Key Changes in GCP,
Implementation and Being Prepared to Address Inspection Questions

Date: 26 November 2018
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 1 - Day Course
Hours: 9:00 – 17:00
Price: 1,950 NIS + VAT
Credit Points: 1
SKU: 18977
Course Language: English
About the Course
Attending this one-day course will help you fully understand the ICH E6(R2) changes that impact our industry and how one can ensure compliance as soon as possible. Identify how the changes specifically impact roles/processes/responsibilities and how to best strategize and execute solutions that will safeguard not only data and patients but also your employees and company.

Major changes to ICH E6(R1) became effective on 14 June 2017, impacting how pharmaceutical companies should develop and manage clinical trials, and most importantly, assure data integrity and patient safety.
Has your company updated employee mindset, procedures, and documentation to support compliance?  
Global regulators have long agreed on ICH principals, making ICH guidance the most followed and inspected against throughout the world.  Since first being released in 1996, the original ICH E6(R1) principals have been successfully indoctrinated into our daily practices. It’s challenging to shift our personal and company-wide mindset and embrace change. ICH guidance is not law; it’s easy to place incorporation of the changes low on the priority list in the midst of a busy daily schedule and established company mindset and goals, not to mention all those fires that need fighting. ICH remains the regulatory glue that global programs rely on and that bonds global regulators together.  
When they come to visit, the new version will be in their pocket. Don’t be caught off guard!

At the completion of this session, you will be able to:
  • Understand and discuss the ICH E6(R2) changes
  • Execute a gap analysis to identify how the ICH E6(R2) will specifically impact your company
  • Identify strategies for closing any gaps you have identified
  • Determine how to best document your gap analysis and strategy to demonstrate your due diligence considering that the guidance has been in effect for over a year.
Who should attend
This course will be of benefit to employees working in a GCP regulated environment who set strategy for, manage, execute, and/or audit pharmaceutical clinical trial activities, including but not limited to:
  • Clinical Development
  • Clinical Operations
  • Quality Systems (Quality Assurance, Training, Document Management, etc.)
  • Data Management
  • Information Technology
  • Drug Safety/Pharmacovigilance
Benefits to the Participants
  • Gain an understanding of ICH E6(R2)
  • Learn how ICH E6(R2) impacts Clinical Trial Management and Documentation
  • Acquire strategies for managing organizational, process, and document changes needed for ICH E6(R2) compliance
  • Obtain an ICH E6(R2) gap analysis tool template that can be used immediately
Contact us
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  • Email
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Issues to be covered
  • Introduction to ICH E6(R2)
  • Historical Overview of ICH
  • New terms and concepts introduced by the ICH E6(R2)
  • The expanded risk assessment principals in ICH E6(R2) and strategies for implementation
  • The impact of the ICH E6(R2) on long-standing clinical trial regulations and industry standards
  • New company roles, responsibilities, and skillsets that may be needed for ICH E6(R2) implementation
  • The ICH E6(R2) impact to vendor relationships, contractual agreements and oversight
  • How to create and document a compliance strategy as soon as possible
About The Lecturer

Ms. Penelope Przekop

Penelope Przekop, RQAP-GCP, is a Quality Management Systems, Assurance & Compliance Consultant with 25 plus years of experience in Pharmaceutical GXP Global Quality Systems with key focus in clinical research and development, data management, computer systems validation, and pharmacovigilance. Her areas of expertise include quality systems quality assurance, regulatory compliance, inspection readiness, training, and strategic planning for quality.
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