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

Recorded on: March 24, 2021

Description: Tom Comstock presents LNS Research’s latest findings on the intersection of Industrial Transformation (IX) and Quality 4.0 specific to life sciences organizations, including pharmaceutical, biotechnology, medical device and more. He discusses:

• How you can improve your quality monitoring and outcomes;
• Why your data and its analysis are core to both Industrial Transformation IX and Quality 4.0;
• The role of executive leadership in transformation and the quality team as a key business partner; and
• What the leading cause of failure is in meeting your quality objectives and how you can avoid it.

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Speakers: Tom Comstock, Principal Analyst, LNS Research; Stephen McCarthy, Vice President of Digital Innovation, Sparta Systems

Recorded on: March 18, 2021

Description: Cynthia Schnedar ensures that you understand how the FDA conducts its postmarket safety surveillance and what you must do to ensure postmarket adverse reporting inspection readiness. She explains:

• The FDA Adverse Event Reporting System (FAERS) and how the FDA evaluates the information in the database;
• Nuances of the FDA Program Guide CHAPTER 53 - Postmarketing Surveillance and Epidemiology: Human Drug and Therapeutic Biological Products Program: 7353.001;
• How the FDA uses its MedWatch program to provide information on mandatory reporting by manufacturers; and
• What type of reports a manufacturer must submit to the FDA when deviation from current good manufacturing practice regulations occur.

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Speaker: Cynthia Schnedar, Executive Vice President of Regulatory Compliance, Greenleaf Health

Recorded on: March 18, 2021

Description: Sundeep Agarwal addresses manufacturers’ challenges in designing a compliant AI framework that is safe, effective and beneficial for human health around the world, including:

• Introduction to artificial intelligence (AI);
• Overview of the regulatory framework of AI in the U.S. and EU;
• AI-based software classification; and
• Quality system and good machine learning practices (GMLP).

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Speaker: Sundeep Agarwal, General Manager of Compliance & Regulatory Affairs, Datt Mediproducts, India

Recorded on: March 16, 2021

Description: Susan M. Proulx, PharmD, Managing Director, Drug Safety at Leaderboard Branding is an international leader in preventing medication errors due to brand name confusion. She shares:

• How the prescreening process relates to attributes that may contribute to medication errors in naming drugs;
• Suggested methods of evaluating the risk of medication errors related to naming;
• The FDA process for notifying applicants that have similar names in the FDA queue; and
• The phonetic and orthographic computer analysis (POCA) criteria and its use in evaluating name similarity.

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Speaker: Susan Proulx, Managing Director of Drug Safety, Leaderboard Branding

Recorded on: March 10, 2021

Description: The FDA restarted inspections last summer under a new guidance and during this webinar FDA inspections expert Kalah Auchincloss shares how assessments are proceeding and what criteria the FDA is using to determine which sites are inspected.

• FDA criteria for in-person inspections;
• Alternatives to on-site inspections;
• Preparation for FDA inspections; and
• The likelihood of foreign inspections resuming.

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Speaker: Kalah Auchincloss, Senior Vice President and Deputy General Counsel, Greenleaf Health, Inc.

Recorded on: Feb. 18, 2021

Description: A panel of experts discusses how to modernize and digitally transform your manufacturing operations to support quality metrics, review by exception and smartsourcing. They share:

• Training as a strategic function;
• The differences between content standards and integration standards;
• Elearning standards and why they are important; and
• Choosing the right vendors.

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Speakers: Kent Malmros, Sr. Director of Vault Training, Veeva Systems; Lexie Pieper, Head of Quality, Celularity; John Constantine, Consultant, Orchestrall; Amy Benton, Vice President of Information Technology, Travere Technologies