Recorded on: Dec. 16, 2020

Description: Regulatory compliance expert Steven Lynn shares the basics of the COVID-affected supplier relationship, emphasizing the best practices you must incorporate to manage it over time. He discusses:

• How to structure a pharmaceutical supplier agreement that incorporates specific clauses to assist you in monitoring your supplier during the pandemic;
• How to use new technology to develop best practices for monitoring and overseeing your supplier partnerships; and
• How to conduct world-class supplier audits during the pandemic.

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Speaker: Steven Lynn, Executive Vice President of Pharmaceuticals, Regulatory Compliance Associates

Recorded on: Dec. 9, 2020

Description: GxP expert David Chesney shares best practices for creating effective new SOPs for electronic document management or improving existing SOPs. He discusses:

• The legal basis of FDA records access authority;
• The types of documents commonly requested during inspections;
• The perils of emails as GxP documentation, and how to avoid them; and
• The impact of the shift to real-time electronic review of documents during inspections.

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Speaker: David Chesney, Principal and General Manager, DL Chesney Consulting

Recorded on: Dec. 8, 2020

Description: Food and drug attorney Alan Minsk discusses the FDA’s new labeling guidance on instructions for use (IFU). He covers:

• The kind of language IFUs should be written in to be patient friendly;
• What the guidance recommends in terms of voice, commands and sentences;
• Examples of sample labeling that covers all elements of an IFU from dosage and usage to storage and disposal; and
• Recommendations the FDA makes in terms of design and layout, such as the use of easy-to-read fonts, sequential numbering and white space.

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Speaker: Alan Minsk, Partner, Arnall Golden Gregory

Recorded on: Dec. 3, 2020

Description: Validation expert Tim Fischer discusses the FDA’s new Computer System Assurance (CSA) and its focus on quality risk management. He covers:

• Critical risk thinking;
• Computer systems to which CSA applies;
• Performance metrics needed; and
• Transition and next steps.

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Speaker: Tim Fischer, Great Solutions

Recorded on: Dec. 2, 2020

Description: Information systems experts Pradip Banerjee, Brian Friel and Bob Friedman discuss the uses of predictive technologies. They cover:

• Modern technologies and algorithms to strategize, plan and implement predictive risk management solutions;
• Digital technologies to help identify, predict and manage risks of the entire clinical trials process;
• Real-time data monitoring and data integrity issues and solutions; and
• Technologies that can help prioritize actions to make operations more efficient.

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Speakers: Pradip K. Banerjee, Chairman of the Board and Chief Executive Officer, Brian Friel, Compliance and Risk Specialist, and Bob Friedman, Chief Technologist and Chief Solutions Architect, Xybion

Recorded on: Dec. 2, 2020

Description: Regulatory experts Stefanie Doebler and Christopher Hanson discuss FDA requirements for promotion — incorporating claims substantiation, fair balance and off-label promotion — and the key differences between drug and device promotion. They cover:

• The primary requirements for advertising and promotion set forth in the Food, Drug and Cosmetics Act and implementing regulations;
• The FDA’s recent guidance on promotion consistent with the approved labeling;
• The scope of the prohibition on preapproval promotion; and
• The difference between promotion and disease awareness communications.

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Speakers: Stefanie Doebler, Partner, Covington & Burling, and Christopher Hanson, Special Counsel, Covington & Burling

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