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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
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