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

Recorded on: Oct. 15, 2019

Description: Device expert Connie Hoy shares best practices for responding to nonconformities found during an audit inspection. She discusses:

• How to analyze the criticality of the audit findings;
• How to avoid complicating the corrective actions and inadvertently overburdening organizations;
• How to prioritize plans by identifying corrections and corrective actions;
• How to write a sufficient corrective action and preventive action (CAPA) procedure; and
• How to draft an appropriate response to the auditing agency.

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Speaker: Connie Hoy, Founder, Hoy & Associates Regulatory Consulting

Recorded on: Oct. 10, 2019

Description: Risk management expert Mark Levy shares best practices for having a solid process for compliance with current law and guidance in regard to medical product off-label use and marketing. He discusses:

• The current law and guidance on off-label promotion and how it affects quality, regulatory and compliance professionals;
• How to detect potential allegations of wrongdoing and how to deal with them;
• The nuances of the False Claims Act and how the First Amendment intersects with claims; and
• How to conduct an effective internal investigation when alleged unlawful off-label promotion is detected.

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Speaker: Mark Levy, Litigator and Trial Attorney, Eckert Seamans

Recorded on: Oct. 9, 2019

Description: Quality systems expert Dan O’Leary shares insights to help find solutions to the five highest-risk areas that prompt 483s and warning letters. He discusses:

• The most commonly cited section in warning letters;
• The distribution of warning letters by source, region and part;
• The Forgotten Five — the bottom 5 of the top 10 — most cited observations;
• The issues cited in the warning letters; and
• How to address the issues before inspection.

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

Recorded on: Oct. 9, 2019

Description: Technology expert Filip Matakovic shares best practices for making a paperless transition, including how updated guidelines and new technology have lowered the hurdles and streamlined the transition to going electronic. He discusses:

• System compliance and audit readiness;
• The costs and current methodologies of paper binder storage;
• The advantages of managing documents electronically; and
• eSignatures and Part 11 compliance.

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Speaker: Filip Matakovic, Vice President and General Manager, Site Services Group, MedPoint Digital