e-labeling : innovation for patient or regulation nightmare Pharmapack Feb, 11 th, 2015
|
|
- Lizbeth Little
- 8 years ago
- Views:
Transcription
1 e-labeling : innovation for patient or regulation nightmare Pharmapack Feb, 11 th, 2015 PHARMAPACK
2 Mobile health x2 30 months mapps Source: research2guidance, mhealth App Market Report PHARMAPACK
3 Medical apps category patient Health care profesional PHARMAPACK
4 Regulation around medical apps FDA issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff on September 25, 2013 For EMEA Software that has a medical purpose could be a medical device. A medical device is defined in the medical device Directive (MDD) PHARMAPACK
5 Collaborative reflections Clinical Trials ISPE IP COP ISPE, the International Society for Pharmaceutical Engineering is the world's largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. IP COP= Investigational Products Community of Practice Transcelerate TransCelerate BioPharma Inc. is a non-profit organization focused on advancing innovation in research and development (R&D), identifying and solving common R&D challenges and further improving patient safety, with the goal of delivering more high quality medicines to patients. To prepare the Regulatory and Industry Environment for the Digital Clinical Supply Chain of the Future To write a concept paper to shape the content of the new clinical trial directives with respect to IMP labeling Q
6 Involved companies ISPE Transcelerate Sanofi Johnson & Johnson Merck BMS Novo Nordisk Roche Novartis Accenture Catalent Sanofi/Genzyme Janssen AstraZeneca BMS Boehringer Ingelheim Roche Pfizer Parexel CCL Label ThermoFisher Amgen Marken AbbVie GeronimoCons TemmlerWerke Lilly Accenture GlaxoSmithKline Transcelerate Cubist Forest AbbVie UCB PHARMAPACK
7 The situation Situation Surveys have demonstrated that for about 90% of the kits, booklets are not open (so, not read) New technologies offering new opportunities main objective with e-labelling is to suppress multilangual booklets Make the KIT ObjectiveThe more user friendly for the patient and enable study compliance Reduce/eliminate the need for relabeling due to protocol changes Proposal Label kits as late as possible in the language(s) of the patient Reduce waste by pooling supplies PHARMAPACK
8 What is e-labeling Integrated local regulatory and study specific requirements are provided via electronic media at the time of dispensation of medication to the patient via: Mobile/Smart Phone PC Tablet PC Others E-labeling PHARMAPACK
9 Principles Pick & pack Ship Dispense IP to patient Read e-label PHARMAPACK
10 How it works (full integrated systems) Supply Chain Untranslatable labels Clinical Sites IVRS/IWRS Design labels E-label Print labels Allocate kit ID Select language Expiry date, storage conditions Patient ID, Investigator name, Sponsor databases ERP EDC PHARMAPACK
11 E-Labeling: options Optionally, Personal & central monitoring is possible Patient diairy T monitoring per medication kit Link with an intelligent blister that register pressing out tablets/capsules Instructions movies can be shown e.g. on: How to administer the medicine What the study is about What to do in case of emergency Etc Alerts and messages can be personalized per patient PHARMAPACK
12 Benefits Pharmaceutical Companie - More information on - Monitoring/Reports - Label step is no more a products bottleneck - Additional information on products/study - More friendly information - Readibility of information (font size) - Last up to date information - Alerts, reminders - Improve their health (not injure themselves) - - Direct reminders on key points of the study protocol (inclusion/exclusion criteria) - Treatment compliance e-labeling benefits - Language can be added as fast as it is known - No more additional/over labeling - Treatment compliance => better study results - Recall is facilitated PHARMAPACK
13 Questions & Regulation Data privacy Back-up systems Use of untranslatable labels Future regulations Retain samples How to keep data privacy of the patient? What are the solutions in case of apps breakdown? Are untranslatable label authorized? What is the potential impact? How can the process be managed? By default the system must be hosted by an approved, external company. - Retrieve label info on secured web site - Print a label/ dispensing card during dispensation - Helpdesk access by phone Refer to ISPE Good Practice guide: Booklet labels What could be the pictogram For Clinical Trial Use Only? Annex VI of European regulation => Expiry date is required on inner and outer packaging Keep a sample of untranslatable kit and lay out in each language PHARMAPACK
14 Enabling e-labeling to marketed products Improve prevention and education Up to date information Direct access to essential information User friendly Appropriate language Increase Patient safety Video, alerts, reminders Patient centricity PHARMAPACK
15 Conclusion Are you ready to satisfy needs of the patients using the latest technologies in the pharmaceutical industry? Ecological practice PHARMAPACK
16 Thank You! 16
Beyond the White Box: Why Patient Friendly IP Packaging Matters
Beyond the White Box: Why Patient Friendly IP Packaging Matters KRISTEN DEVITO Global Director, CSS Business Solutions Catalent Pharma Solutions Presented to 17 March 2015 Introduction The increasing complexity
More informationCHEM-E4140 Selectivity 12. Pharma Business
CHEM-E4140 Selectivity 12. Pharma Business Prof. Ari Koskinen Laboratory of Organic Chemistry C318 Pharma Business Total volume ca 1100 G$ (Shell 421G$; Walmart 486G$; Toyota 252 G$). Annually approx 25
More informationPharma s Sharp Right Turn on R&D Creating an IT Platform to Fuel Future Growth
Accenture Life Sciences Rethink Reshape Restructure for better patient outcomes Pharma s Sharp Right Turn on R&D Creating an IT Platform to Fuel Future Growth Leading pharmaceutical companies are evaluating
More informationIn the largest and perhaps the most ambitious collaborative
FEATURES THE BIRTH OF TRANSCELERATE BIOPHARMA, INC. Revolution in Clinical Research Partnerships by Dalvir Gill and Garry Neil In the largest and perhaps the most ambitious collaborative effort ever initiated
More informationClinical Trial Supply Europe 2016 Barcelona, 2 nd & 3 rd March 2016 2016 SPEAKERS INCLUDE
Clinical Trial Supply Europe 2016 Barcelona, 2 nd & 3 rd March 2016 2016 SPEAKERS INCLUDE Jan-Pieter Kappelle, Senior Director, Global Clinical Trial Supplies, UCB Didier Basseras, Vice President, Clinical
More information6 th Proactive GCP Compliance Effective Risk- Based Approaches for Optimizing Clinical Quality
6 th Proactive GCP Compliance Effective Risk- Based Approaches for Optimizing Clinical Quality March 24-25, 2015 Wyndham Philadelphia Historic District, Philadelphia, PA www.exlevents.com/gcp Sponsors
More informationThe Role Of Industry in the Australian Clinical Trials Sector
Mitch Kirkman, Development QA Manager Australian Clinical Trials Alliance Symposium 09 October 2015 CORP0270 September 2015 Global Clinical Development Local Clinical Trials Australian Medical Research
More informationSharing Industry Clinical Trial Data: Improving Public Health While Maintaining the Oversight Relationship Between Regulator and Sponsor
Sharing Industry Clinical Trial Data: Improving Public Health While Maintaining the Oversight Relationship Between Regulator and Sponsor Steven Snapinn SCT/QSPI/FDA Workshop Innovations in the Science
More informationBlockbuster!!! Content Management in the Pharmaceutical Industry An Overview. Global Pharma Market Shares by Sales (Approx. USD 700 Billion) Global
Content Management in the Pharmaceutical Industry An Overview Blockbuster!!! Avatar USD 2 Billion revenues Lipitor USD 12.5 Billion in 2008 Dr Arun Gangatkar http://in.linkedin.com/in/drarungangatkar drarunj@gmail.com
More informationRx-360 An International Pharmaceutical Supply Chain Consortium
Rx-360 An International Pharmaceutical Supply Chain Consortium Overview Rx-360 and the Audit Sharing Program September 2011 Rx-360 Members (Continuously updated list at www.rx-360.org) Manufacturers (24)
More informationLorna Briddick Managing Partner Brizzey LLC. 10/30/2014 October 30, 2014 1
Global Clinical Supplies & The Road Less Traveled: Navigating the bumps, pot holes and detours that come with the development and delivery of Investigational Products Lorna Briddick Managing Partner Brizzey
More informationOutcomes of Monitoring Committee Reviews. Medicines Australia Code of Conduct
Outcomes of Monitoring Committee Reviews Medicines Australia Code of Conduct 1 Medicines Australia ABN 23 126 990 001 Level 1, 16 Napier Close Deakin ACT 2600 Phone: 02 6122 8500 Fax: 02 6122 8555 Web:
More informationClinical Supply Chain Management - Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management
Brochure More information from http://www.researchandmarkets.com/reports/2226324/ Clinical Supply Chain Management - Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management Description:
More informationClinical trial research agreement Agreed schedule 4 or 7 clause amendments
Clinical trial research agreement Agreed schedule 4 or 7 clause amendments Medicines Australia and Medical Technology Association of Australia templates The sponsors in the table have agreed clauses for
More informationCODE FOR DISCLOSURE OF TRANSFERS OF VALUE BY PHARMACEUTICAL COMPANIES TO HEALTHCARE PROFESSIONALS AND HEALTH ORGANIZATIONS
CODE FOR DISCLOSURE OF TRANSFERS OF VALUE BY PHARMACEUTICAL COMPANIES TO HEALTHCARE PROFESSIONALS AND HEALTH ORGANIZATIONS Adopted November 2013, in force since 1 st of January 2014. INTRODUCTION The Association
More informationDecember 17, 2014 HOW PHARMA MARKETERS FIND AND SELECT DIGITAL MARKETING AGENCIES
December 17, 2014 HOW PHARMA MARKETERS FIND AND SELECT DIGITAL MARKETING AGENCIES by Dennis van Rooij with Tim van Tongeren EXECUTIVE SUMMARY More than half of pharma marketers don t or can t leverage
More informationBest Practice Approaches to Improving Clinical Supply Chain Management. Matthew Do Client Development Lead Almac Pharmaceutical Services
Best Practice Approaches to Improving Clinical Supply Chain Management Matthew Do Client Development Lead Almac Pharmaceutical Services A variety of challenges complicate trial supply management Multiple
More information1) SCOPE OF THE PROGRAM
CALL FOR PROJECTS 2015/16 CANADA/GERMANY JOINT PROGRAM DEADLINE: 15 TH JANUARY 2016 1) SCOPE OF THE PROGRAM The main goal of the Canada/Germany joint program is to strengthen research in Canada and Germany
More informationIntroduction. VP, Sales in a Global Courier Company
ARTICLE AUGUST 2014 Abstract: Impact analysis of Just in Time packaging and labeling on clinical supply chain Clinical supply chain is in intense pressure for better management due to factors like globalization
More informationDigital Leaders Deal With a Range of Organizational Challenges
May 22, 2014 OVERCOMING OBSTACLES TO DIGITAL TRANSFORMATION SUCCESS IN THE PHARMACEUTICAL INDUSTRY Digital Leaders Deal With a Range of Organizational Challenges by Tim van Tongeren with Dennis van Rooij
More informationDrug Pooling in Clinical Trial Supply Chain
Drug Pooling in Clinical Trial Supply Chain Drug pooling in clinical trial is a process where common IMPs or Non-IMPs are pooled together for similar protocols running at each site followed by pooled distribution
More informationIdentity Management & Digital Signatures in the BioPharmaceutical Industry John Hendrix; Program Director CTST 2009
Identity Management & Digital Signatures in the BioPharmaceutical Industry John Hendrix; Program Director CTST 2009 2009 SAFE-BioPharma Association Overview Conducting Business in the Electronic World
More informationManaging the Extended Clinical Supply Chain in an Outsourced World
Managing the Extended Clinical Supply Chain in an Outsourced World Business Pressures on Sponsors, Contractors and CROs are Increasing Most recent research on clinical trials focuses on the outsourced
More informationTo know more about Pharmacovigilance and Clinical Trials Data Management
To know more about Pharmacovigilance and Clinical Trials Data Management 1. What is Pharmacovigilance? Pharmacovigilance (PV) is the pharmacological science related to the detection, assessment, understanding
More informationKEEPING CLINICAL TRIALS IN AUSTRALIA
OCCASIONAL PAPER SERIES KEEPING CLINICAL TRIALS IN AUSTRALIA WHY ACTION IS NEEDED NOW OCCASIONAL PAPER SERIES > Medicines Australia is producing Occasional Papers to promote a contest of ideas, thought
More informationClinical Supply Chain Management. Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management
Clinical Supply Chain Management Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management GBI Research Report Guidance GBI Research Report Guidance The report focuses on the current
More informationReflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials
1 2 3 5 August 2011 EMA/INS/GCP/600788/2011 Compliance and Inspection 4 5 6 7 Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials
More informationGuidance on the content of a pharmacy manual to support clinical trial protocols
Guidance on the content of a pharmacy manual to support clinical trial protocols This guidance has been produced to help investigators with the content of pharmacy manuals for clinical trials. We gratefully
More informationehealthinsight Series: Online Patient Recruitment Strategies
A Datamonitor report ehealthinsight Series: Online Patient Recruitment Strategies Published: May-08 Product Code: Providing you with: Overview of benefits and drawbacks of online Analysis of online patient
More informationAcknowledgements. We thank these organizations and individuals for their unrestricted support.
Power to the People Presented by Dawn Richards, PhD, Person with Rheumatoid Arthritis Arthritis Consumer Experts Advisory Board Member Canadian Arthritis Patient Alliance Vice President Acknowledgements
More informationLogistics. Drug Pooling in the Clinical Trial Supply Chain
Drug Pooling in the Clinical Trial Supply Chain Abstract Global clinical trials require efficient and robust supply chain which can bring more transparency and can introduce risk mitigation strategies.
More informationStakeholder Perspectives: Mild Cognitive Impairment and Dementia
A Datamonitor In-Depth Analysis Stakeholder Perspectives: Mild Cognitive Impairment and Dementia Aricept in Race to Pioneer Unexplored Markets Published: Aug-03 Product Code: DMHC1924 Why buy this analysis?
More informationIMP management at site. Dmitry Semenyuta
IMP management at site Dmitry Semenyuta TOP 5 FDA inspections finding 1999-2009 Center of Drug Evaluation and Research (CDER) Failure to follow the protocol Failure to keep adequate and accurate records
More informationOptimizing the Clinical Trial Supply Chain
white paper Optimizing the Clinical Trial Supply Chain Ensuring the right items arrive in the right place, in the right quantity, at the right time and within budget. Testing out new medicines around the
More informationPharmaceutical sales in Canada have a 2.5 percent share of the global market, making th
Industry Canada (/eic/site/icgc.nsf/eng/home) Home Industries and Business Canadian Life Science Industries Biopharmaceuticals and pharmaceuticals Pharmaceutical industry profile Life Science Industries
More informationBenefits to Attending
Day 1 Stream 1 Enterprise IT: Technologies, Challenges and Strategies Maximising the benefits of cloud computing Building IT infrastructure for Big Data Developing and applying semantic web technologies
More informationInterested parties (organisations or individuals) that commented on the draft document as released for consultation.
18 February 2014 EMA/INS/GCP/100058/2012 Good Clinical Practice Inspectors Working Group (GCP IWG) Overview of comments received on 'Reflection paper on the use of interactive response technologies (interactive
More informationGlobal Peptide Therapeutics Market 2014-2018
Brochure More information from http://www.researchandmarkets.com/reports/3022209/ Global Peptide Therapeutics Market 2014-2018 Description: About Peptide Therapeutics Peptides are amino acids sequences
More informationEvolving tactical video production- Creative Studios
WHITEPAPER JUNE 2014 www.beroe-inc.com Evolving tactical video production- Creative Studios Abstract / Business Case 1. Introduction:This whitepaper help pharma clients who allocate lower budgets to their
More informationHow To Understand Your Role In A Pharmacy
Element 1 Element 2 Assist with the maintenance of pharmaceutical Issue pharmaceutical 277 278 Element 1 Element 2 Assist with the maintenance of pharmaceutical Issue pharmaceutical Background See background
More informationMain Conference Agenda
Sponsored by: (Co-located with Bioequivalence: Intersection between Science & Regulatory Conference) Main Conference Agenda Day One Wednesday, November 5 th, 2014 7:30 Registration Opens & Continental
More informationAnnual Press Conference 2012. Business Year 2011
Business Year 2011 Highlights of the Business Year 2011 Andreas Barner Chairman of the Board of Managing Directors Corporate Board Division Pharma Research, Development and Medicine Value through Innovation
More informationSecure Digital Identities for Authentication & Signing in an Electronic Healthcare Community
Secure Digital Identities for Authentication & Signing in an Electronic Healthcare Community John Hendrix; Program Director CTST 2009 Overview Challenges to Secure Transactions in an Electronic Environment
More informationThe power of creativity www.originbranding.com. Pharmaceutical Branding 2012
The power of creativity www.originbranding.com Pharmaceutical Branding 2012 We are an independent, boutique agency passionately focused on developing pharmaceutical brands. For over 15 years we have delivered
More informationMost recent research on clinical trials
Reprinted from PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE July/August 2012, Vol. 32 No. 4 www.pharmaceuticalengineering.org Copyright ISPE 2012 This article presents the R&D supply chain
More informationCommercial Insight Osteoarthritis and Rheumatoid Arthritis
A Datamonitor In-Depth Analysis Commercial Insight Osteoarthritis and Rheumatoid Arthritis New Growth In A Mature Market Published: Jul-03 Product Code: DMHC1891 Why buy this analysis? Target current and
More informationASCO. R&D Supply Chain and Clinical Trials Supply Management A Life Sciences Solution. Award for the "Best Business Transformation project 2010
ASCO Award for the "Best Business Transformation project 2010 R&D Supply Chain and Clinical Trials Supply Management A Life Sciences Solution Geert Crauwels Partner Life Sciences Industry Lodestone Amelia
More informationUsing IVRS in Clinical Trial Management
Using IVRS in Clinical Trial Management Bill Byrom Interactive voice response systems can work for project managers as an inventory management tool, a real-time project information tool, and a subject
More informationAdoption by GCP Inspectors Working Group for consultation 14 June 2011. End of consultation (deadline for comments) 15 February 2012
10 December 2013 EMA/INS/GCP/600788/2011 Compliance and Inspection Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular
More informationGlobal Non-Small Cell Lung Cancer Therapeutics Market 2015-2019
Brochure More information from http://www.researchandmarkets.com/reports/3453273/ Global Non-Small Cell Lung Cancer Therapeutics Market 2015-2019 Description: About non-small cell lung cancer therapeutics
More informationMayo Central Laboratory for Clinical Trials A Division within Mayo Clinical Trial Services
Mayo Central Laboratory for Clinical Trials A Division within Mayo Clinical Trial Services LABORATORY TESTING SERVICES YOUR PARTNER IN LABORATORY MEDICINE The key note of progress in the 20th century is
More informationEuropean Statistical Workshop (EFSPI/PSI): EMA Clinical Trial Data Transparency
European Statistical Workshop (EFSPI/PSI): EMA Clinical Trial Data Transparency Dr. Christoph Gerlinger 2013-08-22 Overview How it all began Current status EFSPI s Position EMA s draft Policy Aim of this
More informationGSK Public policy positions
Product Donations The Issue As a global healthcare company operating in countries throughout the world, GSK recognises a responsibility to make product donations in the form of ongoing humanitarian assistance
More informationQuality Systems Appropriate for Extemporaneously Prepared Early Phase Clinical Trial Materials. Agenda Topics for Discussion
Quality Systems Appropriate for Extemporaneously Prepared Early Phase Clinical Trial Materials Richard Hoffman, MS Eli Lilly & Co. Principal Consultant - Regulatory PDA/FDA Joint September 20 th, 2011
More informationAccenture Life Sciences. Helping Life Sciences companies rethink, reshape or restructure for better patient outcomes
Accenture Life Sciences Helping Life Sciences companies rethink, reshape or restructure for better patient outcomes The Life Sciences industry is at a remarkable inflection point. As the Life Sciences
More informationOFFICE OF ATTORNEY GENERAL LAWRENCE G. WASDEN AVERAGE WHOLESALE PRICE LITIGATION REPORT AUGUST 2013
Introduction OFFICE OF ATTORNEY GENERAL LAWRENCE G. WASDEN AVERAGE WHOLESALE PRICE LITIGATION REPORT AUGUST 2013 In 2007, Attorney General Wasden filed lawsuits against 33 pharmaceutical companies for
More informationExtemporaneously Prepared Early Phase Clinical Trial Materials
Extemporaneously Prepared Early Phase Clinical Trial Materials Richard Hoffman, MS, RAC Eli Lilly & Co. Regulatory Advisor International Consortium for Innovation & Quality in Pharmaceutical Development
More informationthrough advances in risk-based
Insight brief Quintiles is a market leader with >100 risk-based monitoring studies Quintiles developed solutions that bring as much as 25% cost reduction over traditional trial execution approaches Transform
More informationPharma working capital performance highly variable
April 2014 Pharma working capital performance highly variable 41 Billion in Excess Working Capital We last completed this survey in 2012. We expected that there would be a broad improvement across the
More informationAvoca s Quality Metrics Consulting Service Offering
Avoca s Quality Metrics Consulting Service Offering Avoca s Quality Metrics Consulting The Challenge Biopharmaceutical companies and CROs struggle in defining how best to utilize quality metrics to optimize
More informationBenefits to Attending
Day 1 Stream 1 Enterprise IT: Technologies, Challenges and Strategies Maximising the benefits of cloud computing Building IT infrastructure for Big Data Developing and applying semantic web technologies
More informationThe Role of DrugDev in Modern Clinical Trials
DD_Brochure_Layout 1 5/5/15 11:17 AM Page 3 Do More Trials Do More Trials DrugDev is an innovative technology company which provides cloud-based solutions to help sponsors, CROs and investigators do more
More informationClinical Trial Logistics
BOOK BY 31ST MARCH TO SAVE 100 SMi presents the 8th conference and exhibition series... Clinical Trial Logistics 21ST - 22ND MAY 2014 MARRIOTT REGENTS PARK LONDON, UK EUROPE'S LEADING CLINICAL TRIAL LOGISTICS
More informationAGILE RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT SOLUTIONS: A RECIPE FOR SPEED, SIMPLICITY AND SERVICE
WHITE PAPER AGILE RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT SOLUTIONS: A RECIPE FOR SPEED, SIMPLICITY AND SERVICE Randomization is fundamental to clinical trials it enables treatment group balance, eliminates
More informationSage ERP I White Paper
The Premier Provider of Effective Business Software Solutions National Presence, Local Touch 1.800.4.BLYTHE www.blytheco.com I White Paper Proactive Regulatory Compliance for Biopharmaceutical Global Competitiveness
More informationMinimize overspend by gaining visibility of total demand
Minimize overspend by gaining visibility of total demand Patti Seymour 9th Annual Clinical Trials Supplies and Packaging October 10-12, 2011 BioProcess Technology Consultants www.bptc.com Supply and Demand
More informationMedical Writing Takes Off in India
Visit http://store.centerwatch.com to learn more about State of the Clinical Trials Industry 2008 Special Article Reprint For the latest news and views on the clinical trials industry visit ClinicalTrialsToday.com
More informationSmall-Cell Lung Cancer Global Clinical Trials Review, H2, 2015
Brochure More information from http://www.researchandmarkets.com/reports/3398017/ Small-Cell Lung Cancer Global Clinical Trials Review, H2, 2015 Description: Small-Cell Lung Cancer Global Clinical Trials
More informationHow to Run Clinical Trials in Private Practice
How to Run Clinical Trials in Private Practice Thomas M. Siler, MD Midwest Chest Consultants, PC Saint Charles, MO DISCLOSURE Dr. Siler has received research grants from GlaxoSmithKline, Forest, Boehringer
More informationPharmacovigilance Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013-2019 Single User License: US $ 4595
Transparency Market Research Pharmacovigilance Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013-2019 Single User License: US $ 4595 Buy Now Request Sample Published Date:
More informationIntroduction 2. 1. The Role of Pharmacy Within a NHS Trust 3. 2. Pharmacy Staff 4. 3. Pharmacy Facilities 5. 4. Pharmacy and Resources 6
Index Index Section Page Introduction 2 1. The Role of Pharmacy Within a NHS Trust 3 2. Pharmacy Staff 4 3. Pharmacy Facilities 5 4. Pharmacy and Resources 6 5. Prescription Charges 7 6. Communication
More informationValue added services of pharmaceutical fullline wholesalers. Contact GIRP for discussing partnerships + 32 2 777 99 77 girp@girp.
Value added services of pharmaceutical fullline wholesalers Contact GIRP for discussing partnerships + 32 2 777 99 77 girp@girp.org Selected examples from GIRP s integrated member companies: Please note
More informationThe Evolution of Data Platforms in IMI. Anthony Rowe, Janssen R&D IT 08 April 2016 Med-e-Tel Luxembourg
The Evolution of Data Platforms in IMI Anthony Rowe, Janssen R&D IT 08 April 2016 Med-e-Tel Luxembourg Three trends in technology today Ubiquity of the Internet Three trends in technology today Ubiquity
More informationEBiSC the first European bank for induced pluripotent stem cells
Press Release EBiSC the first European bank for induced pluripotent stem cells Pharmaceutical companies who are members of the European Federation of Pharmaceutical Industries and Associations (EFPIA)
More informationAn information platform that delivers clinical studies better, faster, safer and more cost effectively
An information platform that delivers clinical studies better, faster, safer and more cost effectively Powering Process & Performance Proactively manage study start-up and execution Risk profile new sites
More informationClinical Trial Logistics
Company Brochure Clinical Trial Logistics contents 1. 2. 3. 4. 5. 6. About us Values Facility Quality Management System Services Why PCS Clinical Trial Logistics about us MEET US PHARMA COMPLEX SOLUTIONS
More informationSerialization Technology - Seidenader: Integral Solution Provider
Serialization Technology - Seidenader: Integral Solution Provider Sindusfarma August, 28th 2013 Dr. Stefan Loelkes Agenda 1 2 Your challenge Company overview 3 4 Integral solution provider Products 2 Your
More informationData Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International
Data Management and Good Clinical Practice Patrick Murphy,, Family Health International 1 What is GCP? Good Clinical Practice is an international ethical and scientific quality standard for designing,
More informationDecision Matrix: Selecting a CRM Vendor in the Pharmaceutical Market (Competitor Focus)
A Datamonitor report Decision Matrix: Selecting a CRM Vendor in the Pharmaceutical Market (Competitor Focus) Published: Oct 07 Product Code: DMTC2133 Providing you with: Identifies which technology vendors
More informationThe Effective Management of Change Across the ICHQ10 Lifecycle
The Effective Management of Change Across the ICHQ10 Lifecycle Rob Hughes AstraZeneca 1 Change Management the guide This presentation will: describe a structured approach to change across the ICH Q10 lifecycle
More informationGuidance to Research Ethics Committees on Initial Facility Assessment
Guidance to Research Ethics Committees on Initial Facility Assessment Introduction One of the roles of a Research Ethics Committee is to provide an opinion on a proposed study, based on the suitability
More informationPresented by Rosemarie Bell 24 April 2014
Global Good Manufacturing Practice A Comparability Study to Link Good Manufacturing Practice Standards for World Wide Compliance Within the Cellular Therapy Industry Presented by Rosemarie Bell 24 April
More informationGS1 AIDC in Healthcare
GS1 AIDC in Healthcare Ask the Experts - GS1 DataMatrix, GS1 Healthcare Demo Scanner & Intelligent Packaging GS1 Healthcare Conference Copenhagen 22 October 2014 Consumers have become digital and this
More informationISPE Proposals for FDA Quality Metrics Program - Whitepaper
20 December, 2013 ISPE Proposals for FDA Quality Metrics Program - Whitepaper Summary This white paper proposes an initial list of quality metrics which are reportable to FDA to support a risk-based inspection
More informationTABLE OF COMMITMENTS
Reaching Goals On, a range of public and private partners are announcing a new, coordinated push to accelerate progress toward eliminating or controlling 10 neglected tropical diseases (NTDs) by in support
More informationWhat Lies Ahead? Trends to Watch: Health Care Product Development in North America
What Lies Ahead? Trends to Watch: Health Care Product Development in North America What Lies Ahead? for 2015 DIA has released its third annual What Lies Ahead? report, providing experts insights into the
More informationThe Center for Clinical Trials of Drugs and Medical Devices
Siberian State Medical University maintaining traditions to develop the medicine of the future The Center for Clinical Trials of Drugs and Medical Devices SIBERIAN STATE MEDICAL UNIVERSITY www.ssmu.ru
More information2014 & 13 th Annual China Pharmaceutical, Life Science & Healthcare Industry Summit
2014 & 13 th Annual China Pharmaceutical, Life Science & Healthcare Industry Summit Addressing the most critical issues facing China s pharma & life science sector 10 th & 11 th April, 2014 Shanghai China
More information1083.4 SUPPLY CHAIN INTEGRITY AND SECURITY
BRIEFING 1083.4 Supply Chain Integrity and Security. A new series of general informational chapters describing various aspects of the pharmaceutical supply chain replaces Good Distribution Practices Supply
More informationICH CRA Certification Guide March 2009
ICH CRA Certification Guide March 2009 ICH CRA CERTIFICATION GUIDE... 1 GENERAL INFORMATION... 2 BENEFITS OF CERTIFICATION... 2 INDUSTRY RECOGNITION... 2 ABOUT THE EXAM... 2 CRA DEFINITION... 2 REQUIREMENTS
More informationNevirapine 200 mg tablets WHOPAR part 5 09/2010, version 1.0 (Matrix Laboratories Ltd), HA396 LABELLING. Page 1 of 8
LABELLING Page 1 of 8 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING HDPE bottle carton label 1. NAME OF THE MEDICINAL PRODUCT Nevirapine
More informationPharma working capital leaves room for improvement
October 2012 Pharma working capital leaves room for improvement 50.7 Billion in Excess Working Capital Ten years ago it was not unusual to be asked why working capital mattered to a pharmaceutical company.
More informationCarol Lefebvre Senior Information Specialist UK Cochrane Centre National Institute for Health Research Oxford, UK
Clinical trials registers and clinical trials results registers: their contribution as health information sources to evidence-based healthcare decision-making Carol Lefebvre Senior Information Specialist
More informationOvercoming Clinical Challenges. A White Paper
Overcoming Clinical Challenges in BRIC Markets A White Paper REUTERS/Dylan Martinez APRIL 2014 table Of contents Beth Nuskey PhArmAceuticAl research AnAlyst clinical trials At thomson reuters in this role,
More informationAvg cost of a complex trial $100mn. Avg cost per patient for a Phase III Study
1 Industry Perspective Over the last several years, clinical research costs have sky rocketed while new drug approvals are at multi-year lows. Studies have become global in nature and more complex to manage
More informationPARTIAL DELEGATE LIST (as of Jan. 15, 2013) Electronic Data in Clinical Trials /Integration and Leveraging Clinical Trial Operations Data Conferences
PARTIAL DELEGATE LIST (as of Jan. 15, 2013) Electronic Data in Clinical Trials /Integration and Leveraging Clinical Trial Operations Data Conferences February 5-7, 2013 - Hyatt Regency Miami Miami, FL
More informationValidation and Data Integrity in eclinical Platforms. June 2014 A Concept Paper by the ISPE GAMP Community of Practice
Validation and Data Integrity in eclinical Platforms June 2014 A Concept Paper by the ISPE GAMP Community of Practice Page 2 Validation and Data Integrity in eclinical Platforms Acknowledgements This concept
More informationValue Creation through Business Innovation in the Pharmaceutical and Medical Technology Sector
Value Creation through Business Innovation in the Pharmaceutical and Medical Technology Sector Fred Nijland Annemarie van Hoogstraten Nanning de Jong 1 Summary The Dutch market for the pharmaceutical and
More informationManufacturer of drug substance
Original s and Biosimilars (marketing authorizations in the EU) Date: January 2016 1) Somatropin s ORIGINAL PRODUCTS: Authorization Genentech Genotropin Somatropin Pharmacia/ Pfizer E. coli Humatrope Somatropin
More informationTransCelerate's Role in Transforming Pharmaceutical Trials Presentation to PCORNet
TransCelerate's Role in Transforming Pharmaceutical Trials Presentation to PCORNet Dalvir Gill, PhD - Chief Executive Officer 17 October, 2014 Presentation Objectives + TransCelerate History + Participating
More information