Recorded on: April 23, 2019

Description: Former FDA counsel John Fuson explains how to navigate FDA inspections. He discusses:

• Best practices for answering FDA Form 483 observations;
• Strategies for avoiding warning letters and serious enforcement actions;
• Tools for assessing company exposure to regulatory risk; and
• FDA factors that render enforcement or escalation.

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Speaker: John Fuson, Partner, Crowell & Moring, LLP

Recorded on: April 18, 2019

Description:Dan Matlis and Mike Jovanis discuss the application of modern technologies to product lifecycle management. They cover:

• ICH Q12 and its potential benefits;
• How technology can support ICH Q12 and simplify change management; and
• Innovative ways leading pharma companies are addressing PACM.

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Speakers: Daniel R. Matlis, Founder and President, Axendia, and Mike Jovanis, VP-Vault Quality, Veeva Systems

Recorded on: April 4, 2019

Description: Quality systems expert Dan O’Leary explains the hybrid system where you maintain a device certificate under the MDD and a QMS under the MDR. He discusses:

• The dates from the EU-MDR for when the hybrid system can apply;
• The three elements from the MDR Chapter VII – post-market surveillance, market surveillance and vigilance;
• The role of device registration and the required data elements; and
• How to structure the technical documentation for the hybrid system.

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Speaker: Dan O’Leary, President, Ombu Enterprises LLC

Recorded on: March 29, 2019

Description: IRB official Kristin J. Craun clarifies key aspects of the revised Common Rule and approaches for educating research teams and ensuring compliance. She discusses:

• How new exempt categories may reduce obligations in human subject protection;
• How new required elements of consent change the standards for informing patients and obtaining consent;
• How the use of continuing review policies apply to minimal risk research and its effect on daily responsibilities in managing clinical trials; and
• How the new Common Rule requirement allows flexibility in some clinical trial areas and the key factors in determining when and how this flexibility can be utilized.

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Speaker: Kristin J. Craun, Senior Director, Institutional Review Board, University of Southern California

Note: Due to technical issues, the first 2 minutes of this recording is missing.

Recorded on: March 28, 2019

Description: Cell and gene therapy expert Scott R. Burger discusses the FDA’s requirements for biologics license applications, common mistakes applicants make and how to avoid them. He covers:

• How a cell or gene therapy BLA fits into the framework of the CTD;
• What reviewers in the Office of Tissues and Advanced Therapies expect to see in a BLA; and
• How the earlier stages of development affect the content of the BLA.

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Speaker: Scott R. Burger, Principal, Advanced Cell and Gene Therapy

Recorded on: March 26, 2019

Description: Research integrity expert Donna Kesslier discusses the increased focus on the reliability of research data, honesty in reporting and data reproducibility in an era of heightened competition and pressure. She covers:

• How regulatory authorities are defining research misconduct;
• What are questionable research practices (QRPs), especially in dealing with vulnerable populations; and
• Tips for compliance in conducting proper research in the areas of subject recruitment, consent, recordkeeping and patient outreach and communication.

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Speaker: Donna Kesslier, Research Integrity Officer, Duke University

Recorded on: March 25, 2019

Description: Patient centricity advocates Maggie Buckley, Pamela Bennett and Danya Kaye discuss how to improve clinical trials by involving patients in recruitment efforts, consent agreements, educational materials and engagement. Topics include:

• Things to consider before beginning a patient engagement program;
• Ways to engage directly with patients as advisors; and
• Elements necessary to engage patients and patient advocacy organizations in clinical trial development and treatment.

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Speakers: Maggie Buckley, Volunteer Patient Advocate; Pamela Bennett, Executive Healthcare and Corporate Affairs Consultant; and Danya Kaye, Director of Business Development, R&D and Innovation, Inspire

Recorded on: March 22, 2019

Description: Regulatory expert Lynn Mehler addresses the FDA’s expectations for REMS assessment. She discusses:

• How REMS assessments have changed in the past decade;
• How REMS assessments can lead to additional requirements, separate and apart from modifications to a REMS; and
• How to use REMS assessments to build a case for REMS modification, including elimination of requirements.

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Speaker: Lynn Mehler, Partner, Hogan Lovells

Recorded on: March 21, 2019

Description: Attorney Jessica Ringel discusses how the FDA will prioritize its regulatory efforts in 2019, including:

• Recent revisions to the medical device guidance and activities required by the FDA Reauthorization Act (FDARA);
• Nuances pertaining to quality and regulatory professionals included in CDRH’s FY 2019 guidance agenda; and
• Status of the ever-evolving voluntary FDA pilot programs.

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Speaker: Jessica Ringel, Counsel, King & Spalding

Recorded on: March 20, 2019

Description: : Pediatric trial experts Lisa Benson and Janelle Allen discuss how to deal with the differences and challenges faced while conducting pediatric clinical trials. Topics include:

• How to develop study budgets specific to pediatric clinical trials, including recruitment and administrative costs;
• Approaches to recruitment in pediatric research, including the pros and cons of using different forms of standard and social media;
• How to identify the challenges faced when conducting pediatric clinical trials; and
• Strategies for successful retention of children in clinical trials.

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Speakers: Lisa Benson, Senior Vice President of Research, Education and Quality, and Janelle Allen, Director of Research, Education and Quality for the Institute of Advanced Clinical Trials for Children