Strategic communication skills are essential for regulatory professionals serving in top-level positions — and those who want to get there.
The RAPS Advanced Strategic Communication Certificate Program is where experienced regulatory affairs professionals develop the critical skills they need. Collaborate with your peers to analyze case studies, solve problems, and practice communication techniques you can apply immediately at your job.
Over the course of four online workshops, expert presenters will guide you in lessons on:
- Conducting presentations for high-level agency officials
- Presenting, explaining, and defending external regulatory positions and proposals to staff and stakeholders
- Building a diverse team with varied skills that function effectively to accomplish the organization’s mission
- Communicating effectively with staff by conducting regular meetings to discuss initiatives and current events
- Communicating sensitive information with broad organizational repercussions
Join us for a scenario: after an FDA inspection, your company is faced with a potential recall of pacemakers that have already been implanted in 45 patients. The stakes are high as patient safety and your company's financial future hang in the balance. But there is an opportunity to present an alternative solution to the FDA. How will you approach the meeting? What key points will you emphasize to persuade FDA officials? Most importantly, how will you project the image of a confident and credible leader?
Learning Objectives
After completing this workshop, you will be able to:
- Uncover vital background information about the FDA officials you will meet
- Identify persuasive evidence that resonates with the agency's priorities
- Construct a credible argument that can influence agency decisions
- Master the art of executive presence to command the room
- Prepare for and tackle tough questions with thoughtful, evidence-based responses.
An unexpected Request for Additional Information (RFAI) letter from the FDA threatens to derail your company’s approval timeline and impact this year’s earnings. What should you do now in this high-pressure situation? In this interactive session, you will collaborate in breakout groups to explore how to communicate the situation’s implications to different stakeholders including senior management, key opinion leaders, and your regulatory staff.
Learning Objectives:
- Develop clear, concise communication strategies for crisis situations
- Predict how various department heads will react to regulatory challenges
- Craft presentations that preemptively address stakeholders' concerns
- Secure agreement on alternative solutions that align with organizational goals
- Discuss methods for communicating critical information to regulatory staff in a manner that maintains a department’s positive culture
- Analyze benefits vs. risks for different courses of action
As a senior manager, you are tasked with creating a diverse, high-performing team that can navigate complex challenges. Learn how to turn diversity into a competitive advantage by understanding biases, promoting open communication, and leveraging diverse perspectives to enhance your organization’s performance. In breakout rooms, you and the other participants will tackle a challenging crisis based on a real life situation where diversity among department heads is expressed in a different way. Breakout group members will have functional roles with diverse points of view that are in direct conflict with each other.
Learning Objectives
- Leverage diversity to boost organizational performance
- Identify and address biases within your team and the broader organization
- Develop solutions for the challenges presented when creating and sustaining a diverse workforce
- Design activities that promote the benefits of diversity and build team cohesion
- Anticipate and navigate conflicts arising from differing organizational viewpoints
In today’s high-pressure business environment, the need to protect sensitive information is paramount. This session will teach you the critical do's and don’ts of communication to safeguard your career and your organization from legal and financial risks. Learn from past cases where miscommunication or mishandling of confidential information led to costly legal battles and damaged reputations.
Learning Objectives
- Recognize the limitations of marking documents as "Confidential".
- Prevent meeting minutes from becoming legal liabilities
- Avoid making notations on documents that could be damaging in lawsuits
- Recognize the challenges when staff members write self-serving memos to the file
- Design policies that will prevent your staff from writing dangerous documents
- Identify words and phrases that draw scrutiny from legal professionals
Registration Fees & Deadlines
Present – 26 February 2026: Early Bird Member $1,235| Nonmember $1,455
27 February 2026 – 27 March 2026: Regular Member $1,455 | Nonmember $1,725
Who Should Attend?
Regulatory professionals who have attained the equivalent of a senior manager, director or vice-president position in a healthcare organization.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speakers
Nancy Singer, JD, LLM, RAC, FRAPS founded Compliance-Alliance LLC to specialize in the professional development of government and business professionals in regulated industries. She is an adjunct associate professor at the USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences and has been on the faculty at George Washington School of Medicine and Health Sciences. She presently teaches classes for the FDA Staff Colleges and the FDA Program 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 Honors Program at the United States Department of Justice, doing litigation for FDA enforcement cases.
Richard DeRisio is a retired medical device executive who collaborates on the development and presentation of training courses for regulatory affairs and quality system professionals. Early in his career, Richard worked in FDA’s Washington-area headquarters offices supporting field operations, managing foreign inspections of medical device and pharmaceutical manufacturers and, in CDRH’s Office of Compliance, reviewing compliance actions, conducting industry training, and serving as the Office’s sterilization sciences expert.After serving at FDA, Richard led global and divisional clinical, quality, regulatory and government affairs organizations at Abbott, J&J, Covidien, and Pfizer, among other companies. His experience encompasses cardiothoracic, electrophysiology, robotic, ophthalmology, and wound healing devices. Prior to retiring, Richard was VP, Medical Health Services, Americas Region for the German notified body TÜV SÜD. In that role, Richard’s organization was responsible for CE-Mark approval of medical devices manufactured in North America.
Rosanne Melikian, PhD, MSRS, RAC
Sr. Director, Regulatory Affairs, Johnson & Johnson MedTech Vision
Rosanne Melikian leads a global regulatory affairs team responsible for new product development and life cycle management of medical devices designed to treat cataracts and glaucoma. Her portfolio includes cataract extraction systems, laser cataract devices, intraocular lens implants and insertion systems and ophthalmic viscosurgical devices (OVDs).
Rosanne began her career at Abbott in a hybrid role that combined regulatory affairs with research science. She now oversees global regulatory approvals and life cycle management for Johnson & Johnson Surgical Vision’s largest business franchise. She is also committed to talent development within the regulatory affairs organization, has supported critical business development projects, and actively participates in US and international device standards meetings. Rosanne frequently presents to health authorities such as the FDA, Health Canada, and European notified bodies on novel technologies and clinical trials.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the successful completion of the Program.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org.