Parexel Principal Consultant and former Pharmaceutical Assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) with over 10 years of experience in working in CMC and regulatory affairs, including six years licensing medicines at the Agency.
Assessment work performed for MHRA entailed national and EU initial applications which covered DCPs, MRPs, centralised (Rapp and Rapp peer reviewer) and the assessment of NCEs. Also reviewed IMPDs as part of Clinical Trial Applications.
As a Principal Consultant at Parexel helps clients prepare their CTA/IND, MAA/NDA and variation submissions as a CMC Subject Matter Expert (SME) and provides regulatory, strategic and technical input for lifecycle activities in European and international markets. In addition, helps prepare questions and briefing packages for clients for regulator advice meetings and attends on their behalf.
Conducts training and mentoring of staff on current CMC and regulatory topics, as well as presenting at external events.
A registered pharmacist, also has a background in clinical and community pharmacy.
• Fundamentals of EU Regulatory Affairs, eighth edition. Chapter 28 Generic Medicinal Products. Published by Regulatory Affairs Professional Society
• Global Pharmaceutical and Biologics Regulatory Strategy, second edition. Chapter 7 CMC Regulatory Strategy. Published by Regulatory Affairs Professional Society
• Providing Early Access to Innovative Medicines in the UK, 23rd May 2018. Regulatory Affairs Professional Society
Monday, September 14, 2020
2:05 PM – 3:00 PM EDT
Tuesday, September 15, 2020
9:35 AM – 10:30 AM EDT