February 2013: Spectrum is now registered with the European Medicines Agency (EMA) as a micro autonomous regulatory consultancy. This means that we are eligible to apply for a range of incentives from the EMA. These include administrative and procedural assistance, fee reductions of up to 90% for scientific advice and scientific services, and fee exemptions for certain EMA administrative services.
September 2012: Jo has joined Spectrum after six years as a medical writer in a large multi-national pharmaceutical company. She has experience of working in global teams writing a range of regulatory documents for clinical projects; clinical study reports, clinical summaries and overviews. Jo has worked across an array of therapeutic areas including respiratory, oncology, transplantation, orphan products, cardiovascular and metabolism. Jo is a graduate of the University of London and has post-doctoral experience in the field of oncology.
July 2012: Elaine qualified as a Registered Nurse at St. Thomas’s Hospital, London and subsequently worked in various UK hospitals. She moved into industry in 1998, working principally in the specialism of pharmacovigilance of both medicines and biotech. She obtained a PgD in Pharmacovigilance from the University of Hertfordshire in 2005. Most recently, for approximately five years, she worked in pharmacovigilance consultancy, with primary responsibility for the writing and quality review of procedural documents such as SOPs, WIs and DDPSs. She also brings three years’ experience of Quality Assurance.
At Spectrum, Elaine is responsible for the maintenance and development of the Company’s Quality Management System in line with Company SOPs and national/international legislation and standards.