Recorded on: July 18, 2024

Description: New U.S. and EU guidance and governances for AI/ML-enabled medical devices are looming. Do you have an AI quality management system in place that will satisfy the regulators? In this presentation, Eric Henry, senior quality systems and compliance advisor of the FDA & Life Sciences Practice at the King & Spalding law firm, will explain why devicemakers need a full understanding of the upcoming regulatory changes. Presentation takeaways:

• How to make the most of current and pending U.S./EU regulatory frameworks for AI/ML-enabled medical devices
• The role of the FTC in regulating AI, and how it will impact the medical device industry
• The implications of current guidances, predetermined change control plans (PCCPs), lifecycle management considerations, and recommendations for premarket submissions
• The impact of the EU’s landmark AI Act

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Speaker: Eric Henry, Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences Practice, King & Spalding

Recorded on: July 11, 2024

Description: Real-world data (RWD) and real-world evidence (RWE) can be valuable assets in complying with the FDA’s current focus on postmarket surveillance. In a series of guidances released late last year, the agency teased out how manufacturers of drugs, biologics, medical devices and combination products can harness RWD during the postmarket stage, converting the data into evidence to inform the FDA’s regulatory decisions. This FDAnews webinar, presented by former FDA compliance specialist and regulatory, clinical and market-access expert Jonathan Helfgott, will untangle these guidances, offering new ways to unlock the value of RWD and RWE. Presentation takeaways:

• Examine the FDA’s expectations for postmarket surveillance
• Understand ‘fit-for-purpose’ considerations for RWD/RWE
• Dig deep into case examples of the use of RWD/RWE
• Gain a deeper understanding of the documentation needed for inspection readiness

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Speaker: Jonathan Helfgott, Former FDA Compliance Specialist

Recorded on: June 20, 2024

Description: This webinar provides expert insights and practical advice on how to comply with the EU’s new GMP guidelines outlined in EudraLex Volume 4, Annex 1, how Annex 1 compares to the FDA’s 2004 guidance on the manufacture of sterile medicinal products, and how to be ready for an inspection by EU regulators. Presentation takeaways:

• Gain a clear grasp of the key elements of Annex 1
• Find out how to assess your company’s level of Annex 1 compliance, and prepare a remediation plan
• Acquire practical advice on using risk management methods, and developing a contamination control strategy
• Create a preparation plan for an inspection by the regulatory authorities
• Immerse yourself in what can be learned from current inspections related to sterile manufacturing

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Speaker: Londa Ritchey, Director and Principal Consultant QMC, Cencora PharmaLex; and Patrick Nieuwenhuizen, Director and Senior Consultant, PharmaLex Ireland

Recorded on: June 13, 2024

Description: In this extended webinar, prominent FDA-watchers and regulatory experts Wayne Pines, Jim Czaban, Betsy Foss-Campbell, Nimi Chhina, and Sarah Blankstein look at recent developments in the drug and device environment and predict what we can expect from the FDA for the rest of fiscal 2024 and into 2025. Presentation takeaways:

• Discover how this year’s election outcome could impact the agency
• Find out how a budget cut for fiscal 2025 could impact the FDA’s ongoing activities and new initiatives
• Understand current FDA enforcement activities and how they are evolving  
• Hear about CBER’s strategy to advance cell and gene therapies
• Learn about the latest moves at CDER and CBER to speed development of new treatments for rare diseases
• Examine the FDA’s plans to embrace AI to modernize product reviews, inspections, and other activities

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Speaker: Wayne Pines, President, Healthcare APCO Worldwide; James Czaban, Co-chair, Life Sciences and Chair, FDA Legal and Regulatory Strategies, Loeb & Loeb; Sarah Blankstein, Counsel, Ropes & Gray’s Life Sciences Regulatory and Compliance Practice; Nimi Chhina, Head of Global R&D and Regulatory Policy, BioMarin Pharmaceutical; Betsy Foss-Campbell, Regulatory Policy Strategist, Catalyst Healthcare Consulting

Recorded on: May 30, 2024

Description: In this webinar, presented by Ropes & Gray partner Joshua Oyster, you will gain a clear understanding of the impact of the FDA’s final rule on laboratory developed tests, the many changes that will accompany it, and its long-range implications for the industry. Presentation takeaways:

• Examine the various intricacies of the LDT final rule.
• Survey the scope and timeline for the FDA’s phaseout of enforcement discretion for LDTs.
• Dissect the way the FDA responded to industry comments on the proposed rule.
• Contemplate the legislative solutions being considered by Congress.
• Explore the potential avenues for litigation challenging the final rule.

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Speaker: Joshua Oyster, Partner, Ropes & Gray

Recorded on: April 25, 2024

Description: In this FDAnews webinar, former FDA investigator Sarah Tanksley provides an extensive outline on how to prepare well-crafted 483 responses. Her insights will benefit any company that is inspected by the FDA, including manufacturers of medical devices, pharmaceuticals and biologics. Presentation takeaways:

• Real-life examples of how to — and how not to — respond to 483 observations.
• A practical framework for planning a timely response to inspection findings.
• The means to identify typical response failures and plan corrective actions.
• A method for responding to problematic inspections, such as more serious observations, repeat observations, or when you disagree with the findings.
• How to quickly create a plan that includes immediate action, as well as how to make clear commitments to address issues that can’t reasonably be implemented right away.

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Speaker: Sarah Tanksley, President and CEO, Tanksley Consulting Group

Recorded on: April 23, 2024

Description: In this FDAnews webinar, internationally recognized inspections expert David Chesney will teach you how to optimize and organize your records for your next inspection or remote regulatory assessment while avoiding pitfalls in data retrieval, improper or missing documentation, or electronic data transmission errors. Presentation takeaways:

• Understand the types of documents commonly requested during inspections and remote assessments.
• Handle paper documents properly and provide investigators with access to electronic source data without compromising security.
• Learn the top 10 questions to ask about your archival process.
• Know the perils of emails as documentation and how to avoid them.
• Recognize the difference between copies and originals and what FDA regulations require.

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Speaker: David Chesney, Principal and General Manager, DL Chesney Consulting

Recorded on: April 11, 2024

Description: Learn how you can use regulatory intelligence tools to improve your supplier management and vendor oversight. Presentation takeaways:

• Gain a deeper understanding of the definition of regulatory intelligence.
• Increase your competency in vendor management oversight.
• Obtain actionable methods for leveraging regulatory intelligence.
• Acquire knowledge of FDA and EMA expectations for supplier management.
• Leverage software tools to make quality-based decisions.
• Analyze and interpret regulatory data to effectively monitor supplier performance.

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Speaker: Jaime Santana, President, Santana Quality Consulting

Recorded on: March 28, 2024

Description: Learn the potential impact on drug development of the Inflation Reduction Act (IRA) and negotiated prices for some top-selling Medicare Part D drugs. Presentation takeaways:

• Gain a greaterunderstanding of the “big picture” — examining what the IRA means for the future of drug innovation.
• Understand the IRA legislation’s key provisions.
• Identify the drug development areas that will be most impacted.
• Revise your strategic plans in the face of the IRA’s mandates.
• Prepare your drug development business for enforcement of the IRA.

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Speakers: Ken Getz, Executive Director of the Tufts Center for the Study of Drug Development (CSDD) and a Research Professor in the Tufts University School of Medicine; and Emily Botto, Senior Research Analyst, Tufts CSDD

Recorded on: March 21, 2024

Description: Learn best practices for interacting with the FDA and other global regulators in meetings at the different review stages, and how you can be proactive in planning to ensure a timely review and — if all goes well — approval of your product. In preparation for a product meeting with the FDA, you’ll develop a gameplan that:

• Defines the purpose of the meeting(s)
• Shows the value of preparation and rehearsing before meetings
• Understands the process at every stage of the product journey
• Adheres to timelines to ensure success

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Speakers: Mark Lane, Vice President of Development Consulting and Scientific Affairs, PharmaLex; Patrick Larcier, Senior Director of Strategic Product Development Solutions, PharmaLex; and Anna Perelka, Director of Regulatory Affairs U.S., PharmaLex