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Informal preliminary meeting

The preliminary meeting is an informal optional discussion between the investigator and the bodies that decide or advise on the application. The preliminary meeting takes place before the application is officially submitted. There are no fees for the preliminary meeting.

The investigator can either opt for a preliminary meeting that is attended by all bodies relevant to implementation and advice, or conduct preliminary meetings with each assessment body separately. In the latter case, the investigator needs to contact each body individually by telephone or by email. The rest of this chapter relates to a joint preliminary meeting.

The aim of the preliminary meeting is to exchange information so that, when submitting the application, the investigator submits the correct data with the correct degree of detail and knows which aspects the different bodies focus on during assessment. This approach is intended to enable the official procedures to be completed as quickly as possible.

The preliminary meeting is an informal discussion that falls outside the statutory frameworks because it takes place before the application is officially submitted. The investigator is not obliged to conduct a preliminary meeting. While an investigator may take notes during the preliminary meeting, which may be of use when compiling the documents required for the official submission, the investigator cannot derive any rights from the preliminary meeting (or any notes thereon).

Some practical issues regarding a joint preliminary meeting:

 

Contact Information

Gene Therapy Office
Coordinator: Dr. D.A. Bleijs

PO Box:
PO Box 1
Intern Postvak 1
3720 BA Bilthoven
The Netherlands

Address:
Intern Postvak 1
Antonie van Leeuwenhoeklaan 9
3721 MA Bilthoven
The Netherlands

Tel: +31 30 274 7569
Fax: +31 30 274 4401
Internet: www.loketgentherapie.nl
Email: contact@loketgentherapie.nl

GMO Office, Dr. D.A. Bleijs
+31 30 274 2793
CCMO, Dr K.R.J. Vanmolkot
+31 70 340 6700

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