Learn the fundamentals of the drug and biologics regulatory approval process as it applies to US, Canadian and European markets. This course includes an overview of the regulations that must be met in order to initiate human clinical trials, the regulatory pathways for approval to market pharmaceuticals and biologics, an understanding of the clinical trials process, and the role of the regulatory professional in today’s pharmaceutical industry. At the end of the course, students will be asked to develop a global regulatory strategy for a biologic or drug pharmaceutical product.
This course can be applied towards:
Noncredit courses do not produce academic credit nor appear on a Colorado State University academic transcript.
Brenda Fielding is the EVP of Regulatory Affairs for Clinipace Worldwide. Previously, she was the Founder, Chairman of the Board and President of Regulus Pharmaceutical Consulting, Inc. She has more than 20 years experience in the pharmaceutical and biotechnology industry, primarily in the area of Regulatory Affairs and Quality. She has held senior management positions in US pharmaceutical and biotechnology companies, including Cortech, Gilead Sciences, and Napro BioTherapeutics, Inc. (now Tapestry Pharmaceuticals, Inc.). She has been involved in the successful clinical development of novel drugs, biologics, and drug delivery systems, over a wide range of therapeutic areas including oncology, anti-infectives, immunotherapeutics and ophthalmology. She regularly represents clients at meetings with Regulatory Authorities, including the US Food and Drug Administration. Brenda received her BSc from London University, UK and attended graduate school in London. Brenda has been the invited speaker at numerous drug development and regulatory affairs seminars and conferences, and has chaired symposia for professional organizations.