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Proactive GCP Compliance 2019

Mon, March 18 - Wed, March 20, 2019 Philadelphia, Pennsylvania
The Inn at Penn, a Hilton Hotel 3600 Sansom St Philadelphia, Pennsylvania 19104 United States +1 215-222-0200

About Proactive GCP Compliance 2019

PROACTIVE GCP COMPLIANCE, PHILADELPHIA, MARCH 18-20, 2019

Now in its tenth year, ExL’s Proactive GCP Compliance conference continues to act as the annual forum for both senior-level clinical quality and clinical operations executives to gather, learn and discuss strategies to achieve and maintain global GCP compliance. Join us to learn how to effectively build quality risk management approaches into your clinical operations to optimize research, maintain GCP compliance, contain costs and ensure patient safety.

Top Five Reasons to Attend

  • This is the original GCP event and the only event with a longstanding history of delivering quality education and attracting a senior-level audience comprised of clinical quality, compliance, and operations professionals with the power to influence industry change.
  • This influential event has become the annual gathering of senior-level clinical executives and acts as a candid forum to share experiences, conduct meaningful conversations and make valuable connections.
  • Benefit from educational sessions on topics identified through intensive industry research to be the most critical issues surrounding and barriers to achieving GCP compliance, including identifying risk indicators, measuring compliance, risk-based monitoring, inspection readiness, quality by design, vendor oversight, clinical CAPAs, quality systems implementation and many more.
  • Case study presentations from renowned industry leaders spearheading the development and implementation of proactive risk-based approaches to managing quality in clinical research, representing companies of all sizes.
  • Customizable agenda allows you to choose your preferred topics and learning environment with interactive workshops, session tracks, educational presentations, interactive panels, intimate roundtables and ample networking opportunities.

Who Should Attend

This conference is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical trial service providers whose responsibilities involve the following:

  • Good Clinical Practice (GCP)
  • Clinical Quality Assurance (CQA)
  • Clinical Quality Control (CQC)
  • Clinical Trial Operations/Management
  • Clinical Research
  • Quality Management/Global Quality Management
  • Audits/Inspections
  • Compliance/Global Compliance
  • Data Management/Systems Operations
  • Clinical Monitoring
  • Regulatory Affairs
  • Safety and Risk Management/Operations

 

About Proactive GCP Compliance 2018

PROACTIVE GCP COMPLIANCE, PHILADELPHIA, MARCH 19-21, 2018

Now in its ninth year, ExL’s Proactive GCP Compliance conference continues to act as the annual forum for both senior-level clinical quality and clinical operations executives to gather, learn and discuss strategies to achieve and maintain global GCP compliance. Join us to learn how to effectively build quality risk management approaches into your clinical operations to optimize research, maintain GCP compliance, contain costs and ensure patient safety.

Top Five Reasons to Attend

  • This is the original GCP event and the only event with a longstanding history of delivering quality education and attracting a senior-level audience comprised of clinical quality, compliance, and operations professionals with the power to influence industry change.
  • This influential event has become the annual gathering of senior-level clinical executives and acts as a candid forum to share experiences, conduct meaningful conversations and make valuable connections.
  • Benefit from educational sessions on topics identified through intensive industry research to be the most critical issues surrounding and barriers to achieving GCP compliance, including identifying risk indicators, measuring compliance, risk-based monitoring, inspection readiness, quality by design, vendor oversight, clinical CAPAs, quality systems implementation and much more.
  • Case study presentations from renowned industry leaders spearheading the development and implementation of proactive risk-based approaches to managing quality in clinical research, representing companies of all sizes.
  • Customizable agenda allows you to choose your preferred topics and learning environment with interactive workshops, session tracks, educational presentations, interactive panels, intimate roundtables and ample networking opportunities.

Who Should Attend

This conference is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical trial service providers whose responsibilities involve the following:

  • Good Clinical Practice (GCP)
  • Clinical Quality Assurance (CQA)
  • Clinical Quality Control (CQC)
  • Clinical Trial Operations/Management
  • Clinical Research
  • Quality Management/ Global Quality Management
  • Audits/Inspections
  • Compliance/Global Compliance
  • Data Management/Systems Operations
  • Clinical Monitoring
  • Regulatory Affairs
  • Safety and Risk Management/Operations

About 8th Proactive GCP Compliance 2017

8th Proactive GCP Compliance, April 05-07, 2017:

What is this event?

Proactive GCP Compliance event will bring senior-level clinical quality and clinical operations executives together to learn and discuss strategies to achieve and maintain global GCP compliance.

Event will explain how effectively build quality risk management approaches into your clinical operations to optimize research, maintain GCP compliance, contain costs and ensure patient safety.

Where is this event located?

This event will take place at Sonesta Philadelphia Rittenhouse Square, 1800 Market Street, Philadelphia, Pennsylvania, USA.

Who should attend this event?

This conference is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical trial service providers.

What are some highlights of this event?

Event Highlights:

  • The Changing Landscape Of Clinical Quality And Compliance
  • Regulatory Changes To GCP
  • Applying Best Practices From GMP
  • Alexion Case Study: Quality By Design
  • Eisai Case Study: Clinical Quality Management Plan
  • Clinical Data Integrity
  • Top Concerns And Challenges

 Faculty:

  • Katie Alberta
  • Nathalie Bourgouin, PMP
  • Dwayne Brazelton
  • Celeste M. Gonzalez
  • Fiona Jeitner

Why should I attend this event?

By attending this event you will walk away with:

  • Develop and Execute an Effective Clinical Quality Management Plan to Ensure GCP Compliance.
  • Utilize Quality by Design Principles to Optimize Compliance and Data Integrity.
  • Report on the Progress of Executing a Risk-Based Monitoring Approach and Effectively Overcoming Implementation Challenges.
  • Leverage the Trial Master File as a Tool to Proactively Identify Risk Areas.

 

 

About 7th Proactive GCP Compliance

7th Proactive GCP Compliancewill take place March 14-16,2016 at The Sonesta Hotel Philadelphia , Pennsylvania , USA. The conference will focus on how to effectively build quality risk management approaches into your clinical operations to optimize research, maintain GCP compliance, contain costs and ensure patient safety. The 3-day sessions program includes variety of topics, such as: MEASURING AND ASSESSING RISK RISK-BASED MONITORING PREPARATION SUCCESSFUL RBM IMPLEMENTATION EFFECTIVE SITE MONITORING INSPECTIONS AROUND THE WORLD GCP QUALITY AGREEMENTS RISK INDICATORS QUALITY BY DESIGN RISK MANAGEMENT AT SMALL TO MID-SIZED COMPANIES RISK-BASED MONITORING PLAN AUDITING RISK-BASED MONITORED TRIALS MHRA INSPECTIONS VENDOR AUDIT MANAGEMENT TRIAL MASTER FILE GCP COMPLIANCE IN LATE PHASE RESEARCH CLINICAL CAPAs Who Should Join: This conference is designed for professionals from pharmaceutical, biotechnology and medical device companies with responsibilities in the following areas: • Good Clinical Practice/GCP • Clinical Quality Assurance/CQA • Clinical Quality Control/CQC • Clinical Trial Operations/Management • Clinical Research • Audits/Inspections • Quality Management/Global Quality Management • Compliance/Global Compliance • Data Management/Systems Operations • Clinical Monitoring • Regulatory Affairs • Safety and Risk Management/Operations

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