Agenda – 4th European Clinical Trials Inspection Readiness

  • Day One
  • Day Two

Day One

 DAY ONE | MONDAY – 21 MAY 2018

9:00 – 9:15

CO-CHAIRS’ OPENING REMARKS
Sameera Ibrahim, Senior Specialist — Quality Assurance, Johnson & Johnson
Ann Cadwallader, Regulatory Compliance, Johnson & Johnson

9:15 – 10:00

OPENING KEYNOTE SESSION
Sameera Ibrahim, Senior Specialist — Quality Assurance, Johnson & Johnson
Ann Cadwallader, Regulatory Compliance, Johnson & Johnson

10:00 – 10:45

PV — GCP CLINICAL TRIAL MANAGEMENT
Lindsay Watt, Deputy QPPV, ROCHE; Former MHRA Inspector

10:45 – 11:15

NETWORKING BREAK

11:15 – 12:00

IT – GCP CLINICAL TRIAL MANAGEMENT
Nicola Parr, Senior Specialist, JOHNSON & JOHNSON

12:00 – 12:45

ANALYSE THE IMPACT OF ICH E6 R2 ON PREPAREDNESS AND REGULATOR INSPECTIONS
Geoff Taylor, Director, Clinical Quality Assurance, EISAI EMEA KNOWLEDGE CENTRE

12:45 – 13:45

LUNCHEON

13:45 – 14:30

GROW AND SUSTAIN A RELATIONSHIP BETWEEN SPONSOR AND VENDOR TO ENSURE SMOOTH INSPECTIONS
Karen Hue, Quality Assurance Associate Director — Europe, AIMMUNE THERAPEUTICS

15:15 – 15:45

NETWORKING BREAK

16:30 – 17:15

TMF – HOW TO PREPARE FOR INSPECTION
Maria Nymann Jensen, Competency Development Professional, NOVO NORDISK
Anna Szaff Lundsgaard, Senior Clinical Trial Administrator/Trial Master File Supporter, NOVO NORDISK


Day Two

 DAY TWO | TUESDAY – 21 MAY 2018

9:00 – 9:15

CO-CHAIRPERSON’S RECAP OF DAY ONE
Ann Cadwallader, Regulatory Compliance, Johnson & Johnson
Louise Mawer, Consultant Auditor, Mirabilitas Ltd, FORMER MHRA GCP INSPECTOR

9:15 – 10:00

EXPLORE THE EFFECTS NEW DATA INTEGRITY GUIDELINES AND REQUIREMENTS HAVE ON INSPECTION READINESS
Kath Williams, KEW Quality Consulting Ltd, FORMER MHRA GCP INSPECTOR;

10:00 – 10:45

INSPECTION READINESS IN CHINA: DIFFERENCES TO THE “STANDARD” EU/US CONSIDERATIONS
Susanne Erman-Bech, MRC QA Lead, Inspections, H.LUNDBECK A/S

10:45 – 11:15

NETWORKING BREAK

11:15 – 12:00

MOCK INSPECTION
Patricia (Moore) Pengelly, Associate Director Clinical Quality Assurance, ABBVIE

12:00 – 13:00

LUNCHEON

13:00 – 13:45

BUILD AN INSPECTION PREPAREDNESS PLANNING PROCESSES
Fareha Nagi, Manager, Clinical Development Quality Assurance, GLAXOSMITHKLINE

13:45 – 14:30

HOW TO SURVIVE THREE FDA GCP SPONSOR INSPECTIONS IN EIGHT MONTHS
Winnie Søjborg Sussoh, International Trial Manager Specialist, Inspection Readiness, NOVO NORDISK

14:30 – 15:15

CASE STUDY: MID-SIZED SPONSOR EXPERIENCE ON A COMPLEX PMDA PREAPPROVAL INSPECTION
Kristy Nease, Sr. Director, Head GCP Quality Management, Regeneron Pharmaceuticals, Inc.

15:15 – 16:00

REVIEW THE POST-INSPECTION ACTIVITIES CONDUCTED BY THOUGHT LEADERS AND DISCUSS WHY THESE ACTIVITIES ARE COMPLETED
Noha Kassem, Senior Director — Clinical Trials Capabilities, ELI LILLY AND COMPANY

16:00 – 16:15

CO-CHAIRPERSON’S CLOSING REMARKS
Ann Cadwallader, Regulatory Compliance, Johnson & Johnson
Louise Mawer, Consultant Auditor, Mirabilitas Ltd, FORMER MHRA GCP INSPECTOR