Accel Life Sciences Ireland Project

1
Accel Life Sciences Ireland Project

• Need for Excellence in QA/RA to maximise Export
  potential

2
Why have regulations?

• Before drugs, medical devices and other health
  products reach the marketplace, they must first
  undergo a complex approval process.
• This process is vital to making safe and
  effective healthcare products available
  worldwide.

3
Regulatory Affairs Role

• The approval processes and Legal responsibilities
  are
• defined as legal regulations, statutes or laws
• supported by standards and guidelines
• Vary from country/region to another.
• Guiding health products through this demanding
  process is the role of regulatory affairs.

4
Medical Device/Diagnostics Regulations and
Standards

• Regulations
• Medical Device Directives (MDD)
• In Vitro Diagnostic Directive (IVD)
• Active Implantable Medical Device (AIMD)
• FDA Quality System Regulation (QSR)
• Canadian Medical Device Directive (CMDCAS)
• Pharmaceutical Affairs Law (PAL)
• Standards
• ISO13485 (quality System)
• ISO14971 (Risk Management)

5
Regulatory Affairs
LAW ''must legally'
Regulations
''should'' / ''must''
Standards
Guidelines
''Good practice''
6
Regulatory Affairs Process
Product Development
Product in use

• The roles and responsibilities begin in the
  research and development phases, moving into
  clinical trials and extending through premarket
  approvals, manufacturing, labelling and
  advertising and post-market surveillance.

7
Typical Regulatory Process

• Strategy
• Classification
• Applicable standards

R D

• Trial permissions
• Trial/Test Strategy

Preclinical
Clinical

• Technical docs
• Clinical submission
• DFU/labelling

Manufacturing

• Submission
• Techncial docs
• Plant/product audits
• Deal with Reg authority

• Survellience
• Vigilence/complaints
• Updates for changes
• Recertification
• Compliance

Permission to market
Post market
8
Regulatory Affairs
LAW ''must legally'
Regulations
Quality System
''should'' / ''must''
Standards
Guidelines
''Good practice''
9
CE Marking Route
Product
Depends on classification
Quality System
10
Making the most of Quality System

• Good QMS ?tool ? business goals
• Business model
• Defined process and responsibility
• Process measures in place
• Clear measurable objectives
• Used to drive improvement

11
Making the most of Quality System

• Process auditing ? business goals
• Improve efficiency
• Assure compliance
• Escalate issues to management
• Communication tool
• Should be used an improvement tool

12
Maximise Potential

• Knowledge and understanding
• Complaince
• Efficient system
• QMS as business tool

flexibility
Compliance
13
Accel Life Sciences Ireland Project

• Course Details
• General and European QA/ RA requirements
• US FDA QA/ RA requirements
• QA/RA appreciation for Medical Device Suppliers

14
Accel Life Sciences Ireland Project
General and European QA/ RA requirements
15
Accel Life Sciences Ireland Project
US FDA QA/ RA requirements
16
Accel Life Sciences Ireland Project
Quality and Regulatory Appreciation for Medical
Device Suppliers
17
Accel Life Sciences Ireland Project

• Quality and Regulatory Courses
• Maximum 12 participants for each course
• Courses will be run at least twice
• Courses will be run off site in central locations
  
• Courses will be probably be held in Sligo, Galway
  or Athlone
• Times and dates to be agreed