Communicating with Agency Officials, Top Management, and Other Stakeholders for Gaining Alignment on Strategic Initiatives

Effective strategic communication is essential for Regulatory Affairs professionals who want to advance to senior roles within their organization. Career progress can be hampered if effective communication skills have not been mastered. Senior Regulatory Affairs professionals should be able to frame their messages clearly and effectively to ensure that they are heard and that their recommendations are adopted by decision-makers both inside and outside their organizations. In this session, participants will work through real-world scenarios and examples where feedback from a Health Authority such as the FDA could potentially result in a significant impact on the regulatory affairs staff and the company as a whole. Participants will gain insights into anticipating the objectives of key stakeholders whom they must influence regarding regulatory recommendations in times of crisis.

Time Agenda Item Speaker(s)
7:30 – 8:30 AM Networking Breakfast & Welcome for Workshop Registrants

8:30 AM All Preconference Workshops Begin

8:30 – 10:30 PM Avoiding Disastrous Mistakes When Briefing High-Level Agency Officials

• Engage in an exercise that combines a challenging FDA inspection and a reported patient safety issue, which will have a serious impact on the organization.

• Learn about resources for becoming familiar with the background and special interests of regulatory officials who will be attending your scheduled meetings with their Health Authority.

• Select the types of evidence that regulatory affairs professionals would present during briefings with Health Authority officials.

• In a small group, deliver a short talk to inform Health Authority officials about the consequences that could arise from their proposed demands and receive feedback about the talk.

• Recognize the traits that contribute to executive presence.

Richard DeRisio
MS

Rosanne Melikian
PhD, MSRS, RAC

Nancy Singer
JD, LLM, RAC, FRAPS

10:30 – 11:00 AM Refreshment Break for Preconference Workshop Registrants
 
11:00 – 12:30 PM Getting to Yes: Mastering the Art of Presenting Regulatory Positions to Staff and Stakeholders

• Discuss methods for conducting a “regulatory risk assessment” prior to filing an application with the FDA to determine if there are issues where, unexpectedly, the Health Authority could require additional supporting information in a Request for Additional Information (RFAI) letter.

• Determine the most effective method for delivering information to company executives and your regulatory staff about the potentially serious implications of an RFAI letter from the FDA.

• Recognize how different functional heads will respond to information that has a significant impact on their department’s objectives.

• Use proven techniques to gain agreement from functional heads on the actions to take as a result of the RFAI letter.

• Discuss how to achieve consensus among members of your organization where resources and costs are impacted to address a Health Authority’s concerns.

Richard DeRisio
MS

Rosanne Melikian
PhD, MSRS, RAC

Nancy Singer
JD, LLM, RAC, FRAPS

12:30 – 1:30 PM Lunch & Networking for Preconference Workshop Registrants

1:30 – 3:00 PM The Little-Known Secrets for Building Effective Teams That Embrace Diversity and Open Communication.

• Identify the challenges and opportunities companies experience in building a diverse staff with people from different backgrounds, ages, genders and ethnicities.

• Learn how a diverse workforce can improve the quality of regulatory decisions and the design of clinical and engineering test protocols.

• Discuss actions that companies can take to develop and sustain a diverse workforce.

• Identify the unique priorities that different functional heads have within an organization.

• Explore techniques that can be used to reach consensus in a potential recall situation when faced with competing priorities among different department heads.

Richard DeRisio
MS

Rosanne Melikian
PhD, MSRS, RAC

Nancy Singer
JD, LLM, RAC, FRAPS

3:00 – 3:15 PM Refreshment Break for Preconference Workshop Registrants

3:15 – 4:00 PM Avoiding Landmines When Communicating Sensitive Information

• Identify the actions that companies should take to protect confidential information.

• Recognize the effect of writing “Confidential” on internal documents as it relates to outside parties.

• Identify the problems with writing an emotional email to stimulate action within the company.

• Recognize the types of information to include in meeting minutes and other documents.

• Identify words to avoid in company documents and replace them with synonyms that express the same thoughts.

Richard DeRisio
MS

Rosanne Melikian
PhD, MSRS, RAC

Nancy Singer
JD, LLM, RAC, FRAPS

4:00 PM All Preconference Workshops Adjourn for Day