DADM Conference 22-AUG-2017

12. June 2017 16:08 by Ibrahim Kamstrup-Akkaoui in Conference

Dear All,

It is a great pleasure to be able to invite you to an exciting event, with national and internationel topic experts (sign-up form is below the program). Thanks for all your great input on topics!

 

Please sign up immediately and no later than 23-JUN-2017, so that we can arrange the practicalities. Conference including dinner is at a cost of 150 DKK per attendee.

 

DADM Conference 22 Aug 2017

Venue

H. Lundbeck A/S
Ottiliavej 9
2500 Valby

Contact

Katja Bernstein

Payment 150,-

Account number

1551 7952110490 (Danske Bank)

Contact

Lene Haastrup (treasurer)

Schedule

Activity

Speaker(s)

8.30 – 09.00

Breakfast

All

9.00 – 10.30

Coding – Approaches/issues

Lundbeck,

Kirsten Sanggaard, Principal Safety Scientist

Novo Nordisk,

Ajser Serif & Mette Pedersen, Med. Coding Experts

ALK,

Claus K. Ullman, Principal Data Manager

10.45 -11.45    

Handling of pseudo-anonymized (blinded) data in clinical trials

Novo Nordisk, TBD

 

11.45 – 12.30

Lunch

All

12.30 – 13.15

Data integrity

Larix, Majbritt Haugaard Møller, System Validation Expert & Mette Ravn, VP of DM, IT & System Validation

13.30 – 14.00

GDPR - Global Data Protection Regulation

Ferring, Omar Hamidi, Clinical Project Data Manager & Susanne Hjort, Sr Compliance & Process specialist

14.00 – 14.15

Coffee break

All

14.15 – 15.00

eInformed Consent/eSource/Direct data entry

OmniComm, Ken Light, EVP of Corporate Strategy

15.15 – 16.30

Innovation and DM through the crystal ball

ICON, Willie Muehlhausen, VP Head of Innovation

17.30 -

Dinner (self-transport)

All

Looking forward to see you at the event,

DADM Board

 

General Meeting 2017 - Meeting Materials

24. February 2017 14:05 by Ibrahim Kamstrup-Akkaoui in

 

Dear All,

It was great to see so many attendees at the meeting+dinner and special thanks to Anders Mortin from Triticon ApS for a good and insightful presentation on Risk Based Monitoring.

Please find the meeting materials attached.

Kind regards,

DADM Board

General_Meeting_minutes_DADM_2017.doc (39.00 kb)

DADM_GF2017.ppt (1.45 mb)

TriTiCon_Anders_Mortin_RBM_for_DM_DADM_25Jan2017.pdf (3.67 mb)

Suggested_CDM_Risk_Monitoring_and_Data_Review.xlsx (13.99 kb)

Central_Monitoring_Tool_Categories.xlsx (14.68 kb)

General Meeting 2017

8. September 2016 13:21 by Ibrahim Kamstrup-Akkaoui in Meetings

Dear All,

 

Announcement/registration for the DADM General Meeting 2017 - will be held on the 25-Jan-2017 from 15:00-17:30. Hereafter we invite you for dinner at Rungsted Havn.

 

Venue: ALK, Bøge Alle 1, Reception, 2970 Hørsholm

 

15:00 Welcome & General Meeting. Agenda:

1.        Election of chairman

2.        The President’s report

3.        Presentation and approval of financial report

4.        Update of the declaration (Document attached below and changes highlighted in red)

4.        Presentation and approval of budget and activities including endorsement of membership fee

5.        Election of Treasurer, Executive Officers, Alternating Officers, and Auditor

6.        Proposed motions

           - Suggestion from DADM Board to pay President & Treasurer roles (e.g. 2000 DKK/year), as there is a lot of administration associated to these roles.

7.        Miscellaneous

16:00 RBM - Risk-based monitoring

  • Define/interpret the key RBM concepts in CDM terminology and context
  • RBM areas and activities along the study process – map to CDM responsibilities and tasks
  • Present a suggested CDM checklist for RBM: Where to look, how to look, what to do

 

17:30 Off for dinner/See you later 

 

Best regards,

DADM Board

Declaration.docx (20.88 kb)