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Mahapatra, Soumya
Essenvia
Sponsored Presentation: Crossing the eSTAR Chasm: How to Transition to FDA’s Mandatory 510(k) eSTAR Submission Process
Location/Room:Exhibit Hall: Ignite! Stage (Booth 623)
Soumya Mahapatra
Favorite
Maloney, Rani
Integrated Project Management
Solutions Circle: The Journey to RAC!
Location/Room:Exhibit Hall: Solutions Circles
Rani Maloney
Favorite
Sponsored Presentation: Drive on the Regulatory Autobahn – Stretch Your Team with No Speed Limit
Location/Room:Exhibit Hall: Discover! Stage (Booth 123)
Rani Maloney
Favorite
Mandaokar, Saumya
USC
Student Capstone Poster Display: Clinical Paradigms in Immune Checkpoint Inhibitors: Pembrolizumab, Durvalumab, and Atezoliuzmab
Location/Room:Exhibit Hall: Career Central (Booth 633)
Saumya Mandaokar
Favorite
Student Capstone Poster Display: Clinical Paradigms in Immune Checkpoint Inhibitors: Pembrolizumab, Durvalumab, and Atezoliuzmab
Location/Room:Exhibit Hall: Career Central (Booth 633)
Saumya Mandaokar
Favorite
Marcal, Anabela
European Medicines Agency
Conversations That Matter - Interactions with Health Authorities: Drugs, Biologics and Combination Products
Location/Room:511E
Anabela Marcal
Favorite
Health Authority Forum: European Medicines Agency (EMA)
Location/Room:510B
Anabela Marcal
Favorite
Lessons on the EU-Clinical Trials Regulation
Location/Room:511F
Anabela Marcal
Favorite
Marchaim, Hagit
HMC-Regulation
What are the Requirements for an IND Submission?
Location/Room:510B
Hagit Marchaim
Favorite
Marks, Peter
United States Food and Drug Administration
Conversations That Matter - Interactions with Health Authorities: Drugs, Biologics and Combination Products
Location/Room:511E
Peter Marks
Favorite
Health Authority Forum: CBER & CDER - FDA’s Center for Biologics Evaluation and Research (CBER) & Center for Drug Evaluation and Research (CDER)
Location/Room:510B
Peter Marks
Favorite
Martin, Jewell
BioMarin Pharmaceuticals, Inc.
Actionable Steps to Meeting Regulatory and Ethical Considerations in Clinical Trial Diversity
Location/Room:513D
Jewell Martin
Favorite
Ensuring Patient Registries Support Regulatory Decision-Making
Location/Room:510B
Jewell Martin
Favorite
Massoud, Alexandra
Exact Sciences
Transforming Patient Engagement in Medical Technologies' Evolving Regulatory Landscape
Location/Room:510B
Alexandra Massoud
Favorite
Mayer-Nicolai, Christine
Merck KGaA, Darmstadt, Germany
Challenges in Implementation of IVDR Requirements for CDx Clinical Performance Studies
Location/Room:513F
Christine Mayer-Nicolai
Favorite
Plenary Session: RAPS Patient-Centered Health Award Presentation and Panel Discussion: Progressing Patient-Centered Health Through Collaboration: A TransCelerate Multi-Stakeholder Panel
Location/Room:220 B
Christine Mayer-Nicolai
Favorite
McBride, Linda
IAA Consulting LLC
Health Authority Forum: CBER & CDER - FDA’s Center for Biologics Evaluation and Research (CBER) & Center for Drug Evaluation and Research (CDER)
Location/Room:510B
Linda McBride
Favorite
Pediatric Drug Development: Failure is not an Option
Location/Room:513B
Linda McBride
Favorite
RAPS Store Stage: Meet the Authors - Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective
Location/Room:RAPS Store Stage (Level 2 Registration Foyer)
Linda McBride
Favorite
Solutions Circle: Pediatric Drug Development: Failure is not an Option
Location/Room:Exhibit Hall: Solutions Circles
Linda McBride
Favorite
McDole-Russell, Monika
Medtronic Endoscopy
Seven Key Qualities of a Successful Regulatory Leader and How to Develop Them
Location/Room:513F
Monika McDole-Russell
Favorite
Understand the Evolving Role of Real World Evidence
Location/Room:513B
Monika McDole-Russell
Favorite
McMaster, Owen
Food and Drug Administration
Considerations for Cannabidiol Product Development: The Regulatory Landscape and Safety Concerns.
Location/Room:513F
Owen McMaster
Favorite
McMillan, Robin
Abbott
What can Legacy Manufacturers Learn from Effective PMS and PMPF Implementation in Order to Prepare to Become IVDR compliant?
Location/Room:510A
Robin McMillan
Favorite
McMoil, Bill
Regulatory Affairs Professionals Society (RAPS)
Financial Acumen for Regulatory Affairs
Location/Room:513F
Bill McMoil
Favorite
RAPS Convergence 2023 Welcome & Opening Plenary Session: The Futuristic Regulatory Professional
Location/Room:220B
Bill McMoil
Favorite
Mead, Douglass
CP Pathways LLC
Drug-Led Combination Products - Submission Guidance and Contents
Location/Room:511D
Douglass Mead
Favorite
Mead, Rachel
BSI Group
Common Pitfalls in Manufacturer Technical Documentation Submissions to Notified Bodies; Ways to Overcome These.
Location/Room:511F
Rachel Mead
Favorite
Mendelsohn, Jesse
Model N
The Inflation Reduction Act and Beyond: Impacts of the Evolving Reimbursement Landscape on Drug Development
Location/Room:511D
Jesse Mendelsohn
Favorite
Messmer, Kirsten
POLITICO’s AgencyIQ
Navigating Global Regulatory Frameworks for Cell and Gene Therapy Development
Location/Room:513D
Kirsten Messmer
Favorite
Michel, Sarah
Velvet Chainsaw Consulting
RAPS Convergence 2023 Welcome & Opening Plenary Session: The Futuristic Regulatory Professional
Location/Room:220B
Sarah Michel
Favorite
Middleton, Rosanne
Lifescan
Solutions Circle: Regulatory Intelligence Solutions Circle
Location/Room:Exhibit Hall: Solutions Circles
Rosanne Middleton
Favorite
Millet, Stephane
Acolad Life Sciences
Sponsored Presentation: Global SSCP/SSP Implementation: Navigating the Challenges, Solutions, and Best Practices
Location/Room:Exhibit Hall: Discover! Stage (Booth 123)
Stephane Millet
Favorite
Mitchell, Renee
Boston Scientific
Transforming Patient Engagement in Medical Technologies' Evolving Regulatory Landscape
Location/Room:510B
Renee Mitchell
Favorite
Moeller, Ludger
MDSS GmbH
Sponsored Presentation: Synergies for the EU Authorised Representative, UK Responsible Person and Swiss Authorised Representative
Location/Room:Exhibit Hall: Discover! Stage (Booth 123)
Ludger Moeller
Favorite
Momonoi, Yoko
Takeda Pharmaceuticals
Navigating the Unique Complexities of CMC Challenges for Cell Therapies
Location/Room:511F
Yoko Momonoi
Favorite
Moon, Linda
BSI Group
Sponsored Presentation: Sustainability: potential challenges and solutions for the MedTech industry, Notified Bodies and auditing organizations.
Location/Room:Exhibit Hall: Discover! Stage (Booth 123)
Linda Moon
Favorite
Morel, Keith
Qserve Group
PRRC – A New EU Requirement
Location/Room:510A
Keith Morel
Favorite
Servicing Medical Devices – What Parts or Components SIGNIFICANTLY Change the Performance or Safety (Art 23)
Location/Room:510A
Keith Morel
Favorite
Morrison, Nancy
RQM+
Predetermined Change Control Plans (PCCPS) are Now Codified in FDORA - What should you do?
Location/Room:511F
Nancy Morrison
Favorite
Motta, Daniëlle
Qserve Group BV
Career Development Session for Students
Location/Room:513F
Daniëlle Motta
Favorite
Tackling a Whirlwind of Uncertainties: Lessons Learned on UK Market Access
Location/Room:510A
Daniëlle Motta
Favorite
