e-labeling : innovation for patient or regulation nightmare Pharmapack Feb, 11 th, 2015

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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

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