Company Info





Product Index
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WB1   Patient Registries: Current Opportunities, Challenges and Future Directions
WB2   Patient Reported Outcomes in the Pharmaceuticals
2323   Pediatric Clinical Studies for Pharmaceutical and Medical Device Products Conference
WB-7096   Pharma Regulatory Writing Webinar Series: Composition of Completed and Detailed CSRs and Narratives
WB-7108(A)   Pharmaceutical & Medical Device Advisory Committee Meeting Preparation & Management Series
WB-7108(B)   Pharmaceutical & Medical Device Advisory Committee Meeting Preparation & Management Series
2282   Pharmaceutical Procurement and Strategic Sourcing Conference
2271   Pharmaceutical Publication Planning and Management Conference
2266   Pharmaceutical Sample Compliance and Accountability Conference
WB-7148   Portfolio Management: Strategies for Device Development Selection
WB-7201   Positioning Online Training Content to Maximize Engagement, Retention and Return on Investment
WB-7262   Positively Impacting Localization through DITA/CMS Implementation
WB-7023   Post-Market Surveillance and Vigilance Requirements for EU IVDs
WB-7220   Practical Approaches for Managing Life Science Risks and Corruption in Asia
WB-7258   Practical Approaches to New Audit Formats Part 1: MDSAP
WB-7182   Practical Guidance and Best Practices for Developing and Maintaining Investigator Brochures
WB-7187   Practical Guidance for Implementing and Maintaining eMDR via ESubmitter
WB-7249   Practical Methods for Strengthening Risk Management Practices in Medical Device Sourcing
WB-7257   Practical Solutions for Medical Device Design History File (DHF) Construction and Maintenance
WB-7157   Pre Market Reimbursement Strategies for New Technologies
WB-7003   Pre- & Post- Market Adverse Event Reporting Requirements for European Device Trials
WB-7081   Primary Challenges in Supplier Quality Assurance: Change Control
WB-7120   Quantifying the Value of Quality/Patient Safety Improvement Initiatives – Calculating ROI
WB-7224   Recent Experiences with PD-L1 Companion Diagnostics and FDA interactions: A Positive Case Study
WB-7162   Recognizing the Importance of Managed Care Field Training and Pull Through Activities for Diagnostics
WB-7184   Redefining AMP: An Overview of the Final Rule and Strategies for Updating Government Price Reporting Processes to Latest Guidance
WB-7248   Reinforcing Quality Management Systems through Greater Alignment of ISO 13485:2016 & the EU MDR
WB-7138   Responding Effectively to FDA 483 Observations and Warning Letters
WB-7112   Scientific Publications and Transfer of Value Reporting
WB-7229   Software as a Medical Device (SaMD): Clinical Evaluation- New Guidance from FDA and Global Regulators
WB-7097   Software as a Medical Device: Anticipated Guidance Documents Highlight Ongoing Challenges in EU and US
WB-7228   Status Update- MDR Surprises and Key Regulatory Developments
2262   Strategic Medical Device New Product Development Conference
WB-7084   Strategies for Developing Sustainable Packaging for Medical Devices
WB-7180   Strategies for Maintaining Compliant Relationships with Advocacy Organizations
WB-7152   Strategies for Managing Trial Registration Requirements Compliantly and Efficiently
WB-7070   Strategies for Preparing a Comprehensive Letter of Intent (LOI) in EU Life Science M&A & Private Equity Transactions
WB-7202   Strategies for Successful Implementation & Support of Medical Communication in Emerging Markets
WB-7170   Strategies for Utilizing the De Novo Submission Pathway
WB-7001   Sunshine-Readiness: Key Considerations when Implementing an Aggregate Spend System
WB-7134   Technical Guidance for Designing Diagnostic Clinical Studies
WB-7073   Technical Standards and Guidance for FDA’s e-Copy Submission Program
WB-7086   The ‘Big’ Picture of eCTD Document Navigation
WB-7065   The Latest Developments in Europe’s Regulation of Medical Devices and Projections for 2014
WB-7121   The Power of Study Design: Clinical Outcome Studies vs Diagnostic Clinical Performance Studies
WB-7040   The Recall Challenge: Determining When to Conduct a Recall and Whether to Report It
WB-7256   The Total Marketing Approach: Novel Tactics to Drive Medical Device Value and Appeal to Hospitals
WB-7193   The World’s Fastest Growing Market: Preparing for the Regulatory Opportunities and Challenges in China
WB-7181   Thriving Under Administrative Pressures Through Organizational Aptitude
WB-7061   Tools and Techniques to Ensure Successful Outcomes in Clinical Device GCP Audits
WB1075   Training Pharmaceutical Quality Assurance Teams For Success
WB-7098   Translating Market-Access Awareness into Reimbursement Success: Making the Value Case
WB-7099   Unannounced Audit Best Practices and Notified Body Communications
WB-7100   Unannounced Audits of Medical Device Critical Subcontractors and Crucial Suppliers
WB-7094   Unannounced Audits: An Overview of the Commission Recommendation, Strategies for Preparing in Advance, and A Notified Body’s Experience to Date
WB-7158   Uncovering Career Path Development for Patient Advocacy
WB-7142   Understanding CFDA’s New Regulations on Device Manufacturing
WB-7062   Understanding Electronic Labeling Requirements for EU Medical Devices
WB-7194   Understanding EU Product Sampling Processes During an Unannounced Audit
WB-7046   Understanding Legal and Regulatory Developments in Off-label Promotion
WB-7167   Understanding the Brazilian Regulatory Environment for Medical Devices
WB-7211   Understanding the Intricacies of the Finalized EU IVD and Medical Device Regulation
WB-7093   Unique Device Identification (UDI): The Latest Developments and Preparation for Upcoming Deadlines
WB-7130   United Kingdom Device Reimbursement Case Study - Ensuring Qualified Patients Gain Access
WB-7091   Uniting Corporate Philanthropy and Advocacy Relations to Maximize Impact and Corporate Reputation
WB-7196   Update on the Drug Supply Chain Security Act
WB-7047   Updates on Avoiding Re-Inspection through the FDA’s 13485 Voluntary Audit Submission Pilot Program
WB-7090   Updates on Medical Device Post-Market Reporting Regulations
WB-7035   Using Information Management to Support Data Driven Actions in the Life Sciences Industry
WB-7056   Utilization Of Human Factors Engineering (HFE) Practices To Reduce Potential Adverse Events
WB-7188   Utilization of Special 510(k) Submissions- Pathway Benefits and Scenario Analysis
WB-7000   Utilizing GS1 Standards to Comply with FDA UDI Requirements
WB-7049   Utilizing GS1 Standards to Implement and Comply with FDA UDI Requirements
WB-7128   Utilizing Industry Advocates to Influence Positive Payor Support for Diagnostics
WB-7145   Utilizing Instructional Design to Build a Robust Physician Training System
WB-7125   Utilizing Risk Assessments to Determine Adequate Levels of On-site & Remote Monitoring
WB-7215   VAC Perspective on Evaluating Prospective Medical Devices
WB-7069   What You Need to Know: FDA Auditing in Medical Device Investigator Sponsored Studies
WB-7066   Working With Accountable Care Organizations: Creating a Better Understanding of an ACO’s Structure & Exploration of Future Implications on Adherence

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