FIERCEPHARMA PRESENTS:

VIRTUAL EREGULATORY OPERATIONS

SUMMIT 

MAY 18, 2020 | FREE VIRTUAL EVENT

WATCH NOW Group

FiercePharma brings you an online event that will explore how companies can improve their electronic submission processes and protocols for RIM, and global regulatory submissions. With the goal of establishing a cohesive, compliant, and timely submission process in mind, our expert speaking faculty will discuss how to efficiently work with cross-functional stakeholders and optimize your team’s activities through the use of innovative technologies and processes.

Join us for the Virtual eRegulatory Operations Summit as we examine how to streamline your organization’s regulatory operations – in a new digital environment!

 

Event Highlights

  • Streamline your team’s regulatory processes by building a strong operational foundation
  • Identify changes in submission-related regulations impacting RIM business processes
  • Build inspection readiness into Your eRegulatory operations
  • Optimize regulatory information management from application to registration
  • Foster a digital document ecosystem in clinical trials
  • Explore the use of innovative tools and technology to increase the efficiency of your team

 

Watch On-Demand Now! Group

AGENDA
MONDAY, MAY 18

9:30AM ET
Networking Halls Open

10:00AM-10:15AM ET
Chairperson's Opening Remarks

Anne Marra , Head, Regulatory Operations, Ra Pharmaceuticals

Anne Marra
Head, Regulatory Operations
RA PHARMACEUTICALS, NOW A PART OF UCB

10:15AM-11:00AM ET
Opening Panel: Lead Your Regulatory Operations Team to Success Through Effective Procedures and Solutions

  • Streamline your team’s regulatory processes by building a strong operational foundation
  • Develop a system for staying compliant through continuously changing regulations and requirements
  • Evaluate the pros and cons of implementing a unified E2E solution
  • Building your eRegulatory operations team from the ground up
Mary Ann Wojcik, Expert Submission Writer, Novartis

MODERATOR:
Mary Ann F Wojcik, MS, ELS, MWC

Expert Regulatory Writer
NOVARTIS

Susan Hensley

Susan Hensley
Senior Director, Regulatory Operations, Regulatory Affairs Vaccines
TAKEDA PHARMACEUTICALS

Francis Quinn, Director, US Publishing Hub Lead, Pfizer

Francis Quinn
Director, US Publishing Hub Lead
PFIZER

Carrie Mazzrillo, Associate Director, Regulatory Submission Management, Vertex Pharmaceuticals

Carrie Mazzrillo
Associate Director, Regulatory Submission Management
VERTEX PHARMACEUTICALS

11:10AM-11:55AM ET
Accelerate work during the time of COVID-19

During this pandemic, the way we are working has entirely changed. The problem: In clinical research, we can't afford to halt or decelerate our work. And with COVID-19 trials in particular, we are under pressure to accelerate work even further. So how do you balance a new working environment and new realities, including grounded employees and social distancing, with new pressures for increased efficiency and acceleration? During this presentation, you will learn how groups like Care Access Research and Complion are helping sites, CROs and Sponsors accelerate site selection and ongoing site regulatory work during this time.

Rick Arlow

Rick Arlow
Founder and CEO
COMPLION

Vinny Napoli, Director, Business Development, Care Access Research

Vinny Napoli
Director, Business Development
CARE ACCESS RESEARCH

11:55AM-12:15PM ET
Networking Break

12:15PM-12:45PM ET
Manage Your RIM in a World of Continuous Regulatory and Technological Changes

  • Identify changes in submission-related regulations impacting RIM business processes
  • Create a RIM solution with end-user input/specifications
  • Implement cloud utilization into your regulatory operations
Richard Fredericks

Richard Fredericks
Director, Regulatory Systems and Information Management
GSK

Jessica Nardi

Jessica Nardi
Senior Associate, Regulatory Systems & Information Management
GSK

12:55PM-1:40PM ET
Panel: Strategies for Seamless Collaboration with Outsourcing Partners

  • Choosing the right solution providers and partners for your company
  • How to sustain and grow a relationship between a sponsor and vendor
  • Innovative models & communication strategies to improve your working relationship with your outsourced vendors
Jamie Scialdone, Director, Regulatory Operations, Agios Pharmaceuticals

MODERATOR:
Jamie Scialdone

Director, Regulatory Operations
AGIOS PHARMACEUTICALS

Craig Gassman, Director, Regulatory Operations and Quality Information Systems, Vericel Corporation

Craig Gassman
Director, Regulatory Operations and Quality Information Systems
VERICEL CORPORATION

Jillian Carinci, MS, Associate Director, Regulatory Sciences, BIOGEN

Jillian Carinci, MS
Associate Director, Regulatory Sciences
BIOGEN

Ryan McNeely, Manager, Regulatory Operations, ACCENTURE

Ryan McNeely
Manager, Regulatory Operations
ACCENTURE

1:50PM-2:35PM ET
Panel: Optimize Your Electronic Clinical Documentation and Inspection Readiness Procedures

  • Outline how eClinical Solutions can streamline multicenter sites through role-based remote access and quality control
  • Advance study start-up time and gain access to real-time study oversight
  • Explore cases of inspection readiness and the process taken to ensure documents are prepared and compliant
Janine Penman, Director, Clinical Consulting and Systems, Just in Time GCP

MODERATOR:
Janine Penman

Director, Clinical Consulting and Systems
JUST IN TIME GCP

Carrie K. Lauer, Director of Operations, Global Research, Outcomes & Economics, GE Healthcare

Carrie K. Lauer
Director of Operations, Global Research, Outcomes & Economics
GE HEALTHCARE

Dr. Martina Duevel, Systems Excellence Project Leader, Bayer

Martina Duevel
Systems Excellence Project Leader
BAYER AG

Michele Weitz, Senior Director, Clinical Standards and Innovation, Clovis Oncology

Michele Weitz
Senior Director, Clinical Standards and Innovation
CLOVIS ONCOLOGY

2:35PM-2:50PM ET
Chairperson’s Closing Remarks

Anne Marra , Head, Regulatory Operations, Ra Pharmaceuticals

Anne Marra
Head, Regulatory Operations
RA PHARMACEUTICALS, NOW A PART OF UCB

2:50PM-3:20PM ET
Networking Break

3:20PM ET
Virtual Conference Concludes

SPONSORS