1. Pharmaceutical Industry Feedback HPRA Performance
13th June 2018
Hilton Hotel
Dublin Airport

2. Role of HPRA
“The Health Products Regulatory Authority (HPRA) is the independent regulator of health products in Ireland. Our role is to protect and enhance public and animal health. We do this by assessing the safety, quality and effectiveness of healthcare products on behalf of the public to ensure the benefits they provide outweigh any potential risks.”

3. Agenda Industry Interaction HPRA
Transactional Processes – Maintenance Issues
Consultation – Pre-Submission
Consistency
Costs
Possible Formalised Evaluation

4. Overall Assessment
Innovative
Open
Excellent
No Problems
Pragmatic
Approachable
Knowledgeable
Helpful
Accessible
Available
Good People

5. Transactional Processes
What’s Important?
Speed of Response
Quality of Feedback
Flexibility of Processes
Quality of People
Knowledge
Dedication
Empowerment

6. Consultation What’s Important? Pre-Process Consultation
Opinions required
To minimise error
To minimise delay
To create efficiency
Promotional Activity
Enforcement Actions

7. Consistency What’s Important? Level Playing Field
Same Requirements for Processes e.g Mock-ups, QRD.
Same Rules for all Competitors
Enforcement
Separate Agencies

8. Costs What’s Important?
Recognise that Service Provided must be Funded.
Efficiency is central to Value
Value is central assessment of Service
Benchmarking in EU Context is important

9. Future – Feedback From Industry
Consider a Formalised Feedback Procedure
Regular feedback from Service Users
Anonymous Feedback – Best Quality
Not Just Assessment of Past but More Importantly Guide to Future
Benchmarking Service and Cost in EU Context

10. Conclusion
“The HPRA aims to provide a timely, professional and quality service to its stakeholders and is committed to continuous improvement. We work co-operatively with our stakeholders to ensure effective quality service.” 

11. Thank You