Skip to main content
Toggle navigation
Login
Search
Home
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Full Schedule
Home
Full Schedule
All Days
Wed, Mar 12
Thu, Mar 13
Fri, Mar 14
Full Schedule
Type here to filter the list
Wednesday, March 12, 2025
8:00 AM – 9:00 AM
EST
Breakfast
8:00 AM – 9:00 AM
EST
Breakfast
Location: The Foyer
9:00 AM – 4:00 PM
EST
Bootstrapping Your Regulatory Intelligence: Start and Grow a Successful RI Program from Scratch
9:00 AM – 4:00 PM
EST
Bootstrapping Your Regulatory Intelligence: Start and Grow a Successful RI Program from Scratch
Location: Concourse C
Presenter:
Linda F. Bowen, MS, RAC, FRAPS
– Temple University
Presenter:
Chris J. Whalley, BA
– Pfizer
Preconference Workshop
10:30 AM – 11:00 AM
EST
Refreshments Break
10:30 AM – 11:00 AM
EST
Refreshments Break
Location: The Foyer
12:00 PM – 1:00 PM
EST
Lunch
12:00 PM – 1:00 PM
EST
Lunch
Location: The Foyer
2:30 PM – 3:00 PM
EST
Refreshments Break
2:30 PM – 3:00 PM
EST
Refreshments Break
Location: The Foyer
Thursday, March 13, 2025
8:00 AM – 9:00 AM
EST
Breakfast
8:00 AM – 9:00 AM
EST
Breakfast
Location: The Foyer
Supported by
8:00 AM – 5:00 PM
EST
Registration
8:00 AM – 5:00 PM
EST
Registration
Location: The Foyer
9:00 AM – 10:15 AM
EST
Opening Plenary: The Future of the Regulatory Intelligence Profession: On the Cusp of Being an Essential Part of the Regulatory Profession
9:00 AM – 10:15 AM
EST
Opening Plenary: On the Cusp: The Evolving Role of Regulatory Intelligence from Emerging Field to Core Competency
Location: Concourse A
Moderator:
Linda F. Bowen, MS, RAC, FRAPS
– Temple University
Panelist:
Laura DiAngelo, MPH
– POLITICO's AgencyIQ
Panelist:
Emily Huddle
– Gilead Sciences
Panelist:
Jeff MacDonald, PharmD
– BeiGene
Panelist:
Melissa Walker, MS, RAC, FRAPS
– Graematter, Inc.
Combined Track
Supported by
10:15 AM – 10:45 AM
EST
Coffee and Refreshments Break
10:15 AM – 10:45 AM
EST
Coffee and Refreshments Break
Location: The Foyer
Supported by
10:45 AM – 11:45 AM
EST
Effective Regulatory Commenting
10:45 AM – 11:45 AM
EST
Effective Regulatory Commenting
Location: Concourse A
Presenter:
Elizabeth Rosenkrands Lange, MS, MPH
– EMD Serono/ Merck KGaA, Darmstadt, Germany
Presenter:
Andrew J. Emmett, RAC, MPH
– Pfizer
Presenter:
Kristy Lupejkis, MPH
– Science and Regulatory Advocacy, PhRMA
Presenter:
Steve Berman, MPH
– Biotechnology Innovation Organization (BIO)
Moderator:
Alexander Gaffney, MS, RAC
– AgencyIQ
Combined Track
10:45 AM – 11:45 AM
EST
Hyperlink Hackathon for Regulatory Intelligence
10:45 AM – 11:45 AM
EST
Hyperlink Hackathon for Regulatory Intelligence
Location: Concourse B
Presenter:
Linda F. Bowen, MS, RAC, FRAPS
– Temple University
Presenter:
Chris J. Whalley, BA
– Pfizer
Combined Track
11:55 AM – 12:55 PM
EST
Revolutionizing Small Regulatory Teams: Leveraging Technology for Efficient and Strategic Regulatory Intelligence
11:55 AM – 12:55 PM
EST
Revolutionizing Small Regulatory Teams: Leveraging Technology for Efficient and Strategic Regulatory Intelligence
Location: Concourse A
Presenter:
Rachel O'Leary
– CellCarta
Presenter:
Gert W. Bos, MSc, PhD, FRAPS
– Qserve Group
Presenter:
Eliza Shearer
– Philips
Medical Devices (includes IVDs)
11:55 AM – 12:55 PM
EST
The Amazing Race: Navigating Global Regulatory Policy & Intelligence in Large Organizations
11:55 AM – 12:55 PM
EST
The Amazing Race: Navigating Global Regulatory Policy & Intelligence in Large Organizations
Location: Concourse B
Presenter:
Brianna Gallagher, PharmD, JD
– Viatris
Presenter:
Jewell Martin, MA, MBA, PMP, RAC
– BioMarin Pharmaceutical, Inc.
Moderator:
Alexander Gaffney, MS, RAC
– AgencyIQ
Pharmaceuticals (includes Biologics)
12:55 PM – 2:55 PM
EST
Lunch
12:55 PM – 2:25 PM
EST
Lunch
Location: Flight Deck
Supported by
1:45 PM – 2:15 PM
EST
Table 1:
Solutions Circle: Accelerating Time to Commercialization by Thinking More Critically about the Product Quality and Compliance
1:45 PM – 2:15 PM
EST
Table 1:
Solutions Circle: Accelerating Time to Commercialization by Thinking More Critically about the Product Quality and Compliance
Location: Flight Deck
Sponsor Presenter:
David Wolf
– PTC
Medical Devices (includes IVDs)
Presented by
1:45 PM – 2:15 PM
EST
Table 2:
Solutions Circle: Cybersecurity and Medical Device in China and EU
1:45 PM – 2:15 PM
EST
Table 2:
Solutions Circle: Cybersecurity and Medical Device in China and EU
Location: Flight Deck
Facilitator:
Pei Yu (Amy) Chen
– Compliance and Risks
Medical Devices (includes IVDs)
1:45 PM – 2:15 PM
EST
Table 3:
Solutions Circle: Modernizing Regulatory Intelligence: Leveraging Agile Best Practices for a Future-Ready Approach
1:45 PM – 2:15 PM
EST
Table 3:
Solutions Circle: Modernizing Regulatory Intelligence: Leveraging Agile Best Practices for a Future-Ready Approach
Location: Flight Deck
Facilitator:
Megan Kane
– Velsera
Medical Devices (includes IVDs)
1:45 PM – 2:15 PM
EST
Table 4:
Solutions Circle: Monitoring the EU Regulatory Landscape to Inform Regulatory Strategy
1:45 PM – 2:15 PM
EST
Table 4:
Solutions Circle: Monitoring the EU Regulatory Landscape to Inform Regulatory Strategy
Location: Flight Deck
Facilitator:
Kirsten Messmer, RAC
– KM Intel LLC
Pharmaceuticals (includes Biologics)
1:45 PM – 2:15 PM
EST
Table 5:
Solutions Circle: Regulatory Policy as a Strategic Partner for Early Regulatory Intelligence Detection
1:45 PM – 2:15 PM
EST
Table 5:
Solutions Circle: Regulatory Policy as a Strategic Partner for Early Regulatory Intelligence Detection
Location: Flight Deck
Facilitator:
Andrew Wingen, MS, RAC
– Bayer
Medical Devices (includes IVDs)
2:25 PM – 3:25 PM
EST
Advancing Regulatory Intelligence: Harnessing Evolving Systems and Implementing Impactful Policy Assessments
2:25 PM – 3:25 PM
EST
Advancing Regulatory Intelligence: Harnessing Evolving Systems and Implementing Impactful Policy Assessments
Location: Concourse B
Presenter:
Stephen Philipp, PMP
– Merck
Presenter:
Jennifer Shingle, MS
– Merck
Moderator:
Alexander Gaffney, MS, RAC
– AgencyIQ
Pharmaceuticals (includes Biologics)
2:25 PM – 3:25 PM
EST
Regulatory Intelligence, Input, and Influence
2:25 PM – 3:25 PM
EST
Regulatory Intelligence, Input, and Influence
Location: Concourse A
Panelist:
Andrew Wingen, MS, RAC
– Bayer
Panelist:
Raya D. Zerger, MT(ASCP)SBB
– Beckman Coulter, Inc.
Moderator:
Linda F. Bowen, MS, RAC, FRAPS
– Temple University
Medical Devices (includes IVDs)
3:35 PM – 4:35 PM
EST
Regulatory Detective
3:35 PM – 4:35 PM
EST
Regulatory Detective
Location: Concourse A
Presenter:
Jeff Ballyns, PhD
– BD
Presenter:
Jay Vaishnav, PhD, RAC-Devices, FRAPS
– Canon Medical Informatics, Inc.
Combined Track
3:35 PM – 4:35 PM
EST
Use of Artificial Intelligence / Machine Learning to Enhance Regulatory Intelligence Analysis Capabilities
3:35 PM – 4:35 PM
EST
Use of Artificial Intelligence / Machine Learning to Enhance Regulatory Intelligence Analysis Capabilities
Location: Concourse B
Presenter:
Jeff MacDonald, PharmD
– BeiGene
Pharmaceuticals (includes Biologics)
4:35 PM – 4:50 PM
EST
Coffee and Refreshments Break
4:35 PM – 4:50 PM
EST
Coffee and Refreshments Break
Location: The Foyer
Supported by
4:50 PM – 5:50 PM
EST
Establishing a Robust Regulatory Intelligence Function Within Drug and Device Companies
4:50 PM – 5:50 PM
EST
Establishing a Robust Regulatory Intelligence Function Within Drug and Device Companies
Location: Concourse B
Presenter:
Pooja Somesh Thakur, M.Pharm
– ADVANZ PHARMA
Presenter:
Stephanie S. Kelly, JD, MS
– Kyowa Kirin
Combined Track
4:50 PM – 5:50 PM
EST
Sensing, Incorporating, & Delivering – Making Regulatory Intelligence Part of Your Device Lifecycle
4:50 PM – 5:50 PM
EST
Sensing, Incorporating, & Delivering – Making Regulatory Intelligence Part of Your Device Lifecycle
Location: Concourse A
Presenter:
Jeff Ballyns, PhD
– BD
Presenter:
Laura DiAngelo, MPH
– POLITICO's AgencyIQ
Moderator:
Melissa Walker, MS, RAC, FRAPS
– Graematter, Inc.
Medical Devices (includes IVDs)
6:00 PM – 7:00 PM
EST
Opening Night Reception
6:00 PM – 7:00 PM
EST
Opening Night Reception
Location: The Foyer
Friday, March 14, 2025
8:00 AM – 9:00 AM
EST
Breakfast
8:00 AM – 9:00 AM
EST
Breakfast
Location: The Foyer
Supported by
8:00 AM – 12:00 PM
EST
Registration
8:00 AM – 12:00 PM
EST
Registration
Location: The Foyer
9:00 AM – 10:00 AM
EST
Harnessing Regulatory Intelligence for Global Compliance
9:00 AM – 10:00 AM
EST
Harnessing Regulatory Intelligence for Global Compliance
Location: Concourse A
Presenter:
Rupali Gupta, Associate Director, Regulatory Affairs
– BD
Presenter:
Samhitha Mohan, Sr.Staff Regulatory Affairs Specialist
– BD
Presenter:
Divya Raman, JD, MS, PMP
– Teleflex
Medical Devices (includes IVDs)
9:00 AM – 10:00 AM
EST
Regulatory Precedent and Intelligence from Labels; What Insights Can You Unlock From The Humble Label?
9:00 AM – 10:00 AM
EST
Regulatory Precedent and Intelligence from Labels; What Insights Can You Unlock From The Humble Label?
Location: Concourse B
Presenter:
Sam Kay, Mpharm
– Basil Systems
Pharmaceuticals (includes Biologics)
10:00 AM – 10:30 AM
EST
Coffee and Refreshments Break
10:00 AM – 10:30 AM
EST
Coffee and Refreshments Break
Location: The Foyer
Supported by
10:30 AM – 11:30 AM
EST
Global Regulatory Trends
10:30 AM – 11:30 AM
EST
Global Regulatory Trends
Location: Concourse A
Presenter:
Amra Racic
– Veeva Systems
Presenter:
Josh Silverstein, NA
– Philips
Medical Devices (includes IVDs)
10:30 AM – 11:30 AM
EST
Monitoring Health Authority Websites for Labeling Updates: A Case Study of Reference Safety Information Reporting
10:30 AM – 11:30 AM
EST
Monitoring Health Authority Websites for Labeling Updates: A Case Study of Reference Safety Information Reporting
Location: Concourse B
Presenter:
Patrice Lynds, MSHS, RAC
– Pfizer
Pharmaceuticals (includes Biologics)
11:40 AM – 12:40 PM
EST
Driving Product Success with Strategic Regulatory Intelligence
11:40 AM – 12:40 PM
EST
Driving Product Success with Strategic Regulatory Intelligence
Location: Concourse A
Presenter:
Rupali Gupta, Associate Director, Regulatory Affairs
– BD
Presenter:
Samhitha Mohan, Sr.Staff Regulatory Affairs Specialist
– BD
Medical Devices (includes IVDs)
11:40 AM – 12:40 PM
EST
Harnessing the Power of Collaboration: Explore a unique therapeutic area (TA)-focused Regulatory Intelligence (RI) model
11:40 AM – 12:40 PM
EST
Harnessing the Power of Collaboration: Explore a Unique Therapeutic Area (TA)-Focused Regulatory Intelligence (RI) Model
Location: Concourse B
Presenter:
Yvette Lawal, MBA
– Astrazeneca
Presenter:
Rebecca Lipsitz, PhD
– Astrazeneca
Presenter:
Meena N. Muthiah, MS, MPH, RAC
– AstraZeneca
Pharmaceuticals (includes Biologics)
12:40 PM – 1:40 PM
EST
Lunch Break
12:40 PM – 1:40 PM
EST
Lunch Break
Location: Flight Deck
Supported by
1:40 PM – 2:40 PM
EST
Mastering the Art of Communication: Enhancing Regulatory Policy & Intelligence Dissemination Within Drug and Device Organizations
1:40 PM – 2:40 PM
EST
Mastering the Art of Communication: Enhancing Regulatory Policy & Intelligence Dissemination Within Drug and Device Organizations
Location: Concourse A
Presenter:
Patrick J. Frey, MPP
– Neurocrine Biosciences
Presenter:
Stephanie S. Kelly, JD, MS
– Kyowa Kirin
Moderator:
James Lindsay Cobbs, RPh
– Apath Nexus
Combined Track
1:40 PM – 2:40 PM
EST
Regulatory Intelligence Strategy
1:40 PM – 2:40 PM
EST
Regulatory Intelligence Strategy
Location: Concourse B
Presenter:
Insun Ho, Ph.D
– Regulatory Affairs / Abbott
Presenter:
Elayne Kimmett, MBA, CQA, RAC
– Regeneron
Combined Track
2:40 PM – 3:00 PM
EST
Coffee and Refreshments Break
2:40 PM – 3:00 PM
EST
Coffee and Refreshments Break
Location: The Foyer
Supported by
3:00 PM – 4:00 PM
EST
Closing Plenary: Empowering Decision-Making: The Role of Regulatory Intelligence Professionals in Evaluating Vendors and Solutions
3:00 PM – 4:00 PM
EST
Closing Plenary: Empowering Decision-Making: The Role of Regulatory Intelligence Professionals in Evaluating Vendors and Solutions
Location: Concourse A
Panelist:
Sam Kay, Mpharm
– Basil Systems
Panelist:
Amin Osmani, MSc
– Cedience Inc.
Panelist:
Elizabeth Rosenkrands Lange, MS, MPH
– EMD Serono/ Merck KGaA, Darmstadt, Germany
Panelist:
Chris J. Whalley, BA
– Pfizer
Moderator:
James Lindsay Cobbs, RPh
– Apath Nexus
Combined Track
.png)
.png)
.png)
.png)
.png)
