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

Recorded on: Aug. 20, 2019

Description: Device expert James Pink shares best practices for preparing for the EU MDR deadline (May 26, 2020). He discusses:

• The new MDR classification system and how to apply it;
• New separate software rules and what they say;
• Stricter requirements for implantable devices; and
• The consequences of delay

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Speaker: James Pink, Executive Vice President, Consulting Services, National Sanitation Foundation

Recorded on: Aug. 15, 2019

Description: Research expert Mary Jo Lamberti and analytics expert Francis Kendall share best practices for the use of RWE and RWD to generate evidence and identify gaps and challenges. Tufts CSDD investigated 30 biopharmaceutical companies' use of RWD to generate evidence and showed the top measures for using RWE for return on investment, among other findings. They discuss:

• The types of technology used to access or collect RWD and evidence and partnerships that support usage;
• The significant challenges to using RWD as well as strategies and practices that impact return on investment or performance;
• The key drivers for change and the adoption of RWE; and
• The potential of RWE and how it may be used across the clinical development pipeline and a view on what will happen next in the domain.

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Speakers: Mary Jo Lamberti, Associate Director of Sponsored Research and Research Assistant Professor, Tufts CSDD; Francis Kendall, Senior Director, Cytel