The RIVM as knowledge and training centre
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1 The RIVM as knowledge and training centre Belgrade, Serbia March 2012 Marit Holleman 1
2 Content: 1. Training and Technology Transfer at RIVM 2. Training on influenza vaccines 3. New courses 2
3 Training and TT at RIVM Over 100 years of experience on manufacturing of EPI vaccines in the public domain. Delivered various TT & training programs on vaccine production and QC Numerous developing country vaccine manufacturers and NRA/NCL have sent their staff to attend one of these training programs. hands-on courses where learning by doing is the driving force. Vaccine experts to complete the curriculum Partner of the WHO Global Learning Opportunities for Vaccine Quality (GLO/VQ). 3
4 Vaccinology expertise R&D and Clinical&Regulatory Research Small scale GMP production facility QC department Incl. Animal facility 4
5 Past RIVM training courses and workshops Training program Occurrences Dates DTP vaccine production 3 courses 1998, 1999, 2001 QC of DTP vaccines 6 courses , 2003 Animal husbandry for QC 4 courses 1998, 1999, 2002, 2006 QC of Hib conjugate vaccines 3 courses 2007, 2008 GMP-QA aspects of influenza vaccines 1 course 2009 Production and QC of influenza whole cell and split vaccines 6 courses Sabin IPV workshop 1 session
6 Knowledge transfer and training at RIVM means: Grantees will have access to: Technical advice Process and production technology Documentation Assays (Pre)clinical support 6
7 Technology transfer influenza Vacsera Egypt Consultancy agreement Advice on process development and QC Advice on documentation/validation IVAC VietNam Consultancy agreement Advice production process and QC Experts visits 7
8 Learning by doing 8
9 Training courses on influenza vaccines Since start of the influenza project 2008 several training courses: 2009 June : 1 week Workshop GMP/QA 2009 Dec } 2010 March : 3 week generic course influenza production and QC 2010 April 2010 May : 3 week hands-on operator course Vacsera 2010 June : 2 week hands-on operator course IVAC 2011 Feb : 3 week generic course influenza production and QC 2012 Feb : 2 week hands-on training on influenza vaccine manufacturing for whole virus and split vaccines 9
10 Recipients of influenza vaccine training and TT 2009 Croatia, Institute of Immunology Egypt, Vacsera Indonesia, Bio Farma Iran, Razi Serbia, Torlak Thailand, GPO Vietnam, IVAC 2010 Argentina, ANLIS China, SIBP China, Zejing Pharmaceuticals China, CCIBP Croatia, Inst. of Immunology Egypt, Vacsera India, Indian Immunologicals Iran, Razi Kazakhstan, RIBSP Romania, Cantacuzino Thailand, GPO Thailand, QSMI Vietnam, IVAC 2011 Mexico, Birmex Indonesia, Bio Farma Kazakhstan, RIBSP Korea, Il-Yang Canada/China, Microbix 2012 Ivac, Vietnam Vacsera, Egypt Total number of institutes: 18 Total number of trainees: 65 10
11 TT Recipients Institutes: 18 Trainees: 65 Serbia, Torlak Croatia, Inst.of Imm. Romania, Cantacuzino Kazakhstan, RIBSP Korea, Il- Yang Canada, Microbix China, SIBP, CCIBP & Zejing Pharm. Mexico, Birmex Vietnam, IVAC Iran, Razi Thailand, GPO & QSMI Argentina, ANLIS Egypt, Vacsera India, Indian Imm. Ltd Indonesia, Bio Farma 11
12 Generic training courses in influenza vaccines Three weeks duration 10 bench places Two volume Course Manual Hands-on: practicing production run Two groups: Production & Quality Control 12
13 Impression courses 13
14 Training programs under construction: TRAINING PROGRAM DESCRIPTION TARGET AUDIENCE Critical Quality Attributes for preparation of influenza vaccines Manufacturing and QC of split virus influenza vaccine Evaluate and review product quality, safety and efficacy in (pre-) clinical studies of influenza vaccines. Process validation Comparing different guidelines Tailor made hands on training National Regulatory Authorities, National Control Laboratories, QA/QP Manufacturers Assay validation How to validate an analytical method QC and R&D staff Sabin IPV vaccines QC of conjugate vaccine Hands on training on the manufacturing of Sabin IPV vaccines QC tests and data interpretation for hib vaccine Manufacturers Manufacturers, NRA/NCL From vaccine concept to clinical study Insight in complete route of vaccine development Start up biotechnology companies and academic research groups 14
15 THANK YOU 15
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