Subject: Round 2 SIGHTSoHO eLearning Training: application procedure is open!
From: <[email-masked]>
To: <[email-masked]>, <[email-masked]>
Cc: <[email-masked]>, <[email-masked]>, "Palmieri Anna" <[email-masked]>, "Denaro Ivan" <[email-masked]>, <[email-masked]>, "Gentile Margherita" <[email-masked]>, <[email-masked]>, <[email-masked]>, "BINDER Alexander" <[email-masked]>
Date: Wed, 4 Dec 2024 19:12:25 +0200

Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga.
Tundmatu saatja korral palume linke ja faile mitte avada.	Dear
Competent Authorities for blood, tissues, cells and organs, 
 
Following up the Save-the-Date message for Round 2 SIGHTSoHO eLearning
Training , we are pleased to inform you that the application procedure is
now open until December 20th, 2024 (23:59 CET) at the following link:
SIGHTSoHO Round 2 APPLICATION FORM
 
IMPORTANT: As anticipated, in order to finalise your application, please
bear in mind that you are required to provide a formal commitment (as
explained in the online training information sheet) to attend the training
modules for which you have expressed interest within one week from the
submission of the application, otherwise your place will be reallocated to
another applicant. The note of commitment, herewith attached in word and
PDF, will have to be signed also by the Competent Authority or your direct
responsible person in order to allow participation without restrictions.
 
For further details on the training, including selection criteria, please
find herewith attached the dedicated Information Sheet.
 
If you need more info, please contact the SIGHTSoHO Team at
[email-masked]. 
 
Best regards,
 
The SoHO team.

European Commission 
DG SANTE (Health and Food Safety)
Unit D2 – Medical Products: quality, safety, innovation

Office address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium 
http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm

 
From: SANTE SOHO 
Sent: Thursday, November 28, 2024 2:47 PM
To: SANTE SOHO &lt;[email-masked]&gt;
Cc: SANTE DL SOHO &lt;[email-masked]&gt;; Pupella Simonetta
&lt;[email-masked]&gt;; Palmieri Anna
&lt;[email-masked]&gt;; Denaro Ivan &lt;[email-masked]&gt;; Di
Ciaccio Paola &lt;[email-masked]&gt;; Gentile Margherita
&lt;[email-masked]&gt;; Claudia Carella
&lt;[email-masked]&gt;; maura mareri &lt;[email-masked]&gt;;
BINDER Alexander (HADEA) &lt;[email-masked]&gt;
Subject: Upcoming Call for Expression of Interest: Round 2 SIGHTSoHO
eLearning Training
 
Dear Competent Authorities,
Get ready!
We are pleased to inform you that the application procedure for Round 2
SIGHTSoHO eLearning training will be opening next week. Given the tight
timeline, the application period will close on December 20th, 2024, at
23:59 CET.
As the holiday season is approaching, we kindly request that you share
this message with your networks to ensure that interested participants can
start planning and be ready to respond quickly when the official call is
launched.
To ensure a smooth application process, please note that you will be
required to provide a formal commitment to attend from both the
participants wishing to join the training modules for which they have
expressed interest and from the Competent Authority or direct responsible
of the applicants, to allow participation without restrictions.
Below, we would like to pre-announce the training dates for your
information and planning purposes:
Round 2 SIGHTSoHO eLearning Training Schedule:
1.  Live Opening Event (for All) - 22/01/25
2.  Week 1: EU legal provisions - 27/01/25 - 31/01/25
3.  Week 2: Licensing, Authorisation and Accreditation System - 03/02/25
– 07/02/25
4.  Week 3: Quality Management System – overview - 10/02/25 – 14/02/25
5.  Week 4: Quality Management System – good practices - 17/02/25 –
21/02/25
6.  Week 5: Quality Risk Assessment - 24/02/25 – 28/02/25
7.  Week 6: BTC Preparation Process Authorisation - 03/03/25 – 07/03/25
8.  Week 7: SoHO Vigilance and Biovigilance - 10/03/25 – 14/03/25
9.  Week 8: Serious Adverse Outcomes/Rapid Alerts and Harmonizing data
collection - 17/03/25 – 21/03/25
10. Week 9: Stock and critical supplies, Import/export, Single coding -
24/03/25 – 28/03/25
11. Week 10: Inspection practice, inspection report and post inspection
Activities - 31/03/25 – 04/04/25
12. Week 11: Risk for inspectorate - 07/04/25 – 11/04/25
13. Live Closing Event (for All) - 30/04/25
Please note that the registration process for this training will be
managed directly by the SIGHTSoHO team. 
Stay tuned for further updates, and we look forward to receiving your
applications soon.
Best regards,
The SoHO team.

European Commission 
DG SANTE (Health and Food Safety)
Unit D2 – Medical Products: quality, safety, innovation

Office address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium 
http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm