e-Labelling: The Road to Reduced Med Device Packaging
Posted by Peter M.Schlafender Hase
247 days ago
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Schlafender Hase
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Category Selection:
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Clinical Research *
5
Clinical Reporting
3
Abstract & Poster Development
Clinical Study Report Writing
Manuscript Development
Product Development
9
Analytical Methods Development
Clinical Research
Clinical Research Network Development
Clinical Trial Material Supply
Clinical Trials
Show More (4)
Document Management
Drug Product Manufacturing
Formulation Development
Submissions Management
Show Less (4)
Real World Data Research
6
Analytics Methods Development
Data Standardization & Curation
Evidence Prioritization
Late Phase Data Curation
Lifecycle Evidence Generation
Show More (1)
Observational Research
Show Less (1)
Study Operations & Management
6
Patient Recruitment
Site Contracting & Payments
Site Identification & Activation
Site Relationship Management
Study Tracking & Analytics
Show More (1)
Trial Implementation
Show Less (1)
Trial Design & Planning
6
Data Management Planning
Enrollment Analytics
Patient Recruitment Planning
Protocol Feasibility Planning
Software
Show More (1)
Statistical Analysis Planning
Show Less (1)
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2
Brand Planning & Activation
3
Brand Vision & Positioning
Campaign Concept Testing
Multi-Channel Campaign Launch
Customer Engagement
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Omnichannel Optimization
Patient Engagement
Patient Facing Solution Design
Patient Journey Analysis
Retention Program Effectiveness
Show More (1)
Strategic Account Management
Show Less (1)
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Financial Services
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Billing & Reporting Operations
Internal Audit Support
Investment Performance Analytics
Revenue Forecasting & Planning
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Capital Raising & Financing
Investor Relations
Market Access & Policy *
2
Global Market Access
5
Launch Sequencing
Payer Evidence Generation
Payer Relationship Management
Pricing Strategy
Reimbursement Consulting
Government Policy
2
Advocacy Management
Legislative Monitoring
Medical Affairs *
5
Defining the Value of Medical Affairs
1
Defining the Value of Medical Affairs
Evidence Generation
5
Clinical Trial Concepts
Health Economics Modeling
Internal Medical Education
Patient Journey Mapping
Research Gap Analysis
Scientific Communications Development
2
Market Access Advisory Panels
Payer Advisory Board Strategy
Strategic Communications Planning
3
Competitive Publications Analysis
Publication Planning
Scientific Platform Planning
Strategic Stakeholder Engagement
3
Advisory Board Strategy
KOL Relationship Management
Stakeholder Influence Mapping
Pharmacovigilance *
2
Risk Management
3
Risk Evaluation & Minimization
Risk Management Evaluation
Safety Communications
Safety Systems
3
Safety Data Analytics
Safety Data Intake & Triage
Safety Signal Evaluation
Quality & Mfg *
4
Facilities & Equipment
5
Calibration & PM Programs
Deviation Investigations
Equipment Maintenance
Facility Maintenance Programs
Facility Security Management
Production & Supply Chain
3
Clinical & Commercial Production
Labeling & Packaging
Storage & Distribution
Quality Management
3
Corrective Action Verification
Deviation Investigation
Quality Process Governance
Testing & Release
3
Batch Release Testing
Raw Material Testing
Stability Program Testing
Regulatory *
4
Compliance
5
Agency Meeting Support
Dossier & Application Development
eCTD Publishing & Validation
Pre-Submission Advisory Meetings
Regulatory Compliance
Labeling & Promotions
2
Core Data Sheet Management
Labeling Strategy Development
Maintenance & Renewals
3
Post-Approval Safety Reporting
Promotional Material Compliance
Variations & Supplements
Transparency & Disclosure
2
Clinical Disclosure
Clinical Transparency
Technology & Operations *
6
Automation & Efficiency
3
Clinical Data Automation
Lab Automation Systems
Supply Chain Automation
Data & Analytics
3
Advanced Analytics
Data Curation
Data Visualization
Digital Health Solutions
6
5G Infrastructure
Blockchain Applications
mHealth Applications
Patient Portals
Telemedicine Platforms
Show More (1)
Wearables & Sensors
Show Less (1)
Early Development
2
Clinical Supply Chain Automation
Clinical Trial Management Systems
Informatics Infrastructure
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Cloud Computing Systems
Data Security Solutions
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Communications
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Content Creation & Development
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Schlafender Hase
Regulators in the life sciences industry are making clear moves to connect patients, physicians and other stakeholders across the healthcare system by implementing e-labelling initiatives.
The goal of these initiatives is to ensure a sustainable and consistently up-to-date information source for product and safety information that isn’t dependent on paper.
This eBook assesses the latest regulatory expectations and timelines applicable to the medical device industry. It then sets out the practical next steps manufacturers and suppliers can take now – both to prepare for compliance and to maximize the opportunities operationally and for customers.
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