Peri is a Medical Director with VCLS, She provides input into the drafting and critical review of clinical development plans including prospective drafting and gap analysis); critical review of clinical parts of EMA Scientific Advice, National Scientific Advice and Joint EMA-HTA bodies Scientific Advice briefing documents; responses to issues raised (by CHMP/National regulators)and corresponding presentations, critical review of clinical parts and significant benefit sections of ODD briefing documents and PIP briefing documents and the rehearsal of client presentations on clinical regulatory perspective for oral explanations when required.
Prior to joining VCLS, Peri spent almost 10 years at the MHRA, where she gained a solid background in the assessment of medical aspects of medicinal product authorisation applications of European submissions for new chemical entities, generic products and biologics for centralised, decentralised/mutual recognition and national procedures). This included the preparation of assessment reports, consultation with internal and external expertise as and when necessary and presentation to expert advisory groups and also the Commission for Human Medicines (CHM) at the MHRA. She worked in various therapeutic areas including including women’s health, genito-urinary medicine, infectious diseases (anti-bacterials, anti-retrovirals, antimalarials, antifungal and anti-hepatitis medicines). She also provided assistance when required to the assessment unit which dealt with inborn errors of metabolism, gastroenterology, nutrition, pain, haematology and non-prescription products and so has a knowlegde of these therapeutic areas. Peri also has experience in assessing ‘prescription-only-medication POM’ switches to ‘pharmacy (P)’. She has presented at CHMP and CMDh. As part of her job at the MHRA, Peri provided clear and reliable scientific and regulatory advice on a regular basis to companies before and after submission of their applications to facilitate the better development of products and conduct of trials and positive outcome to all concerned. Peri also provided clincial support to the devices division whenever required on a regular basis. This involved evaluating devices trials applications and amendments, providing clinical advice on adverse events and clincial input on regulatory aspects as required.
Peri specialised in Obstretics and Gynaecology and worked for the NHS initially as a senior house officer and then as a Registrar for more than seven years. She gained excellent clinical skills with regards to women’s health issues. Peri also worked in the field of public health for almost two years where she acquired acquired very good critical and analytical skills.
Peri qualifiied as a Medical Doctor from the University of Ibadan in Nigeria, she is a member of the Royal College of Obstretics and Gynaecology. Peri recently completed a Diploma in Pharmaceutical Medicine at Kings College London.