6. September 2020 10:37 by Lene Haastrup
Despite the situation, DADM is still going strong. The rules in Pharma have forced us to hold the annual conference online. The conference will take place on 5th of October 2020.
We have collected several speakers and exiting topics, as you see in this program.
After the event, you are invited for dinner in real life in Lyngby.
Please indicate your attendance no later than 1th of October 2020 following this link:
Please e-mail no later than four hours before the dinner, if you are not able to attend. Else the no show fee for the dinner will apply.
You will receive a link to the meeting as a calendar invitation.
DADM Conference 05 October 2020
Only speakers and the board
Novo Nordisk, Vandtårnsvej 108
No show dinner
Lene Haastrup (treasurer)
Welcome & Intro
Katja Bernstein & Frank Jensen
Audit Trail – what is the expectation from DHMA to the Sponsors
Ib Alstrup, DHMA (Lægemiddelstyrelsen)
Questions and break
Implementation of Audit Trail in e-dairies
Jennifer Logue Nielsen, Novo Nordisk
Cloud Computing – in a GxP context
Kasper Nørgaard Andersen, Senior Consultant, AlfaNordic
Data protection – in a clinical context
Data management and GDPR - what should you know?
The most recent news on status as a data controller or data processor and joint controllership
Requirements to agreements with suppliers, security breaches and why transfers of personal data to the U.S. may become a material challenge.
Daiga Grunte-Sonne, Kromann Reumert
To be decided
Investigator Christine Dali
Pre-dinner drink (optional)
2800 Kgs. Lyngby
IB Alstrup, DADM questions raised on beforehand:
- How should sponsors document the system functionality? Are PDF files including the data and pictures of how they were gathered (blank CRFs) sufficient?
- Investigators access to data. Is it fine to revoke the access when sponsor have received acceptance of receipt of the hard drive containing the data from sites?
- Audit trail. Is it fine to have this as PDF file only (hard to search for specific data changes)?
- How much review of the audit trail is expected from the regulators? (Please provide examples of which kind of data and reviews you will expect us to look at) Is it sufficient to look for trends ‘by sites’ and ‘by data items’?
New devices/ways of collecting data:
- Before starting working with a new system, what QC is expected to the audit trail functionality? How is this dependent of whether the system is seen as SAAS (Software As A Service)
- BYOD (Bring Your Own Device). What to focus on when documenting why data is collected this way? – When is better patient compliance outweighing the risk for ‘wrong’ data (registered by someone else or local setting changed)?
- Automatic data collection tools (e.g. activity trackers). What to focus on when documenting which data are used? In general a data mining is taking place and the algorithm is not known to the sponsor. Do we need to archive the raw data, or could the data mining result be defined as raw data?
- Any new device. What to focus on when documenting why this device is used. What kind of mitigations are expected to see?
- How are the documentation dependent on the way sponsors use the software? SAAS or sponsor ‘owned’ – and in what category do we see the mobile apps?