Recorded on: May 6, 2020

Description: Safety and regulatory systems expert Jennifer Markey discusses allocating more resources to the sciences of signal detection, epidemiology and risk management. Topics include:

• Approaches and benefits to moving from operational to scientifically driven pharmacovigilance;
• Common challenges, including data quality and team skillset, and how to address them; and
• Advancements in modern technologies to drive operational efficiencies and streamline safety science.

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Speaker: Jennifer Markey, Vice President of Vault Safety Strategy and Consulting, Veeva Systems

Recorded on: May 5, 2020

Description: Quality experts discuss drivers toward a cloud-based quality management system. They cover:

• On-site vs. cloud solutions;
• A variety of cloud models; and
• The emergence of cloud-based regulated systems.

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Speakers: Sandra Rodriguez, Market Analyst, Axendia, Joe Vigil, Director of Quality Management Systems, Ultragenyx, Mike Jovanis, Vice President of Vault Quality, Veeva Systems

Recorded on: May 5, 2020

Description: Training experts Crissy MacDonald and Steve Whittaker discuss how unifying document management and training in a single platform ensures the traceability of training materials from creation to consumption, enabling closed-loop compliance. Topics include:

• How to address common challenges in building an effective GxP training program;
• Best practices of creating an enterprisewide learning strategy; and
• How a unified GxP training environment delivers better training and quality outcomes.

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Speakers: Crissy MacDonald, Vice President of Client Delivery, The Avoca Group and Steve Whittaker, Senior Consultant, The Avoca Group

Recorded on: April 30, 2020

Description: Training experts John Constantine and Kent Malmros discuss how unifying document management and training in a single platform ensures the traceability of training materials from creation to consumption, enabling closed-loop compliance. Topics include:

• How to address common challenges in building an effective GxP training program;
• Best practices of creating an enterprisewide learning strategy; and
• How a unified GxP training environment delivers better training and quality outcomes.

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Speakers: John Constantine, Senior Vice President of Talent Solutions, Orchestrall, and Kent Malmros, Senior Director of Vault Training, Veeva Systems

Recorded on: April 23, 2020

Description: Regulatory expert Dan O’Leary discusses the postmarket surveillance (PMS) requirements under the upcoming EU-MDR. He covers:

• How to prepare your PMS plan;
• How to prepare other related plans — the complaint management plan, the trend report plan; and
• How to determine the reports required for the PMS system.

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Speaker: Dan O’Leary, President, Ombu Enterprises

Recorded on: April 22, 2020

Description: Privacy and data protection attorney Stephan Grynwajc provides a comprehensive overview of the rules that apply to the collection of EU personal data and its use in clinical trials. He discusses:

• The GDPR, the ePrivacy Directive, the Clinical Trials Directive and the draft Clinical Trials Regulation;
• Adapting internal policies and procedures to comply with EU laws and regulations;
• Understanding international transfers of data under the 1995 Privacy Directive/GDPR and the interplay between the GDPR and the EU and Swiss Privacy Shield Frameworks; and
• EU privacy enforcement trends following the adoption of the GDPR.

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Speaker: Stephan Grynwajc, Managing Partner, Law Office of S. Grynwajc

Recorded on: April 21, 2020

Description: Medical device regulatory experts Kristin Davenport and Christina Kuhn explores the nuances of the FDA’s regulation and enforcement related to digital health tools. They discuss:

• Determining which FDA policies apply when wearables are regulated, including how to comply with the FDA’s guidances on clinical decision support;
• Specifying differences between platforms and individual apps; and
• Assessing considerations for artificial intelligence and the intersection of artificial intelligence and the FDA regulation.

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Speakers: Kristin Davenport, Of Counsel, Covington & Burling, LLP and Christina Kuhn, Associate, Covington & Burling, LLP

Recorded on: April 16, 2020

Description: Medical device regulatory expert Dan O’Leary presents best practices, processes and methods for compliant change management. He discusses:

• The overarching change management process and methods;
• How to apply the process to specific change types;
• Determining the change interactions in the change types; and
• Identifying the similarities and differences across quality management system requirements.

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Speaker: Dan O’Leary, President, Ombu Enterprises

Recorded on: April 10, 2020

Description: Device compliance expert Dan O’Leary discusses steps to prepare for notified body review under EU-MDR. He covers:

• Auditing quality management system elements;
• Requirements for the Annex IX application;
• The notified body document review process; and
• Understanding the notified body audit based on Annex VII.

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Speaker: Dan O’Leary, President, Ombu Enterprises

Recorded on: April 8, 2020

Description: Clinical research compliance expert Eve Brunts explains how to overcome the challenges of clinical trial billing compliance using applicable coverage and coding requirements and implementing appropriate policies and operational processes. She discusses:

• Medicare coverage and coding requirements, including Medicare clinical trial policy and investigational devices;
• Federal and state laws addressing coverage of clinical trial services for other third-party payers, including comparisons of federal and particular state provisions;
• Common clinical trial agreement contracting approaches; and
• Development of a clinical trials coverage analysis.

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Speaker: Eve Brunts, Partner, Ropes & Gray