- Draft process for SM to multiple IMPD: to be discussed at next meeting (following simulation exercise
and CTEG review)
The post-meeting version of the meeting documents are attached.
Thank you for all your contribution to the preparation of this meeting as wel as to the discussion today.
Kind regards,
From:
(SANTE)
Sent: Monday, January 18, 2021 1:08 AM
To:
<
@efpia.eu>;
(SANTE)
<
@ec.europa.eu>;
<
@syneoshealth.com>;
Eskola' <
@efpia.eu>;
<
@acrohealth.org>;
(EMA) <
@ema.europa.eu>;
(EMA)
<
@ema.europa.eu>;
<
@merckgroup.com>;
<
@parexel.com>;
org>;
<
@europabio.org>;
<
@eortc.org>;
<t
@merck.com>;
<
@novartis.com>;
<
@pfizer.com>;
' <
@ccmo.nl>;
<
@aemps.es>;
<
@bfarm.de>;
(EMA)
<
@ema.europa.eu>;
(EMA) <
@ema.europa.eu>;
<
@eortc.org>;
<
@clinrex.com>;
<
@bfarm.de>;
<
@sukl.cz>;
(EMA)
@ema.europa.eu>;
@sukl.cz' <
@sukl.cz>;
(EMA)
@ema.europa.eu>;
(EMA)
<
@ema.europa.eu>;
@bfarm.de'
<
@bfarm.de>;
<
@eortc.org>;
(EMA)
@ema.europa.eu>;
<
@abbvie.com>;
' <
@roche.com>;
- The Guild' <
@the-guild.eu>;
@lakemedelsverket.se'
@lakemedelsverket.se>
Cc:
(SANTE) <
@ec.europa.eu>
Subject: RE: SM/NSM group meeting -- 18 January -- supporting documents with NEW
comments
Dear Colleagues,
Please find attached the meeting documents with compiled additional comments from the
review.
Kind regards,
From:
(SANTE)
Sent: Wednesday, January 13, 2021 12:32 AM
- Draft Q&A on classification and focused review of the general SM/NSM table (14:30-
15:15)
- Discussion of the process for multi-trial IMPD changes/changes to common IMPD
(15:15-15:50)
- Next steps, timelines (15:50-16:00)
The aim of the meeting is to:
- Finalise the draft IMPDQ SM/NSM and GMP/CSC table to support QWP/BWP with
their revision of the corresponding guidance documents;
- Finalise the draft general SM/NSM table and classification Q&A with the aim to
present them to CTEG for adoption and publication on 4 February;
- Progress with the draft process for multi-trial IMPD changes and agree on the test
scenarios for the simulation exercise.
Many thanks to EFPIA for developing the draft IMPDQ and GMP SM/NSM documents
and to ACRO POs/EMA for the critical review of the draft process for multi-trial IMPD
changes.
I ask you to send me any critical comments regarding the attached documents or the
organisation of the meeting by Friday noon.
Please feel free distribute further this message to relevant colleagues within your
organisation in case I accidently missed to include anyone from this mailing list. Also let
me know if you do have not received the webex invitation with the link to join the
meeting.
Kindest regards,
- Pharmaceuticals
European Commission
Directorate-General for Health and Food Safety
Unit B4- Medical products: quality, safety, innovation