Wednesday 25th October 2023, 10.30am to 3.00pm, including a lunch break .
Venue: Copenhagen

Content includes*:

Brief overview of significant new requirements ICH E6(R3) may bring for sponsors and investigators, and what E8(R1) does bring.

Trial Master File … a reminder of key requirements to avoid inspection findings, and ‘essentiality’ of documents – a requirement introduced in ICH GCP E6(R3).

Using computerised systems like EDC and ePRO in clinical trials … the new EMA guideline and its practical impact on clinical trial activities - a look at what matters to trial management and investigator site (leaving aside validation, testing and all that stuff!).

Serious breach reporting – practising the requirement in the UK and Europe.

*Content may change in the event of significant new developments.

£695 ex VAT per participant. Contact us for group discounts.