Recorded on: April 7, 2020

Description: Regulatory expert Bradley Merrill Thompson provides a comprehensive overview of current guidance on clinical decision support (CDS) software and discusses:

• Impact of the 21st Century Cures Act on CDS regulation;
• How to determine what types of CDS software functions do not meet the FDA’s definition of a device; and
• How to assess which types of software meet the definition of a device for which the FDA may not enforce compliance under device requirements.

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Speaker: Bradley Merrill Thompson, shareholder, Epstein Becker & Green

Recorded on: March 31, 2020

Description: Attorneys Michael Werner and Sara Klock explain the latest federal regulations for informed consent and human subject protection when using digital technologies. They discuss:

• How digital technologies used to gather, analyze and report healthcare data for medical treatment purposes or to promote a healthy lifestyle can also be used for research purposes;
• How to design clinical trials using digital technologies that comply with the 21st Century Cures Act and changes to the Common Rule; and
• How to identify factors likely to determine whether and to what extent certain technologies are regulated as medical devices by FDA.

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Speakers: Michael Werner, co-leader of Holland & Knight's Healthcare & Life Sciences Team, and Sara Klock, member of Holland & Knight's Public Policy & Regulation Group

Recorded on: March 27, 2020

Description: Human behavior expert Ginette Collazo discusses the psychology of human error and how to investigate and fix problems. She covers:

• Determining when human error is a causal factor of quality and compliance issues;
• Understanding the types of human error, including intentional and unintentional errors of omission and commission; and
• Measuring human error rates by using the root cause determination tool and cognitive load tool.

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Speaker: Ginette Collazo, CEO, Human Error Solutions

Recorded on: March 19, 2020

Description: Former FDA Commissioner Mark McClellan gives an overview of emerging trends in medical product development, including efforts to further improve development and regulatory review. He discusses:

• The overall landscape of value-based payment and delivery reforms and what you must know about their growing linkages to medical product development;
• Increasing concerns associated with the price for transformative medical technologies like gene and cell therapies, and how these anticipated prices are driving stakeholders to explore new types of contract mechanisms and alternative payment models;
• Insight into new policy development areas emerging around challenges with payer coding, coverage and payment processes for innovative medical technologies; and
• The growing need for a real-world data and evidence development infrastructure and its anticipated role in improving your development of medical products as well as regulation and care delivery.

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Speakers: Mark McClellan, Director and Robert J. Margolis Professor of Business, Medicine and Policy, Duke-Margolis Center for Health Policy

Recorded on: March 18, 2020

Description: The FDA’s Douglas Throckmorton discusses how the agency is currently administering the GMP requirements to be followed in the case of drug shortages. He covers:

• The pivotal role manufacturers can play in assessing potential threats to quality;
• The crucial role that data and transparency play in quality issues affecting drug shortages; and
• How drug manufacturers can stay in compliance with FDA regulations on cGMP quality.

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Speakers: Douglas Throckmorton, Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research, FDA, and Peter Pitts, President, Center for Medicine in the Public Interest

Recorded on: March 11, 2020

Description: Device systems expert Dan O’Leary explains how to predict misuse errors and make risk management plans that comply with the revised ISO 14971:2019. He discusses:

• What you must know about the regulatory status of the standards in the U.S., EU and Canada;
• How to comply with the FDA Center for Devices and Radiological Health’s approach to usability engineering;
• How to incorporate the concepts of formative and summative evaluation; and
• Which inputs you must add to your user interface specification.

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Speaker: Dan O’Leary, President, Ombu Enterprises

Recorded on: Feb. 27, 2020

Description: FDA regulatory expert Scott Lassman explains the requirements of pharmaceutical exclusivity. He discusses:

• The new standard governing the scope of 3-year clinical investigation exclusivity;
• Orphan drug exclusivity; and
• Current legislative proposals.

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Speaker: Scott Lassman, Principal, Lassman Law & Policy

Recorded on: Feb. 25, 2020

Description: Trade attorney Jennifer Diaz discusses strategies for resolving FDA and Customs and Border Patrol (CBP) issues. She covers:

• Analysis of important recent enforcement actions;
• Customs and Border Protection detention and seizure processes;
• Mitigating and aggravating factors in enforcement; and
• Submitting a petition for relief.

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Speaker: Jennifer Diaz, President, Diaz Trade Law and Diaz Trade Consulting

Recorded on: Feb. 20, 2020

Description: EU medical device regulatory expert James Pink describes the role of the Person Responsible for Regulatory Compliance (PRRC) under the new EU-MDR. He discusses:

• The relationship between the PRRC and the strategy set for regulatory compliance;
• Evaluating whether your corporate structure is ready to ensure supervision and control of products to achieve EU regulatory compliance; and
• The importance of organizational design to ensure the various roles participating in compliance are understood and coordinated.

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Speaker: James Pink, Vice President, NSF Health Sciences Medical Devices, Europe

Recorded on: Feb. 19, 2020

Description: Quality assurance expert Susan Schniepp discusses how to streamline your audit approach so you can identify quality issues. She covers:

• How to use a risk-based approach to audits;
• Understanding the importance of quality culture and regulatory requirements identifying quality culture;
• Steps to take with the manufacturer when a quality issue is identified; and
• Best practices for documenting and tracking resolutions to identified issues.

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Speaker: Susan Schniepp, Independent Consultant