ZAMBIA MEDICINES REGULATORY AUTHORITY EMPLOYMENT OPPORTUNITY
|
|
- Marcus Washington
- 5 years ago
- Views:
Transcription
1 ZAMBIA MEDICINES REGULATORY AUTHORITY EMPLOYMENT OPPORTUNITY The Zambia Medicines Regulatory Authority (ZAMRA) was set up by the Medicines and Allied Substances Act (No. 3) of 2013 as a statutory body responsible for medicine and allied substances regulation in Zambia. The Zambia Medicines Regulatory Authority invites applications from suitably qualified Zambian citizens to fill the following vacant positions at the Zambia Medicines Regulatory Authority: 1. INSPECTOR GDP & ACCESS (4) To undertake the inspection of distribution channels of medicines and allied substances such as hospital pharmacies and wholesale dealing of medicines and allied and certain health facilities in order to promote access to medicines and allied substances; achieve compliance to set standards and adherence to licensing terms and conditions. BSc degree in Pharmacy No prior experience is required for this position. Recent graduates are encouraged Supervises and undertakes timely, inspection pharmaceutical establishments in order to ensure compliance and adherence to licensing terms and conditions. Supervises and undertakes timely and effectively, product sampling screening in order to facilitate product testing and sample evaluation. Undertakes timely, data entry of inspection reports and schedule into the database in order to facilitate decision-making.
2 Undertakes timely, data entry of inspection reports and schedule into the database in order to facilitate decision-making. Supervises effectively, staff in order to ensure the attainment of the department s objectives. 2. SURVEILLANCE OFFICER DRUG INFORMATION (1) To undertake the monitoring of labeling information, advertisements and promotion of medicines and allied substances in order to ensure the safety and efficacy of medicines and allied substances. BSc degree in Pharmacy/Equivalent No prior experience is required for this position. Recent graduates are encouraged Undertakes the timely, review of application for advertising and promoting of medicines and allied substances in order to conform to marketing authorisation terms. Undertakes effectively, the investigations of reports on quality and labeling of medicines and allied substances in order to conform to marketing authorisation terms and product specification. Undertakes timely and effectively, the recall of medicines and allied substances in order to ensure products not meeting requirements are removed from the market. Timely and effectively supports, the product sampling and screening in order to facilitate product testing and sample evaluation. Undertakes effectively, the labeling, storage and retrieval of samples in order to ensure integrity and chain of custody Undertakes effectively, the entry of data on to the database in order to ensure accurate reporting.
3 3. SURVEILLANCE OFFICER - PHARMACOVIGILANCE (1) To undertake the monitoring of adverse reactions and events in order to ensure compliance to set standards and guidelines. BSc degree in Pharmacy/ Equivalent No prior experience is required for this position. Recent graduates are encouraged Undertakes timely, assessment of adverse drug reaction reports in order to ascertain causality and recommend appropriate intervention. Undertakes effectively, the gathering and dissemination of drug information in order to promote rational use of medicines and allied substances. Undertakes effectively, the development and dissemination of IEC materials in order to promote public awareness. Undertakes effectively, the entry of data on to the database in order to ensure accurate reporting. 4. INSPECTOR - GMP (1) To undertake the inspection of premises for manufacture of medicines and allied substances in order to achieve compliance to set standards and adherence to licensing terms and conditions. BSc degree in Pharmacy /Equivalent No prior experience is required for this position. Recent graduates are encouraged Undertakes timely and effectively, GMP inspections of premises for manufacture of medicines & allied substances in order to achieve compliance. Undertakes timely and effectively, product sampling screening in order to facilitate product testing and sample evaluation. Undertakes timely, data entry of inspection reports and schedule into the database in order to facilitate decision making
4 5. INSPECTOR - INVESTIGATIONS (2) To undertake the enforcement of the law relating to medicines and allied substances in order to discover and punish persons who violate or contravene it. BSc degree in Pharmacy/Equivalent No prior experience is required for this position. Recent graduates are encouraged Undertakes effectively, the gathering of information relating to medicines and allied substances in order to facilitate possible investigations. Undertakes effectively, the investigations relating to medicines and allied substances in order to facilitate decision-making. Undertakes effectively, the prosecution of cases relating to medicines and allied substances in order to punish persons who violate or contravene Medicines and Allied Substances Act No. 3 of 2013 and other related statutes. Performs timely, data entry of investigations and cases into the database in order to ensure accurate capturing of information. 6. LICENSING OFFICER (1) To undertake registration of Biotech products in order to achieve compliance to set To supervise and undertake the processing of licences, permits and certificates for premises and authorisation to import and export medicines and allied substances, in order to facilitate their issuance. BSc degree in Pharmacy/Equivalent No prior experience is required for this position. Recent graduates are encouraged
5 Undertakes effectively, the processing of licences and permits for narcotic drugs, psychotropic substances and precursors in a timely manner in order to facilitate their issuance. Undertakes effectively, the handling of annual returns, transfers and amendments of licences, certificates and permits in order to facilitate compliance to the terms and conditions of licensing. Undertakes timely, the development and review of schedules for monitoring activities in order to prevent misuses and abuse of narcotic drugs, psychotropic substances and precursors. Undertakes and aggregates timely, annual requirements for narcotic drugs, psychotropic substances and precursors in order to ensure prompt reporting to the International Narcotics Control Board (INCB) and facilitation of trade. Undertakes timely, the maintenance of registers in order to have up to date information. Undertakes timely, data entry in order to facilitate decision-making. 7. REGISTRATION OFFICER - BIOTECH PRODUCTS (1) To undertake registration of Biotech products in order to achieve compliance to set BSc degree in Biochemistry/Biomedicine/Molecular Biology/ /Equivalent No prior experience is required for this position. Recent graduates are encouraged Undertakes effectively, the registration of Biotech products for human use in order to authorize their use. Undertakes effectively, the maintenance of the Biotech products information management system in order to facilitate storage, processing, retrieval and dissemination of information Undertakes effectively the screening of applications for registration of medical devices in order to ascertain their completeness and validity Undertakes effectively the receipting, acknowledgement and inputting of information on applications in order to facilitate processing
6 8. REGISTRATION OFFICER - MEDICAL DEVICES (1) To undertake registration of medical devices in order to achieve compliance to set BSc degree in Biomedical Sciences/Equivalent No prior experience is required for this position. Recent graduates are encouraged Undertakes effectively, the registration of Medical Devices for human and animal use in order to achieve compliance to set standards. Undertakes effectively, the maintenance of the medical devices information management system in order to facilitate storage, processing, retrieval and dissemination of information Undertakes effectively the screening of applications for registration of medical devices in order to ascertain their completeness and validity Undertakes effectively the receipting, acknowledgement and inputting of information on applications in order to facilitate processing 9. REGISTRATION OFFICER - ALLIED SUBSTANCES (1) To undertake registration of allied substances in order to achieve compliance to set BSc degree in Pharmacy/Equivalent No prior experience is required for this position. Recent graduates are encouraged Undertake and undertakes effectively, the registration of allied substances for human and animal use in order to achieve compliance to set standards.
7 Undertake effectively, the registration of medical devices for human and animal use in order to achieve compliance to set standards. Undertakes regularly, the development, review and dissemination of market authorisation guidelines in order to inform potential applicants and staff. Undertakes and undertakes effectively, the maintenance of the allied substances information management system in order to facilitate storage, processing, retrieval and dissemination of information Undertakes effectively the implementation of performance management systems in order to facilitate improvement in performance and productivity. ZAMRA is an Equal opportunity employer with good package for successful candidate. Interested Zambian citizens should send applications with detailed Curriculum Vitae that includes , fax, telephone / cell phone numbers and certified copies of original certificates with three (03) traceable references to:- The Director General Zambia Medicines Regulatory Authority Plot No.6903 Tuleteka Road, Off Makishi Road P O Box LUSAKA Closing date: 2 nd February 2018 Please note that only short-listed candidates will be notified.
MEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL SA GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINES This document is intended to serve as guidance on the requirements for Good Manufacturing Practice in South Africa. This
More informationVersion Number: 004 Controlled Document Sponsor: Controlled Document Lead:
Chief Investigators and Principal Investigators in Research Policy CONTROLLED DOCUMENT CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Policy Governance To set out the responsibilities of
More informationUPDATE: Regulatory Framework for Medical Devices in South Africa. SAMED Annual Conference. 14 June 2018 Jerry Molokwane
UPDATE: Regulatory Framework for Medical Devices in South Africa SAMED Annual Conference 14 June 2018 Jerry Molokwane Medicines and Related Substances Act, 1965 (Act 101 of 1965) Act 72 of 2008 and Act
More informationMINIMUM CRITERIA FOR REACH AND CLP INSPECTIONS 1
FORUM FOR EXCHANGE OF INFORMATION ON ENFORCEMENT Adopted at the 9 th meeting of the Forum on 1-3 March 2011 MINIMUM CRITERIA FOR REACH AND CLP INSPECTIONS 1 MARCH 2011 1 First edition adopted at the 6
More informationREPORT ON DRUG REGULATORY SYSTEM ASSESSMENT OF MONGOLIA
REPORT ON DRUG REGULATORY SYSTEM ASSESSMENT OF MONGOLIA ULAANBAATAR 2011 Abbreviations... 3 Acknowledgement... 4 Executive Summary... 5 1. General information on the assessment.... 7 1.1 Purpose of this
More information(b) Service consultation. The facility must employ or obtain the services of a licensed pharmacist who-
420-5-10-.16 Pharmacy Services. (1) The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in 483.75(h) of Title 42 Code of
More informationGuidelines on the Keeping of Records in Respect of Medicinal Products when Conducting a Retail Pharmacy Business
Guidelines on the Keeping of Records in Respect of Medicinal Products when Conducting a Retail Pharmacy Business to facilitate compliance with Regulation 12 of the Regulation of Retail Pharmacy Businesses
More informationGuidance for registered pharmacies preparing unlicensed medicines
Guidance for registered pharmacies preparing unlicensed medicines May 2014 The text of this document (but not the logo and branding) may be reproduced free of charge in any format or medium, as long as
More informationLEGISLATION UPDATE & STATUS OF MCC / SAHPRA and GUIDANCE TO MEET REGULATOR S EXPECTATIONS
LEGISLATION UPDATE & STATUS OF MCC / SAHPRA and GUIDANCE TO MEET REGULATOR S EXPECTATIONS Joey Gouws MCC and Cluster: Food Control, Pharmaceutical Trade and Product Regulation NATIONAL DEPARTMENT OF HEALTH
More informationLegislations and Policies in Jordan/ Related to Health and Pharmaceuticals April 19, 2018
Legislations and Policies in Jordan/ Related to Health and Pharmaceuticals April 19, 2018 Dr. Rania Bader, HRH2030 Health Workforce Competency Lead HRH2030 The Human Resources for Health (HRH2030) is a
More informationProposed amendments to the Marihuana for Medical Purposes Regulations
Proposed amendments to the Marihuana for Medical Purposes Regulations Submission in response to the Canada Gazette publication on the proposed amendments to the Marihuana for Medical Purposes Regulations
More informationFOOD AND DRUGS AUTHORITY GUIDELINES FOR QUALIFIED PERSON FOR PHARMACOVIGILANCE
FOOD AND DRUGS AUTHORITY GUIDELINES FOR QUALIFIED PERSON FOR PHARMACOVIGILANCE Document No. : FDA/SMC/SMD/GL-QPP/2013/03 Date of First Adoption : 1st February, 2013 Date of Issue : 1 st March, 2013 Version
More informationNATIONAL MEDICINAL PRODUCTS POLICY 2013
THE NATIONAL MEDICINAL PRODUCTS POLICY OF THE REPUBLIC OF FIJI 2013 2 NATIONAL MEDICINAL PRODUCTS POLICY 2013 FOREWORD Medicines are required for prevention, control and treatment of illness. When a medicine
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL GUIDELINES FOR RECALL/ WITHDRAWAL OF MEDICINES This document has been prepared to serve as a recommendation to applicants regarding the recalls of medicines, and the Medicines
More informationJob Description. Health Protection Officer. Toi Te Ora Public Health Service
Toi Te Ora Public Health Service Report to: Health Protection Team Leader Liaises with: Health Protection Team Health Services Development Team Health Improvement Team Support Staff Toi Te Ora - Public
More informationGuidance on the Supply by Pharmacists in Retail Pharmacy Businesses of Medicines to Patients in Residential Care Settings/Nursing Homes
Guidance on the Supply by Pharmacists in Retail Pharmacy Businesses of Medicines to Patients in Residential Care Settings/Nursing Homes Pharmaceutical Society of Ireland Version 4 March 2018 Updates made
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL QUESTIONS & ANSWERS: LICENSING OF MEDICAL DEVICE ESTABLISHMENTS This document is intended to provide clarity on guidelines and applications for the licensing of medical device
More informationNAMIBIA MEDICINES REGULATORY COUNCIL MINISTRY OF HEALTH AND SOCIAL SERVICES
1 NAMIBIA MEDICINES REGULATORY COUNCIL MINISTRY OF HEALTH AND SOCIAL SERVICES FEES PAYABLE TO THE REGISTRAR (Regulation 47) 1. In respect of an application for registration of a Category A medicine - (a)
More informationJob Description. Health Protection Officer Toi Te Ora Public Health Service
Job Description Health Protection Officer Toi Te Ora Public Health Service Report to: Liaises with: Health Protection Team Leader Health Protection Team Health Services Development Team Health Improvement
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Routine Project Audit SOP Number: 6 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013 Review date: August
More informationHealth Information and Quality Authority Regulation Directorate
Health Information and Quality Authority Regulation Directorate Compliance Monitoring Inspection report Designated Centres under Health Act 2007, as amended Centre name: Centre ID: Leeson Park House Nursing
More informationAPPROVED REGULATION OF THE STATE BOARD OF PHARMACY. LCB File No. R Effective May 16, 2018
APPROVED REGULATION OF THE STATE BOARD OF PHARMACY LCB File No. R015-18 Effective May 16, 2018 EXPLANATION Matter in italics is new; matter in brackets [omitted material] is material to be omitted. AUTHORITY:
More informationFood Standards Agency in Wales
Food Standards Agency in Wales Report on the Focused Audit of Local Authority Assessment of Regulation (EC) No 852/2004 on the Hygiene of Foodstuffs in Food Business Establishments Torfaen County Borough
More informationScheme of Service for Inspectors of Drugs
REPUBLIC OF KENYA Scheme of Service for Inspectors of Drugs 7th July, 1995 ISSUED BY THE PERMANENT SECRETARY/DIRECTOR OF PERSONNEL MANAGEMENT OFFICE OF THE PRESIDENT OFFICE OF THE PRESIDENT Reference:
More informationAccomplish, achieve and learn in a supportive environment while contributing to the protection of public and animal health
Graduate Programme Accomplish, achieve and learn in a supportive environment while contributing to the protection of public and animal health www.hpra.ie HPRA GRADUATE PROGRAMME Our Graduate Programme
More informationOfficial Journal of the European Union
L 33/30 DIRECTIVE 2002/98/EC OF THE EUROPEAN PARLIAMT AND OF THE COUNCIL of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of
More informationJOB DESCRIPTION. 2. To participate in the delivery of medicines administration depending on local need and priorities.
JOB DESCRIPTION JOB TITLE: Clinical Pharmacy Technician PAY BAND: 5 DEPARTMENT/DIVISION: BASED AT: REPORTS TO: PHARMACY/A5 University Hospitals Birmingham Pharmacy Support Manager PROFESSIONALLY RESPONSIBLE
More informationInternational Pharmaceutical Federation Fédération internationale pharmaceutique. Standards for Quality of Pharmacy Services
International Pharmaceutical Federation Fédération internationale pharmaceutique PO Box 84200, 2508 AE The Hague, The Netherlands Standards for Quality of Pharmacy Services Standards are an important part
More informationResearch Governance Framework 2 nd Edition, Medicine for Human Use (Clinical Trial) Regulations 2004
Title: Outcome Statement: Research Auditing and Monitoring Procedures Researchers in the Trust and research partners will be informed about the requirements and procedures involved in research audit and
More informationAnnexure A COMPETENCE STANDARDS FOR CPD INTRODUCTION
COMPETENCE STANDARDS FOR CPD INTRODUCTION Pharmacists in each field of practice need to accept responsibility for the selfassessment and maintenance of their competence throughout their professional lives.
More informationRQIA Provider Guidance Day Care Settings
RQIA Provider Guidance 2016-17 Day Care Settings www.r qia.org.uk A s s u r a n c e, C h a l l e n g e a n d I m p r o v e m e n t i n H e a l t h a n d S o c i a l C a r e What we do The Regulation and
More informationWrittle College Health and Safety Policy
Writtle College Health and Safety Policy 2015-2016 Document Ownership: Role Title: Chair of the Board Department Approved by Senior Management Team 11 August 2015 Approved by Personnel & Remuneration Committee
More informationRoyal Wolverhampton Hospitals NHS Trust. Job Description Haematology
Royal Wolverhampton Hospitals NHS Trust Job Description Haematology Job Title: Grade: A4C Band 3 (Point 7) Directorate: Pathology Department: Haematology Reports to: BMS staff and section senior Professionally
More informationMHRA Findings Dissemination Joint Office Launch Jan Presented by: Carolyn Maloney UHL R&D Manager
MHRA Findings Dissemination Joint Office Launch Jan. 2012 Presented by: Carolyn Maloney UHL R&D Manager Purpose of presentation To feed back abridged findings from March 2011 MHRA Statutory Systems Inspection
More information(2) Law on the Amendment of Law on the Management of Pharmaceuticals (2007)
Cambodia 1. Principal Laws and Regulations The principal law which specifically addresses the counterfeit medicines in Cambodia is the Law on the Management of Pharmaceuticals (Royal Kram No. NS/RKM/0696/02
More informationTrial Management: Trial Master Files and Investigator Site Files
Title: Outcome Statement: Written By: Trial Management: Trial Master Files and Investigator Site Files Staff working on research studies in NSFT will be informed about the requirements of setting up and
More informationGENERAL STATEMENT OF SAFETY POLICY
THE SOUTHERN EDUCATION & LIBRARY BOARD GENERAL STATEMENT OF SAFETY POLICY POLICY OBJECTIVE: The objective of this Policy is to ensure, so far as is reasonably practicable, that no person is placed in a
More informationAN ACT. Be it enacted by the General Assembly of the State of Ohio:
(131st General Assembly) (Substitute House Bill Number 124) AN ACT To amend section 4729.01 and to enact sections 4723.4810, 4729.282, 4730.432, and 4731.93 of the Revised Code regarding the authority
More informationLaw on Medical Devices
Law on Medical Devices The Law is published in the Official Gazette of the Republic of Montenegro, no. 79/2004 on 23.12.2004. I GENERAL PROVISIONS Article 1 Manufacturing and distribution of medical devices
More informationPAPUA NEW GUINEA PHARMACEUTICAL COUNTRY PROFILE
PAPUA NEW GUINEA PHARMACEUTICAL COUNTRY PROFILE Papua New Guinea Pharmaceutical Country Profile Published by the Ministry of Health in collaboration with the World Health Organization January 2012 Any
More informationSubject to Filing with Minister of Health
Pharmacy Operations and Drug Scheduling Act - BYLAWS Table of Contents 1. Definitions PART I Pharmacy Licences 2. Licence Types 3. New Community Pharmacy Licence 4. Community Pharmacy Licence Renewal 5.
More informationAUDIT REPORT. Audit of Offi cial Controls in Local Authority Supervised Establishments Cork County Council
AUDIT REPORT Audit of Offi cial Controls in Local Authority Supervised Establishments Cork County Council AUDIT REPORT Audit of Official Controls in Local Authority Supervised Establishments Cork County
More informationHuman Samples in Research
Human Samples in Research Adverse Event Reporting Document Identifier HTA-11-SOP-Adverse Event Reporting AUTHOR APPROVER EFFECTIVE DATE: Name and role Signature and date Name and role Signature and date
More informationGeneral Administration GA STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility
General Administration GA 102.01 STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility Approval: Nancy Paris, MS, FACHE President and CEO (17 July 2014) (Signature and
More informationORGANIZATION OF AMERICAN STATES
ORGANIZATION OF AMERICAN STATES INTER-AMERICAN DRUG ABUSE CONTROL COMMISSION GROUP OF EXPERTS ON PHARMACEUTICAL PRODUCTS Guide for health professionals concerning counterfeit drugs Bahamas - Brasil Lima,
More informationCountry Data Profile on the Pharmaceutical Situation in the Southern African Development Community (SADC) Botswana
Country Data Profile on the Pharmaceutical Situation in the Southern African Development Community (SADC) Botswana This document is not a formal publication of WHO and does not necessarily represent the
More informationSummers-Inman Group Health and Safety Policy SUMMERS-INMAN GROUP HEALTH AND SAFETY POLICY. Revision -
SUMMERS-INMAN GROUP HEALTH AND SAFETY POLICY 4 th November 2015 1 Table of Contents 1. Revision History... 5 2. Health and Safety Policy Statement... 7 3. Organisation... 9 Managing Director... 9 Group
More informationHospital and Other Healthcare Facilities
Hospital and Other Healthcare Facilities Council Progress Report December 2015 Judy Chong, RPh, BScPhm Manager, Hospital and Other Healthcare Facilities Agenda Background Drug Preparation Premises (DPPs)
More information247 CMR: BOARD OF REGISTRATION IN PHARMACY
247 CMR 9.00: CODE OF PROFESSIONAL CONDUCT; PROFESSIONAL STANDARDS FOR REGISTERED PHARMACISTS, PHARMACIES AND PHARMACY DEPART- MENTS Section 9.01: Code of Professional Conduct for Registered Pharmacists,
More informationMix of civil law and common law. Official law database Ministry for justice, culture and local government of Malta
Malta European Region Updated: February 2017 This document contains links to websites where you can find national legislation and health laws. We link to official government legal sources wherever possible.
More informationDC Board of Pharmacy and Pharmaceutical Control Update
DC Board of Pharmacy and Pharmaceutical Control Update Patricia M. D Antonio, RPh, MS, MBA,CGP Executive Director, Board of Pharmacy Program Manager, Pharmaceutical Control May 30, 2015 Organization Health
More informationGuidance on the Delivery of Medicines Dispensed on Foot of a Prescription from a Retail Pharmacy Business
Guidance on the Delivery of Medicines Dispensed on Foot of a Prescription from a Retail Pharmacy Business Pharmaceutical Society of Ireland Version 1 July 2014 Contents 1. Introduction 2 2. Guidance 3
More informationPolicies Approved by the 2017 ASHP House of Delegates
House of Delegates Policies Approved by the 2017 ASHP House of Delegates 1701 Ensuring Patient Safety and Data Integrity During Cyber-attacks Source: Council on Pharmacy Management To advocate that healthcare
More informationThe Accredited Drug Dispensing Outlet (ADDO) Model in Tanzania
The Accredited Drug Dispensing Outlet (ADDO) Model in Tanzania Jafary H. Liana Senior Technical Advisor (MSH/SDSI) Stakeholders Consultation on Informal Healthcare Providers Chennai, India Organized by
More informationStrengths and weaknesses: existing veterinary legislation
Strengths and weaknesses: existing veterinary legislation Zimbabwe: (Website) Animal Health Act Established: 1961 2001 - Authority to organize import and export - Authority to appoint officers - Definitions
More informationPharmacovigilance Training
Pharmacovigilance Training Pharmacovigilance Roche systematically monitors the benefit/risk of its products. As a part of this monitoring process, in case you/your company become aware of Adverse Events
More informationInterim Commissioner Lauren A. Smith and Members of the Public Health Council
DEVAL L. PATRICK GOVERNOR TIMOTHY P. MURRAY LIEUTENANT GOVERNOR JOHN W. POLANOWICZ SECRETARY LAUREN A. SMITH, MD, MPH INTERIM COMMISSIONER The Commonwealth of Massachusetts Executive Office of Health and
More informationACTIONS/PSOP/001 Version 1.0 Page 2 of 6
1. The purpose of the Pharmacy Site File To enable the designated trust pharmacy to fulfil its role and exercise appropriate control over all aspects of study medication handling, an accurately maintained
More informationStephen C. Joseph, M.D., M.P.H.
JUL 26 1995 MEMORANDUM FOR: ASSISTANT SECRETARY OF THE ARMY (MANPOWER & RESERVE AFFAIRS) ASSISTANT SECRETARY OF THE NAVY (MANPOWER & RESERVE AFFAIRS) ASSISTANT SECRETARY OF THE AIR FORCE (MANPOWER, RESERVE
More informationSeptember 1, Comments on Draft Reportable Food Registry (RFR) Guidance; Docket No. FDA-2009-D-0260
Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, Maryland 20852 Re: Comments on Draft Reportable Food Registry (RFR) Guidance; Docket No. FDA-2009-D-0260
More informationHealth & Safety and Wellbeing Policy
Health & Safety and Wellbeing Policy Policy Number New or Reviewed Date of next Review Responsibility HCP032 November 2017 November 2018 Principal Empowering learners to shape their future HCP032 1 HEALTH
More informationCenter for Drug Evaluation and Research - Compliance Central with FDA Center Compliance Directors: Part 1
Center for Drug Evaluation and Research - Compliance Central with FDA Center Compliance Directors: Part 1 Donald D. Ashley, JD 2017 FDLI Enforcement, Litigation, and Compliance Conference: For the Drug,
More informationU.S. - EC MRA Pharmaceutical Good Manufacturing Practices Annex. SECTORAL ANNEX FOR PHARMACEUTICAL GOOD MANUFACTURING PRACTICES (GMPs) CHAPTER 1
SECTORAL ANNEX FOR PHARMACEUTICAL GOOD MANUFACTURING PRACTICES (GMPs) PREAMBLE This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European
More informationJOB DESCRIPTION. 1 year fixed term. Division A Pharmacy. University Hospitals Birmingham. Advanced Clinical Pharmacist Trials.
JOB DESCRIPTION JOB TITLE: Pharmacy Technician Haematology Clinical Trials PAY BAND: Agenda for change - Band 5 TERMS AND CONDITIONS DEPARTMENT/DIVISION: BASED AT: REPORTS TO: PROFESSIONALLY RESPONSIBLE
More informationReprinted from FDA s website by
Reprinted from FDA s website by POLICY AND PROCEDURES PURPOSE OFFICE OF EXECUTIVE PROGRAMS Accreditation -- Continuing Education Table of Contents PURPOSE...1 BACKGROUND...1 POLICY...3 RESPONSIBILITIES...7
More informationALABAMA STATE BOARD OF PHARMACY ADMINISTRATIVE CODE CHAPTER 680-X-2 PRACTICE OF PHARMACY TABLE OF CONTENTS
Pharmacy Board Chapter 680-X-2 ALABAMA STATE BOARD OF PHARMACY ADMINISTRATIVE CODE CHAPTER 680-X-2 PRACTICE OF PHARMACY TABLE OF CONTENTS 680-X-2-.01 680-X-2-.02 680-X-2-.03 680-X-2-.04 680-X-2-.05 680-X-2-.06
More informationFrequently Asked Questions
1. What is dispensing? Frequently Asked Questions DO I NEED A PERMIT? Dispensing means the procedure which results in the receipt of a prescription drug by a patient. Dispensing includes: a. Interpretation
More informationDocument Title: Research Database Application (ReDA) Document Number: 043
Document Title: Research Database Application (ReDA) Document Number: 043 Version: 1 Ratified by: Committee Date ratified: 30 September 2014 Name of originator/author: Directorate: Department: Name of
More informationPharmaceutical Sector Country Profile Questionnaire INSERT COUNTRY NAME
Pharmaceutical Sector Country Profile Questionnaire INSERT COUNTRY NAME The Pharmaceutical Sector Country Profile Survey 1. Background and Rationale: Pharmaceutical Sector Country Profiles aim to increase
More informationDocument Title: Investigator Site File. Document Number: 019
Document Title: Investigator Site File Document Number: 019 Version: 1.1 Ratified by: R&D Committee Date ratified: 03/10/2017 Name of originator/author: Directorate: Department: Name of responsible individual:
More informationEstonia PHARMACEUTICAL COUNTRY PROFILE
Estonia PHARMACEUTCAL COUNTRY PROFLE Estonia Pharmaceutical Country Profile Published by the Ministry of Social Affairs in collaboration with the World Health Organization 15-06-2011 Any part of this document
More informationTexas Department of State Health Services
Texas Department of State Health Services DRUGS AND MEDICAL DEVICES GROUP WEB SITE: http://www.dshs.state.tx.us/dmd/ ISSUANCE OF CERTIFICATES OF FREE SALE AND SANITATION AND/OR CERTIFICATES OF ORIGIN AND
More informationApplication for Membership of The Association of the British Pharmaceutical Industry
To be returned to: The Secretary 7 th Floor, Southside, 105 Victoria Street, London SW1E 6QT +44 (0)20 7930 3477 membership@abpi.org.uk Application for Membership of The Association of the British Pharmaceutical
More informationNational Health Insurance. Sham Moodley BSc(UCD-Ire),BPharm(UKZN),PDM(HIV/AIDS),MPhil(HIV/AIDS)(SU) F
+ National Health Insurance Sham Moodley BSc(UCD-Ire),BPharm(UKZN),PDM(HIV/AIDS),MPhil(HIV/AIDS)(SU) 0824504472 031 4613700 031 4687610 031 4612702 F + Perception + International and local imperatives
More informationSENATE, No STATE OF NEW JERSEY. 216th LEGISLATURE INTRODUCED APRIL 28, 2014
SENATE, No. STATE OF NEW JERSEY th LEGISLATURE INTRODUCED APRIL, 0 Sponsored by: Senator LORETTA WEINBERG District (Bergen) Senator JOSEPH F. VITALE District (Middlesex) Senator JAMES W. HOLZAPFEL District
More informationDefinitions: In this chapter, unless the context or subject matter otherwise requires:
CHAPTER 61-02-01 Final Copy PHARMACY PERMITS Section 61-02-01-01 Permit Required 61-02-01-02 Application for Permit 61-02-01-03 Pharmaceutical Compounding Standards 61-02-01-04 Permit Not Transferable
More informationST. JAMES S HOSPITAL
ST. JAMES S HOSPITAL Job Title: Grade: Area Of Assignment: Reporting Relationship: Anti-microbial Pharmacist Senior Pharmacist Pharmacy Department Deputy Director of Pharmacy Salary Scale: 61, 031-70,
More informationRegistration of a new pharmacy premises
Registration of a new pharmacy premises Send your completed application to: Pharmacy premises Applications to Register Customer Service Team General Pharmaceutical Council 25 Canada Square London E14 5LQ
More informationHealth and Safety Policy Part 1 Policy and organisation
Health and Safety Policy Part 1 Policy and organisation ICO H&S Policy Policy and organisation, June 2016 Page 1 of 5 1. Scope 1.1 The Health and Safety policy applies to all employees of the Information
More informationDocument Title: Research Database Application (ReDA) Document Number: 043
Document Title: Research Database Application (ReDA) Document Number: 043 Version: 1.1 Ratified by: Committee Date ratified: 23 February 2017 Name of originator/author: Rachel Fay Directorate: Medical
More informationProfessional Student Outcomes (PSOs) - the academic knowledge, skills, and attitudes that a pharmacy graduate should possess.
Professional Student Outcomes (PSOs) - the academic knowledge, skills, and attitudes that a pharmacy graduate should possess. Number Outcome SBA SBA-1 SBA-1.1 SBA-1.2 SBA-1.3 SBA-1.4 SBA-1.5 SBA-1.6 SBA-1.7
More informationAssessment Framework for Designated Centres for Persons (Children and Adults) with Disabilities
Assessment Framework for Designated Centres for Persons (Children and Adults) with Disabilities January, 2015 1 About the The (HIQA) is the independent Authority established to drive high quality and safe
More informationNigeria PHARMACEUTICAL COUNTRY PROFILE
Nigeria PHARMACEUTICAL COUNTRY PROFILE Nigeria Pharmaceutical Country Profile Published by Federal Ministry of Health in collaboration with the World Health Organization June 2011 Any part of this document
More informationDocument Number: 006. Version: 1. Date ratified: Name of originator/author: Heidi Saunders, Senior Portfolio Coordinator
including Roles and Responsibilities for the Conduct of Research Studies and Clinical Trials including CTIMPs (Clinical Trials of Investigational Medicinal Products) Document Number: 006 Version: 1 Ratified
More informationNIAGARA FALLS POLICE DEPARTMENT GENERAL ORDER
NIAGARA FALLS POLICE DEPARTMENT GENERAL ORDER EFFECTIVE DATE: 03/12/2015 RESCINDS: None Previous SUBJECT: Wearable Video Recorders (Body Cameras) Number 310.10 Number of pages 6 I. PURPOSE The purpose
More informationELECTIVE COMPETENCY AREAS, GOALS, AND OBJECTIVES FOR POSTGRADUATE YEAR ONE (PGY1) PHARMACY RESIDENCIES
ELECTIVE COMPETENCY AREAS, GOALS, AND OBJECTIVES FOR POSTGRADUATE YEAR ONE (PGY1) PHARMACY RESIDENCIES Introduction The competency areas, goals, and objectives are for use with the ASHP Accreditation Standard
More informationSTANDARD OPERATING PROCEDURE SOP 710. Good Clinical Practice AUDIT AND INSPECTION. NNUH UEA Joint Research Office. Acting Research Services Manager
STANDARD OPERATING PROCEDURE SOP 710 Good Clinical Practice AUDIT AND INSPECTION Version 1.3 Version date 27.02.2018 Effective date 3.03.2018 Number of pages 10 Review date February 2020 Author Role Approved
More informationGood Pharmacy Practice in Spanish Community Pharmacy
GENERAL PHARMACEUTICAL COUNCIL OF SPAIN Good Pharmacy Practice in Spanish Community Pharmacy 01 Dispensing Service for Medicines and Medical Devices This document has been developed by the Good Pharmacy
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL SCHEDULING OF SUBSTANCES FOR PRESCRIBING BY AUTHORISED PRESCRIBERS This document provides guidance on the process for amending the Schedules to the Medicines and Related Substances
More informationMcMinnville School District #40
McMinnville School District #40 Code: JHCD/JHCDA-AR Adopted: 1/08 Revised/Readopted: 8/10; 2/14; 2/15 Orig. Code: JHCD/JHCDA-AR Prescription/Nonprescription Medication Students may, subject to the provisions
More informationNational Library of Scotland Health & Safety Policy
National Library of Scotland Health & Safety Policy Last Revised: June 2011 National Library of Scotland Safety Policy Index to contents: Section: 1 General Statement Section: 2 Organisation of Responsibilities
More informationTherefore the provision of medicines is an area for which a Community regulatory framework should be properly supervised to ensure full and
European Association of Pharmaceutical Full-line Wholesalers (GIRP) response to the European Commission Consultation regarding Community action on Health Services Introduction Firstly, GIRP welcomes the
More informationExternal Assessment Specifications Document
External Assessment Specifications Document Curriculum Code: 321301000 Qualification Title: Occupational Certificate: Pharmacy Technician NQF Level: 6 321301000 - Pharmacy Technician External Assessment
More informationThe European network evaluation of the PHAR QA framework of competences for...
The European network evaluation of the PHAR QA framework of competences for... The PHAR QA ( Quality assurance in European pharmacy education and training ) funded by the European Commission, will produce
More informationTHE CIVIL AVIATION ACT (CAP. 80) THE CIVIL AVIATION (APPROVED TRAINING ORGANIZATION) REGULATIONS, 2017 ARRANGEMENT OF REGULATIONS
GOVERNMENT NOTICE NO.56 published on 24/02/2017 THE CIVIL AVIATION ACT (CAP. 80) THE CIVIL AVIATION (APPROVED TRAINING ORGANIZATION) REGULATIONS, 2017 Regulation Title ARRANGEMENT OF REGULATIONS PART I
More informationDEVON COUNTY COUNCIL HEALTH, SAFETY & WELLBEING POLICY
DEVON COUNTY COUNCIL HEALTH, SAFETY & WELLBEING POLICY Policy Date: December 2012 Policy: County Health Safety and Wellbeing Policy Next Review Date: December 2013 DEVON COUNTY COUNCIL HEALTH, SAFETY &
More informationPharmaceutical Sector Country Profile Questionnaire NAMIBIA
Pharmaceutical Sector Country Profile Questionnaire NAMIBIA The Pharmaceutical Sector Country Profile Survey 1. Background and Rationale: Pharmaceutical Sector Country Profiles aim to increase the availability
More informationRadiation Safety Code of Practice
Radiation Safety Code of Practice 2017 Contents REVISION HISTORY... II DEFINITIONS... 1 1 PURPOSE... 3 2 SCOPE... 3 3 REGULATORY CONSIDERATIONS... 3 4 ALARA PRINCIPLE... 4 5 PROGRAM AUTHORITY ROLES AND
More informationPharmacovigilance in Kenya
Pharmacovigilance in Kenya Dr. Dorine Kagai (NASCOP) Mr. George Muthuri (PPB) Ministry of Medical Services 23 nd November, 2009 ARV PV TRAINING TZ ART program. Over 300,000 patients on ARVs: Over 60% female
More informationNon Medical Prescribing Policy
Non Medical Prescribing Policy Author: Sponsor/Executive: Responsible committee: Ratified by: Consultation & Approval: (Committee/Groups which signed off the policy, including date) This document replaces:
More information