Browse by Title

Type here to filter the list

A
A Strategic Approach: Best Practices for Commenting on Draft FDA Guidance Documents for Drug and Device Companies
Favorite

Gopal Abbineni, MS, PhD (he/him/his) – Bayer ### 2277708###Presenter###Director###Bayer###
Presenter: Gopal Abbineni, MS, PhD (he/him/his) – Bayer
### he/him/his @@@ Andrew J. Emmett, RAC, MPH (he/him/his) – Pfizer ### 2316019###Presenter###Executive Director, US Regulatory Policy & Global Intelligence###Pfizer###
Presenter: Andrew J. Emmett, RAC, MPH (he/him/his) – Pfizer
### he/him/his
Advancing Policy Initiatives: The Regulatory Policy Value of Drug and Device Companies' Participation in Trade Associations and Industry Consortia
Favorite

Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC ### 609884###Presenter###Principal Consultant###Salditt Regulatory Consulting LLC###
Presenter: Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC
### @@@ Stephanie S. Kelly, JD, MS – Kyowa Kirin ### 2289417###Presenter###GRA, Global Head of Regulatory Intelligence and Policy ###Kyowa Kirin###
Presenter: Stephanie S. Kelly, JD, MS – Kyowa Kirin
###
C
Closing Plenary: Embracing the Digital Revolution: Applying AI and ML Technology within the Regulatory Policy & Intelligence Functions of Drug and Device Companies
Favorite

Chris J. Whalley, BA – Pfizer ### 2129420###Moderator###Director, Regulatory Intelligence###Pfizer###
Moderator: Chris J. Whalley, BA – Pfizer
### @@@ Bradley M. Thompson, MBA, JD, RAC – Epstein, Becker & Green ### 1005443###Panelist###Attorney###Epstein, Becker & Green###
Panelist: Bradley M. Thompson, MBA, JD, RAC – Epstein, Becker & Green
### @@@ Sam Kay, Mpharm (he/him/his) – Basil Systems ### 2289418###Panelist###VP, Pharma###Basil Systems###
Panelist: Sam Kay, Mpharm (he/him/his) – Basil Systems
### he/him/his @@@ Gopal Abbineni, MS, PhD (he/him/his) – Bayer ### 2277708###Panelist###Director###Bayer###
Panelist: Gopal Abbineni, MS, PhD (he/him/his) – Bayer
### he/him/his @@@ Elizabeth Rosenkrands Lange, MS, MPH (she/her/hers) – EMD Serono/ Merck KGaA, Darmstadt, Germany ### 2316021###Panelist###Senior Director/Head of US Global Regulatory & Scientific Policy###EMD Serono/ Merck KGaA, Darmstadt, Germany###
Panelist: Elizabeth Rosenkrands Lange, MS, MPH (she/her/hers) – EMD Serono/ Merck KGaA, Darmstadt, Germany
### she/her/hers
D
Designing and Maintaining a Robust Regulatory Intelligence Program
Favorite

Amra Racic – Veeva Systems ### 535477###Presenter###Sr. Director Global Government Affairs###Veeva Systems###
Presenter: Amra Racic – Veeva Systems
### @@@ Josh Silverstein, PhD (he/him/his) – Philips ### 2311833###Presenter###Director###Philips###
Presenter: Josh Silverstein, PhD (he/him/his) – Philips
### he/him/his
Driving Strategic Value: Establishing KPIs to Advocate for a Dedicated Regulatory Policy & Intelligence Team in Drug and Device Companies
Favorite

Linda F. Bowen, MSc, FRAPS (she/her/hers) – Pfizer ### 551690###Presenter###Chief of Staff, Oncology Global Regulatory Strategy###Pfizer###
Presenter: Linda F. Bowen, MSc, FRAPS (she/her/hers) – Pfizer
### she/her/hers @@@ Brad Spring (he/him/his) – Roche Diagnostics ### 2288481###Presenter###Global Head - Regulatory Policy & Intelligence###Roche Diagnostics###
Presenter: Brad Spring (he/him/his) – Roche Diagnostics
### he/him/his
H
Harnessing Regulatory Intelligence: Supporting Medical Device Development and Approval Pathway Strategies
Favorite

Melissa Walker, MS, RAC, FRAPS – Graematter, Inc. ### 609472###Presenter###President & CTO###Graematter, Inc.###
Presenter: Melissa Walker, MS, RAC, FRAPS – Graematter, Inc.
### @@@ Brad Spring (he/him/his) – Roche Diagnostics ### 2288481###Presenter###Global Head - Regulatory Policy & Intelligence###Roche Diagnostics###
Presenter: Brad Spring (he/him/his) – Roche Diagnostics
### he/him/his
Harnessing Regulatory Intelligence: Supporting Drug Regulatory Strategies Across the Product Lifecycle
Favorite

Stephanie S. Kelly, JD, MS – Kyowa Kirin ### 2289417###Presenter###GRA, Global Head of Regulatory Intelligence and Policy ###Kyowa Kirin###
Presenter: Stephanie S. Kelly, JD, MS – Kyowa Kirin
### @@@ Brandy Proctor, MS (she/her/hers) – GSK ### 2278888###Presenter###Regulatory Policy Manager###GSK###
Presenter: Brandy Proctor, MS (she/her/hers) – GSK
### she/her/hers
Hidden Gems: Discovering Regulatory Intelligence Within Your Records
Favorite

Patterson Shafer – FTI Consulting ### 2129434###Presenter###Managing Director###FTI Consulting###
Presenter: Patterson Shafer – FTI Consulting
###
Homegrown Regulatory Intelligence Tools in the Drugs and Biologics Space
Favorite

Jeff MacDonald, PharmD (he/him/his) – BeiGene ### 2290094###Presenter###Associate Directory, Global Regulatory Policy and Intelligence###BeiGene###
Presenter: Jeff MacDonald, PharmD (he/him/his) – BeiGene
### he/him/his @@@ Chris J. Whalley, BA – Pfizer ### 2129420###Presenter###Director, Regulatory Intelligence###Pfizer###
Presenter: Chris J. Whalley, BA – Pfizer
###
L
Locating and Analyzing Regulatory Precedent for Drugs and Biologics
Favorite

Linda F. Bowen, MSc, FRAPS (she/her/hers) – Pfizer ### 551690###Presenter###Chief of Staff, Oncology Global Regulatory Strategy###Pfizer###
Presenter: Linda F. Bowen, MSc, FRAPS (she/her/hers) – Pfizer
### she/her/hers @@@ Chris J. Whalley, BA – Pfizer ### 2129420###Presenter###Director, Regulatory Intelligence###Pfizer###
Presenter: Chris J. Whalley, BA – Pfizer
###
M
Mastering the Art of Communication: Enhancing Regulatory Policy & Intelligence Dissemination within Drug and Device Organizations
Favorite

Linda F. Bowen, MSc, FRAPS (she/her/hers) – Pfizer ### 551690###Moderator###Chief of Staff, Oncology Global Regulatory Strategy###Pfizer###
Moderator: Linda F. Bowen, MSc, FRAPS (she/her/hers) – Pfizer
### she/her/hers @@@ James Lindsay Cobbs, RPh (he/him/his) – BeiGene ### 2277840###Presenter###Regulatory Policy Head, GRPI###BeiGene###
Presenter: James Lindsay Cobbs, RPh (he/him/his) – BeiGene
### he/him/his @@@ Donielle Johnson (she/her/hers) – JRC ### 1428960###Presenter###Regulatory Strategy Consultant###JRC###
Presenter: Donielle Johnson (she/her/hers) – JRC
### she/her/hers
Medical Device Hot Topics and Troubleshooting Q&A
Favorite

Melissa Walker, MS, RAC, FRAPS – Graematter, Inc. ### 609472###Moderator###President & CTO###Graematter, Inc.###
Moderator: Melissa Walker, MS, RAC, FRAPS – Graematter, Inc.
### @@@ Laura DiAngelo, MPH (she/her/hers) – POLITICO's AgencyIQ ### 1417843###Panelist###Director, Research###POLITICO's AgencyIQ###
Panelist: Laura DiAngelo, MPH (she/her/hers) – POLITICO's AgencyIQ
### she/her/hers @@@ Diane Wurzburger, JD, RAC (she/her/hers) – GE HealthCare ### 2313527###Panelist###Vice President, Regulatory, Quality & Global Policy###GE HealthCare###
Panelist: Diane Wurzburger, JD, RAC (she/her/hers) – GE HealthCare
### she/her/hers
N
Navigating the Complex Landscape: Understanding the Impact of New Guidance and Laws on Drug Development Companies
Favorite

Alexander Gaffney, MS, RAC (he/him/his) – AgencyIQ ### 1729641###Presenter###Executive Director, Regulatory Policy and Intelligence###AgencyIQ###
Presenter: Alexander Gaffney, MS, RAC (he/him/his) – AgencyIQ
### he/him/his @@@ James Lindsay Cobbs, RPh (he/him/his) – BeiGene ### 2277840###Presenter###Regulatory Policy Head, GRPI###BeiGene###
Presenter: James Lindsay Cobbs, RPh (he/him/his) – BeiGene
### he/him/his
Navigating the Complex Landscape: Understanding the Impact of New Guidance and Laws on Medical Device Companies
Favorite

Amra Racic – Veeva Systems ### 535477###Presenter###Sr. Director Global Government Affairs###Veeva Systems###
Presenter: Amra Racic – Veeva Systems
### @@@ Nicole Smith – Philips ### 2289420###Presenter######Philips###
Presenter: Nicole Smith – Philips
### @@@ Laura DiAngelo, MPH (she/her/hers) – POLITICO's AgencyIQ ### 1417843###Presenter###Director, Research###POLITICO's AgencyIQ###
Presenter: Laura DiAngelo, MPH (she/her/hers) – POLITICO's AgencyIQ
### she/her/hers
O
Opening Plenary: Preparing for the Next Round of User Fee Negotiations
Favorite

Alexander Gaffney, MS, RAC (he/him/his) – AgencyIQ ### 1729641###Moderator###Executive Director, Regulatory Policy and Intelligence###AgencyIQ###
Moderator: Alexander Gaffney, MS, RAC (he/him/his) – AgencyIQ
### he/him/his @@@ Philip Desjardins, JD – Arnold & Porter ### 2290084###Panelist###Partner###Arnold & Porter###
Panelist: Philip Desjardins, JD – Arnold & Porter
### @@@ Jeffrey Francer, JD, MPP (he/him/his) – Eli Lilly and Company ### 2300633###Panelist###Vice President, Head of Global Regulatory Policy and Strategy###Eli Lilly and Company###
Panelist: Jeffrey Francer, JD, MPP (he/him/his) – Eli Lilly and Company
### he/him/his @@@ Stephen Mason – AuRIC Strategies ### 2307972###Panelist###Founding Partner###AuRIC Strategies###
Panelist: Stephen Mason – AuRIC Strategies
### @@@ Lucy Vereshchagina, PhD (she/her/hers) – PhRMA ### 2309861###Panelist###Executive Vice President###PhRMA###
Panelist: Lucy Vereshchagina, PhD (she/her/hers) – PhRMA
### she/her/hers
P
Paving Your Path in Regulatory Policy & Intelligence: Skill Development and Transition Strategies for Drug and Device Professionals
Favorite

Linda F. Bowen, MSc, FRAPS (she/her/hers) – Pfizer ### 551690###Moderator###Chief of Staff, Oncology Global Regulatory Strategy###Pfizer###
Moderator: Linda F. Bowen, MSc, FRAPS (she/her/hers) – Pfizer
### she/her/hers @@@ Tony E. Catka, PhD (he/him/his) – Ionis Pharmaceuticals ### 2289421###Panelist###Director Regulatory Intelligence###Ionis Pharmaceuticals###
Panelist: Tony E. Catka, PhD (he/him/his) – Ionis Pharmaceuticals
### he/him/his @@@ Donielle Johnson (she/her/hers) – JRC ### 1428960###Panelist###Regulatory Strategy Consultant###JRC###
Panelist: Donielle Johnson (she/her/hers) – JRC
### she/her/hers
S
Staying Ahead of the Curve: The Nuts and Bolts of Monitoring and Disseminating External Regulatory Agency News and Publications in Drug and Device Companies
Favorite

Chris J. Whalley, BA – Pfizer ### 2129420###Presenter###Director, Regulatory Intelligence###Pfizer###
Presenter: Chris J. Whalley, BA – Pfizer
### @@@ Alexander Gaffney, MS, RAC (he/him/his) – AgencyIQ ### 1729641###Presenter###Executive Director, Regulatory Policy and Intelligence###AgencyIQ###
Presenter: Alexander Gaffney, MS, RAC (he/him/his) – AgencyIQ
### he/him/his