Clinical & Regulatory Operational Excellence Forum
- Executive Director; Global Clinical Trial Operation
- Merck Sharp & Dohme, Netherlands
I started my journey in Clinical operation 18 years ago in MSD. From CRA to Clinical Research Director, I worked in most therapeutics areas, like CV, DM, Vaccines, Immunooncology and ID. In 2012 I expanded my experience working with all EMEA region with increased responsibilities in delivering across a diverse and fast changing portfolio. I have managed several transformations of the organization and worked closely with external partners and CROs. I enjoy change management and helping others through changes , while still targeting excellence in what we do: advancing new drugs development with speed and quality because we can make a difference in millions of people lives.
Hans van Bruggen, MSc
- Qdossier, A Celegence Company, Netherlands
Hans van Bruggen has been involved in the transition form paper to digitalized paper to data exchange to data sharing. Key areas of expertise: lean regulatory documents, data capture right-first-time, and reuse rather then recreate or copy. Hans has an MSc in Pharmaceutical Medicine from the University of Surrey and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. Using that scientific background he brings together people, processes and tools, leading to lean interdisciplinary and international processes.
Michael Horn, PharmD
- Head of Division Licensing 1
- Bundesinstitut für Arzneimittel und Medizinprodukte, Germany
Dr. Michael Horn studied pharmacy in Hamburg and received a PhD in 1996 in Marburg an der Lahn. Since 1997 he is employee at BfArM and from Dec. 2002 to July 2005 as head of the units “renewals”, Following the reorganisation of the BfArM in July 2005 Michael Horn was appointed as head of the units “simplified procedures”. Since 2007 he is Head of Devision Licensing 1 and responsible e.g. for validation, maintenance of marketing authorisations, parallel trade, drug shortages and drug database management. Michael Horn is responsible for the functional development of a number of national online-portal-solutions, e.g. for the sunset-clause or variations. Since 2000 Michael Horn is assistant professor at the University of Bonn.
Karen Roy, MPharm
- Chief Strategy Officer
- Phlexglobal, United Kingdom
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as CSO, she leads all Phlexglobal partnering across the clinical space, has key strategic input into the development of our eTMF, PhlexEview and serves as a Board member. Karen was also responsible for the development of the TMF Reference Model, an industry driven initiative to standardize the content, naming and structure of Trial Master Files. She still chairs the management of the Model – a Model used by the vast majority of Pharmaceutical companies and CROs.
Peter Schueler, DrMed, MD
- Senior Vice President, Drug Development Neurosciences
- ICON plc (CRO), Germany
Peter Schüler, MD, serves as Senior Vice President, Drug Development Neurosciences, for ICON plc (Germany). He joined ICON as Vice President for Medical Affairs and Drug Safety for Europe, and has authored an eBook about drug development methodology. Dr. Schüler is Head Lecturer for Pharmaceutical Medicine as member of the Scientific Course Committee at the University of Duisburg-Essen (Germany), and invited lecturer at the European Center of Pharmaceutical Medicine at the University of Basel (Switzerland). He is board certified in Neurology in Germany and in Pharmaceutical Medicine at the Swiss Medical Association.
- Head of Quality Assurance
- Phlexglobal Ltd, United Kingdom
Eldin began his records management career in 1986 at Glaxo. He held a variety of information and records management positions of increasing seniority, which continued following his move to Pfizer in 1993. His experience spans most areas of information and records management. In 2004, Eldin established Rammell Consulting, a management consultancy specialising in the provision of records management support, primarily to the pharmaceutical and biotech industries. He is a recognized expert globally in the area of trial master file management, completing over 30 TMF-related consulting projects and being a Steering Committee member of the TMF Reference Model Project.
- Project Manager Companion Diagnostics (CDx)
- TÜV Rheinland , Germany
Dr. Frank Breitenbücher is working as Project Manager Companion Diagnostics at TÜV Rheinland LGA Products GmbH in Cologne, Germany. He holds a PhD in Molecular Genetics and has more than 15 years of experience in biomedical/molecular oncology research focusing on resistance mechanisms to targeted therapies in leukemia and solid tumors. In addition, he developed highly sensitive diagnostic assays to detect oncogenic mutations in the blood of cancer patients. He worked as a research scientist at the University Hospitals Mainz and Essen, Germany and the UCSF Helen Diller Comprehensive Cancer Center in San Francisco, USA.
- Snr Manager Sumission Management
- Amgen Ltd, United Kingdom
I started working at Amgen 16 years ago in the Clinical Quality Assurance and Clinical Education and Training Department. Over the years, I have performed various roles from PA to the head of the CQA department to planning the audit schedule and providing new starters to the UK office with IT Induction training. I moved to Regulatory Operations in 2009 taking on a publishing role focused mostly on CTA Applications. I now manage a team of publishers supporting EU, Ex-EU and Intercontinental regions on all application types from EU MAAs to Clinical Trial Applications. Clinical Transparency and the Clinical Trials Regulation are two areas of my role that really interest me and I hope to focus on moving forward.
- Director, Global Clinical Trial Operations
- Merck & Co., Inc., United States
Laura has a unique role which blends internal and external components. Externally, she is a member of TransCelerate BioPharma's Oversight Committee. This Committee is the governing body for decisions related to the clinical portion of the portfolio, including project sponsorship. Laura draws on her experience as an Operations Director for a busy therapeutic area and as head of a performance and analytics group to provide this perspective. Internally, she has responsibility for driving engagement, and facilitating adoption or internalization of TransCelerate solutions in alignment with Merck’s objectives. Finally, watches for opportunities to match innovative approaches to potential process improvement initiatives or other areas of focus.
- Cunesoft, Germany
Julia Stingl, DrMed
- Vice President and Head of Research
- Bfarm, Germany
Julia C Stingl (formerly Kirchheiner) M.D. is professor of translational pharmacology at the University Bonn Medical Faculty and head of the research division of the Federal Institute of Drugs and Medical Devices. Since 2014 she is Vice President of the institute. Her research mostly focuses on understanding individual variability in beneficial and adverse effects of xenobiotics and the translation of this knowledge in a patient-tailored drug therapy. She developed dose adjustments based on pharmacogenetic polymorphisms promoting the way of pharmacogenetics from bench to bedside. She has more than 180 pubmed-listed publications, and an H-index of 41 (ISI web of science, October 2016).
Valdo Arnera, DrMed, MD
- Scientific Advisor
- Clario, Switzerland
An MD by training, Valdo has 30+ years of experience in the pharma industry. After having practiced medicine, he started in the industry as a clinical pharmacologist at Ciba-Geigy. He then founded the 1st European Central Clinical Lab for clinical trials, SciCor (now Covance Central Lab) in 1992. He joined PHT in 2000, and founded its European affiliate in 2001. PHT was the 1st European modern ePRO provider and Dr Arnera is seen as one of the world pioneers in the ePRO/eCOA field. ERT acquired PHT in 2015. Dr. Arnera currently serves as a Scientific Advisor and the General Manager of ERT Geneva. ERT develops products that facilitate data capture in clinical trials, using mobile and web technologies to collect data from patients and doctors.
- Risk-Based Monitoring Project Leader
- Sanofi-aventis, France
Soazig Chevalier is the Project Leader in charge of the implementation of Risk-Based Monitoring within sanofi. After a Master of Science degree in Statistics in 2000, she graduated from the University of Paris VI with a one-year specialization in statistics applied to medicine. She joined Sanofi R&D in 2001 as a statistician working within several therapeutic areas. She had been a statistician project leader for more than 10 years. She was fully involved on the submission activities of several compounds in Metabolic Disorders, Oncology and Diabetes. She was also a chairman to the Toujeo Data Mining Committee within sanofi, leading the statistical activities to support new studies, unmet needs, and scientific communication
- Head of Innovation & CTO
- Kinapse Ltd., United Kingdom
John has 30 years’ experience in the biopharma industry. He has held global leadership positions in R&D IT, IT Shared Services and Chief Technology Officer roles, and been responsible for the delivery of major technology enabled organisational transformations in Regulatory, Pharmacovigilance, Clinical, Medical Affairs, IT and Global Business Services. These solutions have included Content Management, Publishing, Medical information, Safety, CTMS, Business Intelligence, Business Process Management, NLP, NLG, Machine Learning and AI. John has worked for and with many of the Top biopharma companies throughout his career and holds a BSc in Chemistry and an MBA from Warwick Business School.
- Senior Manager
- Jazz Pharmaceuticals, United Kingdom
Rosalynd Cole is a Senior Manager in Jazz Pharmaceuticals’ Project Management Office in the UK. With a background in pharmaceutical Regulatory Affairs established by working in the trifecta of big pharma, generics and a leading consultancy, Roz has developed a range of expertise across various filing requirements and compliance obligations, specialising in Clinical Data Transparency and the EMA’s flagship Policy 0070.
- Sr. Business Lead in Operational Business Excellence Group of Pharma Technical
- F. Hoffmann-La Roche Ltd, Switzerland
Mark Cottingham is currently working as a Senior Business Lead within the Pharma Technical Regulatory department at Roche. He has worked in the Pharma industry for over 15 years with the last 10 years in Regulatory. He is currently implementing a RIM solution which will provide a strong framework for implementing structured authoring solutions. He likes to focus on automation to enable the business to focus on value adding activities.
Klaus Menges, DrMed
- Project Manager
- BfArM, Germany
Klaus Menges is currently leading a BfArM project replacing an old database on products by an IDMP compatible data base, contributing to the PharmNet.Bund portal, the German platform for medical products providing information to the general public, and services for pharmaceutical companies and regulators. Klaus represents BfArM in the eSubmission Change Management Board (eSub CMB) and is nominated expert in the ICH WG M8 on electronic submission.
- Chief Product Officer
- Phlexglobal, United States
Jim has nearly 30 years of experience with compliant software solutions for regulated processes in both the insurance and life sciences industries. He has held senior management positions at Intracorp (a CIGNA company), Liquent, Thomson Reuters, ePharmaSolutions, DitaExchange and Cunesoft. Following the merger of Cunesoft into Phlexglobal, Jim is now the Chief Product Officer at Phlexglobal. Jim holds a Bachelor of Science in Mathematics from The Pennsylvania State University.
Birgit Ruhfus, PhD
- Vice President, Clinical Project Management Therapeutic Area 2
- Bayer AG, Germany
Dr. Birgit Ruhfus holds a diploma in biology from the University of Bochum and a PhD in biological sciences. She started as a clinical auditor when joining Schering AG in 1997. In August 2004 she moved on to Global Regulatory Affairs in the role of a Regulatory Strategist. In July 2006, Birgit Ruhfus became head of Schering’s Global Clinical Quality Assurance function. After the merger with Bayer she was appointed as Head of GCP Study Audit Management – Europe in 2007, a role which was extended to the full global scope in 2013. In June 2015 she moved to Clinical Development Operations to become Head of Clinical Project Management for various indication areas.
Matthias Wilken, PharmD, MSc
- Head of Drug Regulatory Affairs Europe
- German Pharmaceutical Industry Association (BPI), Germany
Matthias Wilken is pharmacist by training and has been working for the German Pharmaceutical Industry Association (BPI e. V.) since 2005. He is Head of Drug Regulatory Affairs Europe and Pharmaceutical Aspects in Social Law. He studied pharmacy at the University of Münster (Germany) and holds a Master Degree in Drug Regulatory Affairs as well as a Ph.D. in Pharmacy from the University of Bonn (Germany). Before he joined BPI he worked in public pharmacies and in the pharmaceutical industry.
María Magdalena Borda
- Hoffmann-La Roche Ltd., Switzerland
Pharmaceutical professional with more than 20 years of experience in leadership, quality management systems and oversight of clinical operations and quality related activities in pharmaceutical industries (project & trials development, management and execution; budget and resources planning; metrics and processes improvements implemented; risk management; focus on best practices and quality management standards) in addition to close interaction with internal and external customers and multiple main stakeholders aside from clinical operations such as medical affairs, marketing, commercial and regulatory areas to deliver the pipeline through cross functional teams.
Romuald Braun, MS, MSc, RAC
- Managing Director
- Uanotau Gmbh, Switzerland
Braun’s 25-year career to-date has been spent across roles related to Compliance, Document Management, Content Management in the Life Sciences industry – both on the client side and in consulting, spanning delivery, sales, project and line manager roles. His experiences bridge on-premise and cloud environments, in Europe and in US. Braun holds a Master’s degree in Drug Regulatory Affairs from the University of Bonn (Germany) and his diploma in Data Technology from the Technical University (TU) Darmstadt (Germany)
Jan Breemans, MS, PMP
- eClinical Manager
- Grunenthal, Germany
Jan is in the industry for 20 years. He started his career as clinical data manager at Merck Sharp & Dohme. He is now heading up Data & Documents Operations within Grünenthal. In this position he is responsible for TMF management, clinical data management and technical data management. He is also responsible for various (e)clinical systems such as EDC and ePRO as well as systems for trial management, centralized monitoring, budget management & safety reporting. Prior to this Jan held positions in clinical data management, project management and eclinical systems management. He was also part of operational excellence and process improvement initiatives.
Dairine Dempsey, PhD, RPh
- Vice President, Strategic Regulatory Affairs
- ICON plc., Ireland
Dr. Dempsey is VP, Strategic Regulatory Affairs at ICON plc. She is a PhD pharmacist with over 15 years’ experience as a pharmaceutical regulator. She previously held senior positions in the Irish competent authority for medicines where she represented Ireland in the EU & internationally. She later worked as a pharmaceutical consultant during which time she led the establishment of Bahrain’s national regulatory agency. She is an active member of the ACRO Ethics & Regulatory Compliance Committee.
- Operation Team Leader
- CluePoints SA., Belgium
Véronique Grosjean is “Operational Team Leader” at CluePoints and “Project Leader” for the Risk-Based Monitoring implementation to several customers. Possessing a Master in Geographical Science in 1998, she graduated from the University of Louvain-la-Neuve with a one-year specialization in Environmental Science and Management. With experience over the past 17 years in the pharmaceutical industry, she has held positions as statistical programmer, SAS developer, Study and Project Manager for companies such as GSK and UCB. She joined CluePoints in 2015 and participated to the development of the Operations department at CluePoints.
Almut Holz, MSc
- Xendo Deutschland Gmbh, Germany
Almut Holz is leading the Regulatory Operations Team within Xendo since 2016. She supervises Regulatory Affairs projects for Xendo and its clients with a focus on regulatory data management, regulatory intelligence and electronic submissions. Before joining Xendo in 2013, she worked for Bausch & Lomb’s Regulatory Affairs department. She has graduated in Economics (M.Sc.) at Humboldt University Berlin (Germany) and holds a Bachelor Degree in Creative Writing from the Bern University of Arts (Switzerland).
- AGES, Austria
Since 2008 Sonja Königshofer works in the department Marketing Authorisation and Lifecycle Management at the Austrian Agency for Health and Food Safety (AGES). She was supporting the development of a new national database and responsible for data migration. Now her focus is on the implementation of IDPM standards in this database.
Marjolijn van Lier
- eCTDconsultancy B.V., Netherlands
Marjolijn van Lier, got her bachelor degree in Biomedical sciences at the University of Utrecht. In 2006 she finished her PhD in Biochemistry and Haematology. During this PhD she won the Young Investigator Award from the journal Thrombosis and Haemostasis. After her PhD she started working at Genzyme Europe B.V. at the Regulatory Affairs department where she became a specialist in the field of clinical trials. After 4 years she moved to MSD in Oss and in 2013 she started as a Senior Regulatory Affairs Officer at Mylan B.V.. As of September 2017 Marjolijn will be working at eCTD consultancy as a Regulatory Affairs Scientist.
- Biostatistics - Data Sciences
- Boehringer Ingelheim Pharma GmbH & Co. KG , Germany
Medical documentation at Boehringer Ingelheim for 19 years Experiences as Data Manager in clinical trials in Oncology , Pulmonology, HIV, CNS Central Monitor since September 2016.
- Head of Delivery Management
- Amplexor, Slovenia
Tomaž Kobe has 10+ years of experience in delivering IT solutions to clients in the Life Sciences industry, with a particular focus in RIM and Submission Management. He carries deep understanding of the challenges involved in the implementation of complex solutions and applies this in his advice to clients, offering pragmatic guidance to reduce operational costs and improve employee effectiveness while maintaining regulatory compliance. Tomaž has been recognised throughout career for his adaptability, innovation and strong time management skills whilst adhering to very high standards. As the Head of Delivery Management in AMPLEXOR Life Sciences, he is responsible for delivering business solutions in all areas for life sciences industry.
- Xendo Deutschland GmbH, Germany
Hanne Storgaard Schultz
- Assoc. Dir, Clinical Research
- MSD Danmark ApS, Denmark
Hanne graduated as a Doctor of Veterinary Medicine from The Royal Veterinary and Agricultural University in Copenhagen in 1992. After a few years in an animal university hospital joined the Danish Medicines Agency as a Sr. Veterinary Assessor. In 2002 joined a local CRO as a CRA, CRA team-lead and finally as manager of the Clinical Operations Dep. In 2006 joined Schering-Plough as CRA and Clinical Project Manager. In 2010 Clinical Quality Manager for MSD Denmark/Norway. In 2016 Regional Clinical Quality Manager for Clinical Project Managers in EUMEA. In 2017 also Regional Clinical Quality Manager for MSD Nordic Countries. Has in parallel been leading many national GCP courses in the Danish Association of the Pharmaceutical Industry.
Emma W Mears
- Senior Clinical Document Manager
- Vectura Group plc, United Kingdom
Eric Little, PhD
- Chief Data Officer
- Osthus Inc., United States
Eric Little is Chief Data Officer with Osthus Inc., working on data science, analytics and scalable integration standards for pharmaceutical, biotech and related companies. Dr. Little is a recognized expert in semantic technology, analytics applications and formal ontology and has designed and helped to implement semantic technologies and analytics for use in various applied domains.