Professional Bodies:
Membership of the Royal Pharmaceutical Society of Great Britain (MRPharm.S) 1974
Membership of the Pharmaceutical Society Ireland (MPSI) 1988
Branch Secretary and Sherwood Regional Representative, RPSGB, 1980-1987

Research Interests:
Cytotoxic and chemotherapeutic agents, drug-macromolecule interactions
Ph.D - "Development of potential antitumour agents based on doxorubicin"
Pharmaceutical analysis
Pharmaceutical development

Employment:
Research Pharmacist - Sterling Winthrop R & D, UK 1973-1974
Hospital Pharmacist - North Tyneside, AHA, UK 1974-1975
Staff Pharmacist QC - Humberside, AHA, UK 1979-1981
Staff Pharmacist Quality Assurance - Grimsby HA (Qualified Person Status), UK 1981-1987
Senior Pharmacist - National Drugs Advisory Board, Ireland 1987-1995
Pharmaceutical Director - Irish Medicines Board, Ireland 1996-2003
Senior Scientific Advisor - Irish Medicines Board, Ireland 2004 - Present

Responsibilities:
As Pharmaceutical Director
Supervising and co-ordinating pharmaceutical activities of I.M.B. :
• Assessment of applications (CMC data) for marketing authorisation of human and veterinary medicinal products
• Applications for variation, renewal and other post authorisation activities
• Applications for clinical trials
• Pharmaceutical quality sampling and monitoring
with particular reference to the quality of medicines.

As Senior Scientific Advisor
Provision of pharmaceutical, scientific regulatory advice including risk analysis, quality management and technical training. Specific role in running the IMB Borderline products classification service. Involved in a number of multidisciplinary, cross-functional IMB regulatory initiatives.

Committees
Member and Vice Chairman CPMP/CVMP Quality Working Party 1988 to end 2003
Member of European Pharmacopoeia Commission 1996 – present
President of the European Pharmacopoeia Commission, 2004 - 2007

Member EU Pharmaceutical Committee
Former member DIA, Steering Committee Europe- Outstanding Service Award Recipient 2005
Member PDA Ireland Chapter- Organising Committee

Internal-

Member IMB Management Committee since 1996

Chair, IMB Classification Committee 2002-present
Chair IMB PAT team 2007-present
Chair IMB Advanced Therapy Medicinal Products Group 2008-present
Chair IMB Variations implementation group.
Member IMB Communications Review (2008-) and Cosmetics Project Steering Committees (2007-2008)