Instructor Spotlight: Laura Millichamp

One of the many areas of study that CfPIE offers to students in the medical product development field is that of regulatory compliance. Leading the way for students involved in preparing the CMC section of an MAA is Dr. Laura Millichamp. Her course, Preparing the CMC Section for MAAs, ensures that those who work in this field understand the requirements for submitting the CMC section of common technical documents.

Dr. Millichamp’s Start in the Pharmaceutical Industry

Dr. Laura Millichamp received her degree in Pharmacy from the University of Portsmouth, and later went on to receive a Ph.D. in Pharmaceutical Sciences at the U.K.’s University of Manchester. She then spent 12 years working in the pharmaceutical industry. During her time in the industry, she was a Pharmaceutical Assessor at the Medicines and Healthcare Regulatory Agency (MHRA) for over seven years. This role gave her an expert’s understanding of licensing procedures. She also became an EMA expert, giving counsel all over Europe on the matters of regulatory compliance in the pharmaceutical field.

Dr. Millichamp’s Ventures into Consulting and Teaching

With her vast experience in assessing MAAs, including Quality by Design (QbD), Real Time Release Testing (RTRT) and Rapid Microbial Methods (RMM), Laura Millichamp went on to become a very successful consultant. She wrote Scientific Advice briefings and dossier sections for Post Approval Change Management protocol, as well as conducted analyses in all areas of pharmaceutical regulation for companies of all sizes. She has worked with tiny startups and global corporations, as well as labs in all stages of product development.

Today, Dr. Millichamp provides her expertise to the students of CfPIE. She offers instruction in science, regulatory practices, and technology in the pharmaceutical field. Her course is eligible for on-site training, meaning she can bring her expertise to you. Her course can be customized to include company-specific training, so your employees will be trained by one of the leading professionals in this field.

What Dr. Millichamp Provides In Her Course

During Dr. Millichamp’s course, students will go over the EU guidelines that apply to the CMC section of MAAs. Then they will cover everything from the manufacturing process, the science of the products, the control of the product, the stability of the product, and the safety of the laboratory, to the requirements for formulation and compatibility, regional information, and more. Because this course covers so much information, there is a dedicated question and answer session regularly, where Dr. Millichamp offers her advice and instruction so that every student leaves with a thorough understanding.

The Center for Professional Innovation and Education is very proud to work with industry experts like Dr. Millichamp. Students who take this course are sure to leave with a confident understanding of the material thanks to her years of experience and dedication.