Medical Research Council - MHRA-PET panel

MHRA and MRC PET expert panel on regulatory affairs

The panel 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:

Clinical trials involving PET radiopharmaceuticals
PET radiopharmaceutical manufacturer, licensing and inspections of facilities

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 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 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.

MHRA and MRC 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
Cardiff	GMP	Oncology	Dr Chris Marshall
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

Frequently asked questions

Also, a number of study scenarios are available to help researchers understand how different regulatory routes may apply in different circumstances, as well as a decision tree to help researchers understand what documentation will be required for a particular study.

Useful PET - and regulatory-specific information:

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MHRA and MRC PET expert panel on regulatory affairs

MHRA and MRC PET expert panel members

MHRA representatives