Recorded on: Dec. 18, 2019

Description: : Consultant and former FDA investigator Ricki Chase explains how to navigate the FDA’s Adverse Event Reporting System. She discusses:

• The difference between serious unexpected and serious expected events;
• Common inspection observations related to adverse events; and
• What not to report.

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Speaker: Ricki Chase, Executive Director, Lachman Consultant Services

Recorded on: Dec. 17, 2019

Description: A panel of quality systems experts discuss the benefits of using cloud technology solutions. They cover:

• Regulatory impact;
• Hybrid cloud approach; and
• Validating cloud solutions.

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Speakers: Ashley Wentworth, Director of Strategy, Vault Quality, Veeva Systems; Robert Lorence, Managing Director, PwC Consulting; Jhumki Sen, Senior Manager, PwC Consulting

Recorded on: Dec. 16, 2019

Description: Biologics development Scott Burger presents strategies for successful BLA submissions. He discusses:

• FDA requirements for cell therapy or gene therapy BLAs;
• What reviewers in the Office of Tissues and Advanced Therapies expect to see; 
• How a cell or gene therapy BLA fits into the framework of the common technical document; and
• How the earlier stages in development affect the content of the BLA.

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

Recorded on: Dec. 12, 2019

Description: Device industry veteran Jon Speer presents best practices, tips and pointers for internal company change control processes and practices. He discusses:

• The different types of change and how each should be managed;
• How to assure a risk-based approach to change management; and
• How technology solutions can help streamline change management.

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Speaker: Jon Speer, Co-founder and Vice President of QA/RA, Greenlight Guru

Recorded on: Dec. 10, 2019

Description: A panel of experts discusses the pharmaceutical regulatory climate in the coming year. They cover:

• The impact of the new FDA commissioner;
• Drug pricing;
• Drug importation; and
• Generics competition.

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Speaker: Wayne Pines, President of Healthcare, APCO Worldwide; John Kamp, Washington Counsel, Coalition for Healthcare Communication; Kevin Madagan, Partner, Reed Smith; Tish Pahl, Principal, OFW Law

Recorded on: Dec. 9, 2019

Description: Intellectual property experts Chad Landmon and Neema Kumar explore FDA and congressional initiatives to promote generic drug competition. They discuss:

• Implementation of the FDA’s Drug Competition Action Plan;
• Pathways to expedited approval of generic drug applications; and
• How to obtain 180-day exclusivity.

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Speakers: Chad Landmon, Chair, FDA and IP practice groups, Axinn, Veltrop & Harkrider LLP; Neema Kumar, Senior IP Counsel, Hikma Pharmaceuticals USA

Recorded on: Dec. 2, 2019

Description: Regulatory specialist William Garvin provides an update on the implementation processes of the DSCSA. He discusses:

• Handling of suspect and illegitimate products;
• Confirming authorized trading partners;
• Product serialization and exchange of transaction information, transaction history and transaction statement; and
• Recent FDA enforcement actions.

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Speaker: William Garvin, Attorney, Buchanan Ingersoll & Rooney PC

Recorded on: Nov. 25, 2019

Description: Regulatory experts John Fuson and Chalana Damron share current FDA enforcement trends to prepare you for your next inspection. They discuss:

• 2019 FDA enforcement activity—483s and warning letters—versus prior years;
• The most prevalent targets of FDA inspections;
• GMP violations most often cited in 483s and in warning letters; and
• How to manage inspections to minimize the risk of escalation.

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Speakers: John Fuson, Partner in the Health Care, Product Risk Management (PRM) and White Collar and Regulatory Enforcement groups; Chalana Damron, Counsel in the Mass Tort, Product and Consumer Litigation group; Crowell & Moring, LLP

Recorded on: Nov. 21, 2019

Description: Device regulation expert Dan O’Leary shares the challenges of complying with unique device identification (UDI) rules and major variances from FDA regulations in preparation to meet the May 2020 deadline. He discusses:

• The EU’s UDI system;
• Requirements for devices and packages;
• The role and uses of Basic UDI-DI; and
• EU-MR Article 120 transition requirements.

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

Recorded on: Nov. 19, 2019

Description: Quality expert Leslie Sam shares best practices for how to leverage ICH E8(R1) revised guidelines’ quality-by-design approaches, expanded study designs and data source considerations. She discusses:

• The scope and general principles of the ICH E8(R1) guideline;
• The impact to current research practices that may be outlined in SOPs, procedures, processes and documentation;
• The framework and approaches for identifying critical to quality factors; and
• The best way to identify clinical development areas that may be impacted by the adoption of the ICH E8(R1) guideline as well as approaches for compliance.

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Speaker: Leslie Sam, Principal Consultant, Wool Consulting Group