Management Board: Meetings 2011

72nd meeting, 8-9 June 2011

Agenda - 72nd meeting of the Management Board

AdoptedReference Number: EMA/MB/234822/2011

Agenda - 72nd meeting of the Management Board

AdoptedReference Number: EMA/MB/234822/2011

Analysis and Assessment of the Executive Director’s Annual Activity Report 2010

AdoptedReference Number: EMA/MB/416690/2011Summary:

Article 40 of the Financial Regulation, applicable to the budget of the European Medicines Agency,

requires the Executive Director to prepare a report to the Management Board in the form of an annual

activity report on performance of his duties together with financial and management information on

the previous financial year.

Amending Budget 01-2011 for changes to entry grades for eleven posts and subsequent amendment to the establishment plan of the European Medicines Agency for five posts

AdoptedReference Number: EMA/MB/373047/2011Summary:

Any amendment to the Agency’s budget, including the establishment plan, is subject to an amending

budget in accordance with Article 28 of the EMA Financial Regulation. In line with Article 32 of the EMA

Financial Regulation, save in the cases of grades AD16, AD15, AD14 and AD13, the management board

may modify the establishment plan up to 10% of the posts authorised, subject to two conditions:

Extension of mandate of the Acting Executive Director

AdoptedReference Number: EMA/MB/376449/2011Summary:

Pending the nomination of a new Executive Director, the Management Board appointed Andreas Pott as

Acting Executive Director at its meeting of 7 October 2010. The appointment was initially for a period

of 6 months until 30 June 2011 (EMA/MB/578243/2010).

The appointment process for the new Executive Director has not yet been concluded and it is therefore

necessary to extend the mandate of the Acting Executive Director.

Authorisation for the Acting Executive Director to sign a lease and associated documents for the new EMA headquarters office

AdoptedReference Number: EMA/MB/424329/2011Summary:

The leases for the Agency’s current offices at 1, 7 and 11 Westferry Circus, Canary Wharf, London,

expire on 31 December 2014.

The Board selected a new location for the Agency’s headquarters.

Meetings, virtual meetings and alternative ways of communicating

Reference Number: EMA/MB/399835/2011Summary:

As part of its remit to champion the use of technology to supplement, and where possible replace, the

need for “face-to-face” meetings for aspects of the work of the European Medicines Regulatory

Network (the “Network”), the MBTC has prepared the attached document. The paper analyses briefly

the communication needs across the Network, summarises the relative advantages and disadvantages

of face-to-face and virtual meetings, and proposes a way of reducing the number of face-to-face

meetings.

EudraVigilance Veterinary – Status update report (June 2011)

Reference Number: EMA/422934/2011Summary:

The Management Board is being updated twice yearly on the status of EudraVigilance Veterinary.

Outcome of Management Board written procedures during the period from 23 February to 16 May 2011

Reference Number: EMA/MB/375944/2011Summary:

This document is presented in accordance with Article 4 (5) of the Management Board rules of

procedure regarding the outcome of the written procedures.

Summary of transfer of appropriations in the budget 2011 - Management Board meeting: 9 June 2011

Reference Number: EMA/MB/371536/2011Summary:

Article 23(1) of the Agency’s Financial Regulation specifies that the Executive Director may make

transfers from one chapter to another and from one article to another without limit and from one title

to another up to a maximum of 10 % of the appropriations for the financial year shown on the line

from which the transfer is made. In accordance with Article 23(2), the Executive Director may propose

to the Management Board transfers of appropriations from one title to another beyond the limit

referred to in Article 23(1).

71st meeting, 5 May 2011

Agenda for the 71st extraordinary meeting of the Management Board

AdoptedReference Number: EMA/MB/296221/2010

Minutes of the 71st extraordinary meeting of the Management Board: 5 May 2011

AdoptedReference Number: EMA/MB/417000/2011

Revised procedure for the appointment of the Executive Director - Extraordinary Management Board meeting 5 May 2011

AdoptedReference Number: EMA/MB/400828/2009

70th meeting, 16-17 March 2011

Agenda for the 70th meeting of the Management Board, 16–17 March 2011

AdoptedReference Number: EMA/MB/19969/2011

Minutes of the 70th meeting of the Management Board: 16-17 March 2011

AdoptedReference Number: EMA/MB/232704/2011

Amendments to Management Board implementing rules on the Agency’s fees in relation to inflation and extrapolation of MRLs effective from 1 April 2011 - Management Board meeting 17 March 2011

AdoptedReference Number: EMA/MB/757388/2010

Outcome of Management Board written procedures during the period from 25 November 2010 to 22 February 2011 - Management Board meeting 17 March 2011

Reference Number: EMA/MB/105462/2011

Performance of the Agency’s scientific procedures: Survey 2010 for medicinal products for human use - Management Board meeting 17 March 2011

Reference Number: EMA/MB/66833/2011

Summary of transfer of appropriations in the budget 2010 - Management Board meeting 17 March 2011

Reference Number: EMA/MB/111120/2011