Advanced ICH GCP training

Are you ready for the update of ICH GCP E6/E8? Take a proactive approach with a focus on sponsor oversight.

Advanced ICH GCP training
with focus on Sponsor Oversight and upcoming revision (R3)

With this training, PharmaRelations will help you to pre-plan and implement the upcoming revision in your daily work and organization. We will train you in the current guidelines and highlight the important changes in the ongoing revision – with a focus on sponsor oversight.

This training is intended for those clinical research professionals who are already involved in clinical trials and need to know more about the sponsor's responsibilities as laid out in the Good Clinical Practice guidelines (GCP). It will specifically cover risk – and quality management and sponsor oversight.

When ICH E6(R2) came into effect in 2016, new requirements on sponsors' responsibility for risk-based quality management were introduced. Even though this was several years ago, it is evident (based on published inspection findings report) that sponsors still struggle to find a way of working with risk-based approaches. With ICH E8(R1), General considerations for clinical studies, that came into effect in 2022, quality by design was further encouraged.

Apart from covering ICH requirements on these topics, we will discuss risks; identification, analysis & categorization, and planning as well as quality improvement.

It will be an interactive training with lots of discussions and some group exercises so it is recommended to come prepared.

After this course, you will have a deep understanding of:

The Sponsor's responsibilities in Clinical Trials
How to start building quality into the design of the trials
How to identify critical-to-quality factors
The differences in E6 R2 and R3 (according to the draft version)
ICH E8(R1)

When?

January 25th - 8:00 hrs (Full-day training)

Where?

Frösundaviks Allé 1, Stockholm, Sweden

Price model

Sponsors (Biotech, Pharma, Medtech companies)

2500 SEK exc. VAT

Standard fee (CROs, Consultant companies, and freelancers)

5,000 SEK exc. VAT

If there are 5 or more people joining from the same organization, we provide a special price. Please contact beatrice.ostrom@pharmarelations.se directly by sending an email

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Meet the trainer

Anneli Hallmin

Anneli has more than 30 years within the Pharma industry 20 of those within Clinical Trials. Annelie has worked in many different roles at both Big Pharma and Small Biotech.

Sr CRA, Project- and Clinical Study Manager at both regional and global level
GCP Expert and SOP writer
Dedicated GCP & Process Manager

Terms & conditions

Registration is binding and when you have received our confirmation the following conditions are known and accepted.

Registration is irrevocable but not personal. If you are unable to attend, substitution with a colleague from the same company is possible.

Confirmation:

A confirmation will be sent to you by e-mail within 10 working days after your registration.

Payment

An invoice will be sent to you after your booking has been confirmed. Payment terms are 20 Days.

Participation fee and VAT

All prices and participation fees are per person and excluding VAT.

Cancellation and change of event date from the organizer PharmaRelations

PharmaRelations owns the right to cancel or change the dates of an event. In such a case, you will be refunded the full participation fee. We do not reimburse any other costs you may have had in conjunction with the cancellation.