Boston Park Plaza Hotel & Towers, Boston, MA

Join our Americas Team at VIB Events' Outsourcing in Clinical Trials East Coast in Boston, MA.

Our Chief Scientfic Officer & QP, Paul Thomas, will be speaking at this event on Day One of the event:

European case study: outsourcing the manufacture of Investigational Medicinal Products (IMPs) to ensure legislative compliance and increase efficiency

• Reviewing the regulatory guidelines for IMPs to ensure all manufacturing activities meet with European law
• Outlining state of the art technologies and equipment to ensure cost effective manufacture of IMPs
• Clarifying Annex 13: highlighting how this will affect you to maximize efficiency by minimizing non-compliant products
• Accurately completing the product specification file to ensure all data is concise and compliant
• Determining the role of the Qualified Person (QP) and the requirements needed to be met to ensure European regulations
• Case study: exploring product specific examples to determine lessons learned and best practice

To arrange a meeting with one of our Business Devlopment Executives, please email Emma.Furreed@pennpharm.com