Conferences

 

Pharmaceutical and Biotech Gross-to-Net Conference

Increasing Accuracy of Gross-to-Net Forecasts through High Quality Data, Use of Automation & Technology, Alongside Greater Partnerships with Internal & External Stakeholders, Creating Transparency & Precision in Calculating Accruals, Rebates and Ensuring Forecast Accuracy

October 16-17, 2019 | Chicago, IL | HGI Chicago Downtown Magnificent Mile

12th Annual IVD Clinical & Regulatory Affairs Conference: East

Considerations while Navigating Regulatory Pathways for Novel IVD Tests, Companion Diagnostics, & Precision Medicine, Addressing Clinical Trial Design & Validation of Technological Advancements, with Insights on Challenging International Regulations including EU IVDR & Asian Regulatory Pathways

October 22-23, 2019 | Alexandria, VA | Hilton Alexandria Old Town

3rd Semi-Annual Medical Device Human Factors & Usability Engineering Conference: East

Aligning Human Factors & Usability Studies with Expanding Requirements including the Lifecycle of FDA Regulatory Documentation, CE Mark Changes in Light of EU MDR and ISO 62366, Designing and Conducting Comprehensive and Coherent Studies that Provide Accurate Use Data all while Propelling User Needs into the Forefront of Design & Development

October 22-23, 2019 | Alexandria, VA | Hilton Alexandria Old Town

European Medical Device Post-Market Clinical Evaluation Planning Conference

Developing & Implementing Robust Plans to Gather Compliant Post-Market Clinical Follow-Up Data, Practically Defining Clinical Evidence Based on Device Class & Acceptable Information, all while Sharing Solutions to Operational Challenges in Cost-Effective Data Collection

October 29-30, 2019 | Frankfurt, Germany | Le Meridien Frankfurt Hotel

5th Annual Global Pharmaceutical Regulatory Affairs CMC Conference

Employing Comprehensive Product Lifecycle Management Strategies such as Continued Monitoring of ICH Standards and Regulatory Requirements through to Stringent Supply Chain Change Control Processes to Ensure Compliant Pre-Market and Postmarket CMC Operations

October 29-30, 2019 | Philadelphia, PA | Sheraton Philadelphia University City Hotel

6th Semi-Annual Medical Device Sterilization Conference: East

Industry Collaboration and Consensus on Ethylene Oxide Residual Reduction, Risk-Based Approaches to Selection and Validation of Sterilization Modality to Meet Increasingly Complex Regulatory Requirements including FDA Parametric Release, Numerous ISO Standards and EU MDR

October 29-30, 2019 | Alexandria, VA | Sheraton Suites Old Town Alexandria

7th Annual Medical Device Product Management Conference

Exploring the Evolution of the Product Manager Role Brought about by the Increase of Global Regulatory Expectations, Strategic Need for Comprehensive Road Mapping Tools and Heightened Importance of Product Launch Initiatives

November 5-6, 2019 | Chicago, IL | HGI Chicago Downtown Magnificent Mile

Pharmaceutical and Biotech Digital Transformation Conference

Optimizing Digital Transformation Initiatives to Reach Defined Objectives, Effectively Engaging with Stakeholders to Lead an Organization-Wide Cultural Shift, all while Focusing Digitization Efforts on Greater Consumer Data Collection & Processing Capabilities

November 6-7, 2019 | Philadelphia, PA | Penn’s View Hotel

10th Semi-Annual EU Medical Device Regulatory Affairs Conference

Focus on the NB Designation Status & Timeline, Rationale for Prioritization of Specific Product Line Compliance with New Rules & Management of Remaining Tasks, all while Addressing Ongoing MDR Uncertainties in Finalizing the Updated Regulatory Strategy

November 13-14, 2019 | Brussels, Belgium | Park Inn by Radisson Brussels Airport

15th Semi-Annual Diagnostic Coverage and Reimbursement Conference: East

Practical Interpretation of Increasingly Differing Payer Requirements & Efficiently Reflecting Expectations in Clinical Strategies, Overcoming Challenges in Ensuring Maximum Reimbursement for Established & Novel Tests with the Ongoing Impact of PAMA & Fluctuating Diagnostic Rates, in addition to Grey Areas in Prior Authorization Processes

December 3-4, 2019 | Boston, MA | Hyatt Regency Boston Harbor

4th Annual EU Medical Device & Diagnostic Quality Management Conference

Ensuring QMS Preparedness in Light of the MDR & IVDR with a Focus on Economic Operator Compliance, Enhanced Supplier Control & Optimal Design of a Robust PMS Strategy, Successfully Managing International Audit Readiness, all while Digitalizing QMS Processes & Data

December 4-5, 2019 | Frankfurt, Germany

4th Annual Dietary Supplement Regulatory Strategy Conference

Navigating Regulatory Compliance for Dietary Supplements through NDI Filling Procedures and Appropriate Claims Substantiation, Reviewing the Current Status of CBD Regulations, and Analyzing Consumer Trends Ensuring Safe and Effective Supplement Distribution

December 4-5, 2019 | Arlington, VA

EU MDR: Quality System Alignment Conference: Chicago

Implementing Effective and Compliant Quality Management Procedures under the EU MDR through Analysis of Post Market Regulatory Requirements, Risk Mitigation throughout the Supply Chain and Increased Economic Operator Oversight

December 4-5, 2019 | Chicago, IL

4th Semi-Annual Medical Device Human Factors & Usability Engineering Conference: West

Aligning Human Factors & Usability Studies with Expanding Requirements including the Lifecycle of FDA Regulatory Documentation, CE Mark Changes in Light of EU MDR and ISO 62366, Designing and Conducting Comprehensive and Coherent Studies that Provide Accurate Use Data all while Propelling User Needs into the Forefront of Design & Development

December 10-11, 2019 | San Diego, CA | Andaz San Diego Hotel

7th Semi-Annual Medical Device Sterilization Conference: West

Industry Collaboration & Consensus on Ethylene Oxide Residual Reduction, Risk-Based Approaches to Selection & Validation of Sterilization Modality to Meet Increasingly Complex Regulatory Requirements including FDA Parametric Release, Numerous ISO Standards and EU MDR

December 10-11, 2019 | San Diego, CA | Andaz San Diego Hotel

13th Semi-Annual IVD Clinical & Regulatory Affairs Conference: West

Clarification of Regulatory Requirements for Companion Diagnostics and NGS, Insight into the Status of Laboratory Developed Test Specific Policies, all while Strategizing to Ensure Compliance with New European and Asian Market Rules

December 12-13, 2019 | San Diego, CA | Andaz San Diego Hotel

Regulatory Information Management Systems Conference

Aligning Regulatory Data and Information through Enhanced Integration & Utilization of Regulatory Information Management Systems which Support the Highest Levels of Data Integrity and Seamlessly Support Global Regulatory Documentation from throughout the Product Lifecycle

January 14-15, 2020 | Arlington, VA

6th Annual Medical Device Postmarket Surveillance Conference

Ensuring Long-term Product Quality and Efficacy through Streamlined Postmarket Surveillance Processes including Integration of eQMS for Complaint Intake, Employment of Stringent Postmarket Cybersecurity Strategies and Proactively Preparing for EU MDR Compliance

January 22-23, 2020 | Alexandria, VA

Medical Device Post Market Clinical Follow-up Conference

Aligning Post Market Clinical Research to Support Regulatory Demands, Generate Evidence to Meet Market Access & Reimbursement Goals through the Selection and Development of Appropriate,
Risk-Based Research Platforms which Deliver Data On-time and On-Budget

January 22-23, 2020 | Alexandria, VA

Pharmaceutical Risk Based Clinical Quality Assurance Conference

Developing Robust Clinical Trial Protocols through the Standardization of Data Driven Risk Assessment Models, Adequate CRO Oversight & Proper Documentation Practices to Match Regulatory Expectations & Ensure Quality by Design throughout the Clinical Process

February 4-5, 2020 | San Diego, CA

16th Semi-Annual Diagnostic Coverage and Reimbursement Conference: West

Practical Interpretation of Increasingly Differing Payer Requirements & Efficiently Reflecting Expectations in Clinical Strategies, Overcoming Challenges in Ensuring Maximum Reimbursement for Established & Novel Tests with the Ongoing Impact of PAMA & Fluctuating Diagnostic Rates, in addition to Grey Areas in Prior Authorization Processes

February 11-12, 2020 | San Diego, CA

7th Annual Food Labeling Regulatory Compliance Conference

Ensuring Continued Compliance with FDA Label Requirements amidst a Changing Regulatory and Industry Landscape, while Updating Claims based on Consumer Trends and Employing an Overall Science Based Approach

February 11-12, 2020 | Alexandria, VA

Medical Device Software Engineering Conference

Mastering Verification & Validation Challenges for Software as Medical Device as well as Embedded Software by Enhancing Testing Strategies throughout the Product Life Cycle, all while Deploying Agile Methodologies to Software Engineering & Streamlining Quality & Regulatory Compliance

February 25-26, 2020 | San Diego, CA

2nd Annual Combination Product Regulation Conference

Maintaining Compliance with Updated FDA Expectations and International Regulatory Requirements, while Collaborating throughout the Submission Process to Ensure Approval of Drug & Device Constituents, and Considerations for Post Market Reporting Requirements

March 4-5, 2020 | Arlington, VA

10th Annual Pharmaceutical Sales Training Conference

Leveraging Innovative Technologies to Enhance Engagement in Remote Learning | Measuring Effectiveness and Demonstrating Value of Sales Training Strategy | Developing Business Acumen in the Sales Force with a Focus on Reimbursement Knowledge

March, 2020 | Chicago, IL

12th Annual EU Medical Device Clinical Research Conference

Ensuring a Timely & Efficient Approach to Final Steps in Transitioning to MDR Compliant Clinical Strategies Including a Strong Focus on PMCF Requirements, all while Establishing Defined Study End-Points to Optimize Trial Design, Budgeting & Generation of Relevant Quality & Volume of Data

March, 2020 | Amsterdam, NL

13th Semi-Annual Medical Device Clinical Training & Education Conference: West

Tailoring Training Methods & Strategies to Engage Health Care Professionals through Innovative Strategies, Technology & Adaptive Adult Learning Methodologies while Providing Measurable Evaluation on Trainee Retention of Skills, Proficiency & ROI through Value-Driven Metrics

March 31 – April 1, 2020 | San Diego, CA

10th Annual Medical Device Supplier Quality Conference

Assessing and Designating Levels of Risk for a Variety of Suppliers, while Managing the Impact of Regulatory Requirements such as EU MDR, MDSAP, and ISO 13485:2016, in addition to Employing Collaborative Efforts to Validate Supplier Processes and Perform Qualification Audits

April 28-29, 2020 | Arlington, VA

10th Annual Medical Device and Diagnostic Labeling Conference

Streamlining & Optimizing Labeling Strategy in a Rapidly Evolving International Regulatory Environment with a Focus on Developing EU MDR & IVDR Compliant Labels, all while Enhancing Localization & Translation Processes, with the Goal of Reaching Operational Excellence through the Implementation of Impactful ELS, CMS & MDM Technology

May 6-7, 2020 | Chicago, IL

10th Annual Medical Device Packaging Conference

Exploring Robust Testing Methods of Medical Device Packaging, Reviewing Updates and Impact of ISO 11607 and EU MDR, Developing Confident Sampling Plans that Meet FDA Expectations, while Incorporating End User Feedback for Medical Device Packaging Design

May 6-7, 2020 | Chicago, IL

3rd Annual Pharmaceutical Portfolio Strategy and Management Conference

Aligning Asset Strategy & Operational Management to Ensure a Balanced Portfolio of Strong Product Candidates which Complement Commercial Offerings and Support the Overall Corporate Strategy through Optimized Leverage of Resources and Strategic Decision Making Supported by High-Level Data Analytics

May, 2020 | Philadelphia, PA

5th Annual Life Science Ethics and Compliance Training Conference

Reducing Compliance Risks through Effective Training Programs and Developing Specific Content Relevant to Each Internal Function and the Overall Organization, while Utilizing Available Resources to Design Innovative Courses in a Cost-Effective Manner

June, 2020 | Chicago, IL

16th Annual Medical Device Coverage and Reimbursement Conference

Aligning Reimbursement Strategies with CMS & Commercial Payer Requirements to Uphold Medical Necessities, Transition from Volume to Value Based Care, Leverage Existing Codes while Overcoming New Code Expectations and Encourage Growth in the Medical Device Industry

July, 2020 | Chicago, IL

5th Annual Medical Device Cybersecurity Risk Mitigation Conference

Ensuring Compliance with Regulatory Requirements and Industry Standards to Mitigate Cyber Risks and Continuously Improve Medical Device Security in addition to Collaborating and Sharing Responsibility between Health Delivery Organizations and Manufacturers

July, 2020 | Arlington, VA

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