Post on 21-Aug-2020
HPRA:
Supporting Clinical Research in
IrelandLorraine Nolan, Chief Executive, HPRA
HRB CRCI launch
Gibson Hotel, Dublin
September 29th 2016
Overview
• HPRA role
• HPRA Strategic Plan (2016 – 2020)
• Quality Scientific Affairs & Communications
(QSAC) Department, Innovation office
• National Scientific advice
• Clinical Trials & Clinical Investigations - Ireland
• Clinical Trials Regulation 536/2014
5 October 2016 2
HPRA Role
The role of the Health Products Regulatory
Authority (HPRA) is to protect and enhance
public and animal health by regulating
medicines, medical devices and other health
products.
5 October 2016 3
Strategic Plan 2016 – 2020
5 October 2016 4
Supporting Innovation – a key strategic
objective
29 September 2016
Supporting Innovation
• Quality Scientific Affairs Communications
Department
• Innovation office
• National Scientific advice
• Clinical Trials & Clinical Investigations
• Clinical Trials Regulation 536/2014
5 October 2016 6
Development of new Department focusing on
Scientific Affairs
Deputy Chief Executive
ComplianceHuman Products
Authorisation and Registration
Human Products Monitoring
Human Resources and
Change
ICT and Business Services
Quality, Scientific Affairs
and Communications
Veterinary Sciences
Inspections
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Audits
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Site licensing
--------------
Market
compliance
-------------
Enforcement
International
-------------
Finance
-------------
Corporate
affairs
-------------
Legal
Recruitment
and selection
--------------
Learning and
development
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Change
management
Clinical trials and
investigations
---------------
Medicines
licensing
--------------
CHMP, CMDh
--------------
Reclassification
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Device
registration &
notified body
oversight
Pharmacovigilance
---------------
PRAC
---------------
Device vigilance
ICT
--------
CESP
--------
Project
management
--------
Business
services
Communications
-------------
Classification
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Knowledge
management
--------------
Quality
management
--------------
Scientific Affairs
Clinical field trials
---------------
Medicines
Licensing
---------------
CVMP, CMDv
---------------
Pharmacovigilance
---------------
Scientific animal
protection
QSAC Objectives
• Create/develop links with academic
community/others
• Identify/foster new research in core areas of
innovation
• Horizon scanning - HPRA policy
• Identify new areas of scientific knowledge and
expertise/co-ordinate its transfer into and across
HPRA
• Continuously evaluate the scientific/technical needs of
HPRA5 October 2016 8
Innovation Office (1/2)
• Key HPRA action point
• Initial contact point
– Early development/innovative research
• Regulatory & scientific advice
– Provision of a clear understanding of relevant
regulatory pathways
• Enabling identification & generation of data
• Due to be launched in early 2016
• HPRA Innovation day planned5 October 2016 9
Innovation Office (2/2)
• Clinical trial/investigation design
• Populations
• Selection of end-points
• Formulation
• Manufacturing
• Processing
• Technology
• Regulatory science
• Flexible regulatory approaches
• Use of real world data
5 October 2016 10
National Scientific Advice (1/3)
• HPRA guidance published July 2016 & pilot phase
commenced
• To assist applicants in the development of new or
existing human medicinal products by taking into
account:
– the current knowledge of a given condition
– targeted patient population
– existing treatment modalities
– specificities of the product being developed5 October 2016 11
National Scientific Advice (2/3)
Advice may assist applicants/academics in the:
– confirmation of guidelines
– provision of information where guidelines do not
exist on regulatory aspects
– submission of clinical trials
– quality, clinical & pre-clinical (except
environmental regulatory authority (ERA) aspects
5 October 2016 12
National Scientific Advice (3/3)
• Meeting at HPRA offices
• 20 days after the meeting, written advice is issued
• Provide advice on medicinal products:
• Respiratory medicine
• Rheumatology
• Obstetrics and gynaecology
• Dermatology
• Radiopharmaceuticals
• Botulinum neurotoxins
• Endocrinological/gastrointestinal conditions
• Generic medicines and biosimilars
5 October 2016 13
Network Participation
• EMA & HMA Committees
– CHMP, PDCO, COMP, CAT, PRAC, HMPC, CMDh, CTFG
• Input and support to:
– STAMP
– Medicines Adaptive Pathways to Patients (MAPP)/PRIME
– EU Horizon 2020 projects
– EU Network Training Centre
– EU Innovation Network
5 October 2016 14
Clinical Trials and Clinical Investigations in
Ireland
• 108 clinical trials (medicines) were approved by the HPRA in 2015
• 29/108 (27%) – non commercial sponsors
• 15 Voluntary Harmonisation Procedures (VHP)
• HPRA reference National Competent Authority for 8/23 VHPs
• 35% - highest rate in Europe
• 10 clinical investigations (medical devices) applications in 2015
5 October 2016 15
Clinical Trial Regulation (536/2014) (1/2)
• Adopted on 16th April 2014
– entered into force on 16th June 2014
– will become applicable in October 2018
• Harmonise rules throughout the EU
• Create an environment favourable for conducting clinical trials
• Streamline application procedure - single entry point, the EU portal - strictly defined deadlines
• Ensure highest standards of patient safety, for all EU Member States
5 October 2016 16
Clinical Trials – Benefits of HPRA Review
• Authorisation ensures
– Scientific validity of objectives
– Adequate monitoring procedures are in place
– Positive benefit/risk for participants
• Compliance with EU GCP - clinical data
generated robust, credible & with external
validity
5 October 2016 17
Clinical trials – Non Commercial Sponsors
• Simplified/exemptions from certain reporting requirements can be justified in protocol
– e.g. for trials on licenced medicinal products which will be used within the authorised indication
• Q&A for non commercial sponsors available on HPRA website
• No fee for clinical trials - academic sponsors where there is no financial support for the conduct of the trial
5 October 2016 18
In summary
HPRA very active in supporting clinical research in Ireland:
• Encouraging proactive engagement by sponsors/applicants
• Facilitating scientific/regulatory advice & pre-submission meetings
• Reviewing/approving & inspecting of clinical trials
• Ensuring optimised regulatory systems
• Supporting innovation
5 October 2016 19
Thank you