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

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Market

compliance

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Enforcement

International

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Finance

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Corporate

affairs

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Legal

Recruitment

and selection

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Learning and

development

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Change

management

Clinical trials and

investigations

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Medicines

licensing

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CHMP, CMDh

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Reclassification

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Device

registration &

notified body

oversight

Pharmacovigilance

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PRAC

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Device vigilance

ICT

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CESP

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Project

management

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Business

services

Communications

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Classification

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Knowledge

management

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Quality

management

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Scientific Affairs

Clinical field trials

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Medicines

Licensing

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CVMP, CMDv

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Pharmacovigilance

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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