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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
For regulatory professionals to advance in their careers, they need to possess good communication skills. Working under time constraints, they have to present the relevant challenges of a situation and the proposed next steps. They should write and speak succinctly and support their conclusions with evidence.
The RAPS Competency Framework and Guide makes communication one of the eight required domains that reflect the knowledge and skills required for regulatory professionals. RAPS is offering a certificate program in effective communication. To earn the certificate, professionals in the regulatory field need to complete five 90- to 120-minute virtual classes that include:
The virtual classes are designed to impart knowledge that will change the participants’ behavior. Using polls, chat, and breakout rooms, the participants will employ their critical thinking skills and:
Most classes last 90 minutes, and the cost is $150 for RAPS members and $175 for nonmembers during the early bird registration period with rates increasing to $175 for RAPS members and $200 for nonmembers as the program date approaches. Upon completion of the class, the participants will be awarded 1.5 credits toward RAC recertification with two exceptions.
The Conflict Resolution and Negotiation: Effective Tools and Techniques event is 120 minutes and will receive 2.0 credits toward RAC recertification.
The other exception is Talking to Decision Makers: What to Say and How to Say It. Because of the live-practice session, the length of the class is 120 minutes, and the cost is $195 for RAPS members and $230 for nonmembers during the early bird registration period with rates increasing to $230 for RAPS members and $270 for nonmembers after 22 March 2022. For this class, the participants will be awarded 2.0 credits toward RAC recertification.
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 Navy Reserve.