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2269   10th Semi-Annual Medical Device Coverage and Reimbursement Conference
2270   11th Semi-Annual Medical Device Coverage and Reimbursement Conference
WB-7233   13485 2016 – Integrating Changes to Develop a Comprehensive Quality Management System
2163   2013 Device Coverage and Reimbursement Conference - All Presentations
2163B   2013 Device Reimbursement Conference - Breast Cancer Screening: Digital Mammography and Ultrasound Devices
2163A   2013 Device Reimbursement Conference - Case Study: Value Based Benefit Design in Surgical Medical Devices and How It Drove the Market
2163G   2013 Device Reimbursement Conference - Communicating Economic Value to Payers & Healthcare Providers: Delivering Tailored Value Messages across Markets on the iPad
2163Y   2013 Device Reimbursement Conference - Creative Approaches to Successfully Obtain a New CPT Code
2163K   2013 Device Reimbursement Conference - Cutting Edge Strategies to Meet Payer and Hospital Expectations
2163R   2013 Device Reimbursement Conference - Examination of Bundled Payments: Staying Current with Emerging CMS Reimbursement Models
2163C   2013 Device Reimbursement Conference - Fresh Insight on Durable Medical Equipments (DME) – Case Study Presentation
2163T   2013 Device Reimbursement Conference - Medicare Insight: Current Processes for Durable Medical Equipment, Prosthetics, Orthotics and Supplies
2163D   2013 Device Reimbursement Conference - Novel Strategies to Support Economic Value When Clinical Data Is Scarce
2163M   2013 Device Reimbursement Conference - Roundtable Discussion: Analyzing Expansion of ACOS and Anticipation of Cost Reduction
2163F   2013 Device Reimbursement Conference - Strategies to Profile Your Customers’ Market and Economic Status
2163I   2013 Device Reimbursement Conference - Understanding What Factors Lead To Unfavorable Assessments from HTAS
2163J   2013 Device Reimbursement Conference - When the Payer Is No Longer the Payer: Translating Economic Data to Influence Hospital Purchasing Decisions
2163Z   2013 Device Reimbursement Conference - Workshop: Gaining Insight on Challenges and Opportunities of Bundled Payments and ACOS
WB-7115   2014 Revision of Chinese Medical Device Regulations for Product Approval
2278   2015 Semi-Annual Medical Device Strategic Pricing Conference
2259   2nd Annual Customer Centric Medical Information Conference
2265   2nd Annual Innovative Medical Education Programs Conference
2257   2nd Annual Maximizing Medical Device Customer Support Operations Conference
2221   2nd Annual Medical Device Packaging: Innovations in Design and Testing Conference
2297   2nd Annual Medical Device Verification and Validation Conference
2227   2nd Semi-Annual Medical Device and Diagnostic Labeling Conference
2267   2nd Semi-Annual Pharmaceutical Strategic Pricing Conference
WB-7116   340B Drug Pricing Program Challenges & New Developments for Manufacturers
WB-7135   340B Program: The Duplicate Discount Prohibition and Upcoming HRSA Guidance
2165   3rd Annual European Investigator Initiated Studies
2290   3rd Annual Innovations in Clinical Data Management Conference
2291   3rd Annual Medical Device Product Management Conference
2288   3rd Semi-Annual Medical Device and Diagnostic Labeling Conference
2285   3rd Semi-Annual Medical Device Packaging: Innovations In Design and Testing Conference
2153   4th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference
2264   4th Annual European Device and Diagnostic Regulation Conference
2171   4th Annual Medical Device and Diagnostic Ethics and Compliance Conference
2249   4th Annual Regulatory Medical Writing for Product Approvals Conference
2253   4th Annual Regulatory Operations and Submissions Conference
2273   4th Annual Strengthening Patient Advocacy Relations Conference
WB-7183   510(k) Success: Crafting Persuasive Substantial Equivalence Arguments
2276   5th Annual Medical Device Global Regulatory Intelligence Conference
2258   5th Semi-Annual Managed Markets and Payer Marketing Strategies Conference
2279   6th Annual Diagnostic Quality Assurance Conference
2150   6th Annual European Medical Device Clinical Research Conference
2260   6th Semi-Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference
2275   6th Semi-Annual Managed Markets and Payer Marketing Strategies Conference
2281   6th Semi-Annual Medical Device Clinical Training and Education Conference
2208   7th Annual European Medical Device Clinical Research Conference
2268   7th Semi-Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference
2283   7th Semi-Annual Medical Device and Diagnostic Sales Training and Development Conference
2251   8th Annual European Medical Device Clinical Research Conference
WB-7063   A Foundational Overview of Diagnostic Coverage and Reimbursement in the US
WB-7139   A World Wide Medical Content Capability: Inter-Departmental Use of Standard Medical Content
WB-7203   Adding Value to Administrative Work to Elevate the Value of Executive Assistants
WB-7102   Addressing CAPA within a Device Quality System
WB-7007   Addressing Challenges in Developing Drug Delivery Systems: Navigating Regulatory Requirements in the US
WB-7048   An Overview of the Accountable Care Movement for Life Science Industry Professionals
WB-7164   Analyzing FDA Guidance to Develop Adequate Reprocessing Instructions for Devices
WB-7005   Analyzing the Complexities of IVD Clinical Sample Regulation in US Trials
WB-7072   Analyzing the Complexities of IVD Clinical Sample Regulations in US Trials
WB-7161   Analyzing the Effectiveness of Sales Training Programs to Ensure Learner Success
WB-7260   Application of Regulatory Guidance & Good Clinical Practices (GCP) to Ensure Clinical Data Integrity
WB-7008   Approaches to Combination Product Clinical Study Protocol Design and Execution
WB-7028   Authorship Guidelines for Life Science Medical Writers
WB-7168   Avoiding Advocacy Fatigue: Refreshing Initiatives to Stay Relevant in a Progressive Healthcare Environment
WB-7002   Avoiding Re-Inspection through FDAs 13485 Voluntary Audit Report Submission Pilot Program
WB-7078   Best Practices and Lessons Learned from a CIA: Training for Compliant Interactions with HCPs
WB-7265   Best Practices for Medical Device Human Factors Post-Market Surveillance Activities
WB-7237   Best Practices for Medical Device Reporting (MDR) Under FDA’s Final Guidance
WB-7177   Breaking Down Silos to Align Product Portfolio Management
WB-7107   Business Across Borders: The Impact of Culture on Supplier Quality
WB-7197   Calculating Total Cost of Ownership to Improve Strategic Sourcing Decisions
WB-7251   Case Study: First-Time Quality: Guiding a Contract Manufacturer to Eliminate Defects at the Source
WB-7206   Case Study: Utilizing Adult Learning as the Foundation for Clinical Education
WB-7117   Clarifying & Preparing for ISO 9001 Updates
WB-7190   Clarifying PAMA Requirements for Diagnostic Laboratory Reimbursement & Strategies for Demonstrating Compliance
WB-7059   Clinical Billing & Reimbursement During Medical Device Clinical Trials
2272   Clinical Research Transparency and Data Disclosure Strategies Conference
WB-7231   CMC Case Study: Best Practices in FDA Meeting Preparation Strategies
WB-7014   Coding and Payment for Oncology Diagnostics
WB-7159   Collaborating with Payers to Uphold Defined Pricing Structures through Viable Reimbursement Rates
WB-7140   Communicating Medical Information Services and Value to Health Care Providers
WB-7213   Compliance with General Data Protection Regulation (GDPR) Within Medtech
WB-7226   Conducting Successful Device Clinical Trials in China under New Good Clinical Practices (GCP) Guidance
WB-7085   Corruption and FCPA Violations in the Medical Device Industry
WB-7103   Creating a Winning Approach to Successful Validation
WB-7106   Current and Future Oversight and Regulation of Laboratory Developed Tests
WB-7259   Data Integrity and Compliance in Pharmaceutical Manufacturing
WB-7150   Deciphering Regulatory Guidance on Reusable Device Validation and Testing Methods
WB-7272   Decision Criteria: New FDA Guidance Impacting the Requirement for 510(K) Clearance of Modified Devices
WB-7141   Delivering the Training Value Proposition: Moving from 'Investment' to 'Outcomes'
WB-7147   Delivering the Value Proposition in EU Physician Clinical Training and Education
WB-7058   Design & Execution of Clinical Studies to Support Device Reimbursement and Market Access
WB-7083   Developing an Effective 510 (k) Application Strategy in a Resource Constrained Environment
WB-7175   Developing Integrated cGMPs and Regulatory Strategies for Combination Products
WB-7186   Development of a Product Strategy to Launch Efficiently and Successfully
WB-7216   Development of a Single CMC Dossier for Tier 1 Countries to Streamline Submissions
WB-7057   Development of Medical Device Patient Advocacy Relations
WB-7263   Digital Health Technologies: Navigating the Intersections of Innovation and Regulation
WB-7080   Discussing Trends in OPDP Enforcement Letters to Avoid Infractions
WB-7089   Drug Supply Chain Security Act: FDA & Industry Efforts for a More Secure Drug Supply Chain
WB-7236   Effective Strategies for Medical Writing Project Management
WB-7068   Emerging Diagnostic Technologies: Proving the Clinical Application through Gold Standard Data
WB-7114   Employee Competence, Awareness, and Training: Current Trends in Regulatory Compliance and Industry Best Practices
WB-7044   Engaging and Utilizing Digital Opinion Leaders in the Life Science Industry
WB-7039   Ensuring Adequate Process Implementation and Adherence in CAPA Systems
WB-7218   Ensuring Compliance and Quality in the Communication of Pharmaceutical Medical Information in Europe
WB-7219   Ensuring Compliance for PAMA Reimbursement Protocols for Clinical Laboratory Tests
WB-7153   Ensuring Compliance in Medical Device New Product Development
WB-7171   Ensuring Compliance with External Supply Chain Transparency for API Strategic Sourcing Teams
WB-7223   Ensuring Compliant Medical Device Promotion: Aligning Practices with FDA Expectations
WB-7246   Entering Italy with Medical Device Coverage: Clarifying Innovative Access Mechanisms
WB-7019   Establishing Role-Based Training For Diagnostics Employees
WB-7055   Ethicon Case Study: Post-Marketing Evidence Generation For Gastric Band in Morbid Obese Patient
WB-7051   European IVD Regulations and Risk Based Classification - An Overview for Global Quality Professionals
WB-7200   Evaluating Opportunities for Medical Device Strategic Sourcing in Mexico
WB-7214   Expanded Access Update – Developments at the FDA and Beyond
WB-7129   Exploring Options and Industry Implications for Regulating NGS Technologies
8028   Facility Tour & Cocktail Reception
WB3   FDA 510k Process for Medical Devices
WB7   FDA De Novo Process for IVD Companies
WB-7154   FDA Draft Guidance on the Acceptance of Foreign Clinical Data on Devices
WB-7082   FDA Draft Guidance: EAP Program & Premarket/Postmarket Data Collection for PMA’s
WB-7052   FDA Final Guidance for Mobile Medical Apps
WB-7245   FDA MDR Enforcement Actions: Best Practices for Strengthening MedWatch Form Writing and Reporting
WB-8   FDA PMA Process for IVD Companies
WB4   FDA PMA Process for Medical Devices
WB-7143   FDA Postmarket Surveillance Draft Guidance and Implications for Industry
WB-7217   FDA Postmarket Surveillance Final Guidance & Implications for Device Manufacturers
WB-7266   FDA Regulatory Due Diligence in Mergers and Acquisitions for Medical Device Companies
WB6   FDA Reporting for Medical Devices
WB5   FDA Reports of Corrections and Removals for Medical Devices
WB-7133   FDA Status Update on mHealth, Wellness, and Clinical Decision Support
WB-7254   FDA Utilization of Patient Preference Information in Regulatory Development & Decision Making
WB-7204   FDA-CMS Parallel Review Process: Reflection on the Pilot Program and Adapting to Expected Guidance
WB-7071   FDA’S Perspective on Auditing Investigator Sponsored Studies
WB-7105   Focus on Change Control Management in Updating QMS to Include Labeling Needs
WB-7126   Food Marketing Claims: The Role of the FTC
WB-7064   French Transparency Regulations: An Overview for the Life Science Industry
WB-7199   FSMA Update: Insights into Reforms and the Impact on Food Safety
WB-7212   Global Medical Device Registration: Impact of Changes to the EU MDR and Chinese GCP on Manufacturers
2295   Global Regulatory Affairs CMC: Chemistry, Manufacturing and Controls Conference
6000   Global UDI Intensive Workshop
WB-7209   Globalization of Medical Information: The Journey from a Local to a Global Model in Latin America – a Pfizer Case Study
WB-7136   Harmonizing Supplier Quality Practices Across Divisions within a Medical Device Company
WB-7087   Hospital Value Analysis Committee (VAC) Influences on Medical Device Reimbursement
WB-7155   How to Decide When a Modified Device Requires a 510(K) Clearance
WB-7225   How to Decide When a Modified Device Requires a 510(K) Clearance under New FDA Draft Guidances
WB-7239   HRSA Final Rule for 340B- New Requirements for Calculating Ceiling Prices & the New Reality of Civil Monetary Penalties
WB-7255   Identifying Adulterated Botanical Ingredients- A Framework to Protect Industry from Fraudulent Materials
WB-7252   Implementing MHRA’s New Guidance for Own Brand Labelling or ”Virtual Manufacturers”
WB-7271   Implementing New Responsibilities for Economic Operators under the EU MDR
WB-7067   Implementing Solutions for Key Behavioral Trends in Next Generation Adherence Programs
WB-7189   Important Changes to the Draft European IVD Regulation
WB-7074   Improving Sales Results – Three Critical Conversations Your Sales Team Must Master
WB-7149   Increasing Awareness of Medical Information Channels and Metrics for Measurement
WB-7166   Indian Medical Device Registration and Approval
WB-7244   Insight into Medical Device Registrations in Latin America: Brazil & Mexico
WB-7077   Insight into Proposed NEW EU Clinical Trial Regulation & Implications for Pharmaceutical & Medical Device Manufacturers
WB-7151   Integrating Medical Device Articles and Publications to Aid in Reimbursement and Payor Support
WB-7131   Integrating Peer-Reviewed Publications to Develop Compelling Diagnostic Dossiers
WB-7076   Integration of Learning Content Management System to Streamline the Transition to Mobile Learning
WB-7101   Integration of Quality Management Systems Across the Organization
WB-7020   Introduction to Medical Device Coverage & Reimbursement in Russian Markets
WB-7021   Introduction to Medical Device Reimbursement in Chinese Markets
WB-7227   Japanese Healthcare Labeling- Meeting Cultural and Regulatory Expectations by Localizing Translations
WB-7243   Key Postmarket Surveillance Considerations for Transitioning to the New EU Medical Device Regulation
WB-7242   Key Takeaways from FDA’s Draft Guidance on Communications Consistent with Labeling and Memorandum on Off-Label Communications
WB-7123   Labeling Standards and Policy for the Meat Industry
WB-7264   Leveraging KOL Expertise in Women’s Health: Aligning Pre-Launch Marketing Strategies with Thought Leadership
2284   Life Science Data Privacy Conference
WB-7060   Life Science Patient Advocacy Case Study: Establishing and Maintaining Collaborations with Patient Groups
WB-7253   Lifecycle Management: Updates and Insight on Post-Approval Changes, ICH Q12 Guidance and PAC iAM Activities
WB-7122   Long-Term Policy Implications of the Food Labeling and Similar Food Regulation
WB-7285   Maintaining Business Continuity in the Medical Device Industry during Brexit Uncertainty
WB-7127   Making Permissible Claims in the Labeling of Food Products
WB-7036   Managing Data Protection in Life Science Mobile Workforces
WB-7195   Managing the Complexities of a DSUR to Present a Comprehensive Review
WB-7222   MEDDEV 2.7.1 Rev 4: Implementing New Requirements for Clinical Evaluation Reports (CER)
WB-7240   Medical Affairs Case Study - Generating Real World Evidence for Medical Device Life Cycle Management
WB-7109   Medical Communication Transparency Reporting: CME Exemptions and Indirect Payments
WB-7024   Medical Device Clinical Study Requirements: New Changes Proposed by FDA for Foreign & U.S. Studies
2292   Medical Device Corporate Strategy: Mergers and Acquisitions Conference
WB-7050   Medical Device M&A: Current Due Diligence Issues including the Medical Device Tax and America Invents Act
WB-7241   Medical Device Quality Improvement: Implementing Postmarket Cybersecurity Programs Aligned with New FDA Guidelines
WB-7088   Medical Device Recall Best Practices: A Primer for Customer Service Teams
WB-7174   Medical Device Registration and Regulatory Approval Processes in Russia
WB-7207   Methods for Effective Execution & Support of Medical Communication in Brazil
WB-7104   Methods for Strengthening Medical Device Manufacturing Software Supplier Management
WB-7012   Navigating Coding Structures Using Next Generation Sequencing to Determine Reimbursement
WB-7169   Navigating Compliant Collaborations Between Pharma and Patient Support Groups
WB-7185   Navigating FDA Oversight of Laboratory Developed Tests During an Era of Uncertainty
WB-7095   New Contractual Arrangements with Notified Bodies and Suppliers
WB-7165   New Developments in 340B Program Guidance: Effect on Manufacturer Stakeholders
WB-7111   Off-Label Promotion For Medical Devices: Understanding, Assessing and Reducing the Risk
WB-7113   Open Payments: The Benefits of Aligning Across Organizations through Industry Coalitions and Cross-Sector Partnerships
WB-7281   Opportunities in ASC to Navigate the Future of Medical Device Reimbursement
WB-7250   Opportunities in the Asc to Navigate the Future of Medical Device Reimbursement - Value Based Contracting Strategies
WB-7132   Optimizing Call Centers to Improve Functionality and Increase Return on Investment

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