Advanced ICH GCP training | Stockholm

With this training, PharmaRelations will help you implement revision 3 of ICH GCP (E6) and ICH E8(R1) - General considerations for clinical studies in your daily work and organization.

Advanced ICH GCP training
with focus on Sponsor Oversight and the E6 (R3) revision for Enhanced compliance

This training is intended for those clinical professionals that are already involved in clinical trials and need to learn E6(r#) in general, and the sponsor's responsibilies in particular. It will also cover ICH E8 - General considerations for clinical studies as the guidelines goes hand-in-hand.

Apart from the above, the training will also serve as an introduction to risk-based quality management in clinical trials.

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.

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

Register here

Training details

When?

January 23th - 8:30-17:00 hrs (Full-day training)

Where?

Frösundaviks allé 1, 169 70 Solna, Sweden The conference rooms name is WATER & WAVE. It is at the start of the building, down the ramp and to the left.

Price model
Sponsors (Biotech, Pharma, Medtech companies)
3,000 SEK exc. VAT

Standard fee (CROs, Consultant companies, and freelancers)
6,000 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.

Hurry up! Limited number of seats.

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:

You will receive a confirmation email on the same day as 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.