Agenda – 3rd European Clinical Trials Inspection Readiness Summit

  • Conference Day One
  • Conference Day Two

Conference Day One

 Monday, 22 May 2017

9:00 – 9:15

Chairperson's Opening Remarks
Louise Mawer, Director, MIRABILITAS

 EXPLORE INSPECTION READINESS ISSUES IN CLINICAL TRIALS

9:15 – 10:15

A Keynote Session with an Inspector of the MHRA
Kathleen Meely, Senior GCP Inspector, MHRA

10:15 – 11:00

Outline the Differences Between EMA, FDA and PMDA GCP Inspections from a Sponsor Perspective
Birthe Emilie Nielsen, Principal QA Specialist, LEO PHARMA

11:00 – 11:30

Networking Break

12:15 – 13:15

Luncheon

13:15 – 14:00

Interpret the Requirements Described by ICH GCP E6R2 and Strategize to Integrate Them Seamlessly
Geoff Taylor, Director, Clinical Quality Assurance, EISAI

 SELF-EVALUATE TO IDENTIFY OPPORTUNITIES FOR GROWTH

14:00 – 14:45

Understand How Sites Prepare for Inspections and What They Need from Sponsors to Succeed
Pramod Wable, Associate Director, Inspection Management Lead, Medical Quality Assurance, PFIZER UK

14:45 – 15:15

Networking Break

15:15 – 16:15

CASE STUDY: Expand the TMF to Align with Regulatory Expectations
Maria Nymann Jensen, Competency Development Professional, NOVO NORDISK
Dorte Christiansen, Consultant, NNIT

16:15 – 17:00

Discuss the Different Areas of Inspection Readiness and How Each Area Can Affect Preparedness
Michele Weitz, Director, GCP Compliance Operations, CLOVIS ONCOLOGY


Conference Day Two

 Tuesday, 23 May 2017

9:00 – 9:15

Chairperson's Recap of Day One
Louise Mawer, Director, MIRABILITAS

 CREATE A CULTURE TO FOSTER INSPECTION SUCCESS

9:15 – 10:00

Implement an Inspection Readiness Plan that Takes Preparedness from Activity Based to Culture Based
Karen Hue, FRQA, Quality Assurance Manager, GCP, EU, INTERCEPT PHARMACEUTICALS

10:00 – 10:45

Build a Better Team to Ensure Inspection Readiness Is Ingrained in the DNA of Your Organization
Franck Gressier, Head R&D Clinical QA, PIERRE FABRE

10:45 – 11:15

Networking Break

11:15 – 12:00

Demonstrating Effective Sponsor Oversight to Satisfy Expectations During a Regulatory Inspection
Celia Gibson, GCP Quality Assurance Manager, RENEURON

12:00 – 13:00

Luncheon

13:00 – 13:45

CASE STUDY: Remain Prepared for Health Authority Inspections in a Fully Outsourced Partnership Model
Karen Edelmann-Stergiou, Global Senior Inspection and Regulatory Manager, BOEHRINGER INGELHEIM

 REMAIN IN A STATE OF INSPECTION READINESS

13:45 – 14:30

Leverage Internal Auditors to Promote Inspection Readiness as an Organizational Culture
Nina Beck Toubro, Quality Assurance Manager, PHARMACOSMOS

14:30 – 14:45

Networking Break

14:45 – 15:45

PANEL: Maintain an Inspection-Ready TMF
Maria Nymann Jensen, Competency Development Professional, NOVO NORDISK
Nina Beck Toubro, Quality Assurance Manager, PHARMACOSMOS
Julia Waring, Document Manager, Clinical Operations, INTERCEPT PHARMA EUROPE

15:45 – 16:00

Chairperson's Closing Remarks
Louise Mawer, Director, MIRABILITAS

16:00 – 16:00

Conference Concludes