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Wednesday, Sep 18th
10:35 AM – 11:05 AM PDT
Solution Circle (A): How to Prepare for a Successful FDA Q-sub
Location/Room: Exhibit Hall: Solutions Circles Area (A)
Facilitator: Lucy Tan – Abbott
Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Sep 18th
10:35 AM – 11:05 AM PDT
Solution Circle (B): Is this AI/ML Software Application a Medical device? Applying FDA Guidance Documents and On-Line Resources
Location/Room: Exhibit Hall: Solutions Circles Area (B)
Facilitator: Alex Friedman, PhD, RAC – Beckman Coulter
Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Sep 18th
10:35 AM – 11:05 AM PDT
Solution Circle (C): Leveraging Dual RAC Certification to become an Expert in Enhancing the Success of Combination Product Development.
Location/Room: Exhibit Hall: Solutions Circles Area (C)
Facilitator: Charles Nnabuife, B.Pharm, MBA, RAC-Drugs – Veristat Inc
Exhibit Hall: Solutions CircleOther
Wednesday, Sep 18th
10:35 AM – 11:05 AM PDT
Solution Circle (D): Maximizing the Potential of Meetings with the FDA
Location/Room: Exhibit Hall: Solutions Circles Area (D)
Facilitator: Hagit Marchaim, PhD – HMC-regulation; Dr. Hagit Marchaim RA and Drug Development Consulting
Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
Wednesday, Sep 18th
11:10 AM – 11:40 AM PDT
Solution Circle (A): Evaluating the Quality of Real-World Evidence Used to Support Regulatory Decision-Making for Medical Devices
Location/Room: Exhibit Hall: Solutions Circles Area (A)
Facilitator: Michelle Kavin, PhD, PA-C – Johnson and Johnson
Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Sep 18th
11:10 AM – 11:40 AM PDT
Solution Circle (B): Strategies on Tackling Clinical Data Gaps Between Different Designs of Medical Devices (B):
Location/Room: Exhibit Hall: Solutions Circles Area (B)
Facilitator: Matthias Fink, MD – Akra Team Inc.
Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Sep 18th
11:10 AM – 11:40 AM PDT
Solution Circle (C): The Right Balance Between Business, Science, and Regulation in Managing Supply Chains
Location/Room: Exhibit Hall: Solutions Circles Area (C)
Facilitator: Lopa Bakrania, PhD, RAC – Biohaven Pharmaceuticals
Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
Wednesday, Sep 18th
11:45 AM – 12:15 PM PDT
Solution Circle (A): Career Pathways in Regulatory Affairs
Location/Room: Exhibit Hall: Solutions Circles Area (A)
Facilitator: Jay Patel, MS – KPMG
Exhibit Hall: Solutions CircleOther
Wednesday, Sep 18th
11:45 AM – 12:15 PM PDT
Solution Circle (B): Establishing a Regulatory Talent Pipeline Strategy for Industry 4.0
Location/Room: Exhibit Hall: Solutions Circles Area (B)
Facilitator: Filsun Moussa, MBA, PMP – Medtronic
Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Sep 18th
11:45 AM – 12:15 PM PDT
Solution Circle (C): Phase and Product Appropriate Regulatory Strategies in Impurity Characterizations and Controls
Location/Room: Exhibit Hall: Solutions Circles Area (C)
Facilitator: Hai Wang, PhD – El Vista Consulting LLC
Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
Wednesday, Sep 18th
11:45 AM – 12:15 PM PDT
Solution Circle (D): Post-Market 510(k) and De Novo Change Management: Cinderella Strategies for Keeping Your House in Order
Location/Room: Exhibit Hall: Solutions Circles Area (D)
Facilitator: Kathy Herzog, BSME – DuVal & Associates, P.A.
Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Sep 18th
12:20 PM – 12:50 PM PDT
Solution Circle (A): LDT, RUO, IVD: What Regulatory Status for Tests Used in European Clinical Trial?
Location/Room: Exhibit Hall: Solutions Circles Area (A)
Facilitator: Christèle East – Namsa
Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Sep 18th
12:20 PM – 12:50 PM PDT
Solution Circle (B): Orphan Drug Approval FDA / EMA - What are the Benefits? What is the Process?
Location/Room: Exhibit Hall: Solutions Circles Area (B)
Facilitator: Mark A. Di Cioccio – Team Consulting
Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
Wednesday, Sep 18th
4:00 PM – 4:30 PM PDT
Solution Circle (A): AI's Transformative Impact on CMC in Pharmaceuticals
Location/Room: Exhibit Hall: Solutions Circles Area (A)
Facilitator: Anusha Saripalli – Neuron 23
Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
Wednesday, Sep 18th
4:00 PM – 4:30 PM PDT
Solution Circle (B): Clinical Decision Support Software vs. Software as a Medical Device
Location/Room: Exhibit Hall: Solutions Circles Area (B)
Facilitator: Laura Szkolar-Sienkiewicz, PhD, PMP, RAC – Microsoft
Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Wednesday, Sep 18th
4:00 PM – 4:30 PM PDT
Solution Circle (C): Navigating the New Era of Regulatory Affairs: Technology as a Catalyst for Transformation
Location/Room: Exhibit Hall: Solutions Circles Area (C)
Facilitator: Gregory L. Palagi, PMP. CSM, DASM, SSM – Integrated Project Management
Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
Thursday, Sep 19th
10:35 AM – 11:05 AM PDT
Solution Circle (A): How to Break Through the Regulatory Glass Ceiling and Get Hired!
Location/Room: Exhibit Hall: Solutions Circles Area (A)
Facilitator: Ritam Priya, BA, MBA – Novarum MDRQ Consulting
Exhibit Hall: Solutions CircleOther
Thursday, Sep 19th
10:35 AM – 11:05 AM PDT
Solution Circle (B): National Registrations and Other National Differences in the EU
Location/Room: Exhibit Hall: Solutions Circles Area (B)
Facilitator: Ludger J. Moeller – MDSS GmbH
Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Sep 19th
10:35 AM – 11:05 AM PDT
Solution Circle (C): Submission of Implantable Medical Devices in Brazil: ANVISA's Class III and IV Requirements
Location/Room: Exhibit Hall: Solutions Circles Area (C)
Facilitator: Patricia Luchiari Verrone – Vera Rosas Group
Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Sep 19th
10:35 AM – 11:05 AM PDT
Solution Circle (D): The Impact of Regulatory Control Measures on Access to Opioid Analgesics used for Pain Management in Botswana
Location/Room: Exhibit Hall: Solutions Circles Area (D)
Facilitator: Tshetsana Senau – Botswana Medicines Regulatory Authority
Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
Thursday, Sep 19th
11:10 AM – 11:40 AM PDT
Solution Circle (A): ADCs CMC – Regulatory Overreach or as Easy as ABC?
Location/Room: Exhibit Hall: Solutions Circles Area (A)
Facilitator: Michael Craig, BSc Pharm MPSI – Parexel Regulatory Consulting
Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
Thursday, Sep 19th
11:10 AM – 11:40 AM PDT
Solution Circle (B): Diversity in Clinical Trials
Location/Room: Exhibit Hall: Solutions Circles Area (B)
Facilitator: Anagha Shende, MBBS, MD – Lexicon Pharmaceuticals Inc.
Exhibit Hall: Solutions CircleOther
Thursday, Sep 19th
11:10 AM – 11:40 AM PDT
Solution Circle (C): Health Authority Audit and Inspection 101: Best Practices for Research Organizations
Location/Room: Exhibit Hall: Solutions Circles Area (C)
Facilitator: Olivia A. Seale, PMP, MBA, MS Pharmacology – Integrated Project Management
Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
Thursday, Sep 19th
11:10 AM – 11:40 AM PDT
Solution Circle (D): PCCP - Predetermined Change Control Plan - Strategy With Case Studies for Medical Devices
Location/Room: Exhibit Hall: Solutions Circles Area (D)
Facilitator: Abhineet Johri – Siemens Healthineers
Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Sep 19th
11:45 AM – 12:15 PM PDT
Solution Circle (A): China Drug Master Files: Latest Points to Know for Pharma Manufacturers
Location/Room: Exhibit Hall: Solutions Circles Area (A)
Facilitator: Hamish King, RAC, LLB – Cisema
Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
Thursday, Sep 19th
11:45 AM – 12:15 PM PDT
Solution Circle (C): Transformative Trends: Navigating the Evolving Regulatory Path for Laboratory Developed Tests
Location/Room: Exhibit Hall: Solutions Circles Area (C)
Facilitator: Ayse Demircan
Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Sep 19th
12:20 PM – 12:50 PM PDT
Solution Circle (A): Charting the Course: Interactive Breakout Session on Navigating FDA Communication
Location/Room: Exhibit Hall: Solutions Circles Area (A)
Facilitator: Hilary A. Baldwin – Eximis Surgical
Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Sep 19th
12:20 PM – 12:50 PM PDT
Solution Circle (B): USP’s Nitrosamines Exchange: Accelerating Pharmaceutical Quality Strategies
Location/Room: Exhibit Hall: Solutions Circles Area (B)
Facilitator: Naiffer Romero, MSc MPH – U.S. Pharmacopeia
Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
Thursday, Sep 19th
12:20 PM – 12:50 PM PDT
Solutions Circle (C): Failure is Not an Option: How to Avoid and Recover from an IND Clinical Hold
Location/Room: Exhibit Hall: Solutions Circles Area (C)
Facilitator: Ben McLaughlin, MSE – Amylaza Consulting, LLC
Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
Thursday, Sep 19th
2:30 PM – 3:00 PM PDT
Solution Circle (A): Navigating Regulatory Pathways: When to Submit a Special 510(k) vs. Internal Letter-to-File for Device Changes (Bo
Location/Room: Exhibit Hall: Solutions Circles Area (A)
Facilitator: Crew J. Weunski, M.S., RAC-Devices – MediView XR, Inc.
Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
Thursday, Sep 19th
2:30 PM – 3:00 PM PDT
Solution Circle (B): Taking your Skills to the Next Level: Transform your Career
Location/Room: Exhibit Hall: Solutions Circles Area (B)
Facilitator: Kiran Gulati, MBA, Exemplar Lead Auditor – UCSC Silicon Valley Extension
Exhibit Hall: Solutions CircleOther