ICH E6 (R3) is coming at a time when life science organizations still are struggling to adopt ICH E6 (R2). But should organizations wait until these guidelines are ratified to realize the intended benefits?
The recently released ICH E8 (R1), a precursor to this new guidance provides the answer, specifically calling for establishing a culture that supports critical thinking and open dialogue about quality that goes beyond sole reliance on tools and checklists.
Applying critical thinking during study startup is pivotal to improving study conduct overall. Proactive planning is essential to identifying what is needed to mitigate risk, ensure regulatory compliance and audit-readiness, and in order to avoid serious budget and timeline overages. These issues can derail a study resulting in costly rescue interventions, often due to issues that are preventable.
Please join us for this webcast:
Live: Tuesday, March 30, 2021
1pm EDT | 12pm CDT | 10am PDT
On Demand: available after airing until March 30, 2022
In this webcast, we will explore:
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CRISSY MACDONALD, Executive Director, Client Delivery, The Avoca Group
As leader of Avoca's Integrated Consulting group, Crissy provides consulting to top pharmaceutical, biotech, and contract research organizations, and she oversees client deliverables, systems, and processes across Avoca. Crissy has 12 years of pharmaceutical industry experience, with expertise in clinical research, process development, and strategic management. Her previous professional roles have touched every stage of the clinical trials process, from preclinical research through late-stage clinical development.
Crissy earned a Ph.D. in biomedical engineering from Drexel University and a bachelor's degree from Lafayette College.
ANDY LAWTON, Consultant, Risk Based Approach Ltd
Andy is one of the world’s leading experts on the implementation of risk management and Quality by Design in clinical development. He has provided ICH E6 R2 and ICH E8 consulting to over 40 companies/groups across five continents. Andy has extensive experience in computing, statistics, data management, RDE/RDC, system design, and Risk Based Approach in both CSV and clinical trials.
Andy has 46 years of experience in the pharmaceutical industry and the U.K.’s NHS, and was a founding committee member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His most notable publications, include the paper with Dr. Alistair Ross on GP Audit. Throughout the 80’s and 90’s this was the most quoted paper in the BMJ, and he won “best author of the year 2015 and 2016” from the DIA, for the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal.
ERIKA STEVENS, Principal Consultant, Recherche Transformation Rapide
Erika Stevens leads research transformation advisory and assurance services. In this capacity, she advised cancer centers, life sciences, AMCs, hospitals and health systems process improvement initiatives for productivity, quality and efficiency in operations, cross-functional relationships, administration, manufacturing and compliance. Her regulatory knowledge and quality oversight of the Code of Federal Regulations (CFR) includes, but is not limited to, GMP, GLP and GCP.
Ms. Stevens has over 20 years of research/ R&D experience, including over 12 years in research management serving in roles such as Vice President Research, Senior Managing Director, Director Clinical Trials Office, Director of Clinical Research, Interim Executive Director, Clinical Trials Office and Director of Research Operations. Ms. Stevens is a past president of the Association of Clinical Research Professionals (ACRP) New York Metropolitan Chapter. Ms. Stevens served as chair, for two terms, of the editorial advisory board for “The Clinical Researcher,” the peer reviewed journal publication for Association of Clinical Research Professionals (ACRP). Ms. Stevens is the Chair of the Associate Board of Trustees. Erika is a director for Brightpoint Care and served on the MAGI advisory board. She is also a frequent speaker on research operations and compliance practices at international conferences.
Additionally, she is a published author whose work appears in a variety of peer journals including the American Journal of Obstetrics & Gynecology, The Monitor, Clinical Researcher, Regulatory Focus, Applied Clinical Trials, Clinical and Translation Science and the Journal of Mental Health and Aging.
MARINA ACOSTA ENSLEN, Associate Director, Clinical Management, Rho
Marina is a diversely skilled clinical research professional with 20 years of experience across Phase 1 through 4 studies. Prior to joining Rho, Ms. Acosta Enslen has held positions in the areas of clinical monitoring, site level study coordination, site start-up, and clinical study management. Ms. Acosta Enslen has extensive experience working on regional and global HIV, Oncology, Acute Pain and Vaccine clinical trials. Nearly half of her career has been focused on HIV/AIDS research working on NIH and industry funded clinical trials.
ELVIN THALUND, Director, Industry Strategy, Oracle Health Sciences
Elvin is a recognized industry expert in clinical trials, having over 20 years of experience working as a clinical business analyst consultant at major pharmaceutical companies, including, Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in Oracle Health Sciences effort to optimize Study Startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a master of science in industrial engineering from Aalborg Universitet.