8 April 2011 EMA/166976/2011 Veterinary Medicines and Prduct Data Management Summary frm the wrkshp - Veterinary pharmacvigilance questin time: better regulatin fr electrnic reprting and peridic safety update reprts (PSURs) 24 Nvember 2010, Eurpean Medicines Agency, Lndn Executive summary The aim f the wrkshp was t cnvene regulatry and industry experts in pharmacvigilance t reflect n the veterinary pharmacvigilance system in the Eurpean Unin (EU), with specific fcus n electrnic reprting and peridic safety update reprts (PSURs), in light f the review f the current legislatin fr veterinary medicinal prducts. Key issues raised during the discussin included the fllwing: PSURs place a significant administrative burden n marketing authrisatin hlders (MAHs) and natinal cmpetent authrities (NCAs) which culd be reduced in the future if a mre flexible and prprtinate apprach t PSUR requirements wuld be pssible; develpment f a cmprehensive, functinal EU prduct database is necessary t achieve a fully peratinal electrnic reprting system fr adverse events; electrnic reprting, signal detectin and PSURs are inter-dependent and need t be cnsidered in synchrny t imprve the pharmacvigilance system; further cnsideratin and develpment f the cncept f a risk-based apprach is required t enhance the apprach and methdlgy fr adverse event surveillance; and cncerted effrts and cllabratin are required by stakehlders t develp appraches fr effective adverse event surveillance, making ptimal use f resurces as part f a prprtinate veterinary pharmacvigilance system. The wrkshp was cnsidered fruitful and a welcmed pprtunity fr industry and regulatrs t exchange views and experiences. The discussins highlighted areas where further cnsideratin is required fr develpment f the pharmacvigilance system in future. 7 Westferry Circus Canary Wharf Lndn E14 4HB United Kingdm Telephne +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8447 E-mail inf@ema.eurpa.eu Website www.ema.eurpa.eu An agency f the Eurpean Unin Eurpean Medicines Agency, 2011. Reprductin is authrised prvided the surce is acknwledged.
Intrductin A wrkshp tk place n 24 Nvember 2010 at the Eurpean Medicines Agency, entitled veterinary pharmacvigilance questin time - better regulatin fr electrnic reprting and peridic safety update reprts (PSURs) 1. The aim f the meeting was t cnvene regulatry and industry experts t reflect n the veterinary pharmacvigilance system in the Eurpean Unin (EU), with specific fcus n electrnic reprting and peridic safety update reprts (PSURs), in light f the review f the current legislatin fr veterinary medicinal prducts. Fifty-tw delegates attended the wrkshp. Participants represented veterinary pharmacvigilance experts frm industry (including qualified persns fr pharmacvigilance, QPPVs), industry assciatins (Assciatin f Veterinary Cnsultants, Internatinal Federatin fr Animal Health Eurpe and Syndicat de l Industrie du Médicament Vétérinaire), the Federatin f Veterinarians f Eurpe (FVE) and EU natinal cmpetent authrities (NCAs). The wrkshp cmprised shrt presentatins frm industry and regulatry authrities t set the scene, fllwed by panel and pen discussin sessins, primarily based n questins submitted by participants in advance n the tw key tpics: electrnic reprting and PSURs. This dcument summarises the presentatins and discussins that tk place. Fr sme f thse questins that were nt selected fr discussin at the wrkshp, it was pssible t give apprpriate respnses and these have been cllated in a separate dcument (Dc. Ref. Id. EMA/838435/2009) 2 and circulated fr infrmatin t participants. Summary f the presentatins, panel and pen discussin sessins 1. Setting the scene: the Eurpean Cmmissin public cnsultatin n better regulatin a) On behalf f IFAH Eurpe, B. Crnez (Huvepharma N.V) presented the key challenges fr industry highlighted in the IFAH-Eurpe impact assessment data package fcusing n the current administrative burden f veterinary pharmacvigilance fr marketing authrisatin hlders (MAHs). Apprximately half f the wrklad cmprised PSUR handling, principally invlving cmpilatin, preparatin and management f data fr analysis. Spntaneus adverse event reprt management and develpment and maintenance f the pharmacvigilance system, respectively, made up the remaining wrklad fr MAHs. A mre flexible and less bureaucratic apprach t PSUR handling culd represent a majr imprvement t the current pharmacvigilance system. This wuld enable MAHs t fcus n the cre bjectives f pharmacvigilance i.e. adverse event reprt management and prvisin f supprt t prduct users. b) The Eurpean Medicines Agency Secretariat presented an verview f the CVMP prpsals fr the revisin f the veterinary legislatin n pharmacvigilance, which was part f the CVMP s respnse t the Eurpean Cmmissin s initiative fr stakehlder cnsultatin and review f 1 Veterinary pharmacvigilance questin time: better - 24 Nvember 2010 Prgramme (Dc. Ref. Id. EMA/433980/2010) http://www.ema.eurpa.eu/ema/index.jsp?curl=pages/news_and_events/events/2010/11/event_detail_000342.jsp&murl=menus/n ews_and_events/news_and_events.jsp&mid=wc0b01ac058004d5c3 2 Answers t questins nt addressed at the wrkshp: Veterinary pharmacvigilance questin time (Dc. Ref. Id. EMA/730943/2010) EMA/166976/2011 Page 2/9
the current veterinary legislatin 3. The presentatin prvided an verview f prpsals fr future legislatin n the fllwing areas: reinfrcing the respnsibility f MAHs fr surveillance f veterinary medicinal prducts; strengthening the ptential legal ptins t enfrce cmpliance with pharmacvigilance requirements; tailring the apprach t surveillance; ratinalising the apprach t electrnic reprting, PSURs and renewal prcedures, signal detectin; the extended scpe f pharmacvigilance; Article 78 f Directive 2001/82/EC 4 prcedures; and cmmunicatin with the public and healthcare prfessinals. c) Panel discussin: questin 1: Is a stand-alne pharmacvigilance master file a pssibility? The panel discussed the cncept f the pharmacvigilance master file fr veterinary medicinal prducts. Althugh the cncept is nt within the framewrk f the current legislatin, there was general supprt fr the develpment f the pharmacvigilance system master file fr veterinary medicinal prducts in future. A ptential future master-file wuld entail the detailed descriptin f the pharmacvigilance system being linked t the MAH, rather than the marketing authrisatin fr a veterinary medicinal prduct. This culd minimise the amunt f prduct-specific infrmatin included in the marketing authrisatin applicatin itself. Where apprpriate, prduct specific infrmatin culd be included in an addendum, fr example, which wuld be available t cmpetent authrities upn request. It was recgnised that whilst the pharmacvigilance master file cncept may nt address all the current prblems experienced with the detailed descriptin f the pharmacvigilance system, it may alleviate unnecessary administrative burden experienced by MAHs and cmpetent authrities. Cntrlled and transparent prcesses wuld, hwever, be required fr updates t the pharmacvigilance system, when apprpriate. d) Open discussin n the legal framewrk Participants reflected n the existing legal framewrk fr veterinary pharmacvigilance. The requirements fr veterinary pharmacvigilance under the current legislatin were cnsidered t be t cmplex, which was attributed t the fact that the veterinary legislatin mirrrs the ne fr human pharmacvigilance. It was prpsed that future legislatin shuld be develped in a mre prprtinate way, t address the needs f veterinary pharmacvigilance, which were nt cnsidered t be identical t thse fr human pharmacvigilance. Future revisins f Vlume 9B (when available) wuld require develpment f the guidelines in parallel with the future legislatin. 2. Electrnic reprting: reprting rutes, time t reprt; prpsed Member States and MAH reprting bligatins a) K. Quine (Elanc Animal Health) presented IFAH Eurpe s perspective f electrnic reprting fr the future. A prpsal fr single step reprting was presented, whereby ne adverse event reprt wuld be submitted by MAHs within VICH 5 regins, fr example, t a single central EU database cntaining all EU reprts, and enabling adverse event data t be exchanged between VICH regins. The prpsal prvided the basis fr a ptential glbal adverse event database, in the lng-term. 3 Cmmissin cnsultatin n Better regulatin fr Veterinary Pharmaceuticals - CVMP analysis f the functining f current veterinary legislatin and prpsals fr its evlutin and cmments n the Cmmissin paper http://www.ema.eurpa.eu/dcs/en_gb/dcument_library/other/2010/07/wc500094747.pdf 4 Eurpean Parliament and Cuncil (2001) - Directive 2001/82/EC f the Eurpean Parliament and f the Cuncil f 6 Nvember 2001 n the Cmmunity cde relating t veterinary medicinal prducts as amended by Directive 2004/28/EC and Directive 2009/9/EC. http://eur-lex.eurpa.eu/en/index.htm 5 VICH: Internatinal Cperatin n Harmnisatin f Technical Requirements fr Registratin f Veterinary Medicinal Prducts EMA/166976/2011 Page 3/9
Alternative timeframes fr electrnic reprting f adverse events ccurring within the EU were suggested as fllws: 15 days fr serius adverse events and 90 days fr all ther EU reprts, r by the next PSUR data lck pint (DLP). It was prpsed that third cuntry reprts wuld be accessible t Member States via an EU database cnnected t ther VICH regins and fr MAHs, via their reginal agencies and databases. Cncerning analysis f adverse event data, it was suggested that cmpetent authrities wuld likely use the central EU database fr signal detectin (prir t the develpment f a glbal database), whilst MAHs wuld cntinue t use their wn databases fr signal detectin. Glbal crdinatin was encuraged, which highlighted the need t ensure apprpriate glbal standards and t establish a single glbal database which shuld address all electrnic reprting requirements. T achieve this, psitive interactins between cmpetent authrities and industry wuld need t be maintained and enhanced. b) C. Ibrahim (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit) gave a presentatin n electrnic reprting frm a regulatry perspective. The current electrnic reprting system was cnsidered dependent n the quality f the data cntained within the system and cnsequently quality assurance was cnsidered fundamental fr ensuring rbust and reliable data fr surveillance. The availability f a fully peratinal EU prduct database was highlighted as a pririty fr electrnic reprting. The central EU database, EudraVigilance Veterinary (EVVet), cntained all adverse events reprted expeditedly fr centrally authrised prducts. Hwever, the need t ppulate the database fr nn-centrally authrised EU prducts was cnsidered fundamental and the primary cnstraint preventing the accmplishment f a fully functinal EU-prduct database and fully peratinal electrnic reprting system in the EU. Fr surveillance, the principle f understanding the nature f adverse event data was cnsidered key t enable meaningful cnclusins t be drawn frm analyses. Attentin was drawn t the frthcming surveillance prcedure fr adverse events fr centrally authrised prducts, t be implemented by the Cmmittee fr Medicinal Prducts fr Veterinary Use (CVMP) 6. The prcedure wuld be based n signal detectin queries frm the EVVet Data Warehuse (DWH) and was develped t enhance the harmnised apprach t surveillance using electrnic tls. The key elements fr a successful electrnic reprting system fr veterinary pharmacvigilance were identified as the functinality f EVVet, data quality and adaptatin f data analysis methds fr signal detectin. c) Panel discussin questin 2 - What wuld be the benefit fr a) MAHs and b) NCAs if all adverse event reprts (including nn-serius, suspected lack f expected efficacy (SLEE) etc.) were t be submitted electrnically? It was cnsidered that electrnic submissin f all adverse events may be beneficial fr MAHs if accmpanied by a crrespnding reductin in the current requirements fr PSURs. Hwever, the success f cmprehensive electrnic reprting wuld be dependent n an effective, userfriendly and fully autmated system. It was suggested that a ptential reductin in sme f the PSUR requirements (as a cnsequence f cmplete electrnic reprting) culd nly be feasible after establishment f a functinal system fr signal detectin, using a risk-based apprach fr surveillance. 6 Eurpean Medicines Agency standard perating prcedure: Safety mnitring f centrally authrised prducts (SOP/V/4032) EMA/166976/2011 Page 4/9
Fr cmpetent authrities, electrnic reprting f all adverse events was als cnsidered beneficial as it wuld facilitate reprting and management f adverse events. Hwever, secure transmissin f reprts and develpment f the veterinary medicinal prduct dictinary (t include nn-centrally authrised prducts) wuld be required t ensure the system wuld be fully functinal. It was als suggested that there wuld be a need t clarify rles and respnsibilities fr electrnic reprting and subsequent surveillance f nn-centrally authrised prducts t ensure smth peratin f the system. d) Panel discussin questin 3 - Shuld the MAH send reprts directly t the EudraVigilance Veterinary (EVVet) central database? Differing views regarding the cncept f a single reprting pint were expressed amngst the panel and als participants. Generally, industry representatives expressed that a single reprting pint t the central database culd prvide a simpler apprach cmpared t the current electrnic reprting system. Hwever, different views were expressed between representatives frm the NCAs. Sme NCA representatives favured a single reprting pint, in view f the ptential decrease in administrative burden f adverse event reprt handling. Other NCA representatives felt that it wuld be imprtant fr MAHs t send adverse event reprts t the NCAs befre submissin t EVVet t ensure validatin f reprts, identificatin f duplicates and fr additin f the NCAs causality assessment. e) Panel discussin questin 4 - If all adverse events (serius, nn-serius etc.) were submitted electrnically, wuld line listings in PSURs and PSURs in their present frmat still be apprpriate? It was generally cnsidered that PSURs culd be simplified if all adverse events were available via a central database, prvided the crrespnding benefit-risk assessment was als submitted by the MAH. Additinally, it was suggested that submissin f PSURs culd be adapted in accrdance t experience gained fllwing use f prducts in the field. Fr example three ptential risk categries were described as fllws fr, 1) new prducts and high ptential risks ; 2) well knwn prducts and lw risks ; and 3) well knwn prducts and sme ptential risks. The pprtunity t further discuss and elabrate the basis fr such risk categries was cnsidered a useful future prspect fr develpment f the apprach and methdlgy fr adverse event surveillance. 3. Peridic safety update reprts (PSURs): frequency, cntent and assessment a) C. Trres (Ceva Santé Animale) gave a presentatin n behalf f IFAH-Eurpe n the frequency, cntent and assessment f PSURs. It was reprted that in general industry supprted the idea f a risk-based apprach t surveillance t make best use f available resurces in rder t fcus n safety mnitring. It was prpsed that PSURs shuld nly be submitted after prducts had been n the market fr 10 years r less. PSUR submissin frequency was prpsed as annual fr the first 4 years after initial placing n the market and thereafter every 3 years. After ten years, n PSURs wuld be required unless requested by cmpetent authrities fr safety reasns. Als it was suggested that PSURs shuld nt need t be submitted with renewal applicatins, where the cncept f renewals is t be maintained. Hwever, if changes t the prduct safety prfile wuld be identified, it was suggested that the renewal applicatin culd be accmpanied by a statement frm the QPPV prpsing the update f the summary f prduct characteristics (SPC) and prduct literature cncerning adverse reactins and safety warnings, where apprpriate. The need t decrease the administrative EMA/166976/2011 Page 5/9
burden f PSURs wuld allw MAHs t target resurces t evaluatin f safety data and signal detectin. The value f sharing experiences between industry and regulatrs was emphasised fr cntinued imprvement f the pharmacvigilance system. Finally it was felt that it was imprtant t keep an pen mind and t adapt t the pharmacvigilance system as it cntinues t evlve. b) A. Werner (Bela-pharm GmbH) gave a presentatin n PSURs frm the perspective f generics cmpanies with a view t ptimising resurces fr MAHs and NCAs. The key issues fcused n were: 1) harmnisatin f DLPs; 2) the reductin f PSUR submissin frequencies (particularly fr well-knwn substances), supprted by the submissin f all adverse events electrnically; and 3) ratinalisatin f the safety infrmatin included in SPCs. It was prpsed that safety infrmatin included in the SPC and prduct literature shuld be limited t specific substancerelated infrmatin, supprted by adverse event r clinical data. Updates t SPCs and prduct literature shuld reflect changes in the safety prfile f prducts, withut the need fr separate variatin prcedures t implement the changes. c) P. Ekström (Läkemedelsverket) gave a presentatin n PSURs frm the regulatry viewpint. The imprtance f prvisin f feedback t MAHs n the preparatin and presentatin f PSURs accrding t the current requirements in frce was highlighted. The use f electrnic tls develped fr analysing EVVet data t facilitate signal detectin was described. In additin an apprach fr signal detectin was utlined, with the aim f targeting rare and serius adverse events. Reflectins n pssible future PSUR submissin requirements included an apprach adapted t the perceived risk f the prduct, whilst maintaining the prvisin fr cmpetent authrities t request PSURs when safety cncerns r ptential signals arise. Electrnic reprting f all adverse event reprts by MAHs t a single central database was supprted. MAHs were encuraged t use EVVet, and assciated data analysis tls, fr surveillance and t take the lead fr signal detectin fr their prducts, allwing NCAs t fulfil their supervisry rle whilst alleviating the administrative burden fr Member States. d) Open discussin n PSURs Other PSUR-related tpics raised during the pen discussin amngst participants included the fllwing: PSUR synchrnisatin and wrksharing initiative Industry representatives reprted that a mre systematic and pragmatic apprach t PSUR management and assessment was welcmed. Whilst acknwledging that the PSUR synchrnisatin and wrksharing initiative prvided a valuable learning experience, it was suggested that effrts shuld be cncerted t further streamline the prcess. The cnsideratin f PSUR harmnisatin at VICH level was als suggested as a pssible future prspect. Current PSUR requirements The cnstraints f the current legislatin t allw fr different appraches fr PSUR submissin were cnsidered as it was reprted that there was ften a lack f flexibility with the applicatin f legislatin at natinal level in sme Member States e.g. submissin f PSURs accrding t the internatinal birth date f the prduct. Hwever, n firm prpsals were made t address this issue at the current time. EMA/166976/2011 Page 6/9
4. General/pen discussin sessin - signal detectin and adverse event surveillance appraches During the wrkshp there was extensive discussin n signal detectin and adverse event surveillance. An example f a tw-step apprach t signal detectin was described cmprising: 1) initial screening f adverse events; fllwed by 2) in-depth assessment f signals t determine the ptential causal relatin with the prduct. This in-depth evaluatin wuld entail review f the case reprt narrative and applicatin f clinical knwledge and judgment. It was therefre highlighted that further cnsideratin wuld be required in relatin t the prpsals fr MAHs t use EVVet fr signal detectin and t place the respnsibility fr signal detectin n cmpanies, in light f the frthcming EVVet access plicy, whereby the MAH wuld nt have access t the narrative field f adverse event reprts assciated with their prducts. Taking int accunt resurce availability, it was suggested that it wuld be mre efficient fr MAHs t cntinue t use their wn databases fr signal detectin and fr NCAs t use EVVet, which wuld allw fr analyses at active-substance level. The pprtunity was als taken t highlight the additinal value fr MAHs prvided by the EVVet access plicy which fresees that electrnic tls wuld be made available fr MAHs in future t query data within EVVet. This prvisin was cnsidered a useful facility fr MAHs as it culd enable validatin f signals detected in their wn database against the EVVet dataset. Finally, it was emphasised that there still remained a need t gain experience using the electrnic tls already available and t further develp and refine the methdlgy fr signal detectin. There were initial reflectins n the cncept f a risk based apprach in veterinary pharmacvigilance. Fr example, ne industry representative suggested that a prduct culd be categrised n the basis f the number f adverse events reprted per year e.g. a prduct fr which 15 adverse events (r fewer) were reprted in ne year culd be classified as lw risk and in such cases, a schedule culd be assigned such that adverse event surveillance wuld be based n spntaneus reprts nly, withut the need fr PSURs. It was als prpsed by anther industry representative that fr well-knwn substances, the PSUR submissin frequencies culd be reduced. Althugh the prpsal was supprted by sme f the panel members, ne NCA representative stressed that such an apprach may nt accunt fr the ptential rle f excipients in adverse events and that such a prpsal wuld therefre require further cnsideratin. It was, hwever, generally agreed by industry and regulatry representatives that further develpment f criteria and crrespnding guidance fr a risk based apprach t surveillance wuld be needed. Cnclusin The wrkshp prvided an pprtunity fr regulatrs and industry t reflect n the current veterinary pharmacvigilance system and cnsider imprvements fr the future fr effective regulatin and surveillance f adverse events. Key issues that arse during the discussin fr imprvement f the pharmacvigilance system included the fllwing: future legislatin shuld be prprtinate t ensure effective safety evaluatin f veterinary medicinal prducts with ptimal use f resurces; creatin f a veterinary pharmacvigilance master file; systematic, flexible and a less bureaucratic requirements fr PSURs; simplified and fully autmated electrnic reprting prcess fr adverse events with the ptential fr a glbal system in future; cmpletin f a fully functinal EU prduct database t include nn centrally authrised prducts; EMA/166976/2011 Page 7/9
develpment f a risk based apprach fr adverse event surveillance and enhancing signal detectin; further develpment and gain f experience using electrnic tls and validatin f signal detectin; and sharing f experiences and cntinued dialgue and cllabratin between stakehlders fr evlutin f the pharmacvigilance system. In general, the wrkshp was cnsidered fruitful and a welcmed pprtunity fr industry and regulatrs t exchange views and experiences. The discussins highlighted areas where further cnsideratin is required fr develpment f the pharmacvigilance system in future. EMA/166976/2011 Page 8/9
List f participants Chair: Krnelia Grein, Eurpean Medicines Agency. Panel: Marie-Odile Hendrickx, Pfizer Limited; Rel van Lieshut, Eurvet Animal Health; Fabia Dyer, Veterinary Medicines Directrate; Lisbet Vesterager-Brge, Danish Medicines Agency. Speakers: Bb Crnez, Huvepharma N.V.; Peter Ekström, Läkemedelsverket; Crnelia Ibrahim, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit; Karen Quine, Elanc Animal Health; Cecilia Trres, Ceva Santé Animale; Andreas Werner, Bela-pharm GmbH; Raquel Gpal (n behalf f Js Olaerts), Eurpean Medicines Agency. Regulatry participants: Frédéric Klein, Federaal Agentschap vr Geneesmiddelen en Gezndheidsprducten - Agence Fédérale des Médicaments et des Prduits de Santé; Linel Laurier, Federaal Agentschap vr Geneesmiddelen en Gezndheidsprducten - Agence Fédérale des Médicaments et des Prduits de Santé; Alia Michaelidu-Patsia, Ministry f Agriculture, Natural Resurces and Envirnment; Eleni Vatamidu-Petru, Ministry f Agriculture, Natural Resurces and Envirnment; Vladimir Brychta, Ústav pr státní kntrlu veterinárních bipreparátů a léčiv; Karliina Laine, Lääkealan turvallisuus- ja kehittämiskeskus Fimea; Elisabeth Bégn, Agence Natinale du Médicament Vétérinaire - Agence Natinale de Sécurité Sanitaire de l'alimentatin, de l'envirnnement et du travail; Katrin Kirsch, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit; Angelika Schadewinkel-Scherkl, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit; Klaus Cussler, Paul-Ehrlich-Institut; Elke Schönbrn, Paul-Ehrlich-Institut; Helen Amenta, ΕΘΝΙΚΟΣ ΟΡΓΑΝΙΣΜΟΣ ΦΑΡΜΑΚΩΝ; Edit Nagy, Central Agricultural Office Directrate f Veterinary Medicinal Prducts; Hazel Dunphy, Veterinary Medicines Department; Lisa Wds, Veterinary Medicines Department; Rita Qundam Giandmenic, Minister della Salute; Hanne Bergendahl, Statens Legemiddelverk; Agnieszka Rgwska Jaśkwiak, Urząd Rejestracji Prduktów Leczniczych, Wyrbw Medycznych i Prduktów Bibójczych; Inês Filipa Martins de Almeida, Direcçã-Geral de Veterinária; Henrique Rams da Csta, Direcçã-Geral de Veterinária; Rbert Sldan, Institute fr State cntrl f Veterinary Bilgicals and Medicaments; Katarina Štraus, Agency fr medicinal prducts and medical devices f the Republica f Slvenia; Ramir Casimir, Agencia Españla de Medicaments y Prducts Sanitaris; Remedis Ezquerra Plasencia, Agencia Españla de Medicaments y Prducts Sanitaris ; Susanne Stenlund, Läkemedelsverket; Baukje Schat, Veterinary Medicines Unit Cllege ter Berdeling van Geneesmiddelen; Marjan van Hft, Veterinary Medicines Unit Cllege ter Berdeling van Geneesmiddelen; Gillian Diesel, Veterinary Medicines Directrate. MAH representatives (Qualified Persns fr Pharmacvigilance r their replacements): Marie-Hélène Grillet, AB Science; Sandra Nicll, Abbtt Animal Health; Jrdi Puig, Andersen SA; Dietmar Kretzdrn, Bayer Animal Health GmbH; Serge Carel, Bikema Anstalt; Dirk Hörstemann, Böringher Ingelheim Vetmedica GmbH; William Drury, Cytn Biscience Ltd; Amrit Chhan, Dechra Ltd; Mathilde Luwerens, Dpharma Research; David Sylvester, Ec Animal Health; Jhn Tasker, Ec Animal Health; Marcel Hrlings, Intervet/Schering-Plugh Animal Health; Jhan Vanlerberghe, Janssen Pharmaceutica NV; Rsa Calnge, Labratris Dr. Esteve, S.A.; Lidia Serarls, Labratris Hipra SA; Susanne Heidemann, Merial S.A.S.; Rae Knight, Nvartis Animal Health; Dminique Prtsmuth, Nvartis Animal Health; Laure Gardey, Virbac SA. Assciatin representatives: Declan O Rurke, Assciatin f Veterinary Cnsultants (AVC); Despina Iatridu, Federatin f Veterinarians f Eurpe (FVE); Jan Vaarten, Federatin f Veterinarians f Eurpe (FVE); Sylvie Meillerais, Internatinal Federatin fr Animal Health Eurpe (IFAH); Marie-Anne Barthelemy, Syndicat de l industrie du Médicament Vétérinaire Eurpean Medicines Agency: Isaura Duarte; Pedr Oliveira; Dean Tripli, Esther Day, Anna Vecelli. EMA/166976/2011 Page 9/9