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

Recorded on: Nov. 14, 2019

Description: Clinical experts Maryan Zirkle, Elizabeth Shenkman and Adrian Hernandez share best practices on how to transform the culture of clinical research from one directed by researchers to one driven by the needs of patients and those who care for them. They discuss:

• How to transform trials with information on the patient-centered ecosystem;
• How to obtain information on the health systems, health plans and other stakeholders involved in the infrastructure;
• How PCORnet® is used as a resource in conducting various types of research; and
• How to optimize infrastructure with respect to specific conditions and communities.

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Speakers: Maryan Zirkle, PCORI Associate Director, PCORnet®; Elizabeth Shenkman, Professor and Chair, Department of Health Outcomes and Biomedical Informatics, University of Florida; Adrian Hernandez, Vice Dean for Clinical Research, Duke University School of Medicine

Recorded on: Nov. 12, 2019

Description: Clinical research experts Kerry Dyson and Kris O’Brien share real-world case studies that show how patient engagement leads to successful data capture and better outcomes. They discuss:

• How to approach project planning for the best outcomes in patient participation;
• Case studies of successful patient engagement during actual trials;
• Viewing patients as research partners and the steps needed to keep them involved; and
• Sustaining engagement and motivation throughout a trial.

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Speakers: Kerry Dyson, Global Head of Clinical Research; Kris O’Brien, Vice President of Client Strategy and Development; CROMSOURCE

Recorded on: Nov. 5, 2019

Description: Design control statistical expert Steven Walfish shares best practices for understanding the requirements for statistical techniques and how they impact the design control process and sample size issues. He discusses:

• How to appreciate the nuanced interpretations of 21 CFR 820.250;
• How to recognize the differences between confidence and reliability in the sample size;
• How to understand the importance of how data is collected and how to justify the sample size;
• How to incorporate statistical assumptions as part of all sampling plans; and
• How to grasp how variance in the population impacts the sample size necessary to establish objective evidence.

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Speaker: Steven Walfish, president, Statistical Outsourcing Services

Recorded on: Oct. 31, 2019

Description: Human error reduction expert Ginette Collazo shares best practices for minimizing human error and regulatory citations in manufacturing. She discusses:

• How to prepare an outline and develop world-class SOPs;
• The interrelationship between SOPS, quality and regulatory compliance;
• Why human error is a root cause for lack of quality and how to minimize it; and
• How to create and maintain a procedure that minimizes human error.

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Speaker: Ginette Collazo, chief executive officer, Human Error Solutions

Recorded on: Oct. 30, 2019

Description: Technology experts Jon Carter, Catie Roland and Mark Tomlinson share the differences between EDC and eSource and offer guidelines to help select solutions that suite clinical trial needs. They discuss:

• Pros and cons of EDC vs. eSource;
• The challenges of eSource adoption and pitfalls to anticipate and avoid;
• When should EDC and/or eSource be implemented; and
• Should EDC and eSource be combined in the same study.

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Speakers: Jon Carter, Product Manager; Catie Roland, Program Manager; Mark Tomlinson, Senior Director of Technology Operations; Cmed Technology

Recorded on: Oct. 29, 2019

Description: Regulatory expert Alan Minsk shares best practices for adhering to the recent Instruction for Use (IFU) guidance and expected implications on new drug applications and biologics license applications. He discusses:

• How the current content and format for IFUs will need to be modified;
• Examples of sample labeling that cover all elements of an IFU—from dosage and usage to storage and disposal;
• Examples of the kind of recommendations the FDA makes in terms of design and layout; and
• Practical considerations on patient labeling.

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Speaker: Alan Minsk, partner, Arnall Golden Gregory LLP