1. Slide 1 of 10D.K. Mubangizi, Dar Es Salaam Sept. 2007 Training Workshop for Evaluators from National Medicines Regulatory Authorities in East African Community Dar Es Salaam, Tanzania Date: 10 to 14 September 2007 Evaluation of Quality and Interchangeability of Medicinal Products

2. Slide 2 of 10D.K. Mubangizi, Dar Es Salaam Sept. 2007 Evaluation of Quality and Interchangeability of Medicinal Products Experience from Participation in the WHO-PQ Rotational Position Presenter: Deus K. Mubangizi, pharmacist, MSc(Pharm.) deuskm@yahoo.co.ukdeuskm@yahoo.co.uk, dmubangizi@nda.or.ugdmubangizi@nda.or.ug Chief Inspector of Drugs, National Drug Authority WHO expert

3. Slide 3 of 10D.K. Mubangizi, Dar Es Salaam Sept. 2007 Objectives (1)  Strengthen national regulatory capacity by provision of training and personal development to experts from NMRAs  Strengthen the confidence into PQP and evaluation of prequalified products by provision of deep insight into prequalification processes and expertise  Disseminate understanding of PQP and strengthen Prequalification network by training of local and regional resource persons to be involved in Prequalification networking and trainings

4. Slide 4 of 10D.K. Mubangizi, Dar Es Salaam Sept. 2007 Objectives (2)  Identify new contributors to PQP from wide spectrum of Member States, especially from those Member States that are using or producing Prequalified products  Strengthen PQP by trainees who may temporarily contribute to Prequalification expertise and who may provide unbiased view on Prequalification processes and documents  Motivate and stimulate NRAs and trainees to commit themselves to future co-operation with PQP and initiate such co-operation

5. Slide 5 of 10D.K. Mubangizi, Dar Es Salaam Sept. 2007 The approach to/method of training and capacity building  hands on training through doing work which is then peer reviewed  group and one-to-one discussions  preparation and review of guidelines, SOPs, Templates and Forms  participation in internal and external meetings (The Global Fund, The Global TB Drug Facility, Roll Back Malaria, MSF)  participation in and/or making presentation at seminars, workshops and expert committee meetings: –Introduction of the Model Regulatory Package by TCM –Expert Committee on the Essential Medicine List –Expert Committee on International Non-proprietary Names –Expert Committee on Pharmaceutical Standards, Specification and Guidelines –Expert Committee on Drugs of Dependence  Preparation of responses to and correspondences with countries, companies, organizations and individuals

6. Slide 6 of 10D.K. Mubangizi, Dar Es Salaam Sept. 2007 Activities  Physical and geographical orientation  Administrative structures and Human Resource matters  Computer orientation and training  Orientation meeting/briefings with focal persons of all units in QSM cluster and related to the PQP (Assessment, Inspection, Prequalification and Capacity building for QC Laboratories, Development of Guidelines/Standards/Norms, INN, Essential Medicine List, Pharmacovigilance, Drugs of Dependence, Capacity building and Liaison with Counties and other agencies, Fundraising and liaison with funding agencies, etc)  Review of Guidelines, SOPs and Templates: the quality system of the PQP

7. Slide 7 of 10D.K. Mubangizi, Dar Es Salaam Sept. 2007 Lessons and Recommendations (1)  Review and strengthen our registration guidelines in the areas of the requirements for the Active Pharmaceutical Ingredient (API), Pharmaceutical Development, Efficacy (Clinical trials and Bioequivalence)  Review and strengthen our assessment procedures including assessment templates, details in reports and quality assurance measures (second review).  Develop a Registration Certificate with details that can facilitate the proper identification of the registered product and facilitate evaluation of variations/amendments.  Utilization of risk analysis principles in: –assessment of application for registration of products and variations –inspection of manufacturing sites –analysis of samples

8. Slide 8 of 10D.K. Mubangizi, Dar Es Salaam Sept. 2007 Lessons and Recommendations (2)  Consideration and utilization of reliable regulatory decisions of other agencies, institutions and experts without compromising independency and the objective of capacity building.  Working towards establishment of a documented quality system and appointment of a Quality Assurance officer.  Collaborate with WHO in monitoring the performance of prequalified products and provide feedback.  Use WHO-PQ guidelines and experts to enhance and facilitate harmonization in the EAC and COMESA.

9. Slide 9 of 10D.K. Mubangizi, Dar Es Salaam Sept. 2007 Lessons from Assessment Meetings  Stimulates harmonization: –Among DRAs thru:  group assessment pass on skills  readily available, user friendly guidelines easy to adopt/adapt –Among manufacturers thru:  Use of similar guidelines for application and assessment  Joint training seminars and workshops  Can be platform for mutual recognition and networking: –Between ICH or PIC/S countries and WHO-PQ –WHO-PQ reference for DRA assessments in DCs –Among DRAs using same guidelines adopted from WHO-PQ and have undergone similar training  Enhance reputation and public image of DRAs –Procurement through UN agencies – importation still cleared by DRAs –WHO-PQ list can be used to offer any exemptions by DRA when called for –WHOPARs and WHOPIRs used in expedited evaluation

10. Slide 10 of 10D.K. Mubangizi, Dar Es Salaam Sept. 2007 THANK YOU