Deborah Driscoll has twenty plus years of experience in academia and the pharmaceutical industry. She began her career working as a research technician at the Boston VA Medical Center and Boston University. She began her career in industry at Roche as a pharmacology research scientist working in pre‐clinical neuroscience research. She transitioned from the laboratory to clinical working as a clinical research associate in oncology and HIV research. Deborah spent several years at Pfizer working in Research and Development, including the role of Vice President of Quality Assurance.
Deborah joined Merck as the head of Quality Assurance in July 2015, assuming responsibilities for GCP, GLP, GPvP, CGMP and Animal Welfare oversight within Merck Research Laboratories. Deborah assumed the leadership role for TransCelerate BioPharma Inc. Clinical Quality Management System Team (years 2014‐2017) working with member companies to develop and advance a clinical quality framework to enable consistent and timely delivery of reliable data that may be used by an organisation, its partners, regulators, clinicians, and patients to make informed decisions. Deborah holds a B.S. in Animal Science and an M.S. in Biology.
Monika M. Pietrek is a medical doctor and epidemiologist with more than 30 years of experience in international drug development and post-authorisation safety monitoring/risk management. She has worked in clinical care, pharmaceutical and CRO industries as well as at the German regulatory agency responsible for vaccines and biologics.
Dr. Pietrek is the founder of Pietrek Associates GmbH, an independent consultancy firm to the pharmaceutical, biotechnology and medical device industry, focussing on B/R product assessment, PV system performance and organisational excellence.
Since 2009 the PA team has conducted more than 600 PV/GCP audits and mock inspections world-wide. In addition, the PA consultants contributed their expertise to a multitude of quality initiatives of different scale and focus, ranging from organisational and process enhancements to implementation of new quality systems.
Dr. Pietrek has been actively involved in the development of the European PV legislation and published on best practices for pharmacovigilance. She has presented about PV concepts, system performance, particularly addressing operational hybrid models, at numerous international conferences.
Vice President and Global Head, Quality Assurance
Ms. Meeker-O’Connell is the Global Head, Quality Assurance (QA) at IQVIA. Ann has more than 20 years of clinical and biomedical research experience in government, academia and industry. This included four years at the U.S. Food & Drug Administration, ultimately serving as the Director of the Division of GCP Compliance within the Center for Drug Evaluation and Research. Additionally, she has held QA roles at Johnson & Johnson, Amgen, Genentech, and Pfizer. Ann is a recognised industry thought leader for clinical quality, having developed key FDA guidance related to trial oversight and led cross-industry initiatives on clinical Quality by Design through and clinical Quality Management Systems. She also serves on the Board of Directors for the Association for the Accreditation of Human Research Protection Programs.
Prior to IQVIA, Ann served as the Global Head, Consumer BioResearch Quality and Compliance at Johnson & Johnson. Ann began her career in pharmaceutical development designing clinical trials for the National Cancer Institute.
Ann holds a bachelor’s degree in biological anthropology and anatomy and a master’s degree in pharmacology from Duke University, where she was a Howard Hughes Fellow and an NIH Integrated Toxicology fellow. She also holds certifications as an ISO 31000 risk management professional and trainer.
F.Hoffmann-La Roche AG
Carla is the Global Head of Quality in Product Development in F.Hoffmann-La Roche AG, responsible for global GCP and GVP quality management, located in Basel, Switzerland. She has more than 20 years of leadership experience in global Pharma with growing responsibilities in respective Pharma including Novartis, Otsuka, Procter & Gamble and Dupont/Merck in all areas of quality management across pharmaceutical research and development, manufacturing and market surveillance.
Carla received a degree in Pharmaceutical Science and holds a PhD from the Friedrich-Wilhelm University of Bonn, Germany.
Carla is a strategic leader with a passion for protecting and creating value, improving the quality of lives for patients and in the workplace for people.