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Xtalks Medical Device

Medical Device Webinars

There are a wide range of topics covered under the following medical device webinars - from comparisons of medical device and drug research, in depth analyses of market potentials for medical devices in emerging markets, to discussions of the medical device regulatory environment and technologies to help you achieve regulatory compliance. If the term medical devices is too broad, don’t forget, you can search this page using Ctrl+F(PC), or Command-F(Mac), search entire webinar catalog of webinars using the search bar, or, browse through our other topics.
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Upcoming Medical Device Webinars
October 31, 2017
How Leveraging an Asia-Pacific Network Can Create Regional Efficiencies in Clinical Supply Management

In this webinar, our featured speaker will explore how to leverage the major clinical supply centers of China, Singapore and Japan to support clinical trials within the Asia-Pacific region for both local and global study sponsors.
November 3, 2017
Building Smart Biomedical Devices Using Glass, Lasers, Sensors, and Chips

This webinar will explain where Glass Core Technology will lead out customers to new products with a higher level of integration and more innovative features that result in smart biomedical devices and other emerging technologies.
November 8, 2017
Delivering Efficiencies via the Functional Service Provider Model for Investigator Payments

The speakers will discuss some of the best practices and crucial elements for executing successful FSP engagements specifically for site payments.
November 29, 2017
Achieving Operational Excellence in the Lab

Join this webinar to find out how Bayer uses E-WorkBook to improve lab practices, increase laboratory efficiency and build a laboratory environment suited for business needs both now and in the future.
November 30, 2017
The Pharma Life Cycle: Plagued with Integration and Data Management Challenges, or Opportunities?

Learn how to liberate complex data throughout the pharma life cycle to enable innovation as well as sound and timely decision-making.
 

Future Medical Device Industry Webinars From

 
Archived Medical Device Webinars


Using Early Economic Models in Developing your Evidence Strategy

Join the speakers as they discuss an approach to evidence-generation strategies in drug and medical device development that enables integrated teams to develop and implement targeted and effective value propositions.

Beware the Hidden Costs of Conducting Clinical Trials: Understanding the Landmines and How to Avoid Them

In this webinar, the speakers will explore four areas that can dramatically increase the cost of your clinical program and offer insight into elimination and control of hidden costs through the use of a cardiovascular-based case study.

Outcomes-Based Agreements and Innovative Contracting for Biopharmaceuticals: Where Is The Market Moving?

Viewers will get a deeper understanding of the changing contracting landscape and to learn ways to leverage new and innovative approaches to improve the commercial success of your biopharmaceutical products

Medical Devices: Advancing Bioabsorbable Scaffolds with Polymer Technology

Bioabsorbable vascular scaffolds (BRS) have been clinically shown to afford restored vasomotion, late luminal enlargement, and reduced angina; all benefits of a new vascular restoration therapy that is expected to improve the life of many patients

Medical Devices: The Role of Clinical Endpoint Committees in Medical Device Trials

This webinar will discuss the value of clinical endpoint committees in medical device evaluation programs and explore the process of organizing, managing, and implementing a centralized adjudication process for standardizing study endpoints

Medical Devices: Reviewing Regulatory Changes in the US and EU

This webinar will discuss steps to ensure regulatory compliance and an uninterrupted supply of medical devices in the marketplace, and share insight and best practices from experience in navigating US and global regulations on medical device development.

Understanding Medical Device Regulatory Pathways in China and Japan

This webinar will help viewers understand the most recent and significant regulatory shifts in China and Japan including new product classifications, how to successfully prepare for the process of category registration, the best-fit submission framework to reduce development costs and expedite market introduction timelines, and identify the appropriate development strategy for optimal results.

Digital Transformation in the Clinical Trial Process: Increasing Patient Enrollment and Patient Data Exchange

Join the speakers to discover ways to leverage the digital transformation in pharma to stimulate greater and faster recruitment as well as improve patient and research data harmonization and exchange.

Using Early Economic Models in Developing your Evidence Strategy

Join us to learn best practices for developing early economic models to inform key strategic decisions.
EU IVD Regulations: Top Five Changes for Medical Device Manufacturers to Consider

Better understand the significant changes that IVD manufacturers should prepare for now in order to be successful under the new regulation.
Respiratory Endpoints, Scientific Leadership and the Asia-Pacific Region

In this live webinar, the speakers will outline both the importance of a coherent endpoint strategy as well as the importance of leveraging scientific leadership early-on in trial design.
Optimise Your Medical Publications and Avoid “Predatory Journals"

Join the panel to learn tips and tools to enhance your medical publication efforts and avoid so-called “predatory journals".
Serialization for Late Starters – With Live Industry Research Results

Attend this webinar to get up to speed with serialization regulations quickly and effectively for long term compliance & success.
Technology Solutions for Late Phase Research: Optimising Real World Data Assets

Join this webinar to learn how technological innovation can be applied to late phase research studies and how the smart application of that technology can enhance use of real world data (RWD) assets.
A Holistic Understanding of the Patient Journey Using Multiple Data Sources

This webinar will provide viewers with insight into how to develop a successful patient journey analysis that will yield actionable insights.
Clinical Trial Considerations in Cerebral Protection for TAVR Patients

This webinar explores the potential for EPDs as well as factors Novella Clinical and Medical Metrics believe sponsors should consider when developing or using EPDs in clinical trials. The speakers will examine study design, endpoints and imaging methods.
Developing a Biological Safety Evaluation

This webinar will cover the broad scope of developing a biological safety evaluations and how to assess the biocompatibility of device and process changes.
Predict and Act on Site Risks With Data-Driven Insights
Part 2 of Series "Four Steps to Shorten Your Clinical Trials with Informatics"

This series explores proven ways to develop go/no-go insights faster so clinical development teams can get submission-ready faster, reduce the risk of a rejected submission or potential market withdrawal, and optimize data provisioning, aggregation and review.
Assess Your Compliance Readiness: Tips for DSCSA Implementation – Faster, Easier and Done Right

This webinar will provide tips not only for quick, pain-free implementation as you’re assessing your DSCSA compliance readiness today, but will also help you lay a solid foundation for your serialized workflow that will provide benefits for many years to come.
Designing an Effective Clinical Trial

This talk will focus on various aspects of designing and conducting clinical trials for submission to the FDA, as well as, communicating with FDA during the pre-submission and submission process.
Mid-Study Changes: Keeping Your Clinical Trial on Track with EDC

Learn how technological advances are helping to best support the mid-study change process.
Medical Device Regulation: Finding Your Path to Success

This webinar will explore the development process, the changing regulatory environment, and the device approval pathways to help sponsors optimize the likelihood of regulatory and commercial success.
Clinical Evaluation Reports (CERs): Global Benefits & The Impact of MEDDEV Updates to Manufacturers

In this webinar, the speaker will examine the requirements listed in MEDDEV 2.7/1 revision. 4, discuss notable changes from MEDDEV 2.7/1 revision 3, while focusing on the global benefits of the Clinical Evaluation Report for your product’s path to market.
Trial Design and Scientific Leadership: How to Boost Patient Recruitment in Asia and Around the World

The speaker will discuss the importance of scientific leadership in the trial design process and throughout trial delivery, and examine the challenges of trial design in the Asia-Pacific along with the region's many opportunities for all phases of clinical studies.
Bridging the Clinical Data Structure Gap for Holistic RBM: How Fully Integrated Data Empowers Risk Management

This webinar will focus on data integration, which brings to life risks that are not apparent when examining data from one source alone.
Four Remote Monitoring and Preparing for ICH-GCP E6(R2) at Investigator Sites

This webinar will focus on how Investigator Sites are preparing for ICH-GCP E6(R2) and its impact on remote monitoring.
Four Reasons You’re Not Harnessing Big Data for R&D

This webinar will discuss the findings from a commissioned study conducted by Forrester Consulting on behalf of Attivio surveying 112 life sciences experts involved with data analytics and visualization regarding current challenges such as too many data sets, unstandardized formats, multiple data sources (many outside the firewall), and lack of business-friendly analytics.
Best Practices to Create an Effective and Scalable Sales Enablement Strategy in Life Sciences

Developing and executing a sales enablement strategy is critical to keep sales teams competitive and relevant in the rapidly evolving healthcare landscape.
Site Payment Paradigm Shift: Say Goodbye to Excel

Global financial management is more important than ever and given sizable site payment allocations, you now can gain greater transparency and timely, accurate disbursement.
Patient Centered Strategies for Clinical Trials & Treatment: Reactions to Payer Perspectives on Patient Reported Outcomes

In this webinar, the speakers will share recent data and discuss recommendations for how the industry will move forward to overcome the obstacles in the path of acceptance of PRO as an appropriate measure of the patient’s voice in cancer care
Toxicological Risk Assessment Based on Extractable/Leachable (E/L) Data: Benefits and Limitations

This webinar will discuss the collection of E/L data that are useful and relevant to risk assessment.

Applying Sound Research Practices in Development of Medical Devices

This webinar will look at best practices for running medical device clinical trials.

Reprocessing Medical Devices: Approaches and Considerations for Manual Cleaning Validations

This webinar will explore the critical role and impact of RWE on product life-cycle management from concept through post-launch.

Real World Evidence: What Does It Mean for Your Commercialization Plans?

This webinar will explore the critical role and impact of RWE on product life-cycle management from concept through post-launch.

Overcoming the Challenges of Implementing Serialization Across a Diverse Pharmaceutical Manufacturing Environment

Join a panel of experts from Zenith Technologies and SEA Vision, plus guest speaker Terry Crawford, Serialization Technical Manager at GSK, as they discuss the pharmaceutical latest track and trace regulations and timelines. A current case study will be included.
Conducting Post-Approval Research Requires a Unique Mindset and Specialized Infrastructure. Do You Have What it Takes?

While post-approval research is evolving rapidly, and these studies are becoming far more complex, our knowledge in implementing and conducting such studies has not evolved with the same pace.

Hemocompatibility: Preclinical Biological Evaluation of Medical Devices for Interaction with Blood

This webinar will present various aspects of hemocompatibility testing: selection of tests, identification of what devices need to be tested and what part of the device needs testing.
EvriBeat – Dynamic Electrocardiography

This webinar will guide you through BioTelemetry Research’s exclusive offering, EvriBeat, an advanced method for assessing cardiac safety in early human trials.

Reduce R&D Costs by Simplifying Procurement: Enhance Efficiency, Increase Compliance and Save Costs

Join us for this webinar to learn how to deal with the above mentioned challenges in R&D procurement and employ a strategic buying approach.

Next Generation Clinical Data Review with TIBCO Spotfire®

The clinical data review solution speeds up the process, automatically combining data to allow clinical development team members to interactively explore information and discover new relationships.

Academy of Managed Care Pharmacy (AMCP) Format Update, Version 4.0: Practical Implications for AMCP Dossiers

The presenters will share guidance as provided in the AMCP Format in regard to special content considerations as well as logistical considerations with regard to AMCP dossiers.

When Does Validation Start?

This presentation will discuss what level of Validation is required at the different stages of the pharmaceutical product development lifecycle.

A Buyer and Users Guide to Clinical Trial Software

In this webinar, buyers and users of clinical trial software will learn how to assess current technology options with the goal of streamlining the management of data for clinical trials

Reusable Medical Devices – Getting Market Clearance in the United States

Understanding and mastering the FDA's Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling is the first step in getting new, reusable devices into the US marketplace

Reprocessing Medical Devices: Approaches and Considerations for Manual Cleaning Validations

This webinar will assist medical device designers and manufacturers navigate the reprocessing requirements and successfully execute a manual cleaning validation.

Reducing Variability in Spirometry Testing for Clinical Trials

The speaker will describe the Clinical Laboratory Standards Institute’s Quality System Model, define the path of workflow and the points of variability/error that occur at each stage in spirometry testing, and help viewers understand mechanisms to reduce variability in lung function testing.

Rare Oncology Research in the 21st Century

This webinar will highlight some of the challenges in designing and conducting trials for rare cancers and explore positions adopted by various authors and research consortia on how to best design and conduct these trials, including a review of pending legislation — the 21st Century Cures Act — and how it might affect rare oncology research if passed.

The Global Value for Clinical Evaluation Reports in Medical Device Studies

The speaker will examine the requirements listed in MEDDEV 2.7.1 rev. 3 while focusing on the global benefits of the Clinical Evaluation report for an individual's product’s path to market.

Early-Stage Considerations for Maximizing Success in Initial Oncology Clinical Trials

This webinar will highlight the many aspects a company must consider in planning and executing a trial, and how a CRO can help throughout the process.

The Journey to Study Data Tabulation Model and Beyond

Learn from industry experts as they delve into the journey from CDASH to SDTM and beyond.

Colorants in Devices: Successfully Integrated Strategies towards Regulatory Approval

The speaker will discuss the regulation of colorants in medical devices and present solutions to many of these challenges, therefore preparing you for the attainment of a successful regulatory submission.

Risk Based Monitoring Adoption Simplified

This webinar provides a framework to assist pharmaceutical, biotechnology and/or medical device companies in the development of a risk based monitoring plan that will define the various risks and steps needed to implement a risk-based monitoring strategy.

Interventional Cardiovascular Device Development: Considerations in Clinical Trial Implementation

This free webinar features topics such as considerations of trial design, site/patient selection, data collection and endpoint evaluation as well as best practices to help guide cardiovascular device developers down the path to approval.

Medical Imaging: Maximizing Efficacy and Safety in Oncology Clinical Trials

This free webinar aims to describe novel medical imaging approaches and methodologies to help sponsors maximize clinical trial efficiency along the development pathway.

What is the Future of Cancer Clinical Trials?

In this free webinar, the speakers will explore what we believe are the driving factors of change toward that future, hoping that it will be suitable to a broad audience of stakeholders in cancer clinical trials.

Risk Based Monitoring for Central Nervous System (CNS) Clinical Trials

This webinar will discuss how risk based monitoring can be used to leverage common clinical data sources, advanced statistical methodologies and cutting-edge visualizations for your central nervous system clinical trials.

Closing the Loop: eTMF and eISF Reduce Paper and Support Remote Monitoring

The speakers will discuss replacing manual paper-based procedures and implementing secure offsite document access and management.

Structural and Functional Endpoints in Repeat-Dose Toxicity Cardiovascular Risk Assessments and the Use of In Vivo Physiologic Monitoring

This webinar will discuss the rationale for including functional assessments in repeat-dose toxicology studies, how the data can be used for more impactful risk assessments, and the potential for more relevant clinical biomarker strategies.

Inhalation Exposure Systems for Aerosol Delivery Advancements: Perspective from a Bench Scientist

This webinar will include a discussion about the variety of inhalation exposure applications currently being used in research, identifying the need for better inhalation exposure tools, plus an introduction of DSI’s 14-Port Inhalation Tower and All-in-One Tower Controller

Evaluation of Atrial Fibrillation and Other Arrhythmias within Clinical Trials and Clinical Practice

The speakers will discuss trends in continuous ecg monitoring and the implications for clinical trials of both medical device and therapies for cardiovascular, hematologic, metabolic and cns diseases, with an emphasis on atrial fibrillation and other arrhythmias.

Improving ECG Data Quality and Availability: Automatic Transmission of Data from Devices into eSource Systems

This learn how OmniComm and Mortara use the bi-directional communication between Mortara ECG devices and the TrialOne® eSource system to automatically transmit information between the two, and how the implementation of direct data capture is able to improve clinical trial data quality and availability.

Value Creation in the Medical Device Supply Chain: Strategies and Case Studies

This interactive webinar will review practical strategies, solutions and examples for keeping medical device supply chains responsive, aligned and optimized for today's changing landscape.

Colorants in Devices: Integrated Strategies Toward Regulatory Approval

This webinar will examine strategies, processes, and technology to help maximize productivity and reduce cycle times.

Target Product Profile Guiding Cross-functional Strategies for Medical Device and Diagnostic Organizations

During this presentation, you will discover how the Target Product Profile (TPP) process can provide your company with a clear advantage in early clinical development, leading to the greatest possibility of approval and successful product launch

Continuous Glucose Monitoring Applications in Rodents

Viewers will learn about the advantages of continuous glucose monitoring and the new possibilities DSI’s solution enables for diabetes and metabolic disease research.

Medical Device and Drug Research: Similarities and Differences

This webinar discusses Post market Clinical Follow- up studies and Medical Device Registries. It describes the choice of the two types of studies and the issue of risk.

Medical Device and Drug Research: Similarities and Differences

This webinar will explain the similarities and differences that exist for medical device and drug studies in the US and EU and the nuances of study conduct.

S.E. Asia Drug/Device Update: Market Potential and Regulatory Environment

A discussion of the clinical research scenario in S.E. Asia including market opportunity, registration, new regulatory and safety guidelines for both the drug and medical device markets.

How the Medical Device Industry Can Prepare for the EU Regulatory Changes Ahead

An in depth look at release of a draft revision by the European Commission in 2012 that will impact medical device and medical diagnostic manufacturers in the EU and abroad.


 
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