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

Main Conference Day 2

9:40 am - 10:15 am Interactive Campfire Session: Mitigating the Risk of Integrated Electronic Systems with the View for Future Procurement of a Next Generation QMS

  • Explore the challenges associated with the use of multiple electronic systems and the compliance risks that arise
  • Consider how these challenges may be overcome through methods of harmonisation
  • Understand when a new QMS is needed and what considerations are made in the selection of a new provider

10:15 am - 10:50 am Case Study: Implementation of a New Global QMS in a Mid-Size Company and Lessons Learned

  • Define the steps that must be implemented before the new QMS goes live and how to achieve them
  • Analyse the compliance risk of implementing a new QMS and what to consider for inspection readiness
  • Reflect as Grunethal guides you through their experience following implementation and consider lessons learned
Elke Ufer, Global GxP QMS Manager, Global Quality Assurance at Grünenthal

Elke Ufer

Global GxP QMS Manager, Global Quality Assurance
Grünenthal

10:50 am - 11:20 am Networking Break

12:20 pm - 1:20 pm Mini-Workshop: Operational Excellence to Improve Quality and Compliance related to Computerised Systems

  • Gain insight into lessons learned from a recent inspection, with respect to IT compliance
  • Develop a deeper understanding of the role of quality in IT compliance
  • Establish a task force group by aligning the internal standard for how to interpret regulatory requirements, including governance
  • Benchmark and discuss operational solutions for handling the expectations of authorities  
Caroline Sandström, Director GCP Compliance, Global QA, Development at Ferring Pharmaceuticals

Caroline Sandström

Director GCP Compliance, Global QA, Development
Ferring Pharmaceuticals

1:20 pm - 2:20 pm Networking Lunch

2:20 pm - 2:55 pm CRO Perspective: “Trust Us, we know what we are doing!” - Preparing for an MHRA Inspection

  • Deep dive into PPD’s preparation for their upcoming MHRA inspection
  • Discover PPD’s  strategy  for effective CAPA management, meeting the evolving expectations from Regulatory Agencies
  • Understand how CROs manage the Sponsor: Vendor relationship during an inspection and the challenges that arise during this time
Robrecht Tistaert, Senior Director Quality Strategy at PPD

Robrecht Tistaert

Senior Director Quality Strategy
PPD

2:55 pm - 3:30 pm Long Term Inspection Readiness Strategy for Entirely Outsourced Trials

  • Examine why it is so essential to design an inspection readiness strategy at the start of your clinical trial and the key stages of readiness
  • Discover how small pharma maintain sponsor oversight of entirely outsourced trials and the effective tools they use
  • Define who takes ownership of clinical quality with a detailed task allocation list to ensure the smooth running of your outsourced trial 
Tomasz Kosieradzki, Quality Assurance Advisor at Polpharma Biologics

Tomasz Kosieradzki

Quality Assurance Advisor
Polpharma Biologics

3:30 pm - 4:00 pm Networking Break

  • Understand the factors that must be considered when Implementing ALCOA+ data management systems
  • Define the roles of access control, computer validation, and metadata in ensuring data integrity
  • Ensure you maintain data integrity within European GCP frameworks and the GCP Inspectors’ expectations for data integrity
Francis Crawley, Executive Director at Good Clinical Practice Alliance – Europe & Strategic Initiative for Developing Capacity in Ethical Review

Francis Crawley

Executive Director
Good Clinical Practice Alliance – Europe & Strategic Initiative for Developing Capacity in Ethical Review

4:35 pm - 5:30 pm Troubleshooting Clinic

Bring your unsolvable challenges and unanswered questions to the forefront of the industry in a Q&A with our Expert Speaker Faculty