HPRA: Supporting Clinical Research in Ireland

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1 HPRA: Supporting Clinical Research in Ireland Lorraine Nolan, Chief Executive, HPRA HRB CRCI launch Gibson Hotel, Dublin September 29 th 2016

2 Overview HPRA role HPRA Strategic Plan ( ) Quality Scientific Affairs & Communications (QSAC) Department, Innovation office National Scientific advice Clinical Trials & Clinical Investigations - Ireland Clinical Trials Regulation 536/ October

3 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

4 Strategic Plan October

5 Supporting Innovation a key strategic objective 29 September 2016

6 Supporting Innovation Quality Scientific Affairs Communications Department Innovation office National Scientific advice Clinical Trials & Clinical Investigations Clinical Trials Regulation 536/ October

7 Development of new Department focusing on Scientific Affairs Deputy Chief Executive Compliance Human Products Authorisation and Registration Human Products Monitoring Human Resources and Change ICT and Business Services Quality, Scientific Affairs and Communications Veterinary Sciences International Finance Corporate affairs Legal Inspections Audits Site licensing Market compliance Enforcement Clinical trials and investigations Medicines licensing CHMP, CMDh Reclassification Device registration & notified body oversight Pharmacovigilance PRAC Device vigilance Recruitment and selection Learning and development Change management ICT CESP Project management Business services Communications Classification Knowledge management Quality management Scientific Affairs Clinical field trials Medicines Licensing CVMP, CMDv Pharmacovigilance Scientific animal protection

8 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 HPRA 5 October

9 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 planned 5 October

10 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

11 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 developed 5 October

12 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

13 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

14 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

15 Clinical Trials and Clinical Investigations in Ireland 108 clinical trials (medicines) were approved by the HPRA in /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 October

16 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

17 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

18 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

19 In summary HPRA very active in supporting clinical research in Ireland: Encouraging proactive engagement by sponsors/applicants Facilitating scientific/regulatory advice & presubmission meetings Reviewing/approving & inspecting of clinical trials Ensuring optimised regulatory systems Supporting innovation 5 October

20 Thank you