Recorded on: May 25, 2021

Description: The presenters provide insight into how Pfizer delivered their safe, highly effective COVID-19 vaccine in less than a year — by treating the entire clinical development process as one protocol managed by one team — so you can, too. They’ll discuss:

• Why executive level support is essential in breaking down organizational barriers;
• How to compress cycle times using standardized metrics, machine learning, parallelization and other techniques;
• How risk management is critical to optimizations across the clinical trial continuum and is pivotal to balancing quality, cost and speed constraints; and
• How to centralize and coordinate activities across departments with technology, ultimately eliminating internal silos and building a team of one.

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Speakers: Ralph Russo, Senior Director and Global Head, Clinical Database Management Pfizer; Jonathan Rowe, Associate Principal, R&D Excellence, ZS Management Consulting; Keith Dorricott, MCC Ambassador, and Lead of the MCC Site Selection & Start-Up Process Metrics Development Work Group; and Elvin Thalund, Director, Industry Strategy, Oracle Health Sciences

Recorded on: May 20, 2021

Description: Thomas Altmann, global technical manager at Ecolab, will explain how cleaning processes can be evaluated using bench scale studies, sharing:

• How to improve or optimize cleaning processes using experiments;
• How to perform an assessment on all cleaning processes to determine the variable factors that influence cleaning effectiveness and performance;
• How laboratory bench scale studies can be used to identify an effective cleaning process; and
• How to evaluate lab trials and translate resulting data into manufacturing instructions and SOPs.

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Speaker: Thomas Altmann, Global Technical Manager, Ecolab

Recorded on: May 19, 2021

Description: Two members of King & Spalding’s FDA and Life Sciences practice give you an overview of the ASCA pilot, show you how to conform to it and use it to your advantage, explaining:

• Who may participate in the ASCA pilot;
• Pros and cons of participating;
• What participants can expect;
• Implications of the ASCA pilot moving forward; and
• What information is made available on pilot participants.

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Speakers: Quynh Hoang, Senior Regulatory Consultant in the FDA and Life Sciences practice at King & Spalding; and Elaine Tseng, artner in King & Spalding’s nationally recognized FDA and Life Sciences

Recorded on: May 12, 2021

Description: With this expert advice, you’ll eliminate confusion around defining extractables and leachables and learn to determine which regulatory requirements apply. This webinar covers:

• The specifics of what constitutes an extractable or leachable;
• Evaluating USP guidelines and industry standards;
• How to design an extractable and leachable program that meets your development goals and addresses regulatory requirements; and
• Frequent analytical challenges associated with extractables and leachables.

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Speaker: Kevin Wells, Group Leader at Eurofins BioPharma Product Testing-Columbia

Recorded on: May 6, 2021

Description: This webinar explains what’s coming, identifies the constraints and power shifts within the biotechnology industry and clarifies how you can adjust now so you can move ahead. You’ll learn:

• What clinical trials will look like after the safety restrictions are lifted;
• Which trends will not survive (but should!); and
• Who will call the shots when trials restart.

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Speaker: James Allgood, Product Marketing, Egnyte for Life Sciences

Recorded on: May 5, 2021

Description: Natalie Weber, a quality engineer at MasterControl, Inc., explains the new landscape of remote audits, clarifying:

• How to achieve the same goals during remote audits;remote audits are conducted and what they include;
• Why digitizing is the only way to perform remote audits; and
• Regulators’ attitudes toward remote audits.

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Speaker: Natalie Weber, Quality Engineer, MasterControl, Inc.

Recorded on: April 21, 2021

Description: Two lawyers in Ropes & Gray’s Life Sciences Regulatory and Compliance practice explain what can be gleaned from the forthcoming pandemic-influenced guidances impacting drug development, real-world evidence and digital health. They’ll discuss:

• Regulatory framework for biosimilars and possible changes with planned FDA guidance addressing labeling, promotion, interchangeability and exclusivity;
• Drug exclusivity framework and possible changes with planned FDA guidance addressing 180-day exclusivity, pediatric exclusivity and three-year exclusivity;
• Current state of real-world evidence in drug development, key open questions and planned FDA guidance addressing regulatory considerations with the use of real-world data to support FDA decision-making for drugs and biologics; and
• Emerging topics related to drug development and anticipated FDA guidance addressing decentralized clinical trials, substantial evidence and breakthrough therapy designation.

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Speakers: Kellie Combs, Partner, Ropes & Gray’s Life Sciences Regulatory and Compliance Practice; and Sarah Blankstein, Senior Associate, Ropes & Gray’s Life Sciences Regulatory and Compliance Practice

Recorded on: April 15, 2021

Description: This webinar will help you determine whether an eTMF system is the right choice for your team. Through expert advice and tips, you’ll gain insights into:

• The five signs of eTMF readiness;
• eTMF features and functions;
• Predictors of eTMF success;
• The time and money savings from an eTMF; and
• Building support for an eTMF initiative.

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Speaker: Ken Lownie, Head of North American Operations, Agatha

Recorded on: April 8, 2021

Description: With this webinar, you’ll be able to determine the differences between traditional medical device regulations and software as a medical device (SaMD) regulations. It covers:

• The unique and novel risks software-intensive medical devices pose to the healthcare system;
• Difficulties and benefits that can come from SaMD versus 510(k) compliance;
• How automated RegOps could reduce preparation time for FDA submissions; and
• How building regulatory practices directly into the systems development lifecycle could ease inspection and audit burdens.

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Speaker: Shahid Shah, Founder of Netspective Communications

Recorded on: April 6, 2021

Description: Eric Henry addresses the defense of cybersecurity during facility inspections and product submissions in light of the latest regulatory literature, including:

• How cybersecurity relates to design controls and the quality system more generally;
• Key tips for defending cybersecurity during an FDA inspection or notified body audit, even when the investigator or auditor is not familiar with cybersecurity concepts;
• How addressing cybersecurity risk relates to product risk management; and
• What regulatory literature currently exists globally and some of the ways they compare to each other.

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Speaker: Eric Henry, Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of the law firm King & Spalding