16 - 19 September, 2019 | Pullman Brussels Centre Midi Hotel, Brussels, Belgium

Main Conference Day 1


9:10 am - 9:45 am A Fledgling’s Flightpath: bluebird bio Navigates EMA and FDA GCP Inspections for its Novel Gene Therapy

  • bluebird bio’s True North: creating a patient-centered culture of inspection readiness
  • Draw comparisons on the preparatory strategy for two different regulatory authority inspections 
  • Reflect on lessons learned from subject matter expert training, CRO engagement and mock inspection activity
Mary MacDonald, Sr Auditor, Quality Assurance at bluebird bio

Mary MacDonald

Sr Auditor, Quality Assurance
bluebird bio

  • Dive deep into the differences between European Medicines Agency and National Inspections, to ensure you are prepared for every eventuality 
  • Analyse the European Medicines Agency Inspection process and discover what to expect
  • Understand global GCP harmonization and international collaboration between regulators (EMA, FDA, PMDA etc.)
Patricia Giraldo, Quality Planning & Strategy (QP&S) Trial Oversight Specialist. Johnson & Johnson and (Former Scientific Officer at EMA Inspection Sector) at Johnson & Johnson

Patricia Giraldo

Quality Planning & Strategy (QP&S) Trial Oversight Specialist. Johnson & Johnson and (Former Scientific Officer at EMA Inspection Sector)
Johnson & Johnson

10:20 am - 11:20 am Networking Break

11:20 am - 11:55 am Cross Industry Perspective: Understanding GCP with Respect to the Upcoming ISO DIS 14155:2018 for Medical Devices

  • Analyse the changes that will be implemented following the 2020 revision of  ISO DIS 14155:2018 
  • Draw comparisons between GCP for pharmaceutical clinical trials and medical device clinical trials
  • Take home practical examples of how you can streamline your own approach to GCP with a clear understanding of regulatory expectations
Miloš Stojković, Senior Safety Specialist, Global Medical Affairs, Clinical, Scientific & Medical Affairs, Global R&D at Smith & Nephew

Miloš Stojković

Senior Safety Specialist, Global Medical Affairs, Clinical, Scientific & Medical Affairs, Global R&D
Smith & Nephew

11:55 am - 12:30 pm Preparing for Regulatory Change

  • Understand the major implications of he transition from the 2001 Clinical Trial Directive and the 2014 Clinical Trial Regulation
  • Gain insight into how you can prepare and incorporate these requirements into your current operational strategy
  • Anticipating Brexit: Get a clearer understanding of how Brexit will affect your company and the future regulatory landscape 
Alison Messom, Chairman of the Board of Directors at Institute of Clinical Research

Alison Messom

Chairman of the Board of Directors
Institute of Clinical Research

12:40 pm - 1:40 pm Networking Lunch

1:40 pm - 2:15 pm Break-Out Discussions

  1. Incorporating Metrics into Sponsor Oversight and the Tools Available
  2. Developing Best Practice Strategies for Inspections
  3. Designing Effective CAPA Reports
  4. Inspection Findings & Trends Post ICH GCP E6 (R2)
Jurgen Lissens, Director Regional Compliance at Bristol-Myers Squibb

Jurgen Lissens

Director Regional Compliance
Bristol-Myers Squibb

2:15 pm - 2:50 pm Developing an Effective Risk Management Strategy that Works for Your Company

  • Define the critical factors that must be considered when designing a QRM for a small company
  • Personalise your approach to risk management by selecting the right tool
  • Understand how risk management can be integrated as part of an inspection readiness programme 
Franck Gressier, Head Clinical Quality Assurance at Pierre Fabre

Franck Gressier

Head Clinical Quality Assurance
Pierre Fabre

Marie Boireaud , Clinical Quality Auditor at Pierre Fabre

Marie Boireaud 

Clinical Quality Auditor
Pierre Fabre

2:50 pm - 3:20 pm Networking Break

3:20 pm - 3:55 pm Quality Tolerance Limits – Setting Smart Parameters to Ensure Inspection Readiness

  • Understand how Quality Tolerance Limits stipulated by the updated GCP guidance should be interpreted, and what it means to be compliant 
  • Analyze the benefits of Quality Tolerance Limits and what parameters should be considered for implementation
  • Deep dive into how Quality Tolerance Limits can be implemented successfully with a case study from UCB and reflect on lessons learned
  • Understand the potential impact of Quality Tolerance Limits on future regulatory submissions
Norbert Dank, Clinical Risk Management Lead  at UCB

Norbert Dank

Clinical Risk Management Lead 
UCB

3:55 pm - 4:30 pm Effectively Managing and Tracking CAPAs to Ensure Inspection Readiness

  • Define what it means to create and measure the effectiveness of CAPAs, with tips on what to avoid
  • Understand which process, roles and responsibilities to consider for managing CAPAs
  • Design a strategy to track the implementation of CAPAs, taking guidance from Pfizer’s experience 
Marie-Christine Poisson-Carvajal, Head of TMF & Registry Operations, Clinical Development Quality, Global Product Development at Pfizer

Marie-Christine Poisson-Carvajal

Head of TMF & Registry Operations, Clinical Development Quality, Global Product Development
Pfizer

4:45 pm - 5:45 pm Networking Drinks Reception