Michiel Stam Email & Phone Number

I am a Management Consultant and Senior Regulatory Expert at MAIN5 with 15 years of experience in Regulatory Information Management (RIM) and IDMP. In my role I offer strategic direction and subject matter expertise to implement effective Regulatory Information Management (RIM) solutions.Beyond compliance, my focus lies on unlocking the true value of an organization's data through initiatives like XEVMPD, IDMP, and SPOR. By aligning people, cross-functional processes, and tools, I ensure efficient and sustainable data quality.Additionally, I have extensive experience with eCTD and other electronic submission formats. Throughout my career, I have successfully led various submission and regulatory information management projects for Pharma and Biotech companies. This includes the preparation and submission of initial MAA's and post-authorization maintenance for agencies in the EU (CAPs, NAPs and MRP/DCP), US (NDA and BLA), as well as other regions. Feel free to ask any specific questions if you require further details.

Listed skills include Regulatory Affairs, Ectd, Pharmaceutical Industry, Document Management, and 24 others.