As a Senior Medical Director at VCLS, Peri is responsible for providing input to, and critical review of, the clinical sections of a variety of documents, including client clinical development plans, ODD, PIP, and PRIME briefing documents. She also plays a key role in identifying questions to be raised with Regulators as part of the requests to EMA, National Agencies and Joint EMA-HTA bodies for scientific advice, and in critically reviewing the advice received. Peri also contributes to responses to issues raised (by CHMP/National regulators) and when required actively participates in the rehearsal of client presentations for oral explanations, from a clinical regulatory perspective.
Peri brings to this role extensive expertise across various therapeutic areas including women’s health, genito-urinary medicine, infectious diseases (anti-bacterial, antiretrovirals, antimalarials, antifungal, and anti-hepatitis medicines), hematology (hemophilia, ITP), cystic fibrosis and other pulmonary related diseases, chronic graft versus host disease, inborn errors of metabolism, gastroenterology, nutrition, pain, and non-prescription products, as well as various drug-device combinations products.
Prior to joining VCLS, Peri spent almost 10 years at the MHRA as a Senior Medical Assessor, where she gained significant expertise in the assessment of medical aspects of EU medicinal product marketing authorization applications. She also has experience in assessing ‘prescription-only-medication POM’ switches to ‘pharmacy (P)’.
During her time at the MHRA, she led interactions with companies and provided scientific and regulatory advice to companies before and after the submission of their applications. Peri also provided clinical support to the devices division. This involved evaluating device trial applications and amendments, providing clinical advice on devices, and providing clinical input on regulatory aspects of devices.
While working at the MHRA, she made several presentations to the Committee for Medicinal Products for Human Use (CHMP), Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh), Scientific Advice Working party (SAWP) and Infectious Disease Working Party (IDWP).
Prior to joining the MHRA, Peri worked for more than seven years for the NHS, specializing in Obstetrics and Gynaecology.
Peri qualified as a Medical Doctor from the University of Ibadan in Nigeria and she is a member of the Royal College of Obstetrics and Gynaecology. Peri recently completed a Diploma in Pharmaceutical Medicine at Kings College London.
Peri is based in the VCLS office in Camberley, UK.
Resources by Peri Aghadiuno, MBBS, MRCOG
publication
AMR: Is a Paradigm Shift Needed in Medicines
Antimicrobial resistance (AMR) is the ability developed by bacteria, viruses, parasites or fungi to fight and block the effect of…
presentation
What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products?
What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products? A translational perspective Regulatory environment for…
webinar
Unlocking the EMA Meetings: the Process and How to Prepare Adequately
Clear strategy, compelling argument and well-rehearsed preparation are all key to having a successful EMA meeting, no matter if it…
