 years ago, when she moved to England. One of her jobs prior to working in the Pharmaceutical Industry was in a risk management company where she was responsible for the ISO 9001 steering committee and auditing. She has 20 years of industry experience, which has included several operational roles in small and large pharma as well as in a CRO. She has been involved GCP auditing and compliance for the last 12 years in a variety of companies. She has had various responsibilities in numerous MHRA GCP inspections, some FDA inspections, and including numerous inspection readiness exercises.

Franck Gressier
Head R&D Clinical QA, PIERRE FABRE

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Franck Gressier holds Master’s degrees in Biochemistry as well as in Pharmacology and Biology of Ageing.

He began his career in 1995 at Sanofi Nutrition as an assistant of project manager. From 1996 to 2004, he held the position of Clinical Research Associate at Innovex, Quintiles and then in the French subsidiary of Boehringer Ingelheim. In 2004, he joined the Clinical Quality structure within Boehringer Ingelheim before moving to Sanofi Pasteur from 2008 to 2015, as a Clinical Quality Manager where he had two one-year assignments at Sanofi Pasteur’s Asia (Singapore) subsidiary to ensure the development of Vaccines Clinical Quality Assurance activities in the Asia / Pacific region.

Moving to Pierre Fabre Lab., he is now Head of Clinical Quality Assurance Dpt.

Karen Hue
Quality Assurance Associate Director — Europe, AIMMUNE THERAPEUTICS

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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.

Maria Nymann Jensen
Competency Development Professional, NOVO NORDISK

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Maria Nymann Jensen works as Competency Development Professional within Clinical Operations at Novo Nordisk A/S. She started in Novo Nordisk as Clinical Trial Administrator in 2008 and transferred to her current position in 2012.

Previously, Maria has been involved in two TMF pilot- and optimisation projects and has also taken part in regulatory sponsor inspections from EMA and FDA.

Currently, Maria works full-time with the TMF and is responsible for the TMF support for the global organisation. This includes training and support of the global TMF super- and end-users. Further she takes actively part in audits and inspections.

Before joining Novo Nordisk, Maria was working in the Consulting Engineering industry – also with filing and archiving – and totally Maria has approx. 25 years’ experience with document management and retention.
Maria’s educational background is office clerk and bi-lingual correspondent.

Louise Mawer

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Louise Mawer, Director, Mirabilitas Ltd, is a GxP quality assurance auditor and trainer, with over twenty years’ experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and, more recently, Good Pharmacovigilance Practice (GVP).

A former UK Inspector for GCP and GLP, Louise spent seven years with the Medicines and Healthcare products Regulatory Agency (MHRA), before returning to the pharmaceutical industry in 2011.

She has worked with regulators, academia and the non-commercial research sector, contract research organisations (for GCP, GLP and GVP), biotech and pharmaceutical companies providing quality management systems support.

Lively, outgoing, enthusiastic and colourful, she is far too enthusiastic about 1980’s Rock music, a confirmed member of Pottermore and lives in Yorkshire… Sometimes.

Kathleen Meely
Senior GCP Inspector, MHRA

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Kath Meely joined the MHRA in July 2005 as a Good Clinical Practice Inspector. Since joining the inspectorate, she has been promoted to Senior GCP Inspector in 2008. Whilst at the Agency, she has been involved in performing a variety of National, as well as EMA inspections. Kath attends the EMA GCP IWG meetings and has sat on EMA sub-groups with respect to CHMP-GCP assessment inspection findings and the benefit-risk balance, as well as eSource/eSystems sub-group. She is currently involved in the drafting group for the guidance document ‘Risk proportionate approaches in clinical trials’ being developed in relation to the new Clinical Trials Regulation. Kath has presented at a number of the MHRA symposia over the years as well as other external meetings. Kath studied Pharmacology at Liverpool University and has over 13 years of experience in clinical research within the pharmaceutical industry, holding positions in monitoring and Project Management, before joining the MHRA.

Birthe Emilie Neilsen, Principal QA Specialist, LEO PHARMA

Birthe Emilie Nielsen
Senior Principal QA Auditor, LEO PHARMA

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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. Birthe has been employed as Principal Quality Specialist with LEO-Pharma since 2010, and is based in Copenhagen.

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 EMEA KNOWLEDGE CENTRE

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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.

Nina Beck Toubro
Quality Assurance Manager, PHARMACOSMOS

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Nina Beck Toubro has been working within the field of GCP since 1994, first in hospital settings and in 1997 moved to the pharmaceutical industry, and has since then been with different CRO companies, Nycomed/Takeda, Ferring and currently working as a QA Director at Pharmacosmos in Denmark.

In 2008 she became an ISO certified auditor and has since then been auditing different aspects GCP and Pharmacovigilance processes. Over the years she has taken part in several authority inspections.

Pramod Wable
Associate Director, Inspection Management Lead, Medical Quality Assurance, PFIZER UK

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Pramod Wable is Manager, QA GCP/GLP at Daiichi Sankyo Development, Gerrards Cross, UK. He has been working in clinical quality assurance for past eight years. Pramod holds a bachelor’s degree in pharmacy from University of Pune, India and a master’s in pharmaceutical science from Kingston University, UK. Pramod has published articles within index journals and conferences on different subjects relevant to GCP.

Pramod is a trained Six Sigma Black Belt and is currently doing his doctoral research on quality management systems in GCP in association with the University of Florida.

Julia Waring
Document Manager, Clinical Operations, INTERCEPT PHARMA EUROPE

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Julia Waring is Document Manager/Archivist at Intercept Pharmaceuticals Ltd.

Her responsibilities include TMF Inspection Readiness and working with study teams to develop meaningful TMF metrics.

She has over 25 years’ experience in clinical trials administration and also in drug safety

Michele Weitz
Director, GCP Compliance Operations, CLOVIS ONCOLOGY, INC.

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Michele Weitz has more than 20 years of experience in drug and device development, and has recently joined Clovis Oncology, located in San Francisco, CA, as Director of GCP Compliance Operations. In this role at Clovis, and with previous employers including Roche and FibroGen, she has been tasked with fostering and promoting a GCP-compliant environment through the development and management of a quality-focused infrastructure that includes: standard operating procedures, GCP process evaluations, training, compliance advice, the review of clinical documents, and responses to inspections and audits. She has extensive experience preparing sponsor companies and sites for regulatory inspections, and has successfully led both “front room” and “back room” inspection activities — including being the main point of contact with the FDA Investigator during inspection. She is a Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP), and was part of the first group of ACRP-Certified Clinical Research Associates (CCRA) to achieve 10-year certification status. She began her career in the laboratory performing discovery research, then transitioned into clinical research, where she found her calling. She has held positions as a Site Monitor, International Clinical Auditor, and Training Manager; has been head of several clinical quality assurance groups; and has consulted for more than 20 industry clients. Her professional passions are employee motivation and growth, program development, research ethics, and innovative approaches to quality management.