Proactive GCP Compliance 2021: Full Schedule

10:45am EDT

SENIOR LEADERS PANEL: Clinical Quality Post-Pandemic

Discuss the Impact of the Pandemic on Quality Culture and Operations

How did your company’s culture of quality play a role during the pandemic?
Examine the rapid adaptation of processes resulting from the pandemic and the possible implications for R&D quality
Identify new best practices learned during the pandemic that are here to stay

Speakers

Jonathan Taylor

Vice President, Global Head Product Development Quality, ROCHE/GENENTECH

Over 20 years Quality Assurance experience (GLP, GCPv, GCP, PV) for major pharmaceutical and contract research companies. Senior Management and Global Leadership Team experience.Experienced in conducting Investigator site, document, database, internal system, CRO, clinical laboratory... Read More →

Kristel Van de Voorde

Vice President, Global Clinical Quality and PV, BRISTOL-MYERS SQUIBB

Kristel Van de Voorde has 25 years of experience in the quality area in Bristol-Myers Squibb covering GCP, GPvP and interfaces in R&D with GLP and GMP. Currently, Kristel is the global head of the R&D quality function for clinical trials at Bristol-Myers Squibb. Kristel has set up... Read More →

Sharon Reinhard, M.S.

Vice President, Global Quality, AVROBIO

Experienced pharmaceutical executive with 23 years of industry experience, currently Vice President of Global Quality at AVROBIO, a gene therapy company based in Cambridge, with responsibility across all GXPs. Previously served as Vice President of R&D Quality with CSL Behring... Read More →

Peter Alain

Vice President, Clinical Quality Assurance, ASTELLAS

Peter Alain has more than 35 years of experience in Quality within the pharmaceutical industry. He is currently the Global Head of Clinical Quality Assurance (CQA) within Astellas’ Medical and Development division and is a member of the Quality Assurance Leadership Team. In this... Read More →

Monday June 21, 2021 10:45am - 11:45am EDT

Panel

2:30pm EDT

PANEL DISCUSSION: Proactive Clinical Risk Management

Examine the Critical Elements of Success for A Truly Proactive Clinical Risk Management Approach

Discuss proactive clinical risk management and compare examples to a reactive approach
Identify the elements of a successful proactive clinical risk management plan
Understand the impact, if any, of the pandemic on the ability to execute a truly proactive risk management approach

Speakers

Sharon Reinhard, M.S.

Vice President, Global Quality, AVROBIO

Loreena Sadowski

Regional Clinical Compliance Head, Americas, BRISTOL MYERS SQUIBB

Loreena Sadowski currently leads the Regional Clinical Compliance organization across the Americas region. In this position, Loreena is responsible for development and implementation of a risk-based, quality-by-design clinical compliance program that drives to meet internal and... Read More →

Michele Weitz

Senior Director, Clinical Standards and Innovation, CLOVIS ONCOLOGY

A pragmatist on a mission to make clinical trial regulatory requirements meaningful and accessible to a tough crowd, Michele has worked as both an employee and consultant at pharmaceutical companies of all sizes—from 23 to 111,000 employees, in many therapeutic areas and around... Read More →

Leslie M. Sam, BA, CSSBB

President, LESLIE SAM & ASSOCIATES LLC

Accomplished, results-driven, passionate Clinical Research and Quality Professional with over 20+ years of transferable technical and leadership skills [business acumen, interpersonal skills (verbal and written), Six Sigma Black Belt certification (CSSBB), Quality Improvement Associate... Read More →

Monday June 21, 2021 2:30pm - 3:30pm EDT

Panel

2:00pm EDT

PANEL DISCUSSION: Issue Identification and Escalation

Discuss Best Practices for Creating Open Communication Among Stakeholders Regarding Possible Compliance Issues

Foster a transparent culture that is not based on fear
Share strategies for celebrating early issue discovery rather than shaming
Escalation plans and communication approaches when issues are identified
Evaluate follow-up and effectiveness checks

Speakers

Dawn Lundin

Clinical Research Compliance Director, UNIVERSITY OF PENNSYLVANIA PERELMAN SCHOOL OF MEDICINE

Over 24 years of GxP experience from quality assurance and compliance roles within both industry and academia. Current head of compliance for the Perelman School of Medicine and Director of the Quality Assurance Graduate Program of Study for the University of Pennsylvania. Previous... Read More →

Michael Torok, Ph.D.

Senior Director, Clinical Quality Assurance, ASTELLAS

Michael Torok has over 20 years of experience in pharmaceutical development and has held leadership roles in Clinical Operations, Project and Portfolio Management, and Contracts and Outsourcing. After completing coursework in data analytics and machine learning, Michael transitioned... Read More →

Liz Bodi, M.S., RQAP-GCP

Principal Consultant, Quality, HALLORAN CONSULTING GROUP

Elizabeth Bodi has over 29 years of experience in the biopharmaceutical and medical device industry. Her career has focused primarily on clinical operations and clinical quality assurance activities to ensure excellence and consistency across phase I-V clinical trials. Elizabeth also... Read More →

Celeste Gonzalez, B.S., CVT, RQAP-GCP, CCRP

Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP is an accomplished clinical quality and regulatory compliance professional with in-depth knowledge of all facets of clinical trial operations and the ability to support management and clinical teams that are conducting compliant clinical... Read More →

Tuesday June 22, 2021 2:00pm - 3:00pm EDT

Panel