DRAFT EMEA PANDEMIC INFLUENZA CRISIS MANAGEMENT PLAN FOR THE EVALUATION AND MAINTENANCE OF PANDEMIC INFLUENZA VACCINES AND ANTIVIRALS

Transcription

1 Eurpean Medicines Agency Lndn, 14 Nvember 2005 Dc. Ref. EMEA/397403/2005 DRAFT EMEA PANDEMIC INFLUENZA CRISIS MANAGEMENT PLAN FOR THE EVALUATION AND MAINTENANCE OF PANDEMIC INFLUENZA VACCINES AND ANTIVIRALS ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION 14 Nvember 2005 END OF CONSULTATION (DEADLINE FOR COMMENTS) 27 January 2006 Cmments shuld be prvided t Patrick.celis@emea.eu.int r by fax Nte Annex I t this Plan (EMEA Pandemic Influenza Prcess map) is als released fr cnsultatin. The assciated Wrk Instructins referred t in this Annex are available n request. 7 Westferry Circus, Canary Wharf, Lndn, E14 4HB, UK Tel. (44-20) Fax (44-20) mail@emea.eu.int Reprductin and/r distributin f this dcument is authrised fr nn cmmercial purpses nly prvided the EMEA is acknwledged

2 EMEA PANDEMIC INFLUENZA CRISIS MANAGEMENT PLAN FOR THE EVALUATION AND MAINTENANCE OF PANDEMIC INFLUENZA VACCINES AND ANTIVIRALS Table f Cntents I. INTRODUCTION... 3 II. PRINCIPLES OF THE CRISIS MANAGEMENT PLAN... 3 III. KEY OBJECTIVES OF THE PROCEDURE TO BE FOLLOWED... 4 IV. CRISIS MANAGEMENT STRUCTURES... 4 IV.A. THE EMEA CRISIS TEAMS Cmpsitin Rles f the different EMEA Crisis teams... 5 IV.B. EMEA TASK FORCE Cmpsitin Rle... 7 IV.C. EMEA MANAGEMENT: SPECIFIC ROLES AND RESPONSIBILITIES DURING THE PANDEMIC... 7 V. EMEA COMMUNICATIONS POLICY AND STRATEGY... 9 Annex 1 Annex 2 Annex 3 Annex 4 Annex 5 Annex 6 EMEA pandemic influenza prcess map and assciated Wrking Instructins and SOPs dealing with the EMEA respnsibilities fr influenza pandemic integratin f the activities f review, pst-authrisatin activities, cmmunicatin, meetings, telecmmunicatins. List f all crisis cntact pints within the EMEA List f all crisis cntact pints within the Cmmissin and ther Agencies List f all crisis cntact pints within the Member States List f all crisis cntact details f Rapprteurs, CRapprteurs and assessrs f pandemic influenza vaccines List f all crisis cntact pints within the Industry Page 2/9

3 I. INTRODUCTION The EMEA Pandemic Influenza Crisis Management Plan fr the evaluatin and maintenance f pandemic influenza vaccines and antivirals ( EMEA Pandemic Influenza Crisis Plan ) utlines the plicy, strategy and prcedures t be fllwed: - fr fast-track apprval f pandemic influenza vaccines via the centralised prcedure; - fr pst-authrisatin fllw-up f centrally authrised pandemic influenza vaccines and antivirals; - t react t any safety signals arising frm the use f nn-centrally authrised antivirals r frm the use f bulk active substance f centrally authrised antivirals. The plan highlights, als, the required management structures and the detailed prcedures t be set up t supprt the varius assciated prcesses. The EMEA Pandemic Influenza Crisis Plan will allw the EMEA t respnd rapidly, and efficiently, when a pandemic influenza crisis is annunced. The crisis plan will be validated and tested with pssible crisis scenaris, reviewed and regularly updated. The prpsal is t undertake these activities in the first quarter The EMEA activities described in this plan will run in parallel with Business Cntinuity Planning (BCP) activities invked by the pandemic influenza crisis. These BCP activities are nt described in this plan 1. II. PRINCIPLES OF THE CRISIS MANAGEMENT PLAN The primary bjective f the crisis management plan is t define and implement the EMEA plicy and, cnsequently the strategy fr the rapid and efficient handling f actins required by the EMEA Secretariat related t pandemic influenza vaccines and antivirals, in liaisn with the CHMP, (C-) Rapprteurs, cmpetent authrities f the Member States, the Eurpean Cmmissin (DG Sanc and DG Enterprise) and the Marketing Authrisatin Hlders, r Applicants. The WHO will identify the start f the influenza pandemic. This infrmatin will be prvided t the Cmmissin (DG Sanc) wh will ntify the EMEA. It will require the EMEA t wrk with all f the interested parties cited abve in reviewing variatins t cre dssiers fr influenza pandemic vaccines and / r the review f dssiers submitted t the Agency, fr medicinal prducts falling within its respnsibilities. A prcedure has been develped n surveillance and hw the start f a pandemic will be recgnised and cmmunicated, s that the implementatin f the crisis management plan may be initiated prmptly. A management prcedure is presented in this crisis plan n hw the annuncement f the pandemic will trigger the EMEA pandemic plan as discussed in the prcess map (Annex 1) and underlying wrk instructins and SOPs. In the event f a pandemic, the public will be aware f the situatin in a similar time frame t the Cmmissin, Member States and the Agency, thus the handling f cmmunicatins will becme crucial especially when public cnfidence is at risk. EMEA cmmunicatin plicy n this aspect will be in place t deal with the matters within its remit, taking care f the interface 1 BCP activities are cvered by the general SOP n EMEA Business Cntinuity Planning. Page 3/9

4 and rles and respnsibilities f ther interested parties, including the Cmmissin, the ECDC and Member States. Lists f all crisis cntact pints within the EMEA, Cmmissin and ther Agencies, Member States and Industry and cntact details f Rapprteurs, CRapprteurs and assessrs f pandemic influenza vaccines are prvided at Annexes 2 t 6. III. KEY OBJECTIVES OF THE PROCEDURE TO BE FOLLOWED III.A. Handling f a crisis situatin in case f influenza pandemic In additin t the management teams and systems put in place at the level f the EMEA and with ther interested parties, the aim is t meet the fllwing key bjectives, which are t: Initiate the influenza pandemic plan and activate all parts f the netwrk and t crdinate the different activities between the interested parties as described in the pandemic plan and the assciated prcedures. Manage and c-rdinate the review f dssiers fr pandemic influenza vaccines, which are the respnsibility f the EMEA. Manage and c-rdinate the pst-authrisatin fllw-up f centrally authrised antivirals used during the pandemic. Prvide t CHMP, the Cmmissin and the Cmpetent Authrities f the Member States the utcme f the review f dssiers f pandemic influenza vaccines and the utcme f any pinin related t antivirals and vaccines. Cnvey a clear message n the status f the review f these dssiers at defined timepint t all interested parties in the regulatry field, including the Eurpean Cmmissin, the ECDC and Member States and cmmunicate t health prfessinals and public at defined timepints within the evaluatin prcedure. All f these activities shuld be undertaken in line with this plan and assciated wrk instructins and SOPs (see Annex I). III.B. Integratin f the varius EMEA activities t deal with the crisis Annuncement f an influenza pandemic will trigger further EMEA activities, and mst ntably related t business cntinuity. The EMEA Gld crisis team (see belw) will ensure that business cntinuity decisins elicited by the influenza pandemic (including, but nt limited t, staff presence in the ffice, the hlding (r nt) f Cmmittee and Wrking Party meetings) can be taken in a timely manner. IV. CRISIS MANAGEMENT STRUCTURES In rder t deal successfully with a crisis, the fllwing Crisis Teams and Task Frce have been created: EMEA Crisis Teams EMEA Secretariat EMEA Task Frce (C-)Rapprteurs, BWP/VWP experts, CHMP and VWP chairpersns, EDQM/OMCL representative(s), EC representative(s), EMEA staff. The EMEA Task frce is invlved in the evaluatin f pandemic influenza vaccines submitted via the centralised prcedures. Page 4/9

5 Fr lgistical reasns, and rapid and efficient management, the cre members f the different teams will be supplemented by a wider peratinal team t handle the varius activities required t supprt the review f dssiers and cmmunicatin f utcmes t all f the interested parties. Because f the nature f a pandemic there needs t be a wider pl f staff members (backups) t supprt the EMEA crisis teams and task frce. In preparatin fr such a crisis, a Jint EMEA Industry Task frce is als established (as defined in the guideline 2 and in the wrk instructins). This task frce, which is dealing with pandemic influenza vaccines (nly), has an advisry rle during the interpandemic and pandemic alert perid but nt during the actual pandemic perid. Therefre, it is nt cnsidered further in this crisis management plan. IV.A. The EMEA Crisis Teams 1. Cmpsitin In rder t react prmptly, in case f an influenza pandemic, the fllwing EMEA crisis teams are established: a. Gld crisis team b. Pandemic Silver crisis team c. Pandemic Brnze crisis team The Gld crisis team is cmpsed f the Executive Directr f the EMEA and the Heads f Units, and has already been set up in the EMEA in the framewrk f Business Cntinuity Planning (BCP) 3. This Gld crisis team is assisted by appinted EMEA staff prviding technical supprt and scientific input, accrding t the tpic, which in this case is specifically pandemic influenza. The Pandemic Silver crisis team is cmpsed f the Heads f Operatinal and Supprt Sectrs; the respnsibilities f the sectrs include: Review f dssiers Quality, Safety and Efficacy Pst-authrisatin activities Quality, Safety and Efficacy and Pharmacvigilance Inspectins Executive supprt Infrmatin Technlgy Meetings, Management and Cnference Services Infrastructure Services Regulatry Affairs and Organisatinal Supprt Legal Affairs The Pandemic Brnze crisis team is cmpsed f appinted EMEA Scientific Administratrs and Secretaries, and their back-ups, trained n, and dedicated t, pandemic activities. It als incrprates the Pandemic Intelligence Team. 2. Rles f the different EMEA Crisis teams The different crisis teams are established by decisin f the Executive Directr at the latest during the pandemic alert perid (Phase 4) and shuld becme peratinal within the shrtest pssible timeframe after the annuncement f the pandemic. They will be set up in such a way that they are able t deal with crises arising after ffice hurs, during weekends and public hlidays as well as during nrmal ffice hurs. 2 Guideline n submissin f marketing authrisatin applicatins fr pandemic influenza vaccines thrugh the centralised prcedure (EMEA/CPMP/VEG/4986/03 f 5 April 2004). 3 Fr the exact cmpsitin f the Gld Team, please cnsult the SOP n BCP. Page 5/9

6 The EMEA Pandemic Intelligence Team 4 will screen n a daily basis, fr infrmatin published n fficial Websites (e.g. WHO, OIE, Cmmissin) and in the press related t Pandemic influenza. This infrmatin will be evaluated, and any signals indicative fr an increase in pandemic alert level, r an imminent annuncement f an influenza pandemic, will be crss-checked, prmptly, with dedicated cntacts at Cmmissin (DG Sanc) and/r at WHO r WHO cllabratin labratries. Cnfirmed signals will (via Head f Sectr Quality) be brught t the attentin f the EMEA Gld Crisis Team. The decisin t cnvene the EMEA Gld Crisis Team will be taken by the Executive Directr n the basis f infrmatin cming frm the EMEA Pandemic Intelligence Team and/r frm DG Sanc/WHO. The primary rle f the EMEA Gld Crisis Team is: T cnfirm the nset f the Influenza pandemic; T initiate the crisis plan and prcedure fr the fast-track apprval f pandemic influenza vaccines as described in prcess map and assciated wrk instructins (Annex 1) and infrm CHMP. A frmal annuncement f the pandemic by WHO/DG Sanc is required t initiate the EMEA pandemic influenza crisis activities; T initiate the EMEA Cmmunicatin plicy; T initiate the EMEA business cntinuity plan and t evaluate future BCP actins. The meeting f the EMEA Gld Crisis Team is nrmally chaired by the Executive Directr, r, in his absence, a designated deputy. In additin and depending upn the circumstances, meetings may be held in part, r cmpletely, by telephne r vide-cnference. The primary rle f the EMEA Pandemic Silver Crisis Team is: T mbilise the Brnze Team and infrm them f the decisins f the Gld Team. T assign staff (with back-ups) frm relevant sectrs that will be dedicated t pandemic activities, as required; T direct and manage the crisis plan and prcedure fr the fast-track apprval f pandemic influenza vaccines as described in prcess map and assciated wrk instructins (Annex 1); T keep CHMP infrmed; T ensure that the cmmunicatin plicy and strategy is implemented. The Pandemic Brnze Crisis team will run, in cnjunctin with EMEA Task Frce/CHMP, the prcedures related t the apprval f pandemic influenza vaccines as described in prcess map and assciated wrk instructins (Annex 1). The detailed tasks f the Gld, Silver and Brnze crisis teams and the tasks f the different members f these teams are included in the relevant wrk instructins. IV.B. EMEA Task Frce 1. Cmpsitin (C)-Rapprteurs f the cre pandemic dssiers; (C)-Rapprteurs appinted fr pandemic vaccines fr which a cre dssier has nt (yet) been submitted; Scientific assessment team supprting the (C)-Rapprteurs; VWP / BWP experts; Chairpersn f CHMP, BWP, VWP and PhVWP; EDQM/OMCL representative(s); EC representatives (DG Enterprise and DG Sanc); 4 A detailed Wrk Instructin / SOP describing the establishment, rle and wrking f the EMEA Intelligence Team will be develped. Page 6/9

7 EMEA staff. This task frce can be supplemented with additinal experts and representatives, such as members f the Inspectrate Wrking Party and/r GMP inspectrs frm the supervisry authrities and representatives frm WHO. 2. Rle The EMEA Task Frce is established specifically t deal with pre- and pst authrisatin activities related t pandemic influenza vaccines, and is established at the latest during the Pandemic Alert Perid (Phase 4). The task frce will meet after the annuncement f the influenza pandemic (Phase 6) and befre the submissin f the Pandemic variatin (in case a cre dssier has been apprved) r an applicatin fr a cnditinal marketing authrisatin (in case n cre dssier has been apprved) as described in the Wrk instructins. The rle f this team is t: Evaluatin f data packages submitted by the Marketing authrisatin hlder r applicant prir t the submissin f the pandemic dssier (pandemic variatin r cnditinal marketing authrisatin applicatin). Prepare reprts fr apprval by CHMP; Interact with the manufacturers, including nging scientific discussins prir t the submissin f the pandemic dssier; Prvide infrmatin and advice t EMEA Prvide infrmatin and advice, via the CHMP, t Regulatry Authrities (MRFG, Natinal Authrities, Cmmissin services); Discuss and evaluate pst-authrisatin data, as necessary. The EMEA will prvide supprt t the activities f the EMEA Task Frce as described in the wrk instructins. IV.C. EMEA management: specific rles and respnsibilities during the pandemic Executive Directr f the EMEA, as well as the members f the EMEA Gld Crisis Team: Chair the EMEA Gld Team; When a high-level respnse is required: Act as a public spkespersn 5 ; Liaise with external parties (such as Eurpean Cmmissin, Member States etc) cncerned by the crisis; Plan the public relatins plicy and ensure that at all times an apprpriate public statement is available; Prvide all necessary scientific resurces. Heads f Operatinal and Supprt Sectrs, including; Review f dssiers fr pandemic influenza vaccines Quality, Safety and Efficacy Respnsibilities f the Head f Quality Sectr are t: C-rdinate and prgress the review f all dssiers submitted t the Agency, in liaisn with the Head f Safety and Efficacy Sectr; Reprt t the EMEA Gld team and CHMP n the utcme f these reviews n an n-ging basis, until the reviews are cmpleted; Organise and c-rdinate the actins f the EMEA Task Frce and Evaluatin Prject Team 6 5 Fr rutine, day-t-day cmmunicatins, this task will be perfrmed by the Executive Supprt sectr. Page 7/9

8 Interact with manufacturers and/r marketing authrisatin hlders r applicants f pandemic influenza vaccines and antivirals; Ensure that dcuments fr CHMP are prepared in a timely manner; Infrm the Executive Directr, the EMEA Gld Team and the Head f the Human Units f all develpments; Ensure that supprtive technical dcuments fr external cmmunicatin are prepared and ruted thrugh the Press Officer. Pst-authrisatin activities Safety and Efficacy and Pharmacvigilance Respnsibilities f Head f Pharmacvigilance and pst-authrisatin Safety and Efficacy Sectr are t: C-rdinate the pst-authrisatin and pharmacvigilance activities related t centrally authrised antivirals and pandemic influenza vaccines; Alert the CHMP and gld crisis team n safety signals arising frm the use, during the pandemic, f nn-centrally authrised antivirals r the bulk active substance (f centrally authrised antivirals), identifying the need fr CHMP actins in accrdance with art 5 and art 57 f Regulatin (EC) N 726/2004; Ensure that dcuments fr CHMP are prepared in a timely manner; Infrm the Executive Directr, EMEA Gld Team and the Head f the Human Unit f all develpments; Ensure that supprtive technical dcuments fr external cmmunicatin are prepared and ruted thrugh the Press Officer. Inspectins Respnsibilities f Head f Inspectin Sectr are t: Ensure the assessment f current status f manufacturing sites invlved in the manufacture f pandemic influenza vaccines r antivirals, identificatin f need fr specific inspectin r additinal GMP infrmatin; Crdinate any ther inspectin related activities. Telecmmunicatins/IT Respnsibilities f Head f Infrmatin Technlgy Sectr are t: Assist the Human Units as detailed in the wrk instructins and SOPs, and mre specifically in relatinship t: - Cmputer facilities and remte assess - Tele and vide cmmunicatin - Emergency web update; Crdinate any ther IT related activities related t pre- and pst-authrisatin activities fr pandemic influenza vaccines and antivirals. Meeting Management Respnsibilities f the Head f Meeting Management and Cnference Sectr are t: Assist the Human Units as detailed in the wrk instructins and SOPs in relatinship t the rganisatin f meetings (travel and htel bkings fr experts, bking f meeting rms, etc.) during the influenza pandemic. Executive Supprt Respnsibilities f the Head f Executive Supprt Sectr are t: C-rdinate the cmmunicatin activities based n the plicy f the Agency; Ensure the crdinatin f the Agency s cmmunicatin activities with the activities f ur Eurpean partners (i.e. Eurpean Cmmissin / DG Sanc, ECDC, natinal cmpetent authrities); 6 Evaluatin prject team, as defined in the Guideline n submissin f marketing authrisatin applicatins fr pandemic influenza vaccines thrugh the centralised prcedure (EMEA/CPMP/VEG/4986/03 f 5 April 2004) and assciated wrk instructins, is set up specifically t perfrm the fast-track evaluatin f the Pandemic vaccine type II variatin. Page 8/9

9 C-rdinate the preparatin and finalisatin f infrmatin dcuments, such as press releases, questin and answer dcuments, etc.; Ensure, in cllabratin with the Persnnel Sectr, internal cmmunicatin fr staff related (BCP) issues; Ensure, in cllabratin with the staff respnsible fr Web Services, timely update f the website; Respnd t press enquiries. V. EMEA COMMUNICATIONS POLICY AND STRATEGY Effective cmmunicatins will be crucial in the event f an influenza pandemic. This will require timely and effective c-rdinated respnses frm each f the Agency s Eurpean partners, namely the Eurpean Cmmissin, ECDC and the EU Member States, healthcare prviders, the media and the public in general. Therefre, the EMEA Pandemic Influenza Crisis Management Plan includes details f the EMEA cmmunicatins strategy fcussed n this crisis. This strategy, and its implementatin steps, take int accunt the rle and respnsibilities f the EMEA in relatinship t the ther Eurpean partners cited abve. The EMEA has specific respnsibilities in relatinship t medicinal prducts. In this cntext, the Agency shuld be pr-active and prepare, in advance, texts required accrding t the plicy f the Agency and the strategy t implement that plicy. This will invlve infrming all interested parties, withut encraching n the activities and respnsibilities f ther Eurpean and natinal partners. The Agency s cmmunicatins apprach will be tailred t fit in with thse f the Eurpean Cmmissin, the ECDC and the Member States. The verall aim is t ensure crdinated and cnsistent cmmunicatins, which present cherent messages at the level f the Eurpean Unin. SOPs / wrk-instructins will address hw the plicy and strategy shuld be implemented. The EMEA will issue public statements as described in the wrk instructins, s that interested parties are kept infrmed abut the prgress f the evaluatin f dssiers, in an apprpriate manner. In rder t apply the EMEA plicy and strategy the Executive Supprt and the Press Office will be the single rute thrugh which all cmmunicatins are channelled. Page 9/9