Laura Millichamp

Dr. Laura Millichamp obtained a Masters in Pharmacy degree at the University of Portsmouth, and a Ph.D. in Pharmaceutical Sciences from the University of Manchester, UK.

Laura has 12 years of experience in the Pharmaceutical Industry, including over 7 years as a Pharmaceutical Assessor at the Medicines and Healthcare Regulatory Agency (MHRA) where she assessed a broad range of active substances and finished product types including sterile, oral and topical dosage forms and Orphan Drugs. In this role Laura gained extensive experience of all licensing procedure types (Centralised, Decentralised, National, Mutual Recognition, variations, CMDh referrals, recalls). She was an EMA Expert, providing regulatory and scientific advice on a European level, and presenting challenging applications at the UK Expert committees and CHMP discussion meetings. Laura has experience of assessing MAAs including Quality by Design (QbD), Real Time Release Testing (RTRT) and Rapid Microbial Methods (RMM)..

Laura now provides scientific, technical and regulatory advice to clients at all stages of product development, from Phase 1 to Life Cycle maintenance, and reviews and prepares regulatory pharmaceutical documents: CMC sections of IMPD/IND, briefing packages for Scientific Advice, variations, CTD module 3 for EU and US submissions, and the Quality Overall Summary of MAA

An experienced consultant, Laura has provided highly successful pre and post approval regulatory strategies, authored Scientific Advice briefing packages, IMPD and dossier sections including Post Approval Change Management Protocol, prepared ATC code applications, and conducted gap analyses. Laura has experience of collaborating with companies of all sizes, from start up to global, and at all stages of the drug development process..

www.insidereg.com

Courses:

• Preparing the CMC Section for MAAs-IMPDs