Course 1: Global Identification of Medicinal Products (IDMP)
Vada A. Perkins, DrSc, MSc
- Executive Director, Regulatory Policy and Intelligence
- Bayer Pharmaceuticals, United States
Vada A. Perkins, Bayer Pharmaceuticals, Executive Director, Regulatory Policy & Intelligence, Head Regulatory Intelligence- Vada A. Perkins, CAPT (ret) is a former FDA Senior Advisor for Regulatory Science and a recognized global regulatory policy & intelligence expert with regulatory thought leadership in the application of data governance, technology, data standards throughout the product lifecycle . He is active in interactions with national and international stakeholders in promoting technology and innovation (e.g., RWD/RWE) to support international regulatory convergence for medicinal product regulation. He received his degrees from The Johns Hopkins University, University of Southern California, and the University of Maryland.
- Head of Data Management and Regulatory Information Scientist
- Qdossier, Netherlands
Michiel Stam is heading the Data Management group at Qdossier and works as a Regulatory Information Scientist. He is a specialist in electronic submissions and regulatory information management and worked for various Pharma and Biotech companies in the past 10 years. Michiel has a strong focus on product and registration data management, master data management and IDMP.
- Astellas Pharma Global Development, United States
Brooke Casselberry, MS, RAC
- Senior Director, US Life Sciences Advisory and Consulting
- NNIT, Inc., United States
Brooke Casselberry is Senior Director, US R&D with NNIT Inc. and co-chair for the Regulatory Informatics Business and Technology tracks for DIA RSIDM. She has worked with bio-pharma sponsor organizations for nearly 20 years leading business implementation for systems and processes for regulatory data management in RIM, DMS, and Publishing and developing teams within Regulatory and Pharmacovigilance functions for consulting and sponsor organizations. Additionally, she is the founder of the non-profit organization, Youth STEM Foundation, providing scholarship funding for economically disadvantaged youth to after school STEM programs in the Denver area.