Recorded on: July 13, 2021

Description: SoftServe experts provide a fundamental framework for setting up and scaling the digital technologies your need to successfully engage patients remotely and safely generate and protect participant data. This webinar covers:

• The increased need for and benefits of decentralized trials;
• Improved data and privacy;
• How to avoid costly consequences of unsuccessful trials; and
• Ways to incorporate digital technology.

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Speakers: Steve LoSardo, Vice President, Life Science Solutions and Consulting, SoftServe; and Mariya Boychuk, Senior Business Analyst for Healthcare Solutions, SoftServe

Recorded on: July 8, 2021

Description: Using real-world lessons from companies who have already gone through the process, this webinar will provide you with a detailed understanding of the EU-MDR requirements and regulations, including:

• What to know about expected challenges during the transition;
• Where to focus and prioritize in the EU-MDR certification process;
• Coordinating and planning around your Notified Body; and
• Balancing the Technical file and QMS audit review.

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Speaker: Linda L. S. Lovett, CEO of Lovett Consulting

Recorded on: June 22, 2021

Description: Mary Vater shares current best practices and tips for submitting 510(k)s, the FDA’s changes and how to keep your 510(k)s on track, explaining:

• Specific changes the FDA made to the 510(k) process;
• How to identify suitable and favorable predicate devices;
• How to select a predicate with a relatively clean history; and
• What FDA 510(k) pilot programs are currently underway.

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Speaker: Mary Vater, Consultant, Medical Device Academy

Recorded on: June 17, 2021

Description: The expert speakers explain the latest insights gleaned from Operation Warp Speed that accelerated vaccines and treatment for COVID-19. They’ll share:

• An overview of current clinical trial performance, including common pitfalls that impact startup cycle times in clinical research;
• How to address some of the startup cycle time challenges — without sacrificing quality; and
• How to turn those key pitfalls into opportunities for improvement using an innovative solution which leverages the results of vendor qualification to reduce cycle times and resources in trial initiation.

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Speakers: Lee Jones, President, Diligent Pharma; Ken Getz, Director and Professor, Tufts University School of Medicine; and Jay Turpen, Head of Client Services, Diligent Pharma

Recorded on: June 15, 2021

Description: The experts share how to recognize the behaviors that shape a healthy quality culture, how to diagnose and measure the health of your organization’s quality culture by explaining:

• The importance quality culture in life sciences as described by the FDA;
• The research-based behavioral model of quality culture in life sciences;
• The interdependency of quality culture, quality management systems (QMS) and risk management and how these systems and observed beliefs/behaviors influence effectiveness and desired outcomes; and
• How to apply this model to measure and diagnose the current quality culture of a life science organization.

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Speakers: Teresa Gorecki, Practice Director, Compliance Architects; and Kenneth Ray, Principal Consultant, Kenneth G Ray, LLC

Recorded on: June 15, 2021

Description: Take a step back from the day-to-day and understand the entire training technology ecosystem. You’ll learn:

• How technology makes the training function more strategic;
• How technology helps design, develop, and deliver training to your learners;
• How to prioritize acquiring new technologies and eliminating legacy solutions; and
• Key tips for effectively implementing an LMS within your organization.

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Speaker: Kent Malmros, Sr. Director of Vault Training, Veeva Systems

Recorded on: June 10, 2021

Description: Howard Sklamberg shares how recent cooperation in inspections, regulator focus on global supply chains and other harmonization efforts will affect you. He explains:

• The future of the U.S.-EU Mutual Recognition Agreement and what it means for inspections;
• The long-lasting effects of FDA’s guidance on inspection alternatives during the pandemic;
• How the CARES Act provisions on the supply chain will affect harmonization and how companies should prepare; and
• The effect of pharmaceutical onshoring initiatives in the U.S. and Europe on harmonization efforts and what that means for manufacturers.

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Speaker: Howard Sklamberg, Partner, Arnold & Porter

Recorded on: June 8, 2021

Description: This webinar details how artificial intelligence (AI) can play an important role in quality management through connected quality data. You’ll learn:

• How to effectively connect quality data;
• The production problems that can be solved using AI;
• The future of quality management; and
• The benefits of using AI in your development process, including a quicker and more efficient quality management process.

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Speaker: Sue Marchant, Director, MasterControl

Recorded on: May 27, 2021

Description: Optum experts share how moving to a technology-centered practice can help you achieve better results and how to make that transition smoother and more effective. They’ll cover:

• Key clinical research challenges;
• New approaches to addressing clinical research struggles; and
• Examples of how a technology-focused approach can impact the research process.

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Speakers: Peter Payne, Vice President & Head, Optum Digital Research Network; and Tracy Ohrt, Clinical Operations Manager, Optum Digital Research Network

Recorded on: May 26, 2021

Description: In this webinar, Robert Brooks, PhD, phorum leader for BioPhorum Supply Partner, shares how to harness COVID-era — and post-COVID — supply requirements, so you can speed up the supply chain, explaining how to:

• Develop a joint audit program approach to improve the overall quality assessment of the in-bound supply chain and reduce the overall cost for biomanufacturers and suppliers;
• Better plan for demand while developing more useful risk management mitigation strategies to increase productivity and lower cost;
• Recognize what the supplier industry is focused on doing to alleviate long-term surety of supply issues by increasing capacity of supply sites from multiple sources and how the biomanufacturing industry can help; and
• Accept X-ray sterilization as a viable alternative to gamma irradiation for single-use systems, driving a supply-change notification approach and subsequent change impact assessment and validation package for the industry.

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Speaker: Robert Brooks, Phorum Leader, BioPhorum Supply Partner