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Invitation Only

Separate Ticket or Advanced Registration Required

Repeat Solutions Circle

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Monday, Oct 6th
8:30 AM - 4:00 PM EST
Preconference Workshop: Drug Development in the EU: Regulatory Standards, Supports, and New Approaches
Location/Room: 302
Workshop Leader: Andrea Laslop, MD – Malta Medicines Authority
Workshop Presenter: Karl-Heinz Huemer, PhD MD – khhconsult
Workshop Presenter: Sabine Haubenreisser, MSc, PhD, FRAPS – European Medicines Agency
Workshop Presenter: Daniela Drago, PhD, RAC, FRAPS – NDA Partners
Workshop Presenter: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority
Workshop Presenter: María Concepción Prieto Yerro, MD, PhD – Malta Medicines Authority
Pharmaceuticals (includes Biologics & Drugs)
Monday, Oct 6th
8:30 AM - 4:00 PM EST
Preconference Workshop: Locating and Analyzing Regulatory Precedent; Incorporating Research and Application Techniques in Strategic Regulatory Decision Making
Location/Room: 401
Workshop Leader: Linda F. Bowen, MSc, RAC US, RAC CDN, RAC EU, FRAPS – Temple University
Workshop Presenter: Chris J. Whalley – Pfizer
Workshop Presenter: Jeff MacDonald, PharmD – BeOne Medicines
Workshop Presenter: Aleksandr Merenkov, PharmD, MS, MBA – Genmab US
Workshop Presenter: Karen Zimm, RPh, MS, MBA, PhD, RAC – Temple University
Pharmaceuticals (includes Biologics & Drugs)
Tuesday, Oct 7th
8:30 AM - 4:00 PM EST
Preconference Workshop: AI Across Pharma and Devices: Navigating Innovation, Risk, and Compliance as Regulatory Professionals
Location/Room: 301
Workshop Leader: Aditi Khurana, CG MB MBA RAC – Summit Therapeutics
Workshop Presenter: Sam Rajkumar, RAC (Devices), CMQ/OE, MS, RN, BScN – Analog Devices
Workshop Presenter: Mihikaa Jain, MTM – Artos
Pharmaceuticals (includes Biologics & Drugs)
Tuesday, Oct 7th
8:30 AM - 4:00 PM EST
Preconference Workshop: Implement Changes to Approved Biologic Drug Manufacturing and Controls Using Risk-Based Regulatory Approaches
Location/Room: 406
Workshop Leader: Janmeet S. Anant, Regulatory Affairs Certification – Millipore Sigma
Workshop Presenter: Kavita Aiyer – Teva Pharmaceuticals
Pharmaceuticals (includes Biologics & Drugs)
Wednesday, Oct 8th
9:15 AM - 10:30 AM EST
Embracing the Age of Generative AI in Drug Development
Location/Room: 401
Presenter: Rudy Fuentes, PhD, RAC – Thermo Fisher Scientific
Presenter: Xinjiang Wu, PhD – Biogen
Presenter: Zach Weingarden, MSE – TrialAssure
Presenter (Remote): Florian Lasch, PhD – European Medicines Agency
Pharmaceuticals (includes Biologics & Drugs)
Wednesday, Oct 8th
9:15 AM - 10:30 AM EST
Enhancing Understanding of Biologic Variability Through Representation in Clinical Trials
Location/Room: 403
Moderator: Junyang Wang – EMD Serono
Presenter: Sarah Bentouati, PharmD, MSc – F. Hoffmann-La Roche Ltd
Presenter: Scott D. Schliebner, MPH – Novotech
Presenter: Vinay Pai, PhD, MBA – HealthTequity
Presenter: Suzanna Masartis – Community Liver Alliance
Presenter (Remote): Neha S. Londono – Pfizer
Pharmaceuticals (includes Biologics & Drugs)
Wednesday, Oct 8th
9:15 AM - 10:30 AM EST
Expedited Programs to Support the Development and Approval of Products for Unmet Medical Needs
Location/Room: 317
Presenter: Hagit Marchaim, PhD, MBA – HMC-regulation
Presenter: Philip Johnson, MBA – Ipsen
Presenter: James Lindsay Cobbs, RPh – Apath Nexus
Presenter (Remote): Fabien Carre, MSc – European Medicines Agency
Pharmaceuticals (includes Biologics & Drugs)
Wednesday, Oct 8th
10:35 AM - 11:05 AM EST
Solutions Circle (A): Regulatory Consulting-Ins and Outs
Location/Room: Exhibit Hall: Solutions Circle A
Facilitator: Kamana Singh – APS Pharma Solutions, LLC
Repeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)
Wednesday, Oct 8th
11:15 AM - 11:45 AM EST
Solutions Circle (B): Evolving Health Authority Thinking on Overall Survival for Oncology Trials
Location/Room: Exhibit Hall: Solutions Circle B
Facilitator: Bhargavi Pandit, BPharm, MS, RAC – Galderma
Repeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)
Wednesday, Oct 8th
1:00 PM - 2:00 PM EST
Challenges in Precision Medicine Product Development
Location/Room: 304
Session Leader: Maritza Ward, RAC – Pearl Pathways
Panelist: Doug Rains – Quantigen Biosciences
Panelist: Christine Gathers, RAC – À propos Regulatory Consulting Services
Panelist: Amanda Jensen, PhD – Genentech
Panelist (Remote): Antonella Baron, PhD – European Medicines Agency
Pharmaceuticals (includes Biologics & Drugs)
Wednesday, Oct 8th
1:00 PM - 2:00 PM EST
ICH Q1: 20 Years of Stability and a 2025 Transformation
Location/Room: 401
Presenter: Mohamed K. Ghorab – Parexel
Presenter (Remote): Elisa Pedone, PhD – European Medicines Agency
Pharmaceuticals (includes Biologics & Drugs)
Wednesday, Oct 8th
1:00 PM - 2:00 PM EST
Navigating the New Frontier: The Impact of Joint Clinical Assessments on Regulatory Affairs
Location/Room: 317
Presenter: Antje Behring, PhD – payer GmbH
Presenter (Remote): Michael Berntgen, PhD MDRA – European Medicines Agency
Presenter (Remote): Niklas Hedberg – TLV
Pharmaceuticals (includes Biologics & Drugs)
Wednesday, Oct 8th
2:15 PM - 3:15 PM EST
Accelerating Cell Therapy Development: Challenges and Opportunities
Location/Room: 401
Presenter: Yoshiko Stowell, PhD – Kenai Therapeutics
Presenter: Kok-Seong Lim, BPharm, PhD – -
Presenter (Remote): Zehra Tosun, PhD – U.S. Food and Drug Administration (FDA)
Pharmaceuticals (includes Biologics & Drugs)
Wednesday, Oct 8th
2:15 PM - 3:15 PM EST
Data Science and Management: Strength of Collaborations for Evidence Generation To Advance Medical Product Development
Location/Room: 304
Moderator: Huong Huynh, PhD – Critical Path Institute
Presenter: Ramona Walls, PhD – Critical Path Institute
Presenter: Danielle Boyce, MPH, DPA – ALS Therapy Development Institute
Presenter (Remote): Pierpaolo Moscariello – European Medicines Agency
Presenter (Remote): Ruihao Huang – U.S. Food and Drug Administration (FDA)
Pharmaceuticals (includes Biologics & Drugs)
Wednesday, Oct 8th
2:15 PM - 3:15 PM EST
FDA Forecast: What the FDA has Planned in 2026 for Pharmaceuticals and Biotechnology Products
Location/Room: 317
Panelist: Khushboo Sharma, MBA, RAC – Accumulus Synergy
Panelist: Derrick J. Gingery – Citeline - The Pink Sheet
Panelist: Alexander Gaffney, MS, RAC – AgencyIQ
Panelist: Cartier C. Esham, PhD – Esham Strategies LLC
Pharmaceuticals (includes Biologics & Drugs)
Wednesday, Oct 8th
4:30 PM - 5:30 PM EST
Enhancing the Collection, Communication, and Use of Patient Experience Data: Current Status and Next Steps
Location/Room: 317
Moderator: Barbara Brophy, MPH – PhRMA - Pharmaceutical Research & Manufacturers of America
Presenter: Pujita Vaidya, MPH – Sanofi
Presenter: Brett Hauber, PhD – Pfizer
Presenter: Robyn Bent, MS, BSN – U.S. Food and Drug Administration (FDA)
Presenter: Jason Harris – National Psoriasis Foundation
Pharmaceuticals (includes Biologics & Drugs)
Wednesday, Oct 8th
4:30 PM - 5:30 PM EST
International Reliance and Work-Sharing Programs: Speeding up Access to Medicines
Location/Room: 401
Presenter: Kirsten Messmer, PhD, RAC – KM Intel LLC
Presenter: Gracie Sheng, MS – Genentech
Presenter: Corinne S. de Vries, MA MSc PhD FISPE – European Medicines Agency
Presenter: Tasneem Fatima Keshavji – MHRA
Pharmaceuticals (includes Biologics & Drugs)
Wednesday, Oct 8th
4:30 PM - 5:30 PM EST
Navigating the Future of mRNA Therapeutics-Exploration of Draft Guidelines, Industry Challenges, and Expert Insights
Location/Room: 403
Presenter: Kamana Singh – APS Pharma Solutions, LLC
Presenter: Ye Zhang, MD. PhD – Arcturus Therapeutics
Presenter (Remote): Ka-Wai Wan, PhD – Medicines and Healthcare products Regulatory Agency (MHRA), UK
Pharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
9:15 AM - 10:30 AM EST
Building Resilient Drug Supply Chains: Advanced Strategies for Critical Shortage Prevention
Location/Room: 317
Session Leader: Carrie Harney, JD – USP - US Pharmacopeia
Presenter (Remote): Athanasios Lapatinas – European Medicines Agency
Presenter: Demetra Macheras, MBA – AbbVie
Pharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
9:15 AM - 10:30 AM EST
Companion Diagnostics - Roles and Perspectives of the Therapeutic Product Manufacturer and Diagnostic Partner - Best Practices for Effective Collaboration
Location/Room: 401
Presenter: Joshua D. Levin, Ph.D – GSK
Presenter: Jennifer Dickey, PhD – Labcorp
Presenter: Andrea Renninger – Daiichi Sankyo, Inc.
Presenter (Remote): Ana Trullás Jimeno – European Medicines Agency
Pharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
9:15 AM - 10:30 AM EST
Reliance and Worksharing Procedures: Industry and Regulator Perspectives
Location/Room: 403
Presenter: Guriqbal Singh – Regweb Consulting Services Inc.
Presenter: Peter Fry – QbD Group
Presenter: Corinne S. de Vries, MA MSc PhD FISPE – European Medicines Agency
Pharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
10:35 AM - 11:05 AM EST
Solutions Circle (A): Regulatory Consulting-Ins and Outs
Location/Room: Exhibit Hall: Solutions Circle A
Facilitator: Ann M. Lucchesi, MS – LuCore Regulatory Services LLC
Repeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
11:15 AM - 11:45 AM EST
Solutions Circle (B): Evolving Health Authority thinking on Overall Survival for Oncology Trials
Location/Room: Exhibit Hall: Solutions Circle B
Facilitator: Bhargavi Pandit, BPharm, MS, RAC – Galderma
Repeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
11:55 AM - 12:25 PM EST
Solutions Circle (B): Enhancing Understanding of Biologic Variability Through Representation in Clinical Trials
Location/Room: Exhibit Hall: Solutions Circle B
Facilitator: Junyang Wang – EMD Serono
Solutions Circle: Continuing the ConversationPharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
1:00 PM - 2:00 PM EST
Engineering Safety and Effectiveness for Regulatory Excellence in Drug-Device Combination Products
Location/Room: 317
Presenter: Fubin Wu, MS – GessNet
Presenter: James Wabby, MTOPRA – AbbVie
Presenter: Darin S. Oppenheimer, DRSc, FRAPS, RAC, PMP – BD
Presenter: Sasha Smiljanic – Lilly
Moderator: Pooja Kartik – medtechnik
Pharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
1:00 PM - 2:00 PM EST
Global Oncology Drug Advisory Mechanisms: Insights from FDA’s ODAC and International Counterparts
Location/Room: 304
Presenter: Aditi Khurana, CG MB MBA RAC – Summit Therapeutics
Presenter: James Lindsay Cobbs, RPh – Apath Nexus
Presenter: Amanda Conti – AgencyIQ
Presenter (Remote): Francesco Pignatti – European Medicines Agency
Pharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
1:00 PM - 2:00 PM EST
Optimizing Strategies to Support Implementation of the Global Post-Approval Changes in the Product Life Cycle
Location/Room: 401
Presenter: Arundhati Sengupta, MS, MBA, RAC – Mirum Pharmaceuticals
Presenter (Remote): Evdokia Korakianiti – European Medicines Agency
Pharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
3:15 PM - 4:15 PM EST
China Drug Regulatory Pathways: 2025 Current Landscape & Global Integration Perspectives
Location/Room: 406
Presenter: Hamish King, RAC, LLB – Cisema
Presenter: Wenny Du – Amgen
Presenter: Xiao Michelle Meng, PhD – OBI Pharma
Pharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
3:15 PM - 4:15 PM EST
Is it Time for a New Patient Experience Data Section in Product Labeling?
Location/Room: 304
Session Leader: Allison Martin, MS – Sanofi
Panelist: Sabine Haubenreisser, MSc, PhD, FRAPS – European Medicines Agency
Panelist: Elizabeth Lange, MS, MPH – EMD Serono/ Merck KGaA, Darmstadt, Germany
Panelist: Aviva Rosenberg, JD – Gaucher Community Alliance
Panelist: Robyn Bent, MS, BSN – U.S. Food and Drug Administration (FDA)
Pharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
3:15 PM - 4:15 PM EST
Recent Developments in Nitrosamines
Location/Room: 401
Presenter: Dawen Kou – Genentech
Presenter (Remote): Robert N. Bream, MSci MA PhD – European Medicines Agency
Pharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
4:30 PM - 5:30 PM EST
Expanding Global Biosimilar Access: Converging Regulatory Approaches with Analytical Insights
Location/Room: 401
Session Leader: Chaitanya K. Koduri, BDS, MTech – United States Pharmacopeia
Presenter (Remote): Peter Richardson, Ph. D. – European Medicines Agency
Panelist (Remote): Cristina Ausin – U.S. Food and Drug Administration (FDA)
Presenter: Cassia Roesler – Agência Nacional de Vigilância Sanitária (ANVISA)
Pharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
4:30 PM - 5:30 PM EST
Pediatric Regulatory Strategies and Trends in the EU and US
Location/Room: 403
Session Leader: João Duarte – Ipsen
Presenter: Martine Zimmermann, PharmD – INVENTIVA
Presenter: Karl-Heinz Huemer, PhD MD – khhconsult
Presenter (Remote): Dominik Karres – European Medicines Agency
Pharmaceuticals (includes Biologics & Drugs)
Thursday, Oct 9th
4:30 PM - 5:30 PM EST
Transforming Medication Access: Using Technology and FDA’s New NDA Pathway Empowers Patient Options
Location/Room: 317
Presenter: Paul A. Wardle, MA, MMath – Klick
Presenter: Aleks Lyons, BaSc, BSc – Klick Consulting
Presenter (Remote): Elisabeth Walther, PharmD, JD – U.S. Food and Drug Administration (FDA)
Presenter (Remote): Theresa Michele, MD – U.S. Food and Drug Administration (FDA)
Pharmaceuticals (includes Biologics & Drugs)