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Wednesday, June 18
 

12:00pm EDT

#331 RT: Roundtable Discussion: Transforming the Project Management Role to Meet the Emerging Needs in Pharma - Extending Scope from R&D Focus to Launch Projects
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
Component Type: Session

Join the Project Management Community for a follow up round table discussion tied to session: Transforming the Project Management Role to Meet the Emerging Needs in Pharma - Extending Scope from R&D Focus to Launch Projects (Tuesday, June 17 | 10:30am - 11:30am EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Nancy Linda Styple

Speakers
avatar for Nancy Styple

Nancy Styple

Project Management Leader, Bayer AG, United States
Nancy has been excited to work in Program Management for over 20 years and is a strong advocate for the work that Project Managers and Project Leaders deliver along the value chain in drug development. Nancy starting as a bench research scientist in biotech and has experience in multiple... Read More →
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

1:45pm EDT

#346: Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Application UAN: 0286-0000-25-646-L04-P; CME 1.00; RN 1.00

Operating models and company’s culture can affect an organization’s value and efficiency. This session will delve into Regulatory Affairs operating models, including opportunities and challenges, providing best practices for your organization.

Learning Objectives

Compare operating models being used by regulatory affairs organizations that are driving greater value, efficiency, and career empowerment; Discuss successes and challenges with different operating models.

Chair

Anton Mihic, MSc

Speaker

Panelist
Donna Boyce, MS, RAC

Panelist
Lisa Ruiz, PhD, MBA

Panelist
Alison Maloney, PhD, MBA, MS


Speakers
avatar for Donna Boyce

Donna Boyce

Head and Senior Vice President of Global Regulatory Sciences, Pfizer Inc, United States
Donna Boyce is Senior Vice President of Global Regulatory Sciences and a member of the Pfizer Research and Development (PRD) Leadership Team. She joined Pfizer in May 2013 as the Vice President, Global Regulatory Affairs, Vaccine. In her current role, Donna is responsible for the... Read More →
avatar for Alison Maloney

Alison Maloney

Head of Regulatory Affairs North America, Bayer , United States
Alison Maloney is currently Head of Regulatory Affairs North America for Bayer Pharmaceuticals. Prior to this role, she was the Head of Regulatory Affairs for Bayer Radiology and Consumer Health North America. Alison has also held Canadian positions as the Head of Regulatory Affairs... Read More →
avatar for Anton Mihic

Anton Mihic

Partner, McKinsey & Company, United States
Anton is a management consultant serving clients in McKinsey’s Life Science R&D practice across global PharmaCos, innovative Biotechs, CROs and Private Equity portfolio companies. Anton leads McKinsey’s global Regulatory Affairs, Safety and R&D Quality service line, and focuses... Read More →
avatar for Lisa Ruiz

Lisa Ruiz

VP, Regulatory Affairs Operations, CMC & Device, Abbvie, United States
Lisa Ruiz is a Regulatory Affairs executive leader with over 30 years in the pharmaceutical industry and broad experience in regulatory having held strategic roles across therapeutic areas, functions and geographies. She is currently the Vice President of Regulatory Affairs Operations... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   07: ProjectManagement-StrategicPlanning, Session
  • Level Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Session

2:55pm EDT

#353 RT: Roundtable Discussion: Portfolio Management in Pharma - Strategies and Insights from Large, Medium and Small Pharma
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
Component Type: Session

Join the Project Management Community for a follow up round table discussion tied to session: Portfolio Management in Pharma - Strategies and Insights from Large, Medium and Small Pharma (Wednesday, June 18 | 1:45pm - 2:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Erin Mulrooney, MSc, PMP

Speakers
avatar for Erin Mulrooney

Erin Mulrooney

Director, Portfolio Management, Daiichi Sankyo, Inc, United States
Erin Mulrooney is a Director of Portfolio Management in the Global Project Management and Leadership group at Daiichi Sankyo. There she is responsible for portfolio prioritization and reporting to enable data-driven decision making. Before joining Daiichi Sankyo in August 2024, Erin... Read More →
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
 
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