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Please note there are no charging stations in session rooms. Please bring fully charged devices or back-up power sources.

Please note: Participants enrolled in this workshop are encouraged to bring their own laptops as part of the planned workshop activities.

Preconference Workshop

Skill Building

Sharpening Your Regulatory Soft Skills Toolbox

Monday, September 16, 2024

8:30 AM – 4:00 PM PDT

Location/Room: 104 C

Workshop Leader(s)

Susan Speicher, MS, RAC

Director, Regulatory Affairs and Quality Compliance
Wolters Kluwer UpToDate, Inc.

Slides

Presenter(s)

Sue Hibbeln, MS, RAC

VP
Lumos Diagnostics
Bill McMoil, MBA

RAPS Executive Director
Regulatory Affairs Professionals Society (RAPS)

Preconference Workshop Description: Regulatory affairs is more than just regulation and guidance documents. To be successful, you need a toolbox of soft skills that allow you to communicate effectively to have your voice heard, understand how your company works and how you work in your company, negotiate with leadership and cross-functional teams, and organize your planning and strategy. This session will focus on not just how to hone these skills, but how a regulatory professional can use them effectively in their unique role in an organization. Whether in the US or EU, medical device or pharmaceutical focus, early career professionals can benefit from first-hand experience of seasoned leaders.

Proposed Preconference Workshop Agenda Outline:

7:30 – 8:30 AM: Networking Breakfast & Welcome for Workshop Registrants

8:30 AM: All Preconference Workshops Begin

8:30 – 8:45 AM: Introduction and Agenda Review (Speaker: Susan Speicher)

8:45 – 9:45 AM: Financial Acumen (Speaker: Bill McMoil)

9:45 – 10:30 AM: Teamwork, Leadership, and Engagement (Speakers: Sue Hibbeln and Susan Speicher)

10:30 – 11:00 AM: Refreshment Break for Preconference Workshop Registrants)

11:00 – 12:00 PM: Emotion and Cultural Intelligence (Speaker: Sue Hibbeln)

12:00 – 12:30 PM: Decision Making (Speaker: Susan Speicher)

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

1:30 – 2:15 PM: Negotiation and Persuasion (Speaker: Bill McMoil)

2:15 – 3:00 PM: Project Management (Speaker: Susan Speicher)

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

3:15 – 4:00 PM: Problem Solving Scenarios - Group Discussion (Speakers: Sue Hibbeln, Bill McMoil, Susan Speicher)

4:00 PM: All Preconference Workshops Adjourn for Day

Learning Objectives:

Upon completion of this session, participants should be able to better understand the overall financial aspects of a business, as related to regulatory affairs.
Upon completion of this session, participants should be able plan for regulatory activities/submissions using good / best practice project management concepts.
Upon completion of this session, participants should be able to utilize and put into practice interpersonal and interrelationship skills that foster a collaborative environment with teams, both internal to regulatory affairs and across functional groups.