Dr. Irfan Ahmad is the founder of Complete Pharmacovigilance Solutions (CPVS) and Managing Director of Drug Safety Solutions (DSSL. He is a trained physician and holds a Master’s Degree in Molecular Medicine from University College London. He has over 18 year’s experience in the pharmaceutical industry, having worked for both large and medium-size companies at different levels of responsibility, in clinical development and pharmacovigilance. This experience has resulted in his extensive knowledge and insightful understanding of the international pharmacovigilance and clinical development landscape.
He has hands-on expertise in formulating and applying best practices in pharmacovigilance across Europe/US and has been instrumental in driving a pro-active approach to patient safety and risk management globally; He developed and managed a QPPV office.
Rob is an industry veteran and his experience includes leading pharmacovigilance operations groups for top 10 pharma, and have provided consulting services to Regulatory Authorities. He is passionate about delivering patient safety through process design and technology and he has gained significant experience in traditional pharma products as well as the development of new wave products such as gene and cell therapies.
Maikel Hofwijks is a nurse by training with over 14 years of experience in the pharmaceutical industry. Highly experienced in pharmacovigilance, case processing, and aggregate report writing, he has specialized in working for both marketed and under development product lines. Apart from this Maikel Hofwijks has extensive experience as a PV Operations Manager and QA professional with Global PV auditing experience. Having taken part and played critical roles in pharmacovigilance related projects. PV inspections, and audits, Maikel Hofwijks also served as the acting QPPV for numerous small pharmaceutical companies.
He is a physician by training. He has got over 12 years of experience in the pharmaceutical arena, especially in Pharmacovigilance, Clinical Research, Advising and Training in medium and small size organizations at different levels. This extensive experience has resulted in a deep-rooted knowledge of various Pharmacovigilance databases, systems, and processes. He has vast experience in the implementation of large Pharmacovigilance projects which including but not limited to: global and local literature search, regulatory intelligence, case processing, report writing (RMP, PBRER), data analysis and signal detection activities, PV SOP writing, PSMF writing, etc.