Faculty – 9th Proactive GCP Compliance

Katie Alberta
Global Head, QA, GLP, GCP, GPvP and PDMA, ALKERMES

view speaker profile

Katie transitioned from a career in critical care nursing into the pharmaceutical and biotech industry in the 1990s. Katie spent her career developing global Quality Assurance Programs, Systems and Teams to support global GxPs. Katie has worked in the wide spectrum of start ups to global commercial pharma corporations from Synergen, Amgen, Cephalon, Teva and now Alkermes. Katie has also started a consulting firm Coastal Compliance, LLC, whereby she assisted pharma companies in corporate compliance investigations and due diligence activities. Currently Katie is the Global Head of CQA for GLP, GCP, GPvP and PDMA standards at Alkermes, Inc in Boston, MA.

Catherine Arthey

view speaker profile

Catherine Arthey founded DArcy Consulting, a boutique compliance consulting company, in 2014 to focus on R&D / Clinical Compliance for Pharma/ Biotech companies. Catherine is a passionate not only about compliance but about making organizations efficient. Having worked as a consultant in R&D/ Clinical compliance for most of her career, first with PA Consulting Group and more recently with Deloitte, Catherine has come to realize that Proactive Compliance is not only common sense but is a key enabler to better business performance. The benefits of proactive compliance are easily demonstrable and if communicated in the right way can switch the focus from ‘are we being compliant’ to ‘how well are we performing’. This is what a culture of compliance means and the vision of DArcy Consulting is to build this vision for our R&D / Clinical clients. DArcy Consulting is helping a number of Companies build a culture of compliance within their Clinical Operations and beyond Clinical. Leveraging a suite of frameworks, methodologies and tools, DArcy Consulting can rapidly determine areas where compliance is at risk and work with teams to put in place the requirements for compliant high performance functions.

Richard Azueta
Head, GxP Audit, NOVARTIS

view speaker profile

Rich Azueta has over 24 years of experience in clinical research and the pharmaceutical industry. Rich started working as a clinical research coordinator at the Bronx VA/Mt. Sinai Medical Center first in psychiatry (including imaging) and then in Ophthalmology. He moved onto Forest Laboratories as a Clinical Research Associate where he monitored Phase 1 and Phase 2 studies. Following that Rich joined Pfizer as a Clinical Study Manager of global Phase 3 and Phase 4 studies. Rich made the switch to Quality Assurance by moving to Pfizer’s corporate audit group which had oversight of global GCP and PV targets. Rich continued as a PV auditor at Schering-Plough before moving to Novartis Oncology as a Quality Manager. He has progressed into leadership roles at Novartis both as head of Novartis Oncology’s QA organization to his current role as Head of GxP Audit, Novartis Group Compliance and Audit where he is responsible for internal GxP audits across the Novartis Group network. Rich did his undergraduate work in Psychology at Hunter College. He holds an MS in Quality Assurance and Regulatory Affairs from Temple University and an MBA from Baruch College/Mt. Sinai School of Medicine. Rich is a Certified Quality Auditor by the American Society for Quality and a Registered Quality Assurance Professional (GCP) by the Society of Quality Assurance.

Peggy J. Berry, MBA, RAC

view speaker profile

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

Nancy Bitters
Inspection Management Lead, Biopharma | Global Research and Development Quality, EMD SERONO

view speaker profile

Nancy Bitters has more than 20 years of experience in the pharmaceutical industry. Nancy is currently employed by EMD Serono Inc.

She is an Inspection Management Lead for EMD Serono.

In her role within the Research & Development Quality Assurance Department, Nancy oversees and/or facilitates Good Clinical Practice (GCP) and Pharmacovigilance (PV) inspections worldwide for EMD Serono/Merck KGaA. This includes GCP inspections of clinical investigator sites worldwide, GCP and/or PV sponsor inspections of EMD Serono and inspections related to GCP components of vendors used by EMD Serono. Nancy has overseen and/or facilitated over 100 inspections in her career.

Nancy has been at EMD Serono as the GCP Inspection Management Lead since February 2017. Previously, Nancy was an Inspection Management Lead at Pfizer.

Nancy has a B.S. in microbiology from the University of Connecticut and an MBA from the University of New Haven.

Denise Calaprice, Ph.D.
Senior Consultant, THE AVOCA GROUP

view speaker profile

Dr. Denise Calaprice is a Senior Consultant with The Avoca Group. After receiving her Bachelor’s degree in Biology from Harvard University and her MS and PhD from Princeton, Dr. Calaprice entered the world of clinical research as an NIH fellow at Columbia University’s College of Physicians and Surgeons in 1994. During the subsequent decades she acquired extensive experience in directing clinical research programs, as well as in developing innovative development and operational strategies, in a variety of settings including academia, government, a CRO, a large global pharmaceutical company, a small biotechnology company.

In her 14 years with The Avoca Group, Dr. Calaprice has provided support to pharmaceutical companies, clinical service providers, university investigators, industry consortia, and government agencies engaged in clinical research, with a focus on partnering strategies, relationship management, metric development, protocol quality, patient engagement, risk management, “lean” development strategies, and business data analysis.Among other accomplishments, she has developed a novel quality metrics taxonomy that has been adopted by top Pharma organizations, as well as leading development of the Avoca Patient Engagement Playbook.

Jennifer Clark
Director, Quality Systems, FERRING PHARMACEUTICALS, INC.

Teresa DeVincentis
Senior Director, Clinical Quality Management, CELGENE

view speaker profile

Teresa has almost 30 years of experience working across as a consultant and employee in small, medium and large biotech, pharmaceutical, medical device, and consumer products companies. She has had the pleasure of working with colleagues around the world in R&D, Manufacturing and Medical Affairs functions helping them establish, improve and maintain quality systems, processes, and technologies.

Teresa is currently at Celgene as a Sr. Director Quality Management in Global Clinical R&D Operations. In this role, she is responsible for establishing a quality management function and system through strong collaborations with clinical development and operations. Prior to this role Teresa was at Daiichi Sankyo as in Medical Affairs helping support Global Operations, including establishing global cross-functional policies, procedures and systems across Phase I – IV trials and Investigator Initiated Trials.

Teresa holds a B.S. degree in Biology from the College of St. Elizabeth in Convent Station, NJ. Teresa is an active member of Metrics Champion Consortium working groups and American Society of Quality through whom she is pursuing her Manager of Quality & Organizational Excellence Certification.

Betsy Fallen
Regulatory and Clinical Process Consultant, BAFALLEN CONSULTING, LLC

view speaker profile

Ms. Fallen is an authority on the business processes and associated use of information technology in drug development. A passionate advocate for moving life sciences business online, Betsy is an expert on IT in regulatory and clinical operations, data management, and ancillary supply chains, among other areas.

Betsy recently left Merck after two decades of outstanding contributions. She has participated in many industry initiatives and SIACs, including the TMF Reference Model, Chair of the SAFE-BioPharma Global Business and Regulatory Group, PhRMA Electronic Regulatory Submissions Working Group, NCI caBIG CRIX and the IRISS Steering Committee Chair.

Currently, Betsy is an independent consultant providing expertise to industry. She is an active member of DIA and frequently participates in conferences and meetings as program chair, speaker or session chair. She has also presented globally on diverse topics in clinical and regulatory areas for many conferences.

Karen Freid
Essential Document Lead, MERCK

view speaker profile

Karen has 34 years of experience in the pharmaceutical industry, in TMF and in inspection support. She worked at Schering-Plough for 25 years, leading their global, Clinical Documentation department, and supporting Regulatory Authority inspections from the TMF perspective. Since the Merck/Schering-Plough merger, Karen is an Essential Document Lead, supporting various aspects of the TMF including in/outlicensing projects, outsourced trial TMF, inspection readiness, inspection preparation, and she provides support during Regulatory Authority inspections.

Karen holds a bachelor’s degree in Biology from the University of Scranton, and a master’s degree in Biology/Business Administration from Seton Hall University.

Dan Greenwood
Senior Director, Quality Assurance, TESARO

view speaker profile

Dan has 35 years of experience in the pharmaceutical industry contributing in various roles including R&D scientific roles, R&D Management, non-GXP compliance, Sales and Marketing compliance, GCP compliance and Quality Management.

Dan is currently, Sr. Director in Global Quality for TESARO. In this role he is responsible for Global GCP, GLP and GVP Quality Assurance. Prior to his role at TESARO, Dan was a Global Head of Compliance Standards at Boehringer Ingelheim. In that role, he was responsible for the development and implementation of the global compliance strategy.

Dan holds a B.S. degree in Chemistry from State University of New York, College of Environmental Sciences and Forestry, and a M.S. degree in Chemistry from University of St. Joseph. Dan is trained in various process management approaches (Lean Six Sigma, 8 OMEGA and Process Renewal), Change Management, and CAPA, Dan was an active member of the TransCelerate Issue Management sub team and a coauthor of a DIA TRIS publication. He is currently an active member of Linking Leaders: Clinical Roundtable Network.

In his work, Dan is passionate about providing quality management guidance and support to Global Clinical Develop, Pharmacovigilance and R&D functions. He is actively engaged in the further development of quality processes including auditing, vendor selection and management, non-compliance escalation and CAPA.

Pamela Gustafson
Vice President, Clinical Research, PROTEON THERAPEUTICS, INC.

view speaker profile

Pamela Gustafson has over 25 years of experience in clinical operations and project management in the biopharmaceutical and CRO industries. The focus of Pam’s career has been in the start-up environment, working in multidisciplinary teams to develop novel products in areas of high unmet medical need. In her current position, Pam oversees the clinical team and drives the implementation, management, and reporting of all clinical trials. In collaboration with clinical quality experts, Pam and her team are responsible for implementing best practices to maintain GCP compliance in their oversight of clinical trial sites, CROs, and other vendors. Pam earned a Masters of Public (MPH) Health from Boston University, a Bachelors of Arts in Psychobiology from Wheaton College, and achieved her Project Management Professional Certification (PMP) from the Project Management Institute (PMI).

Laurie Halloran

view speaker profile

Laurie Halloran founded Halloran Consulting Group in 1998, originally operating out of an unfinished bathroom. Her time as a pediatric ICU nurse had inspired her to start a company that helps move new therapies through FDA processes to get them into the hands of patients desperately in need. By providing a strategic development team, innovative start-up companies could have access to world-class expertise at a fraction of the cost. Since its humble beginnings, Halloran has grown into a successful consultancy of like-minded experts who are dedicated to improving human health by making life science companies better at what they do.

Laurie has been named 2018 Women’s Business Enterprise Star by the Women’s Business Enterprise National Council (WBENC) and has won a 2017 Enterprising Women of the Year Award from Enterprising Women Magazine. Halloran Consulting Group was also named an Inc. 5000 Fastest Growing Company for the past three years in a row. In 2015, Laurie was honored by the Boston Business Journal as a Woman of Influence, in 2010 was selected as one of the 100 Most Inspiring People in Life Science by PharmaVoice, and in 2009, she was awarded Clinical Researcher of the Year by the New England Chapter of the Associate of Clinical Research Professionals.

Laurie lectures at Boston University Medical School and the Tufts Center for Drug Development Post-Graduate program. She has previously taught at George Washington University and Harvard University. Laurie earned a Bachelor of Science in Nursing from Russell Sage College and a Master of Science in Management from Lesley University. She is also a Prosci Certified Change Practitioner.

Paul Houri
Vice President, Head of BioResearch Quality Assurance, JOHNSON & JOHNSON

view speaker profile

Paul Houri is currently the Vice President, Head of BioResearch Quality Assurance at Johnson & Johnson.

Paul is responsible for setting the vision and strategy for BioResearch Quality Assurance, a global team focused on execution of non-regulated, GLP, GCP and PV audits and quality control activities. This includes effectively and efficiently delivering the audit program to ensure Janssen’s compliance with global, local regulatory and internal quality and compliance standards and to ensure end-to-end quality oversight. In this role, Paul partners closely with internal and external stakeholders to develop innovative quality oversight, utilizing analytics-based audits and reviews and predictive metrics to focus on key risk areas and improve efficiencies through automation in processes.

Paul brings over 20 years of experience in quality and compliance related functions to this role. He started his career with Warner-Lambert in the Good Manufacturing Practice (GMP) environment working as an Analytical Chemist and progressing to work as a Quality Engineer. Paul then joined Pfizer where he made the transition to the GCP and GVP environments, holding various positions of increasing responsibility in Quality Assurance and Compliance. Paul joined Johnson & Johnson in 2007 as the Director, Americas Regional Head for Pharmacovigilance QA and in 2008 was appointed Senior Director, Americas Regional Head for Global System Quality Assurance focused on GCP, GVP, and IT compliance. From 2012-2017, Paul served as the Vice President, Head of BioResearch Regulatory Compliance, establishing and leading the group which has delivered expert regulatory compliance capabilities, including inspection management and regulatory intelligence programs, conducting special compliance investigations, and facilitating compliance remediation activities across the Johnson & Johnson R&D organizations.

Paul earned a Bachelor of Science in Biochemistry from the University of Scranton, a Masters in Quality Engineering from Lehigh University, and a Masters in Business Administration from St. John’s University.

Karine Julien
Executive Director, Quality Assurance Therapeutic Area Head, Primary Care, MERCK

view speaker profile

Karine Julien is an Executive Director, Therapeutic Area Head, Primary Care, Merck Research Laboratories Quality Assurance, at Merck, since July 2016.

Karine is responsible for quality assurance activities for the Primary Care portfolio working closely with Clinical and Clinical Operations as the single point of contact for QA to develop and execute end to end quality strategies for the Therapeutic areas. Additionally, collaboratively within QA, Clinical and Clinical Operations this role defines overall quality assurance through understanding the programs, history as applicable and makes certain quality principles are considered and incorporated when designing new programs, risk mitigation strategies for programs underway and utilization of quality metrics including audits to inform the business of the state of quality of the programs.

Prior to joining Merck, Karine worked at Pfizer where she was a Director, Quality Assurance Lead in Primary Care within the Global Medical Quality Assurance group. There, she worked across multiple programs in the Cardiovascular and Metabolic Diseases portfolios to ensure implementation and management of quality risk strategies and provided QA strategic guidance across clinical and project teams. She also worked within the QA function to conduct Good Clinical Practice (GCP) and Pharmacovigilance (PV) audits of clinical trial investigator site, third party provider, country office and regulatory submission document audits. Her activities also included support to Regulatory Authority sponsor and site inspections, including PMDA, EMA, FDA and Health Canada inspections.

Karine holds a bachelor’s degree in Microbiology and Immunology from McGill University in Montreal, a master’s degree from University of Montreal in Biomedical Sciences and a master’s degree in Business Administration from l’École des Hautes Etudes Commerciales in Montreal.

Maryann Livolsi, Head of Clinical QA and Compliance Programs, R&D Quality Assurance and Compliance, SHIRE

Maryann Livolsi, MSN, RN, RQAP-GCP
Senior Director, R&D Quality Assurance, ACADIA PHARMACEUTICALS

view speaker profile

Accomplished leader in R&D Quality Assurance with effective management experience worked in small, mid-sized and large pharmaceutical/bio-pharmaceutical companies, in depth knowledge in clinical trial management, GXP auditing, process gap analysis, SOP development and regulatory inspections. Effectively lead process for Quality and Performance Metrics Dashboards for R&D Compliance, adjunct professor for Drexel University Clinical Pharmacology Master’s Program, presents at industry related conferences including Linking Leaders and Exl Pharma. Over 25 years of clinical research experience. Six Sigma Graduated Rutgers University with a Bachelor’s Degree in Nursing and received a Masters of Nursing Administration from University of Pennsylvania and The Wharton School.

Dawn Lundin
Director, Quality Assurance, MERCK

view speaker profile

Dawn has 23 years of experience in GLP, GMP, GCP, and GPvP operational and quality assurance roles with19 years at Merck & Co., Inc.

As a Director in Quality Assurance, Dawn is presently the QMS and Issues Management Oversight lead for Merck Research Laboratories (MRL). She provides GCP expertise and quality support to clinical development teams and is actively engaged in governance updates, audit planning, managing standards and business operations for the quality assurance group in MRL. Dawn is a core member of various process improvement initiatives in support of quality management across the portfolio of assets including RBM, Issues Management, and Clinical Quality Management initiatives. Prior to this role, Dawn has worked in GCP and GPvP auditing roles, as a supervisor in clinical supplies/GMP packaging, and as an associate scientist in the laboratory.

Dawn holds a B.S. degree from Delaware Valley University, and a M.S. degree in Quality Assurance and Regulatory Affairs from Temple University. Dawn is trained in Lean/ Six Sigma, Change Management, and holds a certificate in the Management Engagement Program from The Wharton School, University of Pennsylvania. Dawn is also an active member of the TransCelerate QMS sub team.

Cheryl McCarthy, RQAP-GCP, CQA, CBA
Associate Director, R&D Quality and Compliance, BIOGEN

view speaker profile

Cheryl McCarthy has over 20 years industry experience in a regulated environment. Her GCP experience includes the development and management of Quality Management Systems, Audit Programs, and Computer System Validation Programs. She is currently at Biogen in the role of Associate Director, R&D Quality and Compliance managing their GCP Audit Program. She is a certified SQA RQAP-GCP and ASQ CQA and CBA. She participates regularly in industry events where she speaks on GCP Topics.

Doreen McGirl, Associate Director, Clinical Quality Management, OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.

Doreen McGirl

view speaker profile

Doreen is the Director of Quality Assurance at the Cardiovascular Research Foundation in NYC. She is responsible for the management, maintenance, and oversight of the GCP and GLP quality programs for CRF, leading its quality initiatives, and ensuring compliance with applicable GCP/GLP federal regulations. She manages the audit and CAPA management programs, the CRF Controlled Document program, and provides the processes to ensure that required trainings for regulated areas are current and adequately documented. She is also the primary contact for regulatory and quality assurance issues, and hosts sponsor audits and regulatory inspections.

April Rafkind, M.Sc.
Director, Pharma Clinical Quality Assurance, NOVARTIS

view speaker profile

April Rafkind joined Novartis (East Hanover, NJ) Pharma Clinical Quality Assurance on May 2, 2016, and is currently Development Unit Head Clinical Quality, Respiratory.

Previously, April held various QA roles with increasing responsibility at Merck, Pfizer, and Covance; as a champion for quality, she has gained substantial quality management system experience, including clinical quality assurance, audit, regulatory compliance, inspection management and risk mitigation.

April holds an M.S. in clinical research organization & management from Drexel University College of Medicine, Pennsylvania, and a B.A. in psychology and sociology from Rutgers University, Rutgers College, New Jersey.

Sharon Reinhard, M.S.

view speaker profile

Sharon Reinhard, M.S., has 20 years of industry experience comprised of a unique blend of roles in clinical development, operations, compliance and quality assurance. She has worked for large companies such as Wyeth, mid-sized companies such as Shire and Endo, and small biotech companies like Solstice Neurosciences and iCeutica. She has developed expertise in GCP, risk-based approaches, quality by design and inspection readiness. During her career, she has supported 10 NDA filings, over a dozen regulatory inspections and performed countless audits. Sharon earned her undergraduate degrees from the University of Pennsylvania and her Master’s in Pharmaceutical Sciences from Temple School of Pharmacy. Clinical Compliance Solutions, LLC was formed at the end of 2014 with the goal of providing “right-sized” clinical development and QMS advice to a variety of pharmaceutical and biotechnology companies.

Jonathan Rowe, Ph.D., M.S., M.A.
Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER

view speaker profile

Jonathan Rowe has 20 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Executive Director, Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities include monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles including Clinical Director, with responsibility for the Phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director of Process and Performance. Jonathan spent a number of years in “small pharma” as the Head of Intellectual Property and Portfolio Strategy for Amarin and Dignity Sciences. Jonathan earned his Ph.D. and M.S. at the Albert Einstein College of Medicine and his M.A. from Binghamton University.

Mike Sobczyk
Senior Director, Regulatory Compliance, GILEAD SCIENCES

view speaker profile

Mike Sobczyk has a Bachelor of Science degree in biology from the University of Nebraska at Omaha and a Master of Health Sciences from George Washington University. Mike is currently working at Gilead Sciences Inc. as the Senior Director of Regulatory Compliance. Over the past 25 + years, Mike’s responsibilities have included oversight of GLP, GCP, GMP, Computer Validation, Training and Procedural Documentation. In addition, Mike developed a class in clinical research auditing that he taught for four years at Boston University. Over Mike’s career, he has had an opportunity to facilitate several FDA inspections. In addition, he has had the opportunity to develop and present a GCP and GLP class for the policymakers of the Chinese government. Prior to Mike’s quality assurance experience, he spent several years as the Technical Director of Bishop Clarkson Hospital Renal Disease Center.

Joanne Spallone, Global Head, Clinical Development Quality Assurance, NOVARTIS

Joanne Spallone
Global Development Quality Audit Head, NOVARTIS

view speaker profile

Joanne Spallone is Global Audit Head for GCP/PV, Global Development Quality, at Novartis. Joanne has 35+ years of experience in the pharmaceutical industry, and has spent more than half her career in the clinical and pharmacovigilance quality assurance field. The majority of her career has been with Novartis (and formerly Ciba-Geigy Corporation), where she has worked a total of 36 years. In her current position, Joanne leads the GCP/PV Audit program for Novartis, including audits of clinical sites, affiliates, service providers and systems/processes.

Prior to re-joining Novartis in December 2006, Joanne worked at Schering-Plough Corporation where she was responsible for establishing a corporate pharmacovigilance audit group. She also worked at ALTANA Pharma from May 2003 until February 2005, where she set up a US clinical and PV quality assurance program.

Joanne has led and managed specialized directed investigations, audits and inspections, and systems and due diligence/licensing audits. She has developed and led GCP/PV training programs for global QA and clinical research personnel.

Joanne was formerly an active faculty member with the Pharmaceutical Education and Research Institute, Inc. (PERI) for approximately 13 years, involved as Co-Course Director for Basic GCP and as a faculty member for the Advanced GCP class. She spent several years on PhRMA’s Bioresearch Monitoring Steering Committee (BRMC) in positions including Chairperson, Vice-Chair, Past Chair and member-at-large. Joanne has presented at several conferences.

Steven Talerico, Associate Director, Clinical Quality Management, Inspections Lead, MERCK

Steven Talerico, M.S.
Director, GCP Inspection Management (GIM), Global Inspections Lead, Global Clinical Trial Operations (GCTO), MERCK

view speaker profile

Steve has more than 25 years of experience in the pharmaceutical industry. Starting as a co-op student working on his bachelor’s degree in biology, he has worked with Pennwalt, Wyeth, Astra-Zeneca, Schering-Plough and Merck. He has worked in the areas of pharmacology and toxicology pre-clinical research, clinical quality assurance, clinical corporate compliance and GCP inspection readiness and management. Presently, he is the Inspection Lead with the Clinical Quality Management Group at Merck. He has a bachelor’s degree in biology from Rochester Institute of Technology, a master’s degree in toxicology/environmental studies from University of Rochester School of Medicine and Dentistry, and a second master’s degree in pharmaceutical science from Temple University.

Simon Trowell
Vice President, Quality and Risk Management, R&D Projects, Clinical Platforms and Sciences, GSK

view speaker profile

A Medicinal and Pharmaceutical Chemist by training, Simon joined GSK in 1994 and has worked in a variety of clinical development, learning and development and quality risk management roles within Pharmaceutical R&D.

Simon led the Training & Quality Risk Management group, responsible for the direction of Medical Governance and cross-functional Good Clinical Practice regulatory-based training across Clinical Development, as well as business, business system, and study-level quality risk management.

Simon assumed his current role in 2012, and is accountable for addressing risks across Clinical Development, monitoring and anticipating future challenges, as well as proactively establishing risk mitigation strategies across the global footprint of countries. In 2017, he assumed oversight for risks pertaining to research practices across pharmaceutical, vaccine and consumer healthcare R&D.

Stefan Van Den Akker, M.Sc.
Director, R&D Quality and Risk Management, ACADIA PHARMACEUTICALS

view speaker profile

Stefan’s career includes roles in Process Control and Quality Assurance with a personal goal of exciting teams to include quality, proactive risk management and GCP compliance from the start of each project. Stefan has acted as Subject Matter Expert for clinical trial conduct, modern trial monitoring techniques, GCP process development and continuous improvement. His background as a CRA/Field Monitor, Clinical Trial Manager and Quality Representative in The Netherlands gave him a solid background in 2011 to settle in the USA to start a completely new role in pro-active process and compliance management at Novartis Pharmaceuticals in East Hanover, NJ.  In 2016 he started the R&D Quality and Risk Management group at ACADIA pharmaceuticals tasked with proactive quality management overseeing the compliance in clinical studies and the procedures governing these studies.

Cheri Wilczek

view speaker profile

Cheri A. Wilczek, M.S., B.S., is the founder and President of ClinAudits, LLC, a recognized leader and independent, niche provider of domestic and international Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Pharmacovigilance Practice (GVP) and Good Tissue Practice (GTP) auditing services and has managed its growth since the company’s inception in 1994. She has more than 35 years in the regulated pharmaceutical industry. ClinAudits assists clients in the pharmaceutical, biotechnology, tissue engineering, medical device industries, OTC, RX, gene therapy, and medical universities and institutions, and is focused on meeting end-to-end FDA and other governmental authority compliance requirements around the world.

The company operates strictly within the regulations/guidelines set forth by the FDA and other governmental authorities; regulations/guidelines designed to bring products to market which have demonstrated adherence to exacting standards in terms of manufacturing and production, field-proven efficacy and patient safety. Because we do not conduct or manage clinical trials (e.g., IVRS and EDC processes), ClinAudits is well positioned to emphasize our 100% objectivity and independence across a comprehensive portfolio of critical services.

ClinAudits is proud to have attained a Women-Owned Business Enterprise Certification.

Cheri obtained her Bachelor of Science degree from the University of Delaware and her Master of Science in Genetics from the University of Maryland.

Prior to founding ClinAudits, Cheri had prior positions with The Upjohn Company and Hoffmann La Roche.

Shari Zeldin, B.S., CCRC
Clinical Research Compliance Officer, Department of Medicine, UNIVERSITY OF WISCONSIN

view speaker profile

Shari has over 30 years of clinical research experience working at a large academic institution covering the spectrum of clinical research conduction, monitoring, compliance and GCP education and training. She has earned herself a national reputation as a passionate and enthusiastic presenter on a variety of clinical research related topics.