Conflict Resolution and Negotiation: Effective Tools and Techniques (November2022)

Nancy Singer is President of Compliance-Alliance LLC. She is on the faculty of George Washington University School of Medicine and Health Sciences. She presently teaches classes for FDA Staff Colleges and FDA District Offices, Previously, she served as Special Counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. Nancy is a retired commander in the Naval Reserve.

Susan Rolih is a quality assurance and regulatory consultant specializing in In vitro diagnostic devices (IVDDs). Previously she served as Executive and Corporate Vice Presidents of Global Regulatory and Quality Systems for two US-based in vitro diagnostic companies. She has had extensive experience remediating quality systems and establishing regulatory strategies for both IVDD and life science companies. She has long experience negotiating with foreign and US regulatory agencies, including US FDA, US USDA, US EPA, US ATF, the European Union, Health Canada, and others. She has a Bachelor’s degree in Medical Technology and a Master’s degree in Immunohematology.

Marlene Bobka serves as president at FOI Services Inc. In this role, she oversees operations that facilitate access to FDA records using the Freedom of Information Act. Bobka is a widely published author and speaks frequently on finding and using fugitive drug, device, and biologic regulatory information. Before joining FOI, she taught online searching strategy; conducted extensive medical, chemical, and government literature research; and designed and documented databases at Bibliographic Retrieval Services and the National Cancer Institute. Bobka has been named a “Thought Leader” by Pharmaceutical Executive and was included among Medical Device & Diagnostic Industry’s 100 Influential Device Executives. She holds an MLS with a concentration in biomedical information structure, and has served as a guest lecturer, adjunct faculty member and advisory board member for graduate programs in library and information sciences and FDA regulatory affairs.