Regulatory Compliance
The medical personnel in any organisation will have an interest in and duty of care with any research that an organisation performs. The types of research we undertake could be of direct interest to medical personnel such as drug safety, understanding patient adherence/ compliance, understanding patient treatment pathways through to research of less direct interest such as cost of treatment.
In all cases however we expect to deliver certain standard requirements;
· Respecting regulatory and licensing requirements - national and international e.g. EMA
· Respecting advertising regulations - industry specific e.g. ABPI PMCPA Code of Practice/ European Federation of Pharmaceutical Industries and Associations EFPIA Code or Eucomed Code of Ethical Business Practice
· Respecting advertising regulations - general advertising such as the Committee for Advertising Practice British Code of Advertising and Sales promotion
· Respecting medical device regulations in line with EU Directives of general application e.g. 93/42/EEC; professional rules governing healthcare professionals and national legislation
· Respecting reporting requirements (will be part of regulations) on safety i.e. all drug safety reports in alignment with regulations and company standard operating procedures
· Respecting Data Protection Acts and patient confidentiality
· Respecting ethics and research and development approval – where appropriate
Our methodology stresses that there is no interference with the medical treatment decision or requirement for additional patient visits or use of doctor facilities.
