CAPACITY BUILDING EVENTS FOR QUALITY AND SAFETY : MEDICINES

Transcription

1 Dates Location Title/topics Co-organizer & Participants Organizer & Faculty Audience Restricted or Unrestricted Blood products & related biologicals Oct - 30 November WHO-HQ Assessment of blood regulatory systems Egyptian regulator internship Ana Padilla 28 March - 1 April Brazil Regulation of blood and blood products International Nonproprietary Names January WHO-HQ INN training course for INN stakeholders ANVISA and Mercosur countries Ana Padilla Raffaella Balocco / Jicui Dong / Sophie Lasseur / Antonio Romeo Quality Assurance March Berlin, Germany Master course : Consumer health care, including module 4: Quality assurance and health management Charité and Humboldt Universities Sabine Kopp April Training session of the monitoring as surveillance project Sabine Kopp TBD WHO-HQ Briefing on the International Pharmacopoeia Sabine Kopp Medicines Regulatory Support November Yaounde, Cameroun 2nd Training workshop on strengthening regulatory capacities on registration multisource products with a specific focus on Malaria medicines Internal and external experts from the DPM (NMRA) of Cameroun Alain Prat Restricted 2012

2 Dates Location Title/topics Co-organizer & Participants Organizer & Faculty Audience Restricted or Unrestricted 2nd Semester Nairobi, Kenya Workshop on implementation of quality management system by national medicines regulatory authorities from EAC partner states Staff from the NMRAs of EAC Member States Alain Prat Restricted

3 Dates Location Title/topics Co-organizer & Participants Organizer & Faculty Audience Restricted or Unrestricted Safety & Efficacy (Pharmacovigilance) October Dubrovnik, Croatia One-day refresher course on the WHO PV Programme - PV methods, tools and techniques for PV data collection, and data analysis. Shanthi Pal Restricted (by invitation only) November Ukraine Course on cohort event monitoring of ARVs for Belarus, Moldova and Ukraine Shanthi Pal Restricted to 3 project countries March Lareb, Netherlands Course on consumer reporting of ADRs Shanthi Pal Restricted (by invitation) 21 May-1 June Uppsala, Sweden Basic course on pharmacovigilance Shanthi Pal Unrestricted 7-8 June Oslo, Norway Course on the use of ATC DDD and drug utilization research Shanthi Pal unrestricted September Morocco Pharmacovigilance training course for Francophone countries Shanthi Pal unrestricted 11 November Brasilia, Brazil One-day refresher course on WHO PV Programme, PV methods, tools and techniques for PV data collection, and data analysis. Shanthi Pal Restricted by invitation only Prequalification of Medicines November Dar-es-Salaam, Tanzania Quality assurance of drugs GIZ, regulators, QCLs, manufacturers

4 Dates Location Title/topics Co-organizer & Participants Organizer & Faculty Audience Restricted or Unrestricted November Amman, Jordan Training in microbiogical testing EMRO, QCLs / Jitka Sabartova November Casablanca, Morocco Training on compilation of dossier for generics in CTD format EMRO, regulators, manufacturers 5-9 December Dar-es-Salaam, Tanzania Workshop on quality control of reproductive health medicines UNFPA, QCLs, regulators / Jitka Sabartova December Windhoek, Namibia Workshop on quality control of reproductive health medicines UNFPA, QCLs, regulators / Jitka Sabartova

5 Dates Location Title/topics Co-organizer & Participants Organizer & Faculty Audience Restricted or Unrestricted January Copenhagen Training of quality assessors Regulators Matthias Stahl February Seoul 2nd Line TB Medicine Manufacturers Workshop 28 Feb. - 2 March Accra Workshop on quality control of reproductive health USP, manufacturers, regulators UNFPA, QCLs, regulators March Beijing GMP implementation difficulties SFDA Ian Thrussell / Jitka Sabartova / Ian Thrussell March Johannesburg, SAR Regulatory consultative meeting and PQP requirements for TB manufacturers USP, manufacturers, regulators /ndo Kuwana October Geneva Consultative meeting with collaborating experts - GMP update Collaborating GMP experts Vimal March-May tbd Collaborative registration procedure for PQ medicines AFRO, regulators 7-10 May Jakarta, Indonesia BE studies of IR and alternative dosage forms and WHO Prequalification Programme BADAN-POM, ASEA regulators, Indonesian manufacturers and CROs May May Xiamen, China Quingdao, China Revised GMP in China and its implementation SFDA, FPP manufacturers May 30 May - 2 June Hangzhou, China Nanjing, China 4-6 June Beijing, China PQP programme - 2 consecutive workshops SFDA, FPP manufacturers Good clinical practice, planning, conduct and reporting of bioequivalence studies SFDA, CRO union June Shanghai, China Quality of APIs EDQM, API manufacturers Unrestricted 2) 28 May - 1 June Lagos, Nigeria Selected GMP topics NAFDAC, manufacturers and inspectors

6 Dates Location Title/topics Co-organizer & Participants Organizer & Faculty Audience Restricted or Unrestricted June Beijing, China Quality and prequalification of RH medicines Concept Foundation, manufacturers Sept.-October India Quality of APIs EDQM, API manufacturers Sept.-October India Quality and prequalification of RH medicines October Geneva Workshop for GCP/GLP Concept Foundation, manufacturers Inspectors participating in PQ inspection of CROs/BE studies Stephanie Croft/ Deus Mubangizi Oct.-November China PQP programme SFDA, FPP manufacturers November tbd Annual meeting of PQ QCLs network QCLs Jitka Sabartova Unrestricted 2) Contact information: Dr Samvel Azatyan and Mrs Patricia Guillot at Footnotes: 1) Participation restricted to parties specifically invited by WHO or partnering organizations 2) Public announcement for registration is or will be posted by WHO or its partners 3) Manufacturers of relevant categories of medicines and organizations involved in medicines' development (e.g. Contract Research Organizations) 4) Staff of regulatory authorities 5) Staff of quality control laboratories co-operating with Prequalification of Medicines Programme Glossary: Unrestricted 2) Manufacturers/CROs 3) Regulators 4) Quality control 5) Manufacturers/CROs, Regulators, Quality control 3,4,5)

7 Target audience Regulators

8 Target audience Regulators

9 Target audience Countries particpating in the WHO programme for International Drug Monitoring Staff from PV centre and HIV treatment programmes in countries consumer / patient organizations and pharmacovigilance centres individuals involved in pharmacovigilance Pharmacovigilance community, economists and others involved in drug utilization studies, and in evaluation of long term trends in drug use health professionals, pharmacovigilance community and public health programmes Countries particpating in the WHO programme for International Drug Monitoring

10 Target audience CAPACITY BUILDING EVENTS FOR QUALITY AND SAFETY : MEDICINES

11 Target audience

12 Target audience Quality control 5)