Recorded on: July 22, 2021

Description: Wayne L. Pines, president of healthcare at APCO and former associate commissioner of the FDA, leads an expert team that explains what the first six months of the Biden administration have brought and what to expect going forward, including the answers to:

• What is likely to change at the FDA under Biden that will affect what you do every day?
• How should you plan now for upcoming changes to be ready for developments later in 2021 and in 2022 in drug and device regulation, enforcement, drug pricing and health care innovation?
• What new guidances are likely to be issued later this year?
• Who are the key personnel in Biden’s FDA?

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Speakers: Wayne Pines, Member of APCO Worldwide’s International Advisory Council and President of Health Care for the consultancy; Marc Scheineson, Partner, Alston & Bird LLP; Andrea Chamblee, Senior Counsel, Wilson Sonsini Goodrich & Rosati; Allison Fulton, Partner, Sheppard Mullin Richert & Hampton; and Kellie Combs, Partner, Ropes & Gray LLP

Recorded on: July 21, 2021

Description: MDR and IVDR expert Sundeep Agarwal explains how devicemakers creating in vitro devices will need to move forward with the shift from IVDD to IVDR before the implementation deadline, from software considerations to understanding authorized representatives, including:

• Key changes arising from IVDR;
• Details around certifications and evaluations;
• The benefits of quality management systems;
• Supply chains and subcontractors; and
• Preparing for audits.

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Speaker: Sundeep Agarwal, Consultant, Datt Mediproducts

Recorded on: July 14, 2021

Description: Michael Meighu, PhD — a life science specialist with more than 20 years of experience in the field, focusing on AI and data science — translates AI and machine learning (ML), sharing:

• What natural language processing (NLP) is and how it can help you;
• An understanding of neural networks and deep learning and how you can put them to use;
• What AI open source is and how can it assist in developing prototypes or proof of concepts in the medical product space; and
• An understanding of python and fast.ai toolkits and ways to incorporate them.

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Speakers: Michael Meighu, PhD, Life Science Specialist and Justo Rodriguez, PhD, Data Scientist

Recorded on: July 13, 2021

Description: Greenleaf Health, Inc. experts share how to implement strategic engagement and planning and develop a quality and compliance strategy that aligns with CBER’s regulatory expectations, explaining:

• The relevance of CBER’s four overarching goals for FY 2021-2025;
• What you must understand about CBER’s four priorities that will inform its policy decisions for the next five years; and
• An analysis of the role CGT and personalized medicine development, advanced manufacturing technologies and AI/ML, RWE and RWD will play in CBER’s strategic and regulatory activities.

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Speakers: Kalah Auchincloss, Senior Vice President and Deputy General Counsel, Greenleaf Health, Inc.; Madeleine Giaquinto, Manager of Regulatory Affairs, Greenleaf Health, Inc.; and Kate Cook, Principal, Regulatory Policy, Greenleaf Health, Inc.

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