Specialist Consultant to pharmaceutical and medical devices industry regarding registration, clinical trials, pharmacovigilance services and implementation of Quality Management Systems to ISO13485 compliance. Auditing against ISO 9001:2015 standard.
27 years experience in the pharmaceutical drug and medical device development industry. Drug trial design, development of documents relating to clinical trials: Protocol, Investigator's brochures IMPDs, SOPs, Patient documents - information leaflets and consent documents etc.. Registration of medical devices, all related regulatory services, implementation of QMS including compiling Quality Manuals compliant with ISO 13485. Provision of pre- and post-registration Pharmacovigilance services. Registration of medicines - Regulatory Intelligence services both pre- and post registration. Training of clinical trial site staff in GCP. Lecturer to post graduate students in Pharmacology at University of Witwatersrand Faculty of Health Sciences.
