The Global Health Network
|
|
|
- Grace Reynolds
- 6 years ago
- Views:
Transcription
1 The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014
2
3
4 IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) 1. Sourcing and Receipt 2. Storage 3. Dispensing/Blinding 4. Randomisation 5. Disposal/Destruction
5 IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) 1. Sourcing and Receipt 2. Storage 3. Dispensing/Blinding 4. Randomisation 5. Disposal/Destruction
6 Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Source of Accountability: Delivery waybills, Prescrip9ons, Invoices, Receipt Accountability
7 Receipt Accountability Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Source of Accountability: Delivery waybills, Prescrip9ons, Invoices, Receipt Accountability
8 IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) 1. Sourcing and Receipt 2. Storage 3. Dispensing/Blinding 4. Randomisation 5. Disposal/Destruction
9 Storage Certificate of Analysis (COA) à light, temperature, humidity Rigorous Control à E.g. fridges, air-con, probes, light protection Unique Storage Space Back-Up Plan Sources of Accountability: Temperature Logs, Calibra9on Cer9ficates, SOPs, COAs
10 IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) 1. Sourcing and Receipt 2. Storage 3. Dispensing/Blinding 4. Randomisation 5. Disposal/Destruction
11 Dispensing Dispensing Licence Expiry Dates IP prep (e.g. reconstitution, infusion) Labelling requirements à e.g. Participant ID, Study/Protocol/Investigator ID, Quantity Dispensed, Mode of Delivery, Storage Condition, Exp./Lot/Batch # s Blinding implication for dispensing directly to patient Unblinding procedure Source of accountability: MCC documenta9on, Pharmacy Manual (accountability, labels, pa9ent dispensing logs)
12 Store Accountability Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Source of Accountability: Delivery waybills, Prescrip9ons, Invoices, Receipt Accountability
13 IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) 1. Sourcing and Receipt 2. Storage 3. Dispensing/Blinding 4. Randomisation 5. Disposal/Destruction
14 Randomisation Treatment Allocation/Dispensing Generated by statistician/pharmacist (sponsor or site produced), stored in secure location e.g. pharmacy file à Randomisation schedule or Automated system e.g. IVRS Randomisation log Source of accountability: Randomisa9on schedule and Randomisa9on logs
15 Randomisa9on Schedule Accountability Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Source of Accountability: Delivery waybills, Prescrip9ons, Invoices, Receipt Accountability
16 Randomisa9on Log Accountability Sourcing and Receipt Randomization Log for: ACTIVE IMP Randomization Log for: PLACEBO FOR IMP Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Source of Accountability: Delivery waybills, Prescrip9ons, Invoices, Receipt Accountability
17 IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) 1. Sourcing and Receipt 2. Storage 3. Dispensing/Blinding 4. Randomisation 5. Disposal/Destruction
18 Return/disposal At conclusion of study, final inventory and reconciliation Sponsor-driven: return to sponsor for disposal or site arranges disposal Arrange with waste disposal company Source of accountability: Disposal/Destruc9on Log
19 Destruc9on Log Accountability Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Source of Accountability: Delivery waybills, Prescrip9ons, Invoices, Receipt Accountability
20 SUMMARY Importance of pharmacy role: maintains accountability of IMP from start to finish, ensuring right dose given to right patient at the right time Accountability is a continuous process from start of study until closure Inform/involve pharmacy at the outset Resources available on CRC website -
21 SUMMARY Importance of pharmacy role: maintains accountability of IMP from start to finish, ensuring right dose given to right patient at the right time Accountability is a continuous process from start of study until closure Inform/involve pharmacy at the outset Resources available on CRC website -
22
23 Questions? IMP MANAGEMENT GHTSA WORKSHOP 19 SEP 2014
IMP Management and Accountability
This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document
ECTU Central Office SOP ECTU_TM_17 Management of Trial (IMP) Supplies
ECTU Central Office SOP ECTU_TM_17 Management of Trial (IMP) Supplies SOP number: ECTU TM 17 Signature Date Authored by: Holly Ennis, Trial Manager 6 th Sept 2017 Reviewed by: Laura Forsyth, Trial Manager
ISRCTN: EudraCT Number: Sponsor Protocol Number: UCL 08/0350. Pharmacy Manual
The StAmP Trial: A Proof of Principle, double blind, Randomised Placebo-Controlled, Multi Centre Trial of Statins to Ameliorate Early Onset Pre-eclampsia. ISRCTN: 23410175 EudraCT Number: 2009-012968-13
TITLE: Research Pharmacy Standard Policy SOP #: INV-100 Page: 1 of 5 Effective Date: 8/31/17
SOP #: INV-100 Page: 1 of 5 1. POLICY STATEMENT: DF/HCC research pharmacies follow a standard set of policy requirements for clinical trials. 2. BACKGROUND: None 3. RESPONSIBLE PERSONNEL: 3.1. Research
The interface between Good Clinical Practice and Good Manufacturing Practice
1 The interface between Good Clinical Practice and Good Manufacturing Practice your partner in compliance 1 The interface between GCP and GMP Generally, studies are designed and planned by physicians who
Quality Assurance of Investigational Medicinal Products. Sue McKenzie PPQA (A)
Quality Assurance of Investigational Medicinal Products Sue McKenzie PPQA (A) Agenda for Today IMP Regulations - CTD and Annex 13 Role of QP for IMP Challenges of IMP Manufacture for the QP IMP Regulations
NUH PHARMACY CLINICAL TRIALS. Sheila Hodgson, Lead Pharmacist, Clinical Trials June 30th 2014
NUH PHARMACY CLINICAL TRIALS Sheila Hodgson, Lead Pharmacist, Clinical Trials June 30th 2014 Dedicated pharmacy trials staff Lead Pharmacist, Service Co-ordinator Pharmacists: Band 7 and 8a Technicians:
Trial Master File / Investigator Site File Index Clinical Trials of Investigational Medicinal Products
1 Trial Master File / Investigator Site File Index Clinical Trials of Investigational Medicinal Products SECTION TITLE DOCUMENTS 1. Contact List Including details of relevant study site staff, responsible
BRIEFING 1168 Compounding for Phase I Investigational Studies,
BRIEFING 1168 Compounding for Phase I Investigational Studies, PF 39(5) [Sept. Oct. 2013]. The current proposed chapter in PF 43(3) [May June 2017] is posted online at www.usp.org/usp-nf/notices/compounding-forphase-i-investigational-studies
Document Number: SOP IV Original SOP: March 2010 Revision Number: mjb SOP IV: Transport to Satellite Pharmacies Effective Date: April 2013
S.O.P. IV TRANSPORT of Study Medications to Satellite Pharmacies I. PURPOSE A. To clarify the responsibilities and procedures of the Investigational Pharmacy in the transportation of study medications
IND Drug Log Guidelines
9/24/2009 IND Drug Log Guidelines 1) An NCI DARF (Drug Accountability Record Form) should be kept on each strength of investigational drug. An investigational drug is considered to be any drug (including
SOP04: Standard Operating Procedure for Trial Supplies and Labelling
SOP04: Standard Operating Procedure for Trial Supplies and Labelling Authorship Team: Anne Seagrove & Mair Roberts Joint SOP Group on Trial Administration (viz Angela Evans, Sarah Gaze, Hayley Hutchings,
Assessing the management of anti-tb medicines and supplies
Assessing the management of anti-tb medicines and supplies Management of anti-tb medicines and supplies Objectives: at the end of the assessment reviewers should comment on the availability of anti-tb
VOLUME 4 Good manufacturing practices ANNEX 13 Manufacture of investigational medicinal products JULY 2003
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market : management & legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations Brussels, F2/BL D(2003) Revision
INVESTIGATIONAL DRUG SERVICE (IDS) Standard Operating Procedures
INVESTIGATIONAL DRUG SERVICE (IDS) Standard Operating Procedures The Investigational Drug Service (IDS) strives to meet or exceed the standards of Good Clinical Practice (GCP). 1. UC Davis Health (UCDH)
DRUG ORDERING AND MAINTENANCE
AND MAINTENANCE Disclaimer: Please note that the instructions provided in this chapter mainly apply to agents provided by the Pharmaceutical Management Branch (PMB), of Cancer Therapy Evaluation Program
10/17/2016. Learning Objectives. What is Drug Accountability. Patricia Novo, MPA, MPH Beth Jeffries, BS, CCRP
PREPARATION FOR DRUG MANAGEMENT AND ACCOUNTABILITY IN A CTN CLINICAL TRIAL Presented by Patricia Novo, MPA, MPH Beth Jeffries, BS, CCRP CTN WEB SEMINAR SERIES: A FORUM TO EXCHANGE RESEARCH KNOWLEDGE Produced
BEST PRACTICES IN IRT IMPLEMENTATION:
BEST PRACTICES IN IRT IMPLEMENTATION: A PRIMER FOR APAC ARTICLE www.almacgroup.com By Matt Do, Client Development Lead, Asia Almac IN 2013, 16% OF CLINICAL TRIALS WERE CONDUCTED IN APAC, AND THAT PERCENTAGE
Brussels, C(2017) 8179 final. Guidelines
EUROPEAN COMMISSION Brussels, 8.12.2017 C(2017) 8179 final Guidelines Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the
MAIMONIDES MEDICAL CENTER
MAIMONIDES MEDICAL CENTER CODE: AD-088 (Revised) ORIGINALLY ISSUED: October 2, 1990 SUBJECT: Product Safety Recall and Alert I POLICY In the event of a product safety recall or alert of a medical device
Quality Assurance in Clinical Trials Introduction
Quality Assurance in Clinical Trials Introduction Doctor Catherine CORNU, Lyon clinical Investigation Centre EUDIPHARM December 2012 1 Delphine TEPPE-CROITROU - Catherine CORNU (Hospices Civils de Lyon)
8. Clinical Trial Assessment Phase II
8. Clinical Trial Assessment Phase II Junko Sato, PhD Office of New Drug I, PMDA Disclaimer: The information within this presentation is based on the presenter s expertise and experience, and represents
Supply Chain Management for Global Clinical Trials
Supply Chain Management for Global Clinical Trials Part 3 of the Clinical Supply Knowledge Share Series: Understanding and Delivering your Global Clinical Supply Chain Almac Clinical Services Clinical
Pharmacy. Medication. Checks
Pharmacy Medication Checks Module 2 Table of Contents Section A... 1 A.1 Clinical Medication Order Check... 1 A.2 Final Product and Computer Order Entry Check... 1 Section B... 2 B.1 Documentation of Pharmacy
Consulted With Post/Committee/Group Date Jane Giles Chief Pharmacist 22/09/2014 Professionally Approved By Dr A Jackson MMSG Chairman s action
Vaccine Policy Storage and Monitoring Type: Policy Register No: 10077 Status: Public Developed in response to: Local Need Contributes to CQC Outcome Number: 9 Consulted With Post/Committee/Group Date Jane
Pharmaceutical product technical requirements and the Interagency pharmaceutical product questionnaire
Pharmaceutical product technical requirements and the Interagency pharmaceutical product questionnaire Atieno Ojoo Technical specialist, Pharmaceuticals UNICEF Supply Division 20 th October 2008, UNICEF
Application form UNIVERSITY OF NOTTINGHAM MEDICAL SCHOOL ETHICS COMMITTEE
Application form UNIVERSITY OF NOTTINGHAM MEDICAL SCHOOL ETHICS COMMITTEE In completing this form please refer to the attached Notes of Guidance Application for approval of all studies involving Healthy
GMP meets GCP Management, Supply and Quality Assurance of Clinical Trials
GMP meets GCP Management, Supply and Quality Assurance of Clinical Trials Speakers Inge De Meyer Janssen Pharmaceutica NV Rita Hattemer-Apostel Verdandi AG Ian Holloway GMP/GDP/GCP Inspector, MHRA (invited)
Trial Protocol. Version 1.2. Effective date: 18 May Dr Sarah Duggan, CTU Manager. V May 2010 Update web links.
Trial Version 1.2 Effective date: 18 May 2010 Reviewed by: Approved by: Claire Daffern, QA Manager Dr Sarah Duggan, CTU Manager Revision Chronology: Effective Date Reason for change V1.2 18 May 2010 Update
Trial oversight SOP for HEY-sponsored CTIMPs
R&D Department Trial oversight SOP for HEY-sponsored CTIMPs Hull And East Yorkshire Hospitals NHS Trust 2010 All Rights Reserved No part of this document may be reproduced, stored in a retrieval system
Using Your Prescription. Drug Program. Answers to important questions about retail pharmacy and mail order purchasing
Using Your Prescription Drug Program Answers to important questions about retail pharmacy and mail order purchasing Welcome! We know you re going to enjoy the many advantages of your prescription drug
Complexity of Retention Samples Selection in non-traditional Bioequivalence studies
Complexity of Retention Samples Selection in non-traditional Bioequivalence studies Nageshwar R Thudi Ph.D. Director-Clinical R&D Teva Pharmaceuticals Disclaimer The views expressed herein are the views
Best Practices: Using Lynx Mobile to Maximize Charge Capture in the Infusion Suite
Best Practices: Using Lynx Mobile to Maximize Charge Capture in the Infusion Suite If you need assistance with Lynx Mobile, please call 800.482.6700, option 2, or email msh.techsupport@mckesson.com. Best
GIRP comments on. The vital link in healthcare 1. European Association of Pharmaceutical Full-line Wholesalers
GIRP comments on Guidelines on the principles of Good Distribution Practices for active substances for medicinal products for human use submitted for public consultation Introduction: GIRP, the European
Recording, Managing and Reporting Adverse Events in the UK
This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document
GCP Basics - refresher
p. 01 GCP Basics - refresher Agenda: p. 02 Brief History of GCP GCP Regulations Principles of ICH E6 Sponsor Responsibilities Computer Systems Common Compliance Issues Brief History of GCP 3 Brief History
1.4 Applicable Regulatory Requirement(s) Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
1.1 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended
DOCUMENT EDIT/VOID RULES (When Editing and/or Voiding documents once entered into the system) PURCHASING
DOCUMENT EDIT/VOID RULES (When Editing and/or Voiding documents once entered into the system) PURCHASING Purchase Order Can be fully Edited up until Approval Can be Voided up until Approval Once Approved
Determining Methods of Collaborative, Realistic, and Cost Effective Supply Timelines. Fatima Zaidi Clinical Trial Supply New England
Determining Methods of Collaborative, Realistic, and Cost Effective Fatima Zaidi Clinical Trial Supply New England - 2013 Drug Development and Clinical Supply Annual supply chain spending for drugs under
National Institute of Allergy and Infectious Diseases National Institutes of Health Department of Health and Human Services
National Institute of Allergy and Infectious Diseases National Institutes of Health Department of Health and Human Services The Division of Microbiology and Infectious Diseases (DMID), National Institute
INTRODUCTION TO MODERN RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT SERVICES
WHITE PAPER INTRODUCTION TO MODERN RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT SERVICES Randomization is fundamental to clinical trials it enables treatment group balance, eliminates selection bias and limits
REQUEST FOR AUTHORISATION TO THE COMPETENT AUTHORITY: REQUEST FOR OPINION OF THE ETHICS COMMITTEE:
Annex 1: Clinical trial Application Form REQUEST FOR AUTHORISATION OF A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR OPINION OF THE ETHICS COMMITTEES IN THE
Inspection Form. DPP Information. Inspection Information. Staff Information. Service Information. DPP Designated Member. Street City Postal Code
Inspection Form DPP Information Name of DPP Owner Name of DPP (if different from owner's name) DPP Designated Member Designated Member Email Designated Member Phone number Street City Postal Code Phone
The GAP Analysis for Nonsterile Compounding
VOLUME 17 NUMBER 2 Current & Practical Compounding Information for the Pharmacist provided for by a grant from Perrigo Pharmaceuticals Goal: To provide background information and practical procedures for
Author Signature: Date: 10 October 2017 The author is signing to confirm the technical content of this document
SOP Title: Investigator s Brochure Content, Design, Amendments, Filing & Distribution Author: Clinical Research and Development Office (CRDO) Author Signature: Date: 10 October 2017 The author is signing
Good Clinical Practice (GCP): how does a laboratory that supports a clinical trial ensure compliance with these Regulations
Good Clinical Practice (GCP): how does a laboratory that supports a clinical trial ensure compliance with these Regulations 9th edition of Synevo Clinical Research Symposium. 17 th November 2017 Bucharest.
Extractables and Leachables in Early Phase Development
Extractables and Leachables in Early Phase Development Wayland Rushing, Ph.D. Senior Scientific Advisor, ABC 11/23/2015 Product and Process Variants & Impurities 1 Regulatory Perspective Dr. Ingrid Markovic,
BEAM ASPECTS OF COMPOUNDING PRODUCT DESIGN. Reinout C.A. Schellekens, PharmD, RHPh, QP. Head Clinical Drug Production and Development
- ASPECTS OF COMPOUNDING PRODUCT DESIGN Reinout C.A. Schellekens, PharmD, RHPh, QP Head Clinical Drug Production and Development Department of Hospital and Clinical Pharmacy University Medical Center Groningen,
Industry Perspective on Manufacturing in Early Development
Industry Perspective on Manufacturing in Early Development IQ Workshop, Feb 4-5, 2014, Washington, D.C. Eric Schmitt AbbVie IQ Drug Product Manufacturing Working Group August 2012 issue of Pharmaceutical
European Medicines Verification Organisation: Requirements for the European Medicines Verification System URS Lite
EMVO_0020 3.0 7/3/2017 1 of 51 European Medicines Verification Organisation: Requirements for the European Medicines Verification System URS Lite Copyright 2017 EMVO All rights reserved. Reproduction in
5 th Training Workshop for Micro-, Small- and Medium- Sized Enterprises (SMEs)
5 th Training Workshop for Micro-, Small- and Medium- Sized Enterprises (SMEs) GCP Requirements and Compliance Dr. Katalina Mettke BfArM, Germany Agenda Specialities of Early Development Trials Examples
Multi-Site Coordination Process. Drafted by: Ester Dimayuga Page 1 of 18
Multi-Site Coordination Process Drafted by: Ester Dimayuga Page 1 of 18 MULTI-SITE COORDIATIO (MSC) REGULATOR PROCESS CTO-Regulatory notifies MSC of trial with UMCC as coordinating center MSC prepares
Objectives Discuss the importance of proper data collection. Identify the types of data collected for clinical trials. List potential source documents
Data Management in Clinical Trials Introduction to the Principles and Practice of Clinical Research January 24, 2011 Diane St. Germain, RN, MS, CRNP Nurse Consultant Division of Cancer Prevention National
Compounding Questions and Answers
Compounding Questions and Answers JANUARY 10, 2011 1. Question: What is a reliable supplier? Answer: Some examples of reliable suppliers are FDA licensed manufacturers, CA Department of Public Health Food
Human Research Protection Program Good Clinical Practice Guidance for Investigators Regulatory File Essential Documents
Guidance for s Regulatory File Essential s All principal investigators must maintain a regulatory binder or file system, which contains all study documentation. These records may be reviewed at the time
WHITE PAPER JULY 2017 PHARMACY SERVICES IN A PHASE I CLINICAL RESEARCH UNIT SHERILYN ADCOCK, PH.D. GEORGE ATIEE, M.D. JOHN SRAMEK, PHARM.D.
PHARMACY SERVICES IN A PHASE I CLINICAL RESEARCH UNIT SHERILYN ADCOCK, PH.D. GEORGE ATIEE, M.D. JOHN SRAMEK, PHARM.D. Phase I clinical studies form an important foundation for drug development and eventual
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 25 October 2005 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU
FDA Sponsor and Investigator Responsibility Checklist
FDA Sponsor and Investigator Responsibility Checklist Principal Investigator: Study Name: CPHS #: IND/IDE #: Name of IND/IDE holder: The following checklist is created based on the Sponsor and Investigator
Data collection in the field
6 Data collection in the field This chapter describes procedures for data collection in the field, i.e. at medicine outlets. Public procurement price data are generally gathered centrally at a government
Standard Operating Procedures Guidelines for Good Clinical Practice
SOP # CRSC-105 Effective Date 10-22-2013 Version # 1 Version Date 7-30-2013 Standard Operating Procedures Guidelines for Good Clinical Practice Purpose: This SOP outlines the steps required to follow FDA
SINGAPORE GUIDELINE FOR GOOD CLINICAL PRACTICE (SGGCP)
SINGAPORE GUIDELINE FOR GOOD CLINICAL PRACTICE (SGGCP) Date of Implementation: 1 August 1998 Date of First Revision: 1 October 1999 Printed in July 1998, August 1998 and September 1999. Adapted from the
MRC. Clinical Trials. Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS. Medical Research Council
MRC Clinical Trials Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS 1998 Medical Research Council MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS 1998 MRC GUIDELINES FOR
Operating Room Manual
CHAPTER 6 SUPPLY CHAIN Lead Author: Tangwan Azefor, MD; Clinical Associate, Department of Anesthesiology & Critical Care Medicine; Johns Hopkins Bayview Medical Center Baltimore, MD Checklist 1. How many
GUIDELINES FOR THE USE OF CONTROLLED SUBSTANCES IN RESEARCH MICHIGAN STATE UNIVERSITY ENVIRONMENTAL HEALTH AND SAFETY
GUIDELINES FOR THE USE OF CONTROLLED SUBSTANCES IN RESEARCH MICHIGAN STATE UNIVERSITY ENVIRONMENTAL HEALTH AND SAFETY REVISION 4.2018 INTRODUCTION In conducting research with controlled substances, University
Submitting a CTA application to the MHRA
This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document
Simonetta Viviani, MD BIO-VIPE Consulting Limited, Hong Kong
Simonetta Viviani, MD BIO-VIPE Consulting Limited, Hong Kong DCVMN Clinical Development & Pharmacovigilance Training 17-21 July 2016, Bali, Indonesia Pratical tips on how to write a protocol Write the
Standard Operating Procedure for Statistical Reports
Reports_V01.doc Page 1 of 6 Standard Operating Procedure for Statistical Reports SOP ID Number: Effective Date: 22/01/2010 Version Number & Date of Authorisation: V01,15/01/2010 Review Date: 22/01/2012
STANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Archiving and the Destruction of Records SOP-RES-028 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January
A global view from the Pharmaceutical Industry Mathieu Aman F. Hoffmann-La Roche Ltd, Basel (Switzerland)
Impressions Kaiseraugst A global view from the Pharmaceutical Industry Mathieu Aman F. Hoffmann-La Roche Ltd, Basel (Switzerland) SETRM2016 Rastreabilidade de Medicamento Sao Paulo, Jun 2016 Agenda Worldwide,
Medication errors: Development of prevention strategies for medicines and medical devices
Medication errors: Development of prevention strategies for medicines and medical devices Laurent Auclert Chairman of the PharmacoVigilance Committee EFPIA 1 Medication errors defined as occurring while
CURRICULUM VITAE SHAUN KOEN. Packaging Officer Pharmacist Assistant Logistics & Supply Chain Management. Cell:
CURRICULUM VITAE SHAUN KOEN Packaging Officer Pharmacist Assistant Logistics & Supply Chain Management Cell: 0825228722 Personal information Name: Surname: Shaun Koen Identity number: 8108055016086 Marital
S&OP Checklist How To Implement
S&OP Checklist How To Implement 1. 2. 3. Project team - we have identified the executive champion, steering committee or executive group responsible for supporting and monitoring progress, and the design
Equipment and preparation required for one group (2-4 students) to complete the workshop
Your career today is a Pharmaceutical Statistician Leaders notes Do not give to the students Red text in italics denotes comments for leaders and example answers Equipment and preparation required for
Guide for Recall of Medicinal Products for Human and Veterinary Use
Guide for Recall of Medicinal Products for Human and Veterinary Use SUR-G0019-3 22 NOVEMBER 2017 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes
Developments in Operational Procurement Efficiency. Sarah Griffiths Pharmacy Procurement Lead July 2017
Developments in Operational Procurement Efficiency Sarah Griffiths Pharmacy Procurement Lead July 2017 Aims of the Session GS1 Scan4Safety and PEPPOL The Scan4Safety and PEPPOL principles? What does purchase
Supplier Assurance Program. CBE Pty Ltd
Supplier Assurance Program CBE Pty Ltd This training program is copyright to CBE Pty Ltd and may not be modified, reproduced, sold, loaned, hired or traded in any form without its express written permission.
Study Files and Filing
Study Files and Filing The current version of all Hillingdon Hospital R&D Guidance Documents and Standard Operating Procedures are available from the R&D Intranet and Internet sites: www.ths.nhs.uk/departments/research/research.htm
HardyVal TM CSP RANDOM TEST KIT
HardyVal TM CSP RANDOM TEST KIT Cat. no. HVR1 Random Test Kit 5 tests/kit INTENDED USE Each kit contains: Tryptic Soy Broth, Double Strength (DS), 12ml Syringe, 5.2ml Whirl-Pak Bag Results Log Sheet 5
TYPE 1 - NEW PRODUCT APPLICATION FORM:
A.1 General Information TYPE 1 - NEW PRODUCT APPLICATION FORM: New Nutritional Products to be added to HSE Reimbursement List Applicant Company Name: Product Name: Product Description: Product Pack Size:
Creating a Centralized Compounding Pharmacy within a Health System
SALAS BLANCAS Amy Benner, PharmD Director of Central and Shared Services Scripps Health. Robert Miller, MS Quality Manager Scripps Health Ensuring the production of accurate and safe sterile compounded
Being Prepared for Track and Trace: DSCSA 101
Being Prepared for Track and Trace: DSCSA 101 Susanne Somerville, Founder The LinkLab Eric Garvin, Founder, The LinkLab Brian Daleiden, VP Industry Marketing and Co-Founder, TraceLink Objective of Today
AUDIT STATUS. Continuous Auditing Ideas and Priority Ranking Draft: 8/7/2012
Compliance Identify single day stays and subsequent re-admissions Identify inappropriate unbundling of lab tests Identify frequent use of high risk organizations Match OIG-excluded providers list with
Clinical Research & ICH GCP E6(R2) (Basic / Refresher Training):
Clinical Research & ICH GCP E6(R2) (Basic / Refresher Training): Principles of GCP, Investigator Responsibilities, Essential Documents v3 01-Feb-2017 Objectives To provide refresher training on ICH GCP
Learning Objectives. What is a Compounding Pharmacist? Disclosure
PHARMACY COMPOUNDING: Update on Trends & Regulations Michael Roberge, RPh Certified Compounding Pharmacist Owner, Compounded Solutions in Pharmacy LLC Monroe, CT Learning Objectives Define pharmacy compounding
BEST PRACTICES FOR RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT (RTSM)
WHITE PAPER BEST PRACTICES FOR RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT (RTSM) Guidelines for Sponsor IRT Strategy Study Start-Up, Maintenance and Close-Out Bringing crucial medicines to those who need
OPERATION INTRODUCTION
USP 39 Physical Tests / á795ñ Pharmaceutical Compounding Nonsterile 617 then either 1) select two nearby ph buffers from Table 2 or 2) select one from Table 2 and another documented prepared buffer that
Standard Operating Procedure for Archiving
Standard Operating Procedure for Archiving SOP name: NWORTH07/19 archiving Version 2 Authorship Team: Angela Gliddon & Rhiannon Whitaker Meeting date reviewed 16 th April 2008 Designated NWORTH member
Transitioning to Express Scripts
Transitioning to Express Scripts Welcome to Express Scripts. We re pleased to announce that, beginning January 1, 2017 the Michigan Tech prescription benefit will be managed by Express Scripts. Express
HEALTHCARE SOLUTIONS TRANSCAR AUTOMATED GUIDED VEHICLE
HEALTHCARE SOLUTIONS TRANSCAR AUTOMATED GUIDED VEHICLE 2 TRANSCAR GENERATION 3 SWISSLOG IS A LEADING PROVIDER OF INNOVATIVE, INTEGRATED LOGISTICS SOLUTIONS FOR HOSPITALS Answering tomorrow s hospital logistics
US FDA: CMC Issues for INDs
ISBTC Global Regulatory Summit October 29, 2008 US FDA: CMC Issues for INDs Keith Wonnacott, Ph.D. keith.wonnacott@fda.hhs.gov US Food and Drug Administration Center for Biologics Evaluation and Research
Secure Interim Analysis Data Access. Management with ACES. Eric J. Silva, Cytel, Inc. Steven Ketchum, Ph.D., Sunesis Pharmaceuticals
Secure Interim Analysis Data Access and Automated DMC/DSMB Management with ACES Eric J. Silva, Cytel, Inc. Steven Ketchum, Ph.D., Sunesis Pharmaceuticals Introductions: Today s Speakers Eric J. Silva Manager,
b) Where is the Storage location(s)? (provide the location in the pharmacy, building and room numbers)
University of Miami Institutional Biosafety Committee (IBC) Site-Specific Biosafety Standard Operating Procedure for the Safe handling of study Biological Agents (viral constructs) A Biosafety SOP is required
Barcodes on Unit of Use
Barcodes on Unit of Use 1 What hospitals need Hospitals need medications Ready-to-Administer In Unit-of-Use With Barcode 2 What hospitals need Ready-to-Administer If not, must go through additional pharmacy
STANDARD OPERATING PROCEDURES DIVISION OF COMPARATIVE MEDICINE UNIVERSITY OF SOUTH FLORIDA
STANDARD OPERATING PROCEDURES DIVISION OF COMPARATIVE MEDICINE UNIVERSITY OF SOUTH FLORIDA SOP#: 014.5 Date Issued: 11/00 Date Revised: 8/15 Page 1 of 5 TITLE: SCOPE: RESPONSIBILITY: PURPOSE: Research
Introduction to Clinical Research
Introduction to Clinical Research What is Clinical Research? Clinical research is medical research that involves people like you. People volunteer to participate in carefully conducted investigations that
Automated compounding for intravenous chemotherapy
Automated compounding for intravenous chemotherapy Not valid for printing! Low resolution PDF file. For high resolution files, please contact Communication & Image Dept. The correct preparation and administration
Your Goals. Our Solutions. Budget. Financial Reports INVENTORY MANAGEMENT MODULE. Company Structure. The Total solution system for your business
Your Goals. Our Solutions. Budget Financial Reports Company Structure INVENTORY MANAGEMENT MODULE The Total solution system for your business Your Goals. Our Solutions. Optimum Inventory Module is an integrated
Standard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Creation & Maintenance of an Investigator Brochure SOP Number: 34 Version Number: 1.0 Supercedes: N/A Effective date: August