Experience:

Presentations:

• The Advanced Toxicology Course at the Department of Toxicology of St Bartholomew’s & The Royal London School of Dentistry, 1997 and 2001
• British Association of Research Quality Assurance Professional Development Courses:-
• Regulatory Compliance in "GLP in the Analytical Laboratory" 1996, 1998, 2000, 2001
• Regulatory Compliance in "GLP for Study Directors, Principal Investigators, Study Staff and Management" 1999, 2000, 2001, 2002
• Regulatory Compliance in "Research Quality Assurance for GLP" 2003
• British Association of Research Quality Assurance Annual General Meetings:-
• 1998 Regulatory Inspections - Changes over the years
• 2002 Monitoring Authority Update
• 2003 GLP Inspections-The Future
• University of East Anglia, Diploma in Research Quality Assurance, 2001
• M.Sc/Postgraduate Diploma in Health Care Research Methods and M.Sc./Postgraduate Diploma in Clinical Drug Development
• Ethics and Regulation in Clinical Research - Good Laboratory Practice, 2001

Industry:

• 1997 The 1997 UK GLP Regulations and Code of Practice
• February and July 2000 The 1999 UK GLP Regulations
• 2000 Multisite Studies
• 2004 GLP Inspections-Current Topics
• Medicines and Healthcare Products Regulatory Agency:
• Good Laboratory Practice GLP in Medicinal Product Development. 1998, 1999, 2000.
• The GLP Monitoring Authority Approach to the Inspection of Computerised Systems 2002
• OECD Workshop on Short-Term Studies held in the UK in 1998
• Health and Safety Executive and Department for Food and Rural Affairs.
• 2000 "Good Laboratory Practice"
• The Norwegian GLP Authority
• 2003-The UK GLP Monitoring Authority
• The Center for Professional Advancement
• OECD GLP 2002, 2003, 2004

Other Projects:

• Set up in 1998 and chaired the GLP Liaison Committee with assessors from the following Regulatory Authorities:
• MHRA (Pharmaceuticals)
• VMD [DEFRA] (Veterinary Medicines)
• PSD [DEFRA] (Agrochemicals)
• FSA [DH] (Food Additives)
• FSA [DEFRA] (Feed Additives)
• HSE (Industrial Chemicals)
• MDA (Medical Devices)
• Lead for project to assess and clarify how the different Regulatory Authorities define safety studies, leading to a paper to clarify the issues.
• Lead for project to assess and monitor how the UK GLP Monitoring Authority could work more effectively.
• Paper on archiving in a GLP environment