PRAC: meeting archive 2015-2017

This is an archive of the meeting highlights, agendas and minutes from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) in 2015 to 2017.

Meeting highlights

2017

• Meeting highlights from PRAC 27 - 30 November 2017
• Meeting highlights from the PRAC 23 - 26 October 2017
• Meeting highlights from the PRAC 25 - 29 September 2017
• Meeting highlights from the PRAC 29 August - 1 September 2017
• Meeting highlights from the PRAC 3 - 6 July 2017
• Meeting highlights from the PRAC 6 - 9 June 2017
• Meeting highlights from the PRAC 2 - 5 May 2017
• Meeting highlights from the PRAC 3 - 6 April 2017
• Meeting highlights from the PRAC 6 - 9 March 2017
• Meeting highlights from the PRAC 6 - 9 February 2017
• Meeting highlights from the PRAC 9 - 12 January 2017

2016

• Meeting highlights from the PRAC 28 November - 1 December 2016
• Meeting highlights from the PRAC 24 - 27 October 2016
• Meeting highlights from the PRAC 26 - 29 September 2016
• Meeting highlights from the PRAC 30 August - 2 September 2016
• Meeting highlights from the PRAC 4 - 8 July 2016
• Meeting highlights from the PRAC 6 - 9 June 2016
• Meeting highlights from the PRAC 10 - 13 May 2016
• Meeting highlights from the PRAC 11 - 14 April 2016
• Meeting highlights from the PRAC 14 - 17 March 2016
• Meeting highlights from the PRAC 8 - 11 February 2016
• Meeting highlights from the PRAC 11 - 14 January 2016

2015

• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 November - 3 December 2015
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-5 November 2015
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 October 2015
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 September 2015
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2015
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2015
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 May 2015
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2015
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2015
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 February 2015
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 January 2015

Agendas

Agenda - PRAC draft agenda of meeting 27-30 November 2017

Draft Reference Number: EMA/PRAC/785853/2017

Agenda - PRAC draft agenda of meeting 23-26 October 2017

Draft Reference Number: EMA/PRAC/707172/2017

Agenda - PRAC draft agenda of meeting 25-29 September 2017

Draft Reference Number: EMA/PRAC/634126/2017

Agenda - PRAC draft agenda of meeting 29 August-1 September 2017

Draft Reference Number: EMA/PRAC/568796/2017 Summary:

Draft agenda for the meeting on 29 August-1 September 2017

Agenda - PRAC draft agenda of meeting 3-6 July 2017

Draft Reference Number: EMA/PRAC/423016/2017

Agenda - PRAC draft agenda of meeting 6-9 June 2017

Draft Reference Number: EMA/PRAC/355498/2017

Agenda - PRAC draft agenda of meeting 2-5 May 2017

Draft Reference Number: EMA/PRAC/280563/2017

Agenda - PRAC draft agenda of meeting 3-6 April 2017

Draft Reference Number: EMA/PRAC/227083/2017

Agenda - PRAC draft agenda of meeting 6-9 March 2017

Draft Reference Number: EMA/PRAC/159496/2017

Agenda - PRAC draft agenda of meeting 6-9 February 2017

Draft Reference Number: EMA/PRAC/35833/2017

Agenda - PRAC draft agenda of meeting 9-12 January 2017

Draft Reference Number: EMA/PRAC/816784/2016

Agenda - PRAC draft agenda of meeting 28 November - 1 December 2016

Draft Reference Number: EMA/PRAC/724425/2016

Agenda - PRAC draft agenda of meeting 24-27 October 2016

Draft Reference Number: EMA/PRAC/637685/2016 Summary:

Pharmacovigilance Risk Assessment Committee (PRAC) - Draft agenda for the meeting on 24-27 October 2016

Agenda - PRAC draft agenda of meeting 26-29 September 2016

Draft Reference Number: EMA/PRAC/635914/2016

Agenda - PRAC draft agenda of meeting 30 August – 2 September 2016

Draft Reference Number: EMA/PRAC/495379/2016 Rev. 1

Agenda - PRAC draft agenda of meeting 30 November-3 December 2015

Draft Reference Number: EMA/PRAC/808595/2015 Summary:

Draft agenda for the meeting on 30 November – 3 December 2015

Agenda - PRAC draft agenda of meeting 4-8 July 2016

Draft Reference Number: EMA/PRAC/463028/2016

Agenda - PRAC draft agenda of meeting 6-9 June 2016

Draft Reference Number: EMA/PRAC/231459/2016

Agenda - PRAC draft agenda of meeting 10-13 May 2016

Draft Reference Number: EMA/PRAC/325452/2016

Agenda - PRAC draft agenda of meeting 11-14 April 2016

Draft Reference Number: EMA/PRAC/262317/2016

Agenda - PRAC draft agenda of meeting 14-17 March 2016

Draft Reference Number: EMA/PRAC/199507/2016 Corr.

Agenda - PRAC draft agenda of meeting 8-11 February 2016

Draft Reference Number: EMA/PRAC/94187/2016

Agenda - PRAC draft agenda of meeting 11-14 January 2016

Draft Reference Number: EMA/PRAC/22240/2016 Summary:

Pharmacovigilance Risk Assessment Committee (PRAC) - Draft agenda for the meeting on 11-14 January 2016

Agenda - PRAC draft agenda of meeting 3-6 November 2015

Draft Reference Number: EMA/PRAC/727372/2015

Agenda - PRAC draft agenda of meeting 5-8 October 2015

Draft Reference Number: EMA/PRAC/656971/2015 Summary:

Pharmacovigilance Risk Assessment Committee (PRAC) - Draft agenda for the meeting on 5-8 October 2015

Agenda - PRAC draft agenda of meeting 7-10 September 2015

Draft Reference Number: EMA/PRAC/596669/2015

Agenda - PRAC draft agenda of meeting 6-9 July 2015

Draft Reference Number: EMA/PRAC/455682/2015

Agenda - PRAC draft agenda of meeting 8-11 June 2015

Draft Reference Number: EMA/PRAC/386470/2015 Summary:

Draft agenda for the meeting on 08-11 June 2015

Agenda - PRAC draft agenda of meeting 4-7 May 2015

Draft Reference Number: EMA/PRAC/59170/2015

Agenda - PRAC draft agenda of meeting 7-10 April 2015

Draft Reference Number: EMA/PRAC/59170/2015

Agenda - PRAC draft agenda of meeting 9-12 March 2015

Draft Reference Number: EMA/PRAC/644853/2014

Agenda - PRAC draft agenda of meeting 9-12 February 2015

Draft Reference Number: EMA/PRAC/92670/2015 Summary:

Draft agenda for the meeting on 09-12 February 2015

Agenda - PRAC draft agenda of meeting 6-9 January 2015

Draft Reference Number: EMA/PRAC/9223/2015

Minutes

Minutes of the PRAC meeting 27-30 November 2017

Adopted Reference Number: EMA/PRAC/64990/2018

Minutes of the PRAC meeting 23-26 October 2017

Adopted Reference Number: EMA/PRAC/782491/2017

Minutes of the PRAC meeting 25-29 September 2017

Adopted Reference Number: EMA/PRAC/782068/2017

Minutes of the PRAC meeting 29 August -1 September 2017

Adopted Reference Number: EMA/PRAC/701894/2017 Summary:

Pharmacovigilance Risk Assessment Committee (PRAC) minutes for the meeting on 29 August -1 September 2017

Minutes of the PRAC meeting 3-6 July 2017

Adopted Reference Number: EMA/PRAC/631448/2017

Minutes of the PRAC meeting 6-9 June 2017

Adopted Reference Number: EMA/PRAC/478147/2017

Minutes of the PRAC meeting 2-5 May 2017

Adopted Reference Number: EMA/PRAC/419638/2017 Summary:

Pharmacovigilance Risk Assessment Committee (PRAC) - Minutes of the meeting on 2-5 May 2017

Minutes of the PRAC meeting 3-6 April 2017

Adopted Reference Number: EMA/PRAC/271304/2017

Minutes of the PRAC meeting 6-9 March 2017

Adopted Reference Number: EMA/PRAC/287540/2017

Minutes of the PRAC meeting 6-9 February 2017

Adopted Reference Number: EMA/PRAC/286717/2017

Minutes of the PRAC meeting 9-12 January 2017

Adopted Reference Number: EMA/PRAC/243286/2017

Minutes of the PRAC meeting 28 November - 1 December 2016

Adopted Reference Number: EMA/PRAC/237221/2017

Minutes of the PRAC meeting 24-27 October 2016

Adopted Reference Number: EMA/PRAC/127425/2017

Minutes of the PRAC meeting 26-29 September 2016

Adopted Reference Number: EMA/PRAC/123588/2017 Summary:

Pharmacovigilance Risk Assessment Committee (PRAC) - Minutes of the meeting on 26-29 September 2016

Minutes of the PRAC meeting 30 August - 2 September 2016

Adopted Reference Number: EMA/PRAC/693633/2016

Minutes of the PRAC meeting 04-08 July 2016

Adopted

Minutes of the PRAC meeting 06-09 June 2016

Adopted Reference Number: EMA/PRAC/460046/2016

Minutes of the PRAC meeting 10-13 May 2016

Adopted Reference Number: EMA/PRAC/457201/2016

Minutes of the PRAC meeting 11-14 April 2016

Adopted Reference Number: EMA/PRAC/319149/2016 Summary:

Minutes of the PRAC meeting on 11-14 April 2016

Minutes of the PRAC meeting 14-17 March 2016

Adopted Reference Number: EMA/PRAC/259752/2016 Summary:

Minutes of the PRAC meeting on 14-17 March 2016

Minutes of the PRAC meeting 08-11 February 2016

Adopted Reference Number: EMA/PRAC/251925/2016

Minutes of the PRAC meeting 11-14 January 2016

Adopted Reference Number: EMA/PRAC/92676/2016 Summary:

Some of the information contained in the minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also change during the course of the review.

Minutes of the PRAC meeting 30 November - 3 December 2015

Adopted Reference Number: EMA/PRAC/75116/2016

Minutes of the PRAC meeting 3-6 November 2015

Adopted Reference Number: EMA/PRAC/799709/2015

Minutes of the PRAC meeting 5-8 October 2015

Adopted Reference Number: EMA/PRAC/725044/2015

Minutes of the PRAC meeting 7-10 September 2015

Adopted Reference Number: EMA/PRAC/722174/2015

Minutes of the PRAC meeting 6-9 July 2015

Adopted Reference Number: EMA/PRAC/269153/2015 Summary:

In accordance with the Agency’s health and safety policy, delegates were briefed on health, safety and emergency information and procedures prior to the start of the meeting.

Minutes of the PRAC meeting 8-11 June 2015

Adopted Reference Number: EMA/PRAC/443961/2015

Minutes of the PRAC meeting 4-7 May 2015

Adopted Reference Number: EMA/PRAC/59170/2015 Summary:

In accordance with the Agency’s health and safety policy, delegates were briefed on health, safety and emergency information and procedures prior to the start of the meeting.

Minutes of the PRAC meeting 7-10 April 2015

Adopted Reference Number: EMA/PRAC/332948/2015 Summary:

Minutes of the meeting on 7-10 April 2015

Minutes of the PRAC meeting 9-12 March 2015

Adopted Reference Number: EMA/PRAC/257790/2015 Summary:

Minutes of the PRAC meeting 9-12 March 2015

Minutes of the PRAC meeting 9-12 February 2015

Adopted Reference Number: EMA/PRAC/147021/2015

Minutes of the PRAC meeting 6-9 January 2015

Adopted Reference Number: EMA/PRAC/54777/2015 Summary:

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