Mobile Apps and New
Technologies in Pharma
Research
Eric Staib
Executive Director, Corporate Quality Assurance
PRA Health Sciences
30-September-2015
Agenda
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Mobile Apps/Devices and New Technologies
GAMP Good Practice Guide
Regulation and Guidance
CSV & SDLC
Applying GAMP5
US FDA Quote
“According to industry estimates, 500 million
smartphone users worldwide will be using a
health care application by 2015, and by 2018, 50
percent of the more than 3.4 billion smartphone
and tablet users will have downloaded mobile
health applications. These users include health
care professionals, consumers, and patients.”
Why Mobile Devices and Application?
• To improve patient compliance to a medical
regimen/protocol
• As a channel for patient reporting (ex. ePRO)
• As an interface to a medical device
• To control a medical device
• To make medical literature more available to
physicians
• As a marketing tool
Technologies include:
A smartwatch that tracks heartbeats
Contact lenses that measure blood sugar
A smartphone application that uses a phone's camera
to analyse urine
capecodtimes.ma.newsmemory.com/publink.php?shareid=2b522d67a
US FDA: “Mobile Medical Apps”?
“Mobile medical apps are medical devices that are
mobile apps meeting the definition of a medical
device and/or are an accessory to a regulated
medical device or transform a mobile platform into
a regulated medical device.”
Categories/Types of Mobile Apps
Non-Regulated
Connected to a Device
Internal to Company
Stand Alone
Environmental Difficulties
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Complexity
Rapidly Changing
Volatile
Regulatory Situation Unclear
Blurring boundaries: software, hardware,
drug/device, web ecosystem, product,
internal/external, etc.
ISPE GAMP® Good Practice Guide:
Table of Contents
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Introduction
Specific Aspects of Mobile Applications
Application of GAMP 5 to Mobile Applications
Quality Risk Management for Mobile Applications
Mobile Application Life Cycle
Appendix 1 – Mobile Application Risk Landscape
Appendix 2 – Quality Risk Management Approach
Appendix 3 – Requirements Definition for Mobile Apps.
Appendix 4 – Mobile Application Architecture
Appendix 5 – Production Phase for Mobile Apps.
Appendix 6 – Supplier Management and Good Practice
Appendix 7 – Sample Mobile Application Case Studies
Glossary
References
ISPE GAMP Good Practice Guide:
Regulated Mobile Applications
• Looks at wide variety of mobile application types from those
that are informational to those that are devices.
• Describes the nuances of evaluating and validating/qualifying
mobile applications.
– Describes the various stages of the mobile application lifecycle and what
activities need to be considered, from implementation to retirement.
– Describes what should be considered when developing a mobile application.
– Talks about data and how it should be handled during use and application
retirement.
• Includes case studies to describe the aspects of various mobile
application types.
– Describes the possible issues with specific applications.
– Describes variations on that application and how they would affect the
classification of the mobile application.
• Accounts for regulations in other regions of the world.
Regulation
• Food and Drug Administration Safety and
Innovation Act (2012), requires:
“A proposed strategy and recommendations on an
appropriate, risk-based regulatory framework
pertaining to health information technology, including
mobile medical applications, that promotes
innovation, protects patient safety, and avoids
regulatory duplication.”
Regulation / Guidance
• FDA Mobile Medical Applications, Guidance for Industry and Food and Drug
Administration Staff. Issued on: 25 September 2013 .
• European Commission: MEDDEV 2.1/6 - Guidance document: Qualification
and Classification of Stand Alone Software – Guidelines on the Qualification
and Classification of Stand Alone Software Used in Healthcare within the
Regulatory Framework of Medical Devices. January 2012.
• Regulation of Medical Software and Mobile Medical ‘Apps', Australian
Therapeutic Goods Administration (TGA). 13 September 2013.
• Guidance on Medical Device Stand-Alone Software (including apps), UK
Medicines and Healthcare Products Regulatory Agency (MHRA). 19 March
2014.
• Medical Information Systems – Guidance for qualification and classification
of standalone software with a medical purpose; Swedish Medical Products
Agency (MPA).
Impact on CSV & the SDLC
• Agile now being used heavily by CRO/CMOs
– Customer needs rapidly changing
Industry must have new market differentiating
software solutions.
– Solutions evolve through close partnership and
collaboration between the customer and client.
Agile allows for:
– Prioritization of business requirements, quickly
meeting business needs, frequent release of new
features, adaptability to constant changes, etc.
Risk Based Approach
• Principles of GAMP® 5 must be fully leveraged
along with ISO 14971
Considerations for:
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# of iterations prior to release
creation and/or update to documentation
regression, system/functional and user acceptance testing
“hardening” or system stabilizing sprint(s)
Also risk assessment of requirements and system
functionality should take place
• Must ensure:
1) Product quality, data integrity, and patient safety
2) Fitness for intended use is demonstrated
ISO 14971:2012
Medical Devices - Application of Risk Management for Medical Devices
ANY QUESTIONS?
Please Contact!
Eric Staib
Executive Director, Corporate Quality Assurance
PRA Health Sciences
stiaberic@prahs.com
+1 215.421.8649