The Biotechnology Forum sponsored by the Council for Entrepreneurial Development on Nov. 11 will address “Pre-Clinical Trials and Tribulations: Regulatory Planning an Integral Part of your Business Strategy.”

The panel will discuss product development, regulations and agency interactions, and will bring these issues to life using real-world examples. The talks will focus on drugs and biologics, but they also apply to devices and other regulated products such as cosmetics, food and dietary supplements.

Speakers included moderator Eric Harris, a clinical research scientist with Cato Research; Darcy Perkins of TriPharmSafety; Lynn Pritchard, senior director of regulatory operations and compliance at PharmaResearch Corporation; Christy Shaffer, chief executive officer of Inspire Pharmaceuticals; and Marc Shapiro, attorney and managing director of Hyman, Phelps & McNamara.

The CED Biotech Forum begins at 5 PM at the N.C. Biotechnology Center on Alexander Drive in RTP. The sponsor is Hutchison & Mason PLLC.