Recorded on: Nov. 19, 2020

Description: Quality systems expert Dan O’Leary discusses the coming changes to device certification, obtaining a UK Conformity Assessed (UKCA) mark and registering your device with the Medicines and Healthcare products Regulatory Agency (MHRA). Topics include:

• Making sense of the UK conformity assessment bodies;
• The separate rules for Northern Ireland; and
• Some of the planned changes in the UK regulations.

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Speaker: Dan O’Leary, President, Ombu Enterprises

Recorded on: Nov. 19, 2020

Description: Representatives of Mercy Health discuss the challenges of connecting study teams in multiple states to ensure billing efficiency and compliance. They cover:

• Recent coverage analysis trends;
• Examples and best practices of communication within an organization to ensure study start-up sets the table for compliant billing decisions;
• Importance of coverage analysis utilization by multiple teams within an institution to protect the organization and research participants; and
• Examples of a “living document” that evolves throughout the lifecycle of a clinical trial, including amendments and change requests.

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Speakers: Aubrey Smith and Tiffani Smith, Managers of Business Operations, Mercy Health; Geoffrey Schick, Senior Consultant, WCG Clinical; and Amanda Miller, Manager of Quality and Development, WCG Clinical

Recorded on: Nov. 19, 2020

Description: Pharmacovigilance expert Graeme Ladds discusses best practices around resource reductions, safety reporting, labeling, compliance documents and reporting adverse events. He covers:

• Prioritizing product risks and communicating those risks to regulators during the COVID-19 pandemic;
• Complying with expedited reporting rules during the health crisis;
• Creating world-class SOPs, including those that contain exceptions to accommodate COVID-19 issues; and
• Constructing real-world timelines that take into account compliance requirements around COVID-19.

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Speaker: Graeme Ladds, CEO, PharSafer Associates

Recorded on: Nov. 17, 2020

Description: Clinical trial operations experts Barry Milton, Andy Lawton and Elvin Thalund discuss the concepts of vendor oversight and risk management under ICH E6(R2). They cover:

• The intended purpose of ICH regulations to implement industry best practices;
• How current vendor oversight practices need to evolve to ensure compliance with recent regulatory guidances; and
• How implementing quality-by-design principles can ensure study risk assessment in your vendor oversight – end-to-end.

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Speakers: Barry Milton, Head of Global Program Management, Novartis Institutes for Biomedical Research; Andy Lawton, Consultant, Risk Based Approach Ltd.; and Elvin Thalund, Director of Industry Strategy, Oracle Health Sciences

Recorded on: Nov. 16, 2020

Description: Medical device legal expert Evan Phelps shares the most significant issues that could arise when implementing the FDA guidance on breakthrough devices. He covers:

• The basics of the FDA’s Breakthrough Device Program;
• Program benefits and how the designation will push a device to market earlier;
• FDA criteria to identify breakthrough devices, including specific statutory criteria from Appendix I of the Breakthrough Devices Program Final Guidance; and
• Key elements the FDA uses to review breakthrough device applications.

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Speaker: Evan Phelps, Partner, Amin Talati Wasserman

Recorded on: Nov. 10, 2020

Description: Device quality and regulatory expert Linda Lovett explains how to establish and implement a comprehensive supplier management system using risk management principles. She discusses:

• Setting up a risk-based supplier program that meets quality and regulatory requirements;
• Identifying quality criteria based on supplier risk level (key, custom specification, industry standard and service suppliers);
• Applying risk-based supplier qualifications, auditing and monitoring; and
• Applying examples of supplier quality and risk metrics/key performance indicators.

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Speaker: Linda Lovett, CEO, Lovett Consulting

Recorded on: Nov. 10, 2020

Description: Quality experts Michael Moravia and Tom Barlow discuss updated medical device reporting expectations, including ways to harmonize regulation management strategies across multiple countries and territories. Topics include:

• Global harmonization trends and the overall direction for eMDR and EUDAMED;
• Three data upload strategies for EUDAMED reporting;
• Tools that can help your processes adjust automatically with less probability of error; and
• The harmonization of international reporting terminology, especially around adverse events and country codes.

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Speakers: Michel Moravia, Product Manager of Quality, and Tom Barlow, Strategic Solutions Engineer, ETQ

Recorded on: Oct. 29, 2020

Description: Experts from Greenlight Guru provide insight on industry challenges and barriers to demonstrating closed-loop traceability within a quality management system. They discuss:

• Using purpose-built tools with the latest technologies;
• Optimizing the quality management system for traceability;
• Increasing visibility into relationships withing the quality system; and
• Understanding the impact of change.

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Speakers: Taylor Brown, Senior Medical Device Guru, Tom Rish, Senior Medical Device Guru, and Jason McKibbin, COO, Greenlight Guru

Recorded on: Oct. 29, 2020

Description: A panel of regulatory experts provides tips for evaluating and addressing the new drug patent and exclusivity provisions. They discuss:

• Key resources for drug patent and exclusivity information, including the FDA’s Orange Book and other online CDER resources;
• Key considerations in confirming the duration of patents and exclusivity, such as additive pediatric exclusivity or patent term extensions;
• Timelines and milestones in the patent certification process, including certification to FDA, direct notifications to new drug applications and patent holders and their effect on clearance/approval timelines; and
• Interactions with the drug patent holder when needed, including notifications and rights of reference.

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Speakers: Christina Markus, Partner, King & Spalding, Genevieve Michaux, Partner, King & Spalding, Jessica Ringel, Counsel, King & Spalding, and Quynh Hoang, Consultant, King & Spalding

Recorded on: Oct. 27, 2020

Description: Clinical research operations experts Ken Lownie and Jill Heinz explore the challenges that face sites and a set of strategies to overcome them. They cover:

• An understanding of how ClinOps software fits into the world of the clinical site;
• An example of how one clinical site manager brought in a full range of software solutions successfully; and
• A perspective on the state of the software systems and solutions available today.

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Speakers: Ken Lownie, Head of North American Operations, Agatha Life Sciences, and Jill Heinz, President and Director of Clinical Research, Injury Care Family/ Family Care Research