New York Professional Events List


European Clinical Trials Inspection Readiness


Date
May 22, 2017 - 08:00 AM - May 23, 05:15 PM
Organizer
Location
Radisson Blu Edwardian Heathrow Hotel 140 Bath Rd, Harlington, Hayes UB3 5AW, UK,

United Kingdom,
United Kingdom,
US,
ZIP: United Kingdom
Phone: +1 929 900 1853

3rd European Clinical Trials Inspection Readiness Summit

3rd European Clinical Trials Inspection Readiness Summit

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

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
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Please contact the event manager Marilyn below for the following:
 
- For Tickets/Registrations,
- Discounts for registering  5 or more participants.
- If you company requires a price quotation.
 
Event Manager Contact:


marilyn.b.turner(at)nyeventslist.com or Contact:  +1 929 900 1853
 
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
 
NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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Agenda


Conference Day One
 Monday, 22 May 2017

8:00 – 8:45
Continental Breakfast and Registration
8:45 – 9:00
Chairperson's Opening Remarks
Louise Mawer, Director, MIRABILITAS
 EXPLORE INSPECTION READINESS ISSUES IN CLINICAL TRIALS
9:00 – 9:45

A Keynote Session with an Inspector of the MHRA
Kathleen Meely, Senior GCP Inspector, MHRA
9:45 – 10:30

Outline the Differences Between EMA, FDA and PMDA GCP Inspections from a Sponsor Perspective
Birthe Emilie Nielsen, Principal QA Specialist, LEO PHARMA
10:30 – 11:00

Networking Break
11:00 – 11:45
Explore the Effects New Data Integrity Guidelines and Requirements Have on Inspection Readiness
Louise Mawer, Director, MIRABILITAS
11:45 – 12:30

Interpret the Requirements Described by ICH GCP E6R2 and Strategize to Integrate Them Seamlessly
Geoff Taylor, Director, Clinical Quality Assurance, EISAI
12:30 – 13:30

Luncheon
 SELF-EVALUATE TO IDENTIFY OPPORTUNITIES FOR GROWTH
13:30 – 14:15

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
14:15 – 15:15

CASE STUDY: Use Computer Systems Validation to Support Proper Inspection Readiness and Instrument Calibration
If you are interested in sponsoring this session, please contact David Finkel at [email protected].
15:15 – 15:45
Networking Break
15:45 – 16:30
CASE STUDY: Expand the TMF to Align with Regulatory Expectations
Maria Nymann Jensen, Competency Development Professional, NOVO NORDISK
Dorte Christiansen, Consultant, NNIT
16:30 – 17:15

Discuss the Different Areas of Inspection Readiness and How Each Area Can Affect Preparedness
Michele Weitz, Director, GCP Compliance Operations, CLOVIS ONCOLOGY
17:15 – 17:15

Conference Day One Ends
 

Conference Day Two
 Tuesday, 23 May 2017

8:00 – 8:45
Continental Breakfast
8:45 – 9:00
Chairperson's Recap of Day One
Louise Mawer, Director, MIRABILITAS
 CREATE A CULTURE TO FOSTER INSPECTION SUCCESS
9:00 – 9:45

Implement an Inspection Readiness Plan that Takes Preparedness from Activity Based to Culture Based
Karen Hue, FRQA, Quality Assurance Manager, GCP, EU, INTERCEPT PHARMACEUTICALS
9:45 – 10:30

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
10:30 – 11:00

Networking Break
11:00 – 11:45
Demonstrating Effective Sponsor Oversight to Satisfy Expectations During a Regulatory Inspection
Celia Gibson, GCP Quality Assurance Manager, RENEURON
11:45 – 12:30

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
12:30 – 13:30

Luncheon
 REMAIN IN A STATE OF INSPECTION READINESS
13:30 – 14:15

PANEL: Review the Post-Inspection Activities Conducted by Thought Leaders and Discuss Why These Activities Are Completed
If you are interested in participating in this session, please contact Scott Grossman at [email protected].
14:15 – 15:15
Leverage Internal Auditors to Promote Inspection Readiness as an Organizational Culture
Nina Beck Toubro, Quality Assurance Manager, PHARMACOSMOS
15:15 – 15:45

Networking Break
15:45 – 16:45
PANEL: Maintain an Inspection-Ready TMF
Maria Nymann Jensen, Competency Development Professional, NOVO NORDISK
Nina Beck Toubro, Quality Assurance Manager, PHARMACOSMOS
16:45 – 17:00

Chairperson's Closing Remarks
Louise Mawer, Director, MIRABILITAS
17:00 – 17:00

Conference Concludes
 
 


Speaker Details



Event Categories
HEALTH AND MEDICINE CONFERENCES
,
Healthcare
,
Life Sciences, Biotechnology
,
Technology
Keywords: fun, Clinical , communication , conference , culture, design , development , framework , Fun , identifyin




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