13 March 2018 EMA/PDCO/450556/2016 Rev.1 Procedure Management and Committees Support Division

Paediatric Committee (PDCO) meetings in 2016, 2017 and 2018

2016 1

20171

20181 2

January

27, 28, 29

24, 25, 26, 27

23, 24, 25, 26

February

24, 25, 26

21, 22, 23, 24

20, 21, 22, 23

March

30, 31, 01

21, 22, 23, 24

20, 21, 22, 23

April

27, 28, 29

18, 19, 20, 21

24, 25, 26, 27

May

25, 26, 27

17, 18, 19

29, 30, 31, 1

June

22, 23, 24

20, 21, 22, 23

26, 27, 28, 29

July

20, 21, 22

18, 19, 20, 21

24, 25, 26, 27

August

17, 18, 19

15, 16, 17, 18

21, 22, 23, 24

September

14, 15, 16

12, 13, 14, 15

18, 19, 20, 21

October

12, 13, 14

10, 11, 12, 13

16, 17, 18, 19

November

08, 09, 10, 11

07, 08, 09, 10

13, 14, 15, 16

December

13, 14, 15, 16

12, 13, 14, 15

11, 12, 13, 14

Month

1

From November 2016 onwards the PDCO will start at 14:00hrs on the first meeting date. The extension of the PDCO will be subject to amendment depending on the workload of the committee. 2 PDCO meeting in August replaced by written procedure 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

An agency of the European Union

© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

PDCO meeting dates 2016, 2017 and 2018 - European Medicines ...

Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website www.ema.europa.eu/contact. © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 13 March 2018. EMA/PDCO/450556/2016 Rev.1. Procedure Management and ...

74KB Sizes 22 Downloads 254 Views

Recommend Documents

PDCO meeting dates 2019, 2020 and 2021 - European Medicines ...
Feb 28, 2018 - Inspections, Human Medicines Pharmacovigilance and Committees Division. Paediatric Committee (PDCO) meetings in 2019, 2020 and 2021. Month. 2019. 2020. 2021. January. 29, 30, 31 January and 1 February. 28, 29, 30, 31. 26, 27, 28, 29. F

PRAC meeting dates 2016-2018 - European Medicines Agency
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website www.ema.europa.eu/contact. © European Medicines Agency ...

Management Board meeting dates 2017-2018 - European Medicines ...
Jun 16, 2016 - Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website www.ema.europa.eu/contact. © European ...

European Medicines Agency meeting and holiday dates - 2018
Aug 9, 2017 - An agency of the European Union. Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website ...

Management Board meeting dates 2017 - 2019 - European Medicines ...
Jun 15, 2017 - relocation of the Agency, it might be necessary to hold extraordinary meetings solely dedicated to. Brexit-related topics. In such cases, the ...

CHMP meeting dates 2019, 2020 and 2021 - European Medicines ...
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website www.ema.europa.eu/contact. © European Medicines Agency ...

Management Board meeting dates 2019- 2021 - European Medicines ...
Jun 6, 2018 - 2021 as follows: Management Board sessions 2019. 103rd Management Board. Thursday, 21 March. 104th Management Board. Wednesday ...

Monthly report PDCO 29 May-01 June 2018 - European Medicines ...
Jun 1, 2018 - The PDCO adopted opinions on the refusal of a request for waiver for: •. Liposomal ciclosporin A (L-CsA), EMEA-002344-PIP01-18, from Breath ...

PDCO minutes 20-23 March 2018 - European Medicines Agency
Mar 23, 2018 - 10. 2.1.8. Tenofovir Alafenamide / Emtricitabine - EMEA-001577-PIP03-17 . ...... patients from 6 months to less than 18 years old.

Monthly report PDCO 18-21 April 2017 - European Medicines Agency
Apr 24, 2017 - ... or national competent authorities, as part of an application for a .... EMEA-001760-PIP01-15-M02, from Eli Lilly and Company Limited, for the ...

PDCO Minutes 15-18 August 2017 - European Medicines Agency
Oct 17, 2017 - deemed to contain commercially confidential information. 2.1. ... Eli Lilly and Company Limited; Treatment of intestinal malignant neoplasm, ... Merck Sharp & Dohme (Europe), Inc.; Treatment of abdominal and gastrointestinal.

Monthly report PDCO 8-11 November 2016 - European Medicines ...
Nov 16, 2016 - ... EMEA-001860-PIP04-16, from Eli Lilly and Company Limited, for the ... or national competent authorities, as part of an application for a.

Monthly report PDCO 23-26 January 2018 - European Medicines ...
Jan 26, 2018 - aims to generate the necessary quality, safety and efficacy data through studies to support the authorisation of the medicine for use in children of all ages. .... of Philadelphia chromosome (BCR-ABL translocation)-positive chronic mye

Monthly report PDCO 20-23 February 2018 - European Medicines ...
Mar 6, 2018 - haemagglutinin from strain B Victoria lineage / influenza virus haemagglutinin from strain B. Yamagata lineage (expressed as virus-like particle [VLP]), EMEA-002220-PIP01-17, from. Medicago ... aims to generate the necessary quality, sa

PDCO work plan 2017 - European Medicines Agency - Europa EU
Jan 27, 2017 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the European Union. Telephone +44 (0)20 3660 .... best available scientific expertise in the Network and ensure that paediatric information related

Monthly report PDCO 8-11 November 2016 - European Medicines ...
Nov 16, 2016 - Pharmaceuticals Ireland Ltd, for the treatment of infectious conjunctivitis;. •. Eculizumab, EMEA-000876-PIP03-14, from Alexion Europe SAS .... The PDCO and CHMP discussed proposals for improving inter- committee interactions, extrap

PDCO minutes of the 27-29 April 2016 meeting - European Medicines ...
Jun 1, 2016 - Note on access to documents ..... Discussion of applications. 20 ..... List of letters of intent received for submission of applications with start of procedure ..... incentives for the development for use in the paediatric population a

PDCO minutes 20-23 March 2018 - European Medicines Agency
Mar 23, 2018 - 20 March 2018, 17:30- 19:00, room 3A. 21 March ...... involvement of Committee members and experts in line with the relevant provisions of.

PDCO minutes 24-27 April 2018 - European Medicines Agency
Inspections, Human Medicines Pharmacovigilance and Committees Division ...... Rhythm Pharmaceuticals, Inc; Treatment of appetite and general nutrition ...

PDCO minutes 24-27 April 2018 - European Medicines Agency
The new modified opinion supersedes the previous PDCO opinion. 2.3.22. Etelcalcetide - EMEA-001554-PIP01-13-M02. Amgen Europe B.V.; Hyperparathyroid ...

CAT meetings 2016, 2017, 2018 - European Medicines Agency
May 3, 2016 - Send a question via our website www.ema.europa.eu/contact. © European Medicines Agency, 2016. Reproduction is authorised provided the ...

PDCO Monthly report 22-24 June 2016 - European Medicines Agency
Jun 30, 2016 - The PDCO adopted a positive opinion on (full) compliance check for: ... and the Paediatric Regulation is available in the Regulatory section.

PDCO minutes of the 27-29 April 2016 meeting - European Medicines ...
Jun 1, 2016 - to documents within the framework of Regulation (EC) No 1049/2001 as they are ...... The PDCO re-discussed the compliance request on 27 April 2016 also taking into account the .... defined by clinical or imaging features.

Minutes PDCO 18 - 21 July 2017 - European Medicines Agency
6 days ago - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom ...... Treatment of ischemic stroke to improve recovery .... Treatment of all conditions included in the category of malignant neoplasms (except central ..... The