ICH E6(R2)
Key Changes, Implementation and Being Prepared to Address Inspection Questions

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!

LEARNING OBJECTIVES
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.