Solutions Circles (Located in Exhibit Hall)
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- Solutions Circles (Located in Exhibit Hall)
Solutions Circles
Located in the Exhibit Hall, Solutions Circles are a place where collaboration reigns. These 30-minute sessions, led by industry experts, provide you with the opportunity to dive into thought-provoking topics, tackle regulatory challenges specific to your domain, or bounce ideas off fellow professionals - all within a smaller group environment. Entrance to Solutions Circles is on a first-come, first-served basis, and space is limited, so it is encouraged to arrive early. A waiting area will be provided to allow entrance to sessions as others leave.
*Program and facilitators subject to change. Please check back frequently for updates.
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Wednesday, Oct 4th
10:45 AM – 11:15 AM EDTSolutions Circle: A Roadmap of Expedited Pathways in Europe - The Fast for the CuriousLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Parexel International
Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
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Wednesday, Oct 4th
10:45 AM – 11:15 AM EDTSolutions Circle: Biosimilar Regulations in Middle East - Challenges and Proposed SolutionsLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Regweb Consulting Services Inc.
Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
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Wednesday, Oct 4th
10:45 AM – 11:15 AM EDTSolutions Circle: eCTD Module 3, How Much Detail Do I Submit?Location/Room: Exhibit Hall: Solutions Circles
Facilitator: – Certara Drug Development Solutions
Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
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Wednesday, Oct 4th
10:45 AM – 11:15 AM EDTSolutions Circle: How Soon Can I Implement This? "Navigating FDA Submissions and Review Logistics: A One-Stop GuideLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Pharnext
Facilitator: – CMC-RX Consulting
Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
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Wednesday, Oct 4th
11:25 AM – 11:55 AM EDTSolutions Circle: 5 Ways that an RA Department Will be Impacted by IDMP Data StandardsLocation/Room: Exhibit Hall: Solutions Circles
Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
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Wednesday, Oct 4th
11:25 AM – 11:55 AM EDTSolutions Circle: Enabling Earlier Access to Medicines in Latin America by Rationalizing Legalization RequirementsLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Roche
Facilitator: – Merck KGaA
Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
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Wednesday, Oct 4th
11:25 AM – 11:55 AM EDTSolutions Circle: Q&A on the EU General Pharmaceutical Legislation RevisionLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Alexion, AstraZeneca Rare Disease
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Wednesday, Oct 4th
11:25 AM – 11:55 AM EDTSolutions Circle: Regulatory Strategy for Market Entry to China for Drug Master Filing (DMF)Location/Room: Exhibit Hall: Solutions Circles
Facilitator: – Cisema
Facilitator: – Cisema
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Wednesday, Oct 4th
12:05 PM – 12:35 PM EDTSolutions Circle: Medical Device EU MDR Lessons Learned with Two Different Notified BodiesLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Abbott
Facilitator: – Abbott
Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
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Wednesday, Oct 4th
12:05 PM – 12:35 PM EDTSolutions Circle: Methodologies for Building a Software Predetermined Change Control Plan and Algorithm Change Plan for AI/MLLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Hogan Lovells LLP
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Wednesday, Oct 4th
12:05 PM – 12:35 PM EDTSolutions Circle: Sourcing Comparators and Other Study Drugs for Global Clinical TrialsLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Genentech, Inc.
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Wednesday, Oct 4th
12:05 PM – 12:35 PM EDTSolutions Circle: Strategies for Holistic Labeling: Information Consolidation, Process Orchestration, Intelligent Automation & Resource AugmentationLocation/Room: Exhibit Hall: Solutions Circles
Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
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Wednesday, Oct 4th
12:45 PM – 1:15 PM EDTSolutions Circle: Annex XVI State of PlayLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – DNV Product Assurance AS
Presenter: – BSI
Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
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Wednesday, Oct 4th
12:45 PM – 1:15 PM EDTSolutions Circle: Getting it Right the First Time - Where Regulatory and Design Intersect; Accuracy/Acceptance CriteriaLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Qserve Group US
Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
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Wednesday, Oct 4th
12:45 PM – 1:15 PM EDTSolutions Circle: Regulatory Intelligence Solutions CircleLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Lifescan
Facilitator: – Lifescan
Solutions CircleSkill Building
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Wednesday, Oct 4th
12:45 PM – 1:15 PM EDTSolutions Circle: US Combination Products Updates: What You Need to Know!Location/Room: Exhibit Hall: Solutions Circles
Facilitator: – MEDIcept
Facilitator: – MEDIcept
Solutions CircleBroad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)
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Thursday, Oct 5th
10:45 AM – 11:15 AM EDTSolutions Circle: EU/MDR State of PlayLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – TÜV SÜD
Facilitator: – Akra Team GmbH
Facilitator: – Akra Team GmbH
Facilitator: – Qservegroup
Facilitator: – BSI
Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters
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Thursday, Oct 5th
10:45 AM – 11:15 AM EDTSolutions Circle: Pediatric Drug Development: Failure is not an OptionLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – IAA Consulting LLC
Facilitator: – khhconsulting
Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters
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Thursday, Oct 5th
10:45 AM – 11:15 AM EDTSolutions Circle: Regulatory Trends and Opportunities for Drug Delivery Combination ProductsLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Genentech and Roche
Facilitator: – Genentech
Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters
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Thursday, Oct 5th
10:45 AM – 11:15 AM EDTSolutions Circle: What you need to know about the EU-Clinical Trials RegulationLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Worldwide Clinical Trials
Facilitator: – Worldwide Clinical Trials
Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters
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Thursday, Oct 5th
11:25 AM – 11:55 AM EDTSolutions Circle: Deep Dive into Labeling OperationsLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Desai RA Consultants, LLC
Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters
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Thursday, Oct 5th
11:25 AM – 11:55 AM EDTSolutions Circle: FDA Expectations for Digital Health Tools in Decentralized Clinical TrialsLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – EMD Serono
Facilitator: – Novo Nordisk
Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters
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Thursday, Oct 5th
11:25 AM – 11:55 AM EDTSolutions Circle: How to Improve Your Regulatory Interactions by Practicing Speaking and Active Listening SkillsLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Neuron23, Inc.
Facilitator: – Integrated Project Management Company, Inc.
Solutions CircleSkill Building
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Thursday, Oct 5th
11:25 AM – 11:55 AM EDTSolutions Circle: Trends on Orphan and Pediatric Regulatory FrameworksLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Alexion, AstraZeneca Rare Disease
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Thursday, Oct 5th
12:05 PM – 12:35 PM EDTSolutions Circle: Notified Bodies: IVDR implementation Ask me AnythingLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – DEKRA
Facilitator: – GMED Certification Division
Facilitator: – BSI Group The Netherlands B.V.
Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters
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Thursday, Oct 5th
12:05 PM – 12:35 PM EDTSolutions Circle: The eSTAR and I: Getting to Know the eSTAR Templates for FDA SubmissionsLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – DuVal & Associates, P.A.
Facilitator: – DuVal & Associates, P.A.
Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters
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Thursday, Oct 5th
12:05 PM – 12:35 PM EDTSolutions Circle: The Journey to RAC!Location/Room: Exhibit Hall: Solutions Circles
Facilitator: – Integrated Project Management
Facilitator: – Integrated Project Management, Inc.
Facilitator: – RAPS
Solutions CircleSkill Building
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Thursday, Oct 5th
12:05 PM – 12:35 PM EDTSolutions Circle: Transparent, Translucent, and Opaque: How Global Health Authorities Make Information Publicly AccessibleLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Seattle Genetics
Solutions CircleSkill Building
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Thursday, Oct 5th
12:45 PM – 1:15 PM EDTSolutions Circle: Notified Bodies: IVDR implementation Ask me AnythingLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – mi-CE consultancy
Facilitator: – NSAI
Facilitator: – TÜV SÜD America Inc.
Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters
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Thursday, Oct 5th
12:45 PM – 1:15 PM EDTSolutions Circle: Using Situational Leadership to Manage Yourself and OthersLocation/Room: Exhibit Hall: Solutions Circles
Facilitator: – Quality and Regulatory Expert Partners, LLC
Solutions CircleSkill Building
