Recorded on: Oct. 4, 2019

Description: Experts Julie Larsen and Lenita Sims-Spears share best practices for keeping abreast of the changes, and potential impact, brought by VMSR and NEST. They discuss:

• The real-world impact new medical device reporting programs will have following the formal end to the ASR program;
• How the FDA is transitioning to the VMSR program;
• Which devices and device malfunctions are eligible, or not, for summary reporting in VSMR; and
• The critical components of FDA’s NEST initiative and how the FDA will monitor medical device performance through NEST.

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Speakers: Julie Larsen, Principal Consultant and Director of Inspection Readiness Services, BioTeknica, Inc.; Lenita Sims-Spears, Senior QARA Consultant, BioTeknica, Inc.

Recorded on: Oct. 2, 2019

Description: Clinical experts Irina Petrova and Anna Yanaeva share best practices for preparing to choose the right CRO for your organization, whether they be local or globally located. They discuss:

• How to select the right CRO — Does the CRO have global reach, local regulatory expertise, brand recognition, speed of decision-making, advanced technologies and competitive pricing;
• What pharma-CRO relationships are like — Why are most pharma firms unsatisfied with their experiences;
• How to choose a CRO based on therapeutic area expertise.

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Speakers: Irina Petrova, Director of Clinical Operations; Anna Yanaeva, Director of Business Development; OCT Clinical Trials

Recorded on: Sept. 27, 2019

Description: Regulatory experts Cynthia Schnedar and Liz Oestreich share best practices for exploring the new inspections landscape of the Mutual Recognition Agreement (MRA). They discuss:

• The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and what it has led to;
• How inspectors are using each other’s inspections to maintain a risk-based approach, to include potential benefits for U.S. drug safety;
• How the MRA may complicate regulatory and compliance operations — which inspections will the FDA continue to perform, and which will be assigned to EU member states; and
• What’s next for FDA capability assessments and the possibility of duplicating the MRA model in other regions, including the potential impact of ‘Brexit’ on the MRA.

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Speakers: Cynthia Schnedar Esq., Executive Vice President, Regulatory Compliance; Liz Oestreich Esq., Vice President, Regulator Compliance, Greenleaf Health Inc.

Recorded on: Sept. 27, 2019

Description: Data Management expert Israel Heskiel shares best practices for compliance with FDA Data Integrity Title 21 Part 11. He discusses:

• How to communicate with IT leaders about IT’s role in data integrity compliance;
• How to establish SOPs and getting IT, QA, the Supply Chain and R&D on the same page;
• How IT, quality management and regulatory affairs can be scaled for speed and efficiency under the Final Guidance on Data Integrity and Compliance with Drug cGMP; and
• How to create an “FDA audit IT SWAT team” for continuous improvement.

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Speaker: Israel Heskiel, CEO, CIO, Agrei Consulting

Recorded on: Sept. 25, 2019

Description: Regulatory expert John Smith shares best practices about the approaches the FDA is taking in regard to AI-based image analysis. He discusses:

• How the FDA views AI within its medical device regulatory paradigm;
• The different types of computer-assisted image analysis recognized by the FDA;
• The data that the FDA expects to support AI-based CAD applications; and
• How the FDA views post-market changes to CAD algorithms.

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Speaker: John Smith, M.D., J.D., Partner, Hogan Lovells

Recorded on: Sept. 24, 2019

Description: Regulatory expert John Balzano shares best practices for navigating legal and regulatory issues related to healthcare products and services in China. He discusses:

• Important new regulatory reforms in China related to drug development, including 60-day notification of clinical trial applications, priority review and GCP enforcement;
• Revisions to Human Genetic Resources (HGR) regulations;
• How to prepare for overseas inspections and compliance with emerging distribution and manufacturing rules; and
• How to make sense of the recent guidance documents coming out of China including guidance on foreign data and new application modules.

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Speaker: John Balzano, Esq., Partner, Covington & Burling LLP

Recorded on: Sept. 19, 2019

Description: Quality systems expert Dan O’Leary shares insights on the EU-MDR’s extensive requirements for documenting, conducting and reporting clinical investigations, including which devices are exempt. He discusses:

• The role of the clinical investigation in the EU-MDR;
• Which device types require clinical investigations;
• How to integrate the EU-MDR and ISO/DIS 14155:2018; and
• The role of the Notified Body and Competent Authority.

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

Recorded on: Sept. 17, 2019

Description: Regulatory expert Barbara Blumenfeld shares information on the FDA’s recently enforced interpretation of its stem cell regulatory framework. She discusses:

• The FDA regulatory framework in 21 CFR Part 1271 for human cells, tissues and cellular and tissue-based products (HCT/Ps);
• Enforcement efforts that the FDA has taken since November 2017, including the issuance of warning letters and industry letters and relevant court actions;
• The FTC’s October 2018 settlement with Regenerative Medical Group and Telehealth Medical Group (California) for false and misleading consumer advertising; and
• Various opportunities for the legal development and use of stem cells.

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Speaker: Barbara A. Binzak Blumenfeld, Ph.D., Shareholder, Buchanan Ingersoll & Rooney, PC

Recorded on: Aug. 27, 2019

Description: Device expert Connie Hoy shares best practices for implementation of the new Medical Device Single Audit Program (MDSAP) audit protocol. She discusses:

• The use of the Companion Document to prepare successfully for the MDSAP audit;
• The use of the quality system to ensure that an organization completely covers specific country requirements;
• The specifics of the registration review process; and
• How the MDSAP audit is conducted and how it differs from FDA inspections and ISO audits.

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Speaker: Connie Hoy, Senior Vice President, Regulatory Affairs, Cynosure

Recorded on: Aug. 22, 2019

Description: Industry expert Dan O’Leary shares best practices for preparing for the FDA’s 510(k) design change guidance documents. He discusses:

• The role of risk management (ISO 14971:2007) in the evaluation process;
• The decision-making process embodied in the flowcharts;
• The critera behind the flowchart decision boxes; and
• How to keep quality records that support your decision.

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