OSF Improves the Distributed Pharmaceutical Analysis Lab (DPAL)

Slides:

Advertisements

Similar presentations

الرابطة الدولية لمكافحة المواد الطبيّة المزورة a WHO initiative to combat counterfeit medical products Dr V. Reggi - World Health Organization.

Advertisements

Authors: Rene Soria-Saucedo 1, Veronika J. Wirtz 1, Warren A. Kaplan 2 Institutions: 1 Center for Health Systems Research, National Institute of Public.

GMP Document and Record Retention

Model guidance for storage and transport of time and temperature-sensitive pharmaceutical products (WHO Technical Report Series, no.961, 2011, Annex 9)

Ballot Processing Systems February, 2005 Submission to OASIS EML TC and True Vote Maryland by David RR Webber.

Biopharmaceutical Regulatory Requirements 40. Marketing Authorization for New Chemical Entities Health Canada’s (HC) Therapeutic Products Directorate.

General presentation. 24 March 2003 | | ‹#› Overall objective Main objective To develop and improve preventive and health-promoting efforts and the services.

1 MODULE My.COOP Managing your agricultural cooperative.

Clinical Research Training

Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Staffing and Training.

U.S. Department of the Interior U.S. Geological Survey Planning for Data Management Creating data management plans for your project.

School What does it all mean?. Secondary Education High School courses which should include English, science, social studies, mathematics, and computers.

QUALITY REPRODUCTIVE HEALTH SUPPLIES Dr Hans V. Hogerzeil Director Essential Medicines & Pharmaceutical Policies.

Margarit MELIKYAN Drug Utilization Research Group PO, Armenia, National Institute of Health Access to and Use of Medicines by Households in Armenia: Impact.

Chapter 6 CRISIS MANAGEMENT. Introduction - Crisis: ◦is a situation that specifically involves a pharmaceutical product, medical device or activity with.

INTRODUCTION TO THE UNIDO/REEEP TRAINING MANUAL ‘SUSTAINABLE ENERGY REGULATION AND POLICY-MAKING FOR AFRICA’ User Manual.

ACCESS TO MEDICINES - POLICY AND ISSUES

DEPARTMENT OF HEALTH Medicines Regulatory Affairs

FDA Public Meeting on Electronic Records and Signatures June 11, 2004 Presentation of the Industry Coalition on 21CFR Part 11 Alan Goldhammer, PhD Chair.

Pharmacists Perceptions of the Development of Herbal Medicines in Iran

NRS and MABLE Changes July 1, new data fields for students Highest Credential Achieved Education Location – U.S. or non U.S. Diploma at Entry?

SC18 TG5 Development of a Guidance Document for the implementation of API Specification Q2 Objective Create a guidance document for users of the API Specification.

SOLUTION What kind of plan do we need? How will we know if the work is on track to be done? How quickly can we get this done? How long will this work take.

Quality & Safety of Generic Drugs in the World Market World Bank Conference “Good Intentions – Bad Drugs” March 10, 2005 Washington, D.C. Christine Simmon.

Centre for Research and Analysis of Public Opinion and Predictions EL- PIKIR Methodology of WHO/HAI (Health Action International)Methodology of WHO/HAI.

Emergency Response to Terrorism: Tactical Considerations: Emergency Medical Services FEMA/USFA/NFA ERT:TC-EMS-IG 2nd Edition, 1st Printing.

California Department of Public Health / 1 CALIFORNIA DEPARTMENT OF PUBLIC HEALTH Standards and Guidelines for Healthcare Surge during Emergencies How.

Create a Tri-Venn Diagram, highlight the info. that answers these questions. Command Economy Traditional Economy Market Economy Who or what makes economic.

VICH Training Strategy Steven D. Vaughn, DVM Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine U.S. Food and Drug Administration.

0 eCPIC User Training: v6.5 Webinars August 2014 These training materials are owned by the Federal Government. They can be used or modified only by FESCOM.

Metrology & Accreditation – Their Role in the Global Market Presented at the 2009 NCSLI Conference San Antonio, Texas 30 July 2009 by Roxanne Robinson.

Practising medicine in the UK W Kuriyan. Routes into Medicine in UK Undergraduate degree Postgraduate entrance Foreign graduates 1.Non European Union.

Analytical Method Validation Under Good Laboratory Practices (GLPs) Webinar Details Date : September 02 nd Friday 2016 Time : 01:00PM ET / 10:00AM PT Duration:

By Kirby R. Solomon Jr..  Security Management is a user-access management system to be used in a medical research or clinical laboratory by knowledgeable,

RAC Regulatory Affairs Certification

Taxonomy of Strategies

Regulatory Updates Health Sciences Authority Singapore

Significance of ISO to the Food Industry

The Information Professional’s Role in Product Safety

World Health Organization

Presented by: Yasmin Hichborn, El Dorado County

Research4Life Programmes: Similarities and Differences!

UNC System Archivists and Records Managers Meeting

Dr Samvel Azatyan Technical Officer Regulatory Support

Improvements Made On Drug Abuse Treatment In Canada

Lesson 8: BRITE Seminar: GMP II

Prescription for Pharmaceutical Reform: Healing an Ailing System

Financial and Insurance Considerations for Transplant

Beyond Academia.

Managing Procurement and Logistics of HIV/AIDS Drugs and Related Supplies Introduction and Overview May 30 to June 4, 2005 Abuja, Nigeria.

CompTIA Security+ Study Guide (SY0-401)

Regulation of Medical Products & Patient Safety- A Narrative Review

Managerial and Regulatory Strategies to Improve Drug Use

Operationalizing Export Certification and Regionalization Programmes

Quality Management in Business and Manufacturing Sectors

Data collection.

Training proposal and Reporting

Research4Life Programmes: Similarities and Differences! (Part A)

Curriculum Coordinator: Marela Fiacco Date : February 29, 2015

Research4Life Programmes: Similarities and Differences!

Objective 2 Biomedical Research Methods

Evaluating International Drug and Therapeutics Committees Courses in the Developing World

Data collection.

PSI National Dialogue on Medical Sharps

5th edition NTP MANUAL OF PROCEDURES Chapter 1: Introduction

GMP Legal Framework in Kyrgyzstan

Interconnection of good practices: from development to distribution

NMDWS Internship Portal

Presentation transcript:

OSF Improves the Distributed Pharmaceutical Analysis Lab (DPAL) Margaret Berta

Substandard Pharmaceuticals -substandard pharmaceuticals are medications with >90% of stated API -widespread problem in developing countries -estimated that >30% of pharmaceuticals sold in developing countries are falsified or substandard -often medical regulatory agencies do not have the resources to maintain post-market quality control -graphic showing the number of substandard pharmaceutical cases reported from 2007-2012 Johnston, A., & Holt, D. (2014, Aug). Substandard Drugs: a Potential Crisis for Public Health. Br. J. Clin. Pharmacol., 78(8), 218-243.

Effective Pharmaceutical Regulation -adequate funding -trained personnel -analytical resources -governmental support (Medical Regulatory Authority) (MRA)

Distributed Pharmaceutical Analysis Lab (DPAL)

Program Set-Up Considerations -data security -communication -data sharing -user experience

OSF Registrations for Data Preservation Data Security OSF Registrations for Data Preservation OSF Registrations Non-editable Version Citable Reference Alternative Backup -individual pages but with data submission forms -forms  spreadsheet

Internal “peer review” to maintain quality Communication Internal “peer review” to maintain quality DPAL Project Read-Only -individual pages but with data submission forms -forms  spreadsheet

Institutional data with controlled results submission Data Sharing Institutional data with controlled results submission Cumulative Results Restricted Access Forms View-Only Spreadsheets Institution Component -individual pages but with data submission forms -forms  spreadsheet

HPLC Methodology Manual Usability Informational resources for target audiences HPLC Methodology Manual Students Instructors -individual pages but with data submission forms -forms  spreadsheet

DPAL System Set-Up on OSF Application by Participants Assessment DPAL System Set-Up on OSF Application by Participants -system structure but for effective project, we need everyone to actually use it

Questions?