Update of Results of the Survey on training Priorities Dr Mária Szabó Chargée de mission. OIE Science and New Technologies Department Update of Results of the Survey on training Priorities 8th VICH Outreach Forum meeting Buenos Aires 28 Feb-1 March 2017  

Agenda Background Brazil and Argentina responses VICH Training Priorities – European Region CONCLUSION

DECISION FROM THE 6TH VICH OUTREACH FORUM Tokyo (Japan), 25-30 October 2015: Conduct of a Survey by the OIE and HealthforAnimals in VICH –OUTREACH FORUM (VOF)-OIE Member Countries During the last 6th VICH Outreach Forum a decision was taken to conduct a joint survey by OIE and HealthforAnimals among the VICH-Outreach Forum Countries. The goal was to obtain a general view of the current situation of the VICH Outreach Forum Countries, the ASEAN, CAMAVET and UEMOA region. The results were presented in the 7 th Outreach Forum Meeting., which showed that the priority of quality,, safety and pharmacovigilance related guidelines are the most interested topics.

Responses-OVERVIEW from Brazil (1)- June 2016-February 2017 Brazil has modified and adopted these guidelines : GL3 -(stability guideline ) GL 8 (stability of premix) GL9 (Good Clinical Practices ) GL 7, 12, 13, 14, 15, 16, 19, 20, 21 – general for anthelmintic GLs for different species GL45 Quality Stability Brazil updates legislation to be consistent with international standards, such as VICH and CAMEVET The answer to the question : to what extent has your country adopted VICH guidelines ? Partly - only some guidelines and with modifications to suit local conditions

Responses-OVERVIEW from Brazil (2) June 2016-consultation February 2017 The following guidelines are not currently used but could be of interest: GL1, 2 - Validation of analytical procedures: definitions and terminology, Validation of analytical procedures: methodology GL17 - Stability for biotechnological, biologicals GL27 - Guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance GL22, 23, 28 - Safety residue in human food reproduction, genotoxcity, carcinogenicity; 31, 32, 33,36, 37 - Safety GL41,50 - Vaccine - Safety GL 52 - Bioequivalence

Responses-OVERVIEW from Brazil (3) Priority for trainings: GL 1 and GL2 validation of analytical procedure : definition and terminology –methodology GL9 - Good Clinical Practice GL17 - Stability testing of biotechnological /biological products GL27 - Guidance on pre-approval information for registration of new veterinary medicinal products GL52 - Bioequivalence The answer to the question : to what extent has your country adopted VICH guidelines ? Stability guidelines modification to the special climate

Responses-OVERVIEW from Argentina,(2) last update (2017, February) Some VICH guidelines with modifications to suit local conditions are adopted (GL3, GL48, GL49 ). Argentina is planning to adopt: Good Clinical Practice guideline (GL9), Target Animal Safety for pharmaceuticals (GL43) – just have been revised with very slightly changes.  Some VICH guidelines recommended by the Regulatory Authorities when generating data to submit (especially GL 9 and 43-see above).  All studies are performed according VICH guidelines; are accepted in ARGENTINA

Responses-OVERVIEW from Argentina Top Priority for training Quality GL39 and GL 40 Quality specifications Safety GL6 - GL38 Environmental Impact Assessment for veterinary medicinal products Phase I-II GL24 Pharmacovigilance, GL29 Pharmacovigilance Periodic Safety Report (PSUR ) GL30 GL35 and GL42 Pharmacovigilance - list of terms, data elements-ESTD) GL43 Target Animal Safety for Pharmaceuticals Safety and efficacy GL9 Good Clinical Practice Need to be checked

Responses-OVERVIEW of VICH Training Priorities OIE Regional Seminar, Budapest (Hungary), 11-13 October 2016 Aimed to have a dialogue among European Countries. The European Medicine Agency and Eurasian Economic Commission (former Customs Union) were invited to share their regional experiences and expertise to strengthen the network. VICH Outreach Forum activities were highlighted as well as the application of VICH guidelines. The seminar agenda was designed to be practical with lectures, country experiences and best practices, and exercises to provide skills, encourage participation and facilitate regional dialogue among European countries. The European Medicine Agency and the Eurasian Economic Commission (former Customs Union) shared their regional experience and expertise; future work could consist of establishing greater ‘bridges’ among those two organisations with similar mandates on VPs, for the benefit of the countries in the region.

Responses-OVERVIEW of VICH Training Priorities OIE Regional Seminar, Budapest (Hungary), 11-13 October 2016 We circulated a simplified questionnaire to obtain answers on needs of Member Countries in terms of VICH training priorities and to evaluate the level of VICH knowledge. Responses were more divergent than in the two other Regional Seminars (Africa and Asia-Oceania). European Union Countries and Non-EU Countries responses varied.

Responses-OVERVIEW of VICH Training Priorities OIE Regional Seminar, Budapest (Hungary), 11-13 October 2016 Divergent interest One EU country is interested in receiving training in all VICH Guidelines and one non-EU country indicated that is interested in receiving training in almost all of them The following countries are interested to potentially joining the VICH Outreach Forum: Montenegro, Macedonia, Armenia, Uzbekistan and Georgia One country also indicated there need on regulatory trainining, namely on procedures.

Responses-OVERVIEW of VICH Training Priorities OIE Regional Seminar, Budapest (Hungary), 11-13 October 2016 Russia: is using similar guidelines and considering a way of harmonisation with VICH GLs Switzerland: interested in G1-G7 (quality GLs and 19-29 anthelmintics)

VICH Training Priorities CONCLUSION Recurring Themes: Nil novi sub sole Nothing is new under the sun Nada de novo Nada nuevo bajo el sol 太陽の下で新しいものはありません。 What has been will be again,    what has been done will be done again;    there is nothing new under the sun.

VICH Training Priorities CONCLUSION Recurring Themes: First priority for training still remains the same : QUALITY Second: SAFETY Third: EFFICACY Guidelines 3 key aspects of the evaluation of veterinary medicinal products in order to assure good quality, safe and efficient veterinary medicinal products on the market   What has been will be again,    what has been done will be done again;    there is nothing new under the sun.