Preconference Workshop: Claiming Your Seat at the Table: How to Be Included in All Strategic Business Decisions

Preconference Workshop

Description:
Imagine there is a meeting of the Executive Team and you’re running late. They hold off discussing substantive strategic matters until you, the RA professional, arrives. In this session, we will provide tools and techniques that will help you and your staff move towards making this a reality.

In today’s healthcare organizations, you and your staff as regulatory professionals face common challenges. Regulatory professionals are often called upon to implement strategic decisions rather than to help create them. Despite regulatory approval being a critical milestone in bringing products to market, many times regulatory professionals find themselves excluded from the key conversations that shape business strategy. This interactive, full-day workshop will provide the tools to elevate the regulatory staff’s professional presence, communicate their value effectively, and ensure they are included in critical strategic conversations. Through expert-led sessions, small-group exercises, and real-world case studies, you will get tools to increase the regulatory professionals’ credibility and impact on their organizations.


Workshop Agenda Outline:

7:30 – 8:30 AM: Breakfast & Morning Welcome by RAPS

8:30 – 8:45 AM: Welcome and Introductions

8:45 – 9:30 AM: The Current Landscape –Actions You and Others Can Take When Executives Fail to Appreciate the Importance of Regulatory Professionals

• Why are you seen as compliance focused rather than strategic enablers?

• How can you increase your visibility?

• What changes do you need to make when you are communicating with upper management?

• How can you increase your interaction with other departments?

• What are ways that you can show that you are not against innovations but want to plan for risk mitigation?

9:30 – 10:30 AM: Reserve Your Seat at the Executive Table: Speaking the Language of Business & Finance

• Reference financial statements when explaining your regulatory strategy

• Frame regulatory decisions in ROI and profit margin

• Link regulatory milestones to bottom-line metrics that drive decisions

10:30 – 11:00 AM: Refreshment Break

11:00 – 12:30 PM: Executive Presence

• What is your personal brand?

• Why does appearance matter?

• How to frame needed responses to regulatory actions as strategic advantages rather than business setbacks?

12:30 – 1:30 PM: Lunch & Networking

1:30 – 3:00PM: Executive Presence continued

• How to conduct one on one briefing with superiors. (Interactive session – participants will receive a template and use the template to deliver a 30 second talk in small group with two other participants).

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

3:15 – 4:00 PM: Executive Presence continued

• How to communicate information succinctly at meetings with key executives. (Interactive session -participants will evaluate ten techniques that will increase their credibility and ensure that their ideas are heard and considered during company meetings).

4:00 PM: Adjourn for Day

Session Panelist to include the following industry representatives:

Jethro Ekuta (Chairman of RAPS Board) Chief Regulatory & Safety Officer, Ascendis Pharma Chairman of the Board

Lawrence E. Liberti, PhD, Director, D.K. Kim International Center; Associate Professor of Regulatory and Quality Sciences

Frank Pokrop, Director, Regulatory Affairs Director, Regulatory Affairs Werfen North America

Susan Speicher, Speicher Regulatory Services

Nancy Singer, President of Compliance-Alliance

Bill McMoil, MBA RAPS Executive Director