During
clinical trials, inspections provide a framework to ensure quality and integrity of care, data and drug performance. As sponsors of clinical trials, it is important for pharmaceutical companies to ensure GCP guidelines are upheld by implementing inspection readiness. These inspections, often conducted by the FDA, EMA, MHRA and other regulatory authorities, all have unique regulations and caveats. These nuances mean that becoming - and remaining - inspection-ready can be a difficult, time-consuming battle. Because inspections can occur without notice, sites must be prepared for visits from many different stakeholders over the course of a clinical trial.
Join the 3rd
European Clinical Trials Inspection Readiness Summit and inspire an organizational culture that prioritizes inspection readiness as integral to the success of your organization. Unfavorable inspection findings can delay trials, result in costly corrective measures and shut down drug development. Concentrating on more areas of inspection readiness - such as metrics, data integrity and technology - can guarantee findings are never a surprise.
Organizational culture is often thought to be an unchangeable and steadfast belief system, but is more accurately represented as a state that must evolve to stay relevant. At the 3rd European Clinical Trials Inspection Readiness Summit, our esteemed faculty will address the importance of fostering a culture of inspection readiness within your organization, as well as ways to do so. With interactive sessions, case studies and panel discussions about effective communication pathways, integrated technology application and standardized operating procedures, you will return to work prepared to change your organization to embrace a culture that continually places quality first.
Learning Objectives
- Understand the different perspectives of inspection readiness and how they can be used to improve clinical operations
- Explore systems and methodologies that promote and guarantee compliance with all inspecting agencies and their respective regulations
- Improve oversight and communication to ensure trials are organized and conducted to protect study participants' rights, safety and welfare
- Utilize metrics from past inspections to foster the intelligent design of procedures and to assist in identifying trends that improve and encourage inspection readiness
- Convert inspection readiness from a singular activity to an organizational culture that assures quality, compliance and successful clinical trials
Speakers
- Karen Edelmann-Stergiou, Global Senior Inspection and Regulatory Manager, BOEHRINGER INGELHEIM
- Celia Gibson, GCP Quality Assurance Manager, RENEURON
- Franck Gressier, Head R&D Clinical QA, PIERRE FABRE
- Karen Hue, FRQA, Quality Assurance Manager, GCP, EU, INTERCEPT PHARMACEUTICALS
- Maria Nymann Jensen, Competency Development Professional, NOVO NORDISK
- Louise Mawer, Director, MIRABILITAS
- Kathleen Meely, Senior GCP Inspector, MHRA
- Birthe Emilie Neilsen, Principal QA Specialist, LEO PHARMA
- Geoff Taylor, Director, Clinical Quality Assurance, EISAI
- Nina Beck Toubro, Quality Assurance Manager, PHARMACOSMOS
- Pramod Wable, Associate Director, Inspection Management Lead, Medical Quality Assurance, PFIZER UK
- Julia Waring, Document Manager, Clinical Operations, INTERCEPT PHARMA EUROPE
- Michele Weitz, Director, GCP Compliance Operations, CLOVIS ONCOLOGY, INC.
Please fill in your name and email to receive the conference agenda of this event.
Conference Day One - Monday, 22 May 2017
- Including: Morning & Afternoon Networking Break, Luncheon
Conference Day Two - Tuesday, 23 May 2017
- Including: Morning & Afternoon Networking Break, Luncheon
The agenda is available as PDF under downloads at the right side of the page.
Venue
The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.
Who Should Attend
This conference is designed for professionals from academia and pharmaceutical, medical device and biotechnology companies with responsibilities in the following areas:
- Quality Assurance/Quality Control/Quality Compliance/Quality Management
- Clinical Operations/Research/Planning
- Clinical Outsourcing and Development
- Records/Data Management
- R&D Operations
- Trials Management/Research
- Global Compliance
- Risk-Based/Centralized Monitoring
- Safety and Risk Management Operations
- Site Performance Management
- Internal/External Auditing
- Clinical Project Management
- Trial Master Files
- Clinical Documentation Management
- Global Regulatory Affairs
- CAPA Auditing
- Adverse Event Management
- Metrics and Benchmarks
- Process Optimization
The conference may also be of interest to the following:
- CROs
- Inspection Readiness Software Providers
- Data/Records/Archive Management Vendors
- TMF Vendors
- Quality Management Service Providers
- Electronic Signature Companies
- Regulations/Documentation/Inspection Readiness Consultants
Venue
Radisson Blu Edwardian Heathrow Hotel140 Bath Rd
Harlington
Hayes UB3 5AW
UK
To make reservations, please call +44 207-757-7901 and reference the group name 2223EXL.
You may also make reservations online using
this link The group rate is available until 21 April 2017. Please book your room early, as rooms available at this rate are limited.
