Agenda – 8th Proactive GCP Compliance

  • Full-Day Seminar
  • Main Conference Day One
  • Main Conference Day Two

Full-Day Seminar

 Wednesday, April 5, 2017

8:30AM – 12:00PM

THE CHANGING LANDSCAPE OF CLINICAL QUALITY AND COMPLIANCE
Conceptualizing the Future State of Clinical Quality and Compliance, and Taking Actions Today to Get There

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
Dawn M. Niccum, BSN, M.S., RN, PMP, CCRA, Associate Director, Quality, ENDOCYTE
James Streeter, Global Vice President, Life Sciences Product Strategy, ORACLE HEALTH SCIENCES
Steven Talerico, M.S., Director, GCP Inspection Management (GIM), Global Inspections Lead, Global Clinical Trial Operations (GCTO), MERCK

1:00PM – 4:30PM

THE CHANGING LANDSCAPE OF CLINICAL QUALITY AND COMPLIANCE (Continued)
Conceptualizing the Future State of Clinical Quality and Compliance, and Taking Actions Today to Get There

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
Dawn M. Niccum, BSN, M.S., RN, PMP, CCRA, Associate Director, Quality, ENDOCYTE
James Streeter, Global Vice President, Life Sciences Product Strategy, ORACLE HEALTH SCIENCES
Steven Talerico, M.S., Director, GCP Inspection Management (GIM), Global Inspections Lead, Global Clinical Trial Operations (GCTO), MERCK


Main Conference Day One

 Thursday, April 6, 2017

8:30AM – 9:00AM

CHAIRPERSON’S WELCOME AND INDUSTRY UPDATE
April Rafkind, MSc, Director, Pharma Clinical Quality Assurance, NOVARTIS

9:00AM – 10:00AM

PANEL DISCUSSION: REGULATORY CHANGES TO GCP
Identifying the Regulations Driving Change in Clinical Quality and Compliance Operations and How Companies Are Responding

Panelists:
Kathy Goldstein, Senior Director, Development Quality Operations, R&D Quality and Compliance, ALEXION PHARMACEUTICALS
Joseph F. Gotowko, Assistant Director, RDQA Quality Systems, ABBVIE
Mike Townsley, Director, Clinical Quality Assurance, TREVENA

10:30AM – 11:15AM

APPLYING BEST PRACTICES FROM GMP
Examining Operational Efficiencies Achieved in the GMP Space and Effectively Translating Them to GCP

Patricia Santos-Serrao, RAC, Market Segment Director, Global Pharmaceutical, Blood and Biologics, MASTERCONTROL

11:15AM – 12:15PM

ALEXION CASE STUDY: QUALITY BY DESIGN
Utilizing Quality by Design Principles to Optimize Compliance and Data Integrity

Kathy Goldstein, Senior Director, Development Quality Operations, R&D Quality and Compliance, ALEXION PHARMACEUTICALS

12:15PM – 1:15PM

Lunch

1:15PM – 2:00PM

CLINICAL QUALITY MANAGEMENT PLAN
Developing and Executing an Effective Clinical Quality Management Plan to Ensure GCP Compliance

Fiona Jeitner, Senior Manager, Global Clinical Quality Assurance, EISAI INC.

3:15PM – 4:15PM

PANEL DISCUSSION: LEARNING FROM INSPECTIONS
Discussing Observations and Lessons Learned from Panelists’ Inspection Experiences and Providing Guidance to Optimize Preparation Efforts

Moderator:
Mary Ann Livolsi, MSN, RN, RQAP-GCP, Head Quarters Clinical Quality Management (HQ CQM), Quality & Continuous Improvement (QCI), SQAC, LLC contracted to MERCK RESEARCH LABORATORIES

Panelists:
Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
Jennifer J. Poulakos, Ph.D., Director, Development Quality Assurance, AGENSYS, INC., AN AFFILIATE OF ASTELLAS PHARMA, INC.
Liz Szczesniak, Director of Compliance, Vaccines Clinical Research and Development, PFIZER


Main Conference Day Two

 Friday, April 7, 2017

8:30AM – 8:45AM

CHAIRPERSON’S OPENING AND RECAP OF PREVIOUS DAY
April Rafkind, MSc, Director, Pharma Clinical Quality Assurance, NOVARTIS

9:30AM – 10:15AM

AGENSYS CASE STUDY: TRIAL MASTER FILE
Leveraging the Trial Master File as a Tool to Proactively Identify Risk Areas

Jennifer J. Poulakos, Ph.D., Director, Development Quality Assurance, AGENSYS, INC., AN AFFILIATE OF ASTELLAS PHARMA, INC.

11:30AM – 12:30PM

PANEL DISCUSSION: VENDOR OVERSIGHT
Discussing What Measures and Processes Companies Are Taking to Ensure and Document Vendor Oversight

Moderator:
Steve Whittaker, Senior Consultant, THE AVOCA GROUP
Executive Director, THE AVOCA QUALITY CONSORTIUM

Panelists:
Dwayne Brazelton, Director, Clinical Quality Assurance, MACROGENICS, INC.
Dan Walsh, Director, Clinical Oversight, MYLAN
Cheri Wilczek, President, CLINAUDITS, LLC

12:30PM – 1:30PM

Lunch

1:30PM – 2:15PM

TRAINING OPTIMIZATION
Optimizing Auditor and Monitor Effectiveness Through Harmonized Training

Kristy Nease, Senior Director and Department Head of Clinical Compliance and Training, REGENERON PHARMACEUTICALS, INC.

2:15PM – 3:15PM

PANEL DISCUSSION: TOP CONCERNS AND CHALLENGES
Discussing the Biggest Challenges, Concerns and Obstacles to Achieving GCP Compliance

Moderator:
Katie Alberta, Global Head, Clinical and Pharmacovigilance Quality, ALKERMES

Panelists:
Dawn M. Niccum, BSN, M.S., RN, PMP, CCRA, Associate Director, Quality, ENDOCYTE
Anne Verrocchi, Senior Associate Director/Principal Auditor, BOEHRINGER INGELHEIM
Additional Panelists to Be Determined

3:15PM – 3:30PM

CHAIRPERSON’S CONCLUDING REMARKS
April Rafkind, MSc, Director, Pharma Clinical Quality Assurance, NOVARTIS