MHRA-PET Expert Panel on regulatory affairs
The MHRA-PET expert panel on regulatory affairs has been established to help researchers deal with the UK regulatory framework for medicines, specifically as applied to Positron Emission Tomography (PET) research. The overall aim is to help UK researchers understand and navigate through these regulatory requirements and thereby facilitate increased PET research.
The role of the panel is to act as a dedicated forum for regular, direct discussions between the UK PET community and the Medicine and Healthcare products Regulatory Agency (MHRA) in their role as the primary UK agency responsible for regulations and standards relating to medicinal products and performing clinical trials. Specifically on their roles regarding;
The panel consists of a broad representation of the UK PET community covering a wide range of expertise (good manufacturing productions, quality assurance, PET neuroscience, PET cardiology, PET oncology and industry) and senior staff from the MHRA.
The panel chair is Dr Franklin Aigbirhio (University of Cambridge) with Dr Elaine Godfrey as the principal MHRA lead.
How the MHRA-PET Panel interacts with the MHRA
Core functions:
- Regular discussions on the application of regulations
- Clarification on the interpretation of regulations
- Joint initiatives to facilitate and overcome barriers in PET imaging
- Establishing key relationship between senior MHRA members and the PET community
- Highlighting specific problems to the MHRA on behalf of the community
How it works:
- 1-2 meetings/year, based mainly at MHRA HQ in London or occasionally at a PET centre
- Occasional taskforces and smaller meetings for specific issues or areas of interests (e.g. inspections of GMP, first-in-man requirements for novel radiotracers etc.)
How the MHRA-PET Panel interacts with UK PET researchers
Core functions:
- Guidance – Panel members are available to provide help and guidance on MHRA matters, e.g. clinical trial applications, interpretation of regulations, consultation regards GMP/GCP etc.
- Feedback – Panel members will also be gathering feedback on general issues of concern for researcher with the aim to bring these to the attention of the MHRA.
The aim is that most UK PET centres have a panel member on site that can be readily contacted, however other panel members can be approached if their area of expertise seems more appropriate.
It is important to note that panel members are not an alternative source for official opinions and decisions by the MHRA but they are there to facilitate dealings with the regulatory body. In particular, for more complex or trickier situations, panel members can help by directly contacting senior MHRA staff for additional advice and/or guidance in addressing the problem.
This panel was created specifically to help UK researchers to overcome regulatory problems associated with undertaking PET research and we very much encourage everyone to use it.
For general enquires about the panel and its functions please contact:
Dr Sabine Regel
Email: sabine.regel@kcl.ac.uk
MHRA-PET Expert Panel Members
UK PET Centre |
Primary Expertise |
Area of Research |
Panel Member |
Aberdeen |
GMP |
Oncology Neurology |
Dr Lutz Schweiger |
Bart’s |
CT CT |
Oncology Oncology |
Prof Norbert Avril Dr Hanna Nicholas |
Cambridge |
GMP GMP QA |
Neuroscience Oncology |
Dr Franklin Aigbirhio Dr Dmitri Soloviev Dr István Boros |
Edinburgh |
GMP CT |
Cardiovascular Cardiovascular |
Prof John Clark Prof David Newby |
KCL / St Thomas’ |
CT GMP RP CT |
Oncology Neuroscience Oncology Oncology |
Prof Mike O’Doherty Prof Tony Gee Dr Jim Ballinger Prof Gary Cook |
London – GE |
GMP GMP/CT Regulatory |
Neuroscience |
Dr Sajinder Luthra Dr Colin Archer Ms Bimal Patel |
London – GSK |
CT GMP |
Neuroscience |
Prof Paul Matthews Dr Roy Baxendale |
London – Imanova Ltd |
CEO GMP |
Dr Kevin Cox Dr Jan Passchier | |
London – Imperial |
CT |
Neuroscience |
Prof David Brooks |
London – CSC |
CT |
Oncology |
Prof Eric Aboagye |
Manchester WMIC |
GMP |
Oncology |
Dr Adam McMahon |
Manchester |
RP |
Oncology |
Dr Bev Ellis |
Oxford |
CT |
Oncology |
Dr Kevin Bradley |
Pharmanswers |
GMP |
Mr Shankar Seetharaman | |
Erigal |
GMP |
Dr Ron Barrack | |
IBA Molecular UK Ltd |
GMP/QA |
Dr Ralph Harris | |
PETNET Solutions |
GMP/QA |
Dr Craig Hughes | |
MRC |
NMHB |
Dr Joanna Jenkinson |
CEO: Chief Executive Officer; CT: Clinical Trials; GMP: Good Manufacturing Practice; NMHB: Neuroscience and Mental Health Board; RP: Radiopharmacy; QA: Quality Assurance
MHRA Representatives
Dr Elaine Godfrey |
Pharmaceutical Assessor |
Clinical Trials Unit |
Mr Ian Thrussell |
GMP Inspector |
Inspection, Enforcement & Standards |
Mr Martin O'Kane |
Pharmaceutical Assessor |
Clinical Trials Unit |
Mr Graham McNaughton |
Pharmaceutical Assessor |
Clinical Trials Unit |