Michael Lennon
Specialties: Pharmaceutical, Regulatory
Biography
Michael Lennon is a pharmaceutical professional who has worked in the regulation of medicines in Europe and with Global Health Authorities for over 15 years. He is currently Senior Director of Global Regulatory CMC in a large pharmaceutical company working with large and small molecules. He has overseen the successful global approval for a number of drugs and major post approval changes, in particular new manufacturing site approvals for biological drug substances and drug products.
He held the position of Pharmaceutical Assessor at the HPRA (Irish Medicines Regulator) for seven years working on clinical trial and commercial drug applications (new applications, variations, renewals). During this time, he also represented Ireland on EMA Medicines Committees (Quality Review of Documents (QRD) and Quality Working Party (QWP). He has delivered Regulatory Affairs modules at undergraduate and post graduate level and has previously presented at TOPRA and INFORMA courses on the subject of Variations to Module 3.
He has a degree in Pharmacy from Trinity College Dublin and a post graduate diploma in Biopharmaceutical Science from IT Sligo.(Atlantic Technological University Sligo). He also maintains his status as a registered pharmacist in Ireland.