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Evaluation of Quality and Interchangeability of Medicinal Products. Training Workshop for Evaluators from National Medicines Regulatory Authorities in East African Community Dar Es Salaam, Tanzania Date: 10 to 14 September 2007.
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Evaluation of Quality and Interchangeability of Medicinal Products 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 Experience from Participation in the WHO-PQ Rotational Position Presenter: Deus K. Mubangizi, pharmacist, MSc(Pharm.) deuskm@yahoo.co.uk, dmubangizi@nda.or.ug Chief Inspector of Drugs, National Drug Authority WHO expert
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
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
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
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
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
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.
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