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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 $160 for RAPS members and $175 for nonmembers. Upon completion of the class, the participants will be awarded 1.5 credits toward RAC recertification.
The only exception is the class, 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 $210 for RAPS members and $235 for nonmembers. For this class, the participants will be awarded 2.0 credits toward RAC recertification.
Business Writing in Regulatory Settings
Tuesday, 9 November, 6–7:30 a.m. EST
$160 Members | $175 Nonmembers
1.5 RAC credits
To be effective, regulatory professionals need to write documents in a clear and well‐ organized manner. Under short deadlines, they have to create documents that are correct, complete, and concise.
After completing the virtual class, you will be able to:
Dangerous Documents: Avoiding Land Mines in Your Records and Emails
Last held 23 July, 2021
Regulatory professionals today are under intense pressure. Without thinking, they may write blunt comments on Post-it notes, send personal emails on the organization’s computer, or write comments to their colleagues that can be misinterpreted. If the organization is sued, these documents can become evidence. They could be used to embarrass the employee and the organization.
In this interactive class, you will have the opportunity to analyze improperly written documents and revise them so they will reflect the reader’s true intent. You will leave the session with ideas for protecting yourself and your organizations from unwelcome surprises.
Strategies in Meetings: Achieving Your Objectives
Last held 6 August, 2021
Each week, regulatory professionals attend numerous meetings. During these meetings, each professional is sending a message about the amount of influence he/she has. During this class, you will learn ten techniques that will improve your ability to persuade others to pursue a course of action.
Conflict Resolution and Negotiation: Effective Tools and Techniques
Last held 20 August, 2021
Health care companies want to promote a culture in which the employees enjoy coming to work and interacting with people at all levels within and outside their organization. To be effective, regulatory professionals need skills in conflict resolution and negotiation.
Talking to Decision Makers: What to Say and How to Say It
Last held 27 August, 2021
Do you know how to make yourself an invaluable asset to senior leadership and executives?
Executives are busy. They have too many things to do, and not enough time to do them. When they come to work, they have their time planned out. When one of their employees requests a meeting, the executive expects the employee to explain the issue clearly, and what he/she needs to do. Employees who are able to communicate succinctly are considered assets to an organization and get rewarded with promotions and outstanding performance reviews.
During this high-energy, interactive class you will learn how to prepare and describe an issue in 30 seconds using the “What”, “So What”, “Now What” pattern. After listening to the technique, you will be paired with two other participants and be given the opportunity to practice applying the concepts using your webcam and the audio function on your computer.
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.
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.
Kelly Gerstenberg is the director of education and professional development at the Regulatory Affairs Professional Society (RAPS) where she oversees the selection, development, delivery, and evaluation of synchronous educational programs. Prior to joining RAPS, she served as the director of program delivery and events at ASCD, and previously managed educational workshops while at the American Association of Pharmaceutical Sciences. She holds a bachelor's degree from the University of Virginia and a master's degree in education and human development the George Washington University.