Mathematics and Statistics: Indispensable Tools in NAFDAC Samson B. Adebayo, Ph.D. Professor of Biostatistics Director of Planning, Research & Statistics Nat. Ag. for Food & Drug Admin. & Control (NAFDAC)

Outline 2  Overview of NAFDAC  Directorates in NAFDAC  Use of Mathematics and Statistics in NAFDAC   Planning, Research and Statistics Directorate of NAFDAC – Dashboard  Conclusion

Overview of NAFDAC 3 NAFDAC was established by Decree 15 of 1993 as amended by Decree 19 of 1999 Now the NAFDAC Act Cap N1 Laws of the Federation of Nigeria, This Act mandates NAFDAC to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, chemicals, detergents, medical devices and packaged Vision: Safeguarding the health of the nation

Overview NAFDAC - Structure 4 Human Resources Management Finance and Accounts Service Directorates Planning, Research and Statistics Chemical Evaluation & Research Registration and Regulatory Affairs Ports Inspection Laboratory Services Investigation & Enforcement Technical Directorates NarcoticsandControlledSubstances Drug Evaluation & Research Food Safety & Applied Nutrition Pharmacovigilance and Post Market Surveillance Veterinary Medicine & Allied Products

Use of Mathematics and Statistics in a Regulatory Agency First, it is important that informed decisions are taken in a Regulatory Agency The question is: How do you make an informed decision? Or what do you need to make an informed decision? 5

Mathematics and Statistics as: 6 Mathematics Aristotle Defined Mathematics as: The science of quantity. It is said that Mathematics is the gate and key of all sciences. Therefore, Mathematics is a ‘Science’ of all ‘Sciences’ and ‘Art’ of all ‘Arts’.

Mathematics and Statistics - 2 Statistics Statistics is defined as the science of collecting, analysing and drawing conclusions from data. Another definition of statistics states that it is the science: pure and applied, of creating, developing and applying techniques such that the uncertainty of inductive inferences may be evaluated. 7

Mathematics and Statistics - 3 Statistics - 2 It is very useful since it is concerned with making inferences about a body of data when only a part of the data are observed or studied. Its relevance spans across very wide range of subjects including agriculture, biology, education, business, archaeology, psychology, economics to mention only a few. 8

Mathematics and Statistics - 3 Statistics - 3 Statistics is a branch of Mathematics which has rapidly gained ground in decision theory. It is not far-fetched, therefore, that all statistical techniques take their roots from principles of Mathematics While Mathematical models assume an almost infinitesimally perfect one, statistical models consider some level of uncertainty This level of uncertainty is therefore accommodated with some probabilistic precisions in making informed decisions. 9

Use of Mathematics and Statistics in NAFDAC Mobile Authentication Service: uses the principle of random numbers Issuance of chemical permit: uses the combination of mathematics and forecast approach to match needs with usage Sampling – Inspection – Quality Assurance – Post Marketing 10

Mathematics and Statistics in NAFDAC … Compliance with standards – Food Fortification with Vitamin A Flour Sugar Vegetable Oil – Salt Iodization Statistical quality control of products Calibration of laboratory equipment 11

Mathematics and Statistics in NAFDAC - 2 Comparison of gold standard with test method – HPLC with I-Check – HPLC with TruScan – HPLC with mobile laboratory 12 Gold standardTest method PassedFailed PassedCorrectWrong FailedWrongCorrect

Planning, Research and Statistics (PRS) Directorate of NAFDAC – a Dashboard 13

PRS in NAFDAC Through its PRS Directorate, NAFDAC’s interventions are based on a properly structured Strategic Plan (SP) The process for developing the SP ensures proper integration of the activities for all the Directorates of the Agency Both mathematical and statistical approaches are used in setting its milestones and targets 14

Some Statistical Techniques Deployed by NAFDAC 15 Operation Research Statistical Quality Control Biostatistics Clinical Trial Geostatistics – a combination of GIS & Statistics

Conclusion NAFDAC’s interventions and activities are evidence-driven. This has made the Agency to be known globally for its Evidence-based Regulatory Decision Making All these can be attributed to effective use of Mathematics and Statistics as Indispensable Tools in the Agency 16

Finally, I implore the listeners that; In the realm of uncertainty, consult a statistician 17

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