slide 1 of 10d.k. mubangizi, dar es salaam sept. 2007 training workshop for evaluators from national...
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Slide 1 of 10 D.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
Evaluation of Quality and Interchangeability of Medicinal Products
Slide 2 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Evaluation of Quality and Interchangeability of Medicinal Products
Evaluation of Quality and Interchangeability of Medicinal Products
Experience from Participation in the WHO-PQ
Rotational Position
Presenter: Deus K. Mubangizi, pharmacist, MSc(Pharm.)
[email protected], [email protected]
Chief Inspector of Drugs, National Drug Authority
WHO expert
Slide 3 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Objectives (1)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
Slide 4 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Objectives (2)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
Slide 5 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
The approach to/method of training and capacity building
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
Slide 6 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
ActivitiesActivities
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
Slide 7 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Lessons and Recommendations (1)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
Slide 8 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Lessons and Recommendations (2)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.
Slide 9 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Lessons from Assessment MeetingsLessons 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
Slide 10 of 10 D.K. Mubangizi, Dar Es Salaam Sept. 2007
THANK YOUTHANK YOU