Agenda – 10th Proactive GCP Compliance

  • Workshops
  • Main Conference Day One
  • Main Conference Day Two

Workshops

 MONDAY, MARCH 18

8:30AM – 10:00AM

WORKSHOP: MONITORING POST R2 (ICH E6 R2 5.18)
Outline and Execute a Risk-Based Approach for Monitoring and Trial Management

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN

10:00AM – 10:30AM

30-Minute Networking Break

1:00PM – 2:30PM

WORKSHOP: QUALITY CULTURE IMPLEMENTATION
Shift to a Quality Culture and Manage the Change Effectively

Dawn M. Niccum, M.S., RN, PMP, CCRA, RQAP-GCP, Senior Director, Quality Assurance and Compliance, INSEPTION GROUP
Karin Rezzonico, Associate Director, Clinical Quality Compliance, INSEPTION GROUP


Main Conference Day One

 TUESDAY, MARCH 19

8:45AM – 9:15AM

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

9:15AM – 10:15AM

SENIOR LEADERS PANEL: QUALITY MANAGEMENT POST R2
Reflect on the Actions, Process Adjustments and Cultural Shifts That Have Resulted From ICH E6 R2

MODERATOR:
Greg Dombal, Chief Operating Officer, HALLORAN CONSULTING GROUP
PANELISTS:
Deb Driscoll, Vice President, Quality Assurance, MERCK RESEARCH LABS
Dave Nickerson, Head of Clinical Quality Management, EMD SERONO
Additional Panelists TBD

10:15AM – 10:45AM

Networking Break

10:45AM – 11:30AM

RISK IDENTIFICATION (ICH E6 R2 5.0.1 & 5.0.2)
Identify Critical Processes Moves and Data, and Their Associated Risks

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

11:30AM – 12:15PM

RISK CONTROL AND COMMUNICATION (ICH E6 R2 5.0.4 & 5.0.5)
Define Quality Tolerance Limits and Effectively Communicate These Parameters

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC

12:15PM – 1:15PM

Lunch

1:15PM – 2:00PM

QUALITY BY DESIGN
Build Quality Into Clinical Trials to Proactively Identify and Mitigate Risk

Sharon Reinhard, M.S., Executive Director, MRL Quality Assurance, MERCK
Reetu Dandora, Executive Director, MRL Quality Assurance, MERCK

2:45PM – 3:15PM

Networking Break

3:15PM – 4:15PM

PANEL DISCUSSION: CRO OVERSIGHT (ICH E6 R2 5.2.2)
Ensure and Document Effective Oversight of CRO and Third Parties – Discuss Case Studies and Best Practices

MODERATOR:
Jane Wood, Quality Center of Excellence Lead, YOUR ENCORE
PANELISTS:
Jason Donnelly, Director, Clinical Quality and Compliance, SCHOLAR ROCK, LLC
Dan Walsh, Director, Clinical Oversight, MYLAN
Michael Wieczerak, Associate Director, Clinical Quality Management, EMD SERONO

4:15PM – 5:15PM

ROUNDTABLE DISCUSSIONS


Main Conference Day Two

 WEDNESDAY, MARCH 20

8:30AM – 8:45AM

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

9:30AM – 10:30AM

PANEL DISCUSSION: GLOBAL INSPECTION READINESS
Discuss Global Challenges to Achieve a Constant State of Inspection Readiness Panelists

PANELISTS:
Nancy Bitters, Inspection Management Lead, Biopharma, Global Research and Development Quality, EMD SERONO
Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN
Sheila Gwizdak, Principal Consultant, HALLORAN CONSULTING GROUP

10:30AM – 11:00AM

Networking Break

12:30PM – 1:30PM

Lunch

1:30PM – 2:15PM

ESSENTIAL DOCUMENTATION (ICH E6 R2 8.1)
Identify the Essential Trial Documentation and How It Should Be Maintained

Michele Weitz, Senior Director, GCP Compliance Operations, CLOVIS ONCOLOGY

2:15PM – 3:15PM

PANEL DISCUSSION: NONCOMPLIANCE (ICH E6 R2 5.20)
Address Identified Noncompliance Through Root Cause Analysis and CAPA

MODERATOR:
April Rafkind, MS.c., Director, Pharma Clinical Quality Assurance, NOVARTIS
PANELISTS:
Jolie Weintraub, Executive Director, Quality Assurance, Therapeutic Area Head-Oncology, MERCK
Michele Weitz, Senior Director, GCP Compliance Operations, CLOVIS ONCOLOGY
Additional Panelists TBD

3:15PM – 3:30PM

CHAIRPERSON’S CONCLUDING REMARKS
April Rafkind, MS.c., Director, Pharma Clinical Quality Assurance, NOVARTIS