Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 6th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR Orlando, USA.

Day 2 :

  • Regulatory Affairs
Location: DoubleTree by Hilton Hotel Orlando Airport
Speaker

Chair

Mohammed R Khan

Synergex Consulting, Canada

Speaker

Co-Chair

Jelena Gankina

NPF Materia Medica Holding, Russia

Speaker
Biography:

Abstract:

Background: Effective drug supply management ensures uninterrupted availability of quality approved, safe and effective pharmaceuticals. This can be achieved through proper selection, quantification, procurement, distribution and use of drugs based on consumption and morbidity pattern of the catchment area by using a system like ABC-VEN matrix analysis.

Objective: The objective of the study was to assess pharmaceutical inventory management of Tikur Anbessa Specialized Hospital (TASH) from 2009-2013 by using ABC-VEN matrix analysis method.

Methods: This research was retrospective facility based cross sectional study in which ABC, VEN and ABC-VEN matrix analysis techniques were utilized to assess the 5 years (2009-2013) pharmaceutical inventory management system at TASH. The study was conducted from January-May 2014.The list of drugs with corresponding prices was retrieved from goods receiving vouchers (GRV)/ (models 19).

Results: Out of the five years pharmaceutical ABC analysis; Insulin /NPH/, Examination glove, Gauze Bandage, Surgical Gloves, Vicryl and Normal Saline 1000 ml had exist through five years by covering huge amount of money. From ABC-VEN matrix analysis, majority of items were Category I. Most of the Category I pharmaceuticals in turn were Class A and V items which require great attention for their safety and availability.

Conclusion: The study findings indicated that there are huge pharmaceuticals in TASH, which need proper management and supervision. The hospital Drug Therapeutic Committee and other concerned bodies are invited to use this ABC-VEN matrix work and try to adopt its principle.

Speaker
Biography:

Meshesha Solomon Getnet has completed his Bachelor of Pharmacy from Addis Ababa University in 2008. He has been working in Addis Ababa City Administration Health Bureau as a Director of pharmaceutical supply and services Directorate since October 2008. He is a Member of Ethiopian Pharmaceutical Association. At present, he is a Post-graduate student in pharmacoepidemiology and social pharmacy in Addis Ababa University.

Abstract:

Issues related to the quality of medicines are becoming an increasing global concern especially in developing countries. Achieving a high level of quality requires effective medicines legislation and regulation, a competent medicines regulatory authority, good clinical and manufacturing practices with adequate medicines quality assurance and quality control systems and appropriate medicines information. A qualitative study design was used to obtain primary and secondary information through interviewing key informants and reviewing all available relevant documents respectively from Addis Ababa City Administration Food, Medicine and Health Care Administration and Control Authority. Addis Ababa medicine regulatory authority is an independent organization whose top management was committed to implement quality management system. Data on licensed and resisted health facilities and professionals were up to date but the authority had no policy on confidentiality and code of conduct for staffs, guideline to ensure requirements on quality, safety and efficacy of drugs and also mechanism to trace any counterfeit and substandard drugs. There were no any scientific bodies (laboratories) to advise the organization on scientific issues. The regulatory authority was an independent authority established to ensure food safety and quality, the safety, quality, efficacy, quality and proper use of medicines, competence and ethics of health professionals and standards of health institutions through licensing, registration and regulations against the set standards. The authority has to keep those findings as strength of the organization and much has to be done to meet the authority's goal and objectives.

Break: Networking and Refreshments 10:50-11:10

Mercy Robert Ekwere

Cross River College of Education, Nigeria

Title: Food additives and health

Time : 10:50-11:10

Biography:

Ekwere Mercy R is currently rounding up her PhD in the department of Biochemistry, College of Basic Medical Sciences; University of Calabar, Nigeria and has been teaching Biochemistry for the past 20 years.

Abstract:

The Joint Food and Agriculture Organization of the United Nations and the World Health Organization (Joint FAO/WHO Expert Committee of Food Additives) is responsible for international health matters and public. Through this organization, the safety of various food additives and contaminants are evaluated in order to recommend acceptable daily intakes for humans, and prepare specifications for the identity and purity of additives. The relevant body attending to this matter in Nigeria is the National Agency for Food and Drug Administration and Control (NAFDAC). Although there are several reports on toxicological significance of food additives such as saccharine as a causative agent for cancer , these information do not get to the level of the common man who do not pay attention to cautionary notes on food packages. Apart from this, additives like flavor enhancers rarely include instructions on the safe and acceptable daily intake. There is therefore a general lack of knowledge on the safe level of intake of these additives. In order to investigate the level of use of many of the additives which are readily available in local markets in Nigeria, a survey was carried out among some inhabitance of Port Harcourt the state capital of Rivers State in Nigeria, West Africa. This is expected to provide information on the possible dangers the people may be exposed to due to improper use of these chemicals and to guide regulatory policy on the use of food additives in Nigeria.

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Time : 11:10-11:35

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Time : 11:10-11:35

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Time : 12:00-12:25

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