May 3, 9:30am – 11:00am ET
This webinar is a comprehensive review of the changes included in revision 2 of the ICH E6 guidance. It is designed for anyone who is looking for a broad understanding of the changes, or is in the process of adopting the changes in readiness for compliance.
Delivered by our in house expert, Tammy Finnigan who has already been responsible for training over 1000 people on the R2 changes, and is actively engaged in running R2 compliant trials on a day to day basis.
Cost: $199 per person. Group training discounts available on request.
Why is it important?
With ICH GCP E6 revision 2 (referred to as “R2”) now finalized and adopted by EMA and FDA, all companies developing drugs which will be licensed in member countries will need to be compliant and be able to prove compliance to R2.
R2 impacts roles, processes and technology and for many companies will require a major mind set and operational approach change.
This training event is a fast and cost effective way to ensure that you and your organisation understand what the changes are, how they will impact your organisation and how to start a program of implementation activities.
All attendees will receive a signed certificate of attendance for your training files and a copy of the training materials for future reference.
The webinar will cover the following:
- What was the timeline for the changes, and what were the adoption timelines for EU and US regulatory agencies?
- What are the key components of the changes and what do they mean in terms of processes, roles and technology?
- What is the relationship between the changes and central / risk-based monitoring?
- What will it take to be compliant with the changes?
- What will it take to implement the changes?
- What solutions can be adopted to enable compliance?
- What your adoption road map should look like?
Who Should Attend This Training?
The impact of R2 is far reaching. Clinical operations, QA, data management, safety, project management, biostats, medical writing and sites will all be impacted.
Anyone from those functions involved in the day to day design and delivery of clinical trials will need to understand the changes.
Anyone involved in helping their organisation prepare for R2 will also find this event very valuable.
What does that include?
- The 1 1/2 hour web based training session
- A copy of the training materials
- A certificate of attendance, signed by the trainer
To Register, click here
Once you have registered you will be sent an invoice for the training to your email address. This can be paid for by credit card or PayPal.
Once we have received your payment you will receive your joining instructions and the pre-course materials.
Thank you – we look forward to meeting you at the course !