9 February 2018 EMA/426724/2014 Rev. 3 Product Development Scientific Support Department
Dates of 2018 SAWP meetings and submission deadlines Scientific advice, protocol assistance, qualification of biomarkers and parallel consultation EMA/EUnetHTA requests
SAWP Meeting dates 2018 1st meeting
8 January – 11 January 2018
2nd meeting
5 February – 8 February 2018
3rd meeting
5 March – 8 March 2018
4th meeting
9 April – 12 April 2018
5th meeting
14 May – 17 May 2018
6th meeting
11 June – 14 June 2018
7th meeting
9 July – 12 July 2018
8th meeting
3 – 6 September 2018
9th meeting
1 – 4 October 2018
10th meeting
29 – 31 October 2018
11th meeting
26 – 29 November 2018
Letter of intent latest template: http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2009/11/ WC500011910.pdf
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
by 8 – 11 Jan 18 5–8 Feb 18 5–8 Mar 18 9 – 12 Apr 18 14 – 17 May 18 11 – 14 Jun 18 9 – 12 Jul 18 3–6 Sep 18 1–4 Oct 18 29 – 31 Oct 18 26 – 29 Nov 18
No
6 Nov 17 8 Dec 17 12 Jan 18 9 Feb 18 16 Mar 18 13 Apr 18 18 May 18 15 Jun 18 10 Aug 18 7 Sep 18 5 Oct 18
SAWP1
SAWP2
D40
Start of
Reports
procedure
discussed
8 – 11
5–8
19 – 22
Jan 18
Feb 18
Feb 18
5–8
5–8
Feb 18
Mar 18
5–8
9 – 12
Mar 18
Apr 18
9 – 12
14 – 17
28 – 31
Apr 18
May 18
May 18
Jun 18
14 – 17
11 – 14
25 – 28 Jun 18
9 – 12
23 – 26
3–6
May 18
Jun 18
Jul 18
Jul 18
Sep 18
11 – 14
9 – 12
23 – 26
3–6
17 – 20 Sep 18
1–4
Jun 18
Jul 18
Jul 18
Sep 18
9 – 12
3–6
17 – 20 Sep 18
1–4
15 – 18
29 – 31
Jul 18
Sep 18
Oct 18
Oct 18
Oct 18
3–6
1–4
15 – 18
29 – 31
12 – 15
26 – 29
Sep 18
Oct 18
Oct 18
Oct 18
Nov 18
Nov 18
1–4
29 – 31
12 – 15
26 – 29
10 – 13
14 – 17
Oct 18
Oct 18
Nov 18
Nov 18
Dec 18
Jan 19
29 – 31
26 – 29
10 – 13
14 – 17
28 – 31
11 – 14
Oct 18
Nov 18
Dec 18
Jan 19
Jan 19
Feb 19
26 – 29
14 – 17
28 – 31
11 – 14
25 – 28
11 – 14
Nov 18
Jan 19
Jan 19
Feb 19
Feb 19
Mar 19
Final briefing package by
SAWP3
D70
Discussion
PRAC endorsement
CHMP adoption
(PASS procedures only)
5–8
19 – 22
9 – 12
Mar 18
Mar 18
Apr 18
19 – 22
9 – 12
23 – 26 Apr 18
14 – 17
Mar 18
Apr 18
23 – 26 Apr 18
14 – 17
28 – 31
11 – 14
May 18
May 18
Jun 18
11 – 14
25 – 28 Jun 18
9 – 12
CHMP Adoption
Meeting
(if required)
by 13 Nov 17 – 22 Dec 17 15 Dec 17 – 26 Jan 18 19 Jan 18 – 23 Feb 18 16 Feb 18 – 28 Mar 18 23 Mar 18 – 3 May 18 23 Apr 18 – 1 Jun 18 25 May 18 – 29 Jun 18 22 Jun 18 – 24 Aug 18 17 Aug 18 – 21 Sep 18 14 Sep 18 – 19 Oct 18 12 Oct 18 – 16 Nov 18
8 – 11 Jan 18 5–8 Feb 18 5–8 Mar 18 9 – 12 Apr 18 14 – 17 May 18 11 – 14 Jun 18 9 – 12 Jul 18 3–6 Sep 18 1–4 Oct 18 29 – 31 Oct 18 26 – 29 Nov 18
1
SAWP 1
Presubmission meeting
Start of procedure
Evaluation phase
Presubmission phase
Letter of Intent by
Yes (exceptionally)
No (default)
Final briefing package by
Draft briefing
Draft briefing
package by
package by
6 Nov 17
6 Nov 17
8 Dec 17
3 Jan 18
8 Dec 17
8 Dec 17
5 Jan 18
31 Jan 18
12 Jan 18
12 Jan 18
2 Feb 18
28 Feb 18
9 Feb 18
9 Feb 18
9 Mar 18
4 Apr 18
16 Mar 18
16 Mar 18
13 Apr 18
8 May 18
13 Apr 18
13 Apr 18
11 May 18
6 Jun 18
18 May 18
18 May 18
8 Jun 18
4 Jul 18
15 Jun 18
15 Jun 18
3 Aug 18
29 Aug 18
10 Aug 18
10 Aug 18
31 Aug 18
26 Sep 18
7 Sep 18
7 Sep 18
28 Sep 18
24 Oct 18
5 Oct 18
5 Oct 18
26 Oct 18
21 Nov 18
Start of procedure 8 – 11 Jan 18 5–8 Feb 18 5–8 Mar 18 9 – 12 Apr 18 14 – 17 May 18 11 – 14 Jun 18 9 – 12 Jul 18 3–6 Sep 18 1–4 Oct 18 29 – 31 Oct 18 26 – 29 Nov 18
Pre face to face teleconference (closed: regulators with HTAs only) 12 – 13 Feb 18 12 – 13 Mar 18 16 – 17 Apr 18 22 – 23 May 18 18 – 19 Jun 18 16 – 17 Jul 18 10 – 11 Sep 18 8 – 9 Oct 18 5 – 6 Nov 18 3 – 4 Dec 18 21 – 22 Jan 19
This deadline pertains to PCC procedures only. For PCI procedures, this deadline could vary due to different national-level procedures.
Jun 30, 2017 - Send a question via our website www.ema.europa.eu/contact ... Start of procedure. Presubmission meeting. Final briefing package by. Parallel.
European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 7 December 2017. EMA/CVMP/SAWP/574285/2017. Committee for Medicinal Products for Veterinary Use (CVMP). Work plan for the CVMP Scientific Advice Working
WPs/For secretariats). Send an email to the members of the relevant WP (cc the WP inbox, if ... following link: https://access.ema.europa.eu/sslvpn. You will find ...
(laptop/desktop) on the MMD login page. Please remember to use the Table of Content document .... Page 9/14. Annex I. Lists of permanent agenda points. AWP.
15 Dec 2016 - application. Furthermore, the Scientific Advice Working Party will bring forward scientific advice to facilitate proactive pharmacovigilance planning, and integrated advice on safety, quality and efficacy .... The SAWP shall pay special
Feb 7, 2018 - Answers to requests for modification. (resubmission following clock-stop). â¢. Modifications to an agreed PIP. â¢. Compliance checks. 12/03/2018. â¢. Initial applications for requests of PIPs and product specific waivers. 26/03/2018.
Apr 25, 2017 - Parallel regulatory HTA advice; R and D platform meeting. 3. 0. 5. 10 ... European network for Health Technology Assessment | JA3 2016-2020 ...
static analysis, i.e. a type system that recognizes pulsing processes; its soundness is stated in ..... has the following algebraic characterization (symmetric laws are omitted). Lemma 2. ..... position. Journal of Computer Security, 17(5), 2009. 4.
laws are not comprised in the structural equivalence relation. In our calculus, 0 is just a shorthand for rec X.X. It is easy to see that our 0 is a neutral element for +, ...
Apr 17, 2018 - 10:25 2.3 How are real-world evidence and patient registries used in benefit-risk evaluation to support early access to medicines. For information J. Moseley (EMA). 10:50 Coffee Break. 11:10 â¢. Discussion points. â Identify points
... Sunday 23rd June Two-day exeat weekend. Friday 5th July Term ends at 1300 â houses locked at 1500. Page 1 of 1. Term dates 2018 - 2019 published.pdf.
Page 1 of 7. FLORIDA YMCA YOUTH IN GOVERNMENT. 2017 - 2018 CALENDAR & DEADLINES. PAGE 1 of 7. LAST UPDATED: 9/27/2017 @ 2:05 PM. FLORIDA YMCA. YOUTH IN GOVERNMENT. Program Year 2017-2018: Dates & Deadlines. All materials can be found on www.floridayi
Jul 20, 2017 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom .... Support to and cooperation with EU institutions and Network.
Nov 15, 2013 - parallel scientific advice from FDA and EMA on issues related to the development phase of a new product. ... License Application (BLA) in the US, or (c) a potential marketing authorization applicant. (MAA) under ... differences, meetin
