Recorded on: Aug. 15, 2018

Description: FDA specialist Sonali P. Gunawardhana and clinical research expert Mary Jo Lamberti discuss the evolution of real-world evidence (RWE) in clinical studies and the FDA’s policies and priorities. Topics include:

• Ways drugmakers are using RWE to support promotional claims and premarket applications;
• Impact of recent FDA statements on including RWE in approval and clearance applications and as a basis for drug and device promotional claims; and
• How the agency may use RWE to support regulatory decisionmaking.

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Speakers: Sonali P. Gunawardhana, Of Counsel, Shook, Hardy & Bacon LLP, and Mary Jo Lamberti, Professor and Associate Director of Sponsored Research, Tufts Center for the Study of Drug Development

Recorded on: Aug. 14, 2018

Description: Device regulatory expert Dan O’Leary explains the FDA’s new MDR coding regimen. He discusses:

• Criteria for a mandatory medical device report;
• Required records and their content;
• The reporting system and associated acknowledgements; and
• The schedule for transitioning to the new system.

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

Recorded on: Aug. 1, 2018

Description: Regulatory expert Bradley Merrill Thompson outlines how the FDA has regulated digital health products to date and what it plans in months to come. He discusses:

• AI-powered clinical decision support software;
• Postmarket surveillance;
• Cooperation with industry; and
• Premarket digital safety.

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Speaker: Bradley Merrill Thompson, Attorney, Epstein Becker & Green P.C.

Recorded on: July 31, 2018

Description: European regulatory expert James Pink provides a deep dive into the new EU MDR. He discusses:

• New requirements for documentation confirmation and updating;
• New separate software rules;
• Stricter requirements for implantable devices; and
• Possible sanctions for devicemakers who are not ready to comply with the new rules.

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Speaker: James Pink, Vice President, NSF Health Sciences Medical Devices, Europe

Recorded on: July 26, 2018

Description: Attorney Jessica Ringel outlines provisions of the FDA Reauthorization Act of 2017 and their impact on devicemakers. She discusses:

• Changes in user fees for premarket submissions;
• Improvements anticipated in the FDA inspections process;
• How transparency in certificates to foreign governments issuance and denials will increase;
• Specific FDA efforts to stimulate pediatric device innovation; and
• New guidances, rules and reports anticipated from the agency in coming years.

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Speaker: Jessica Ringel, Counsel, FDA and Life Sciences Practice, King & Spalding LLP

Recorded on: July 18, 2018

Description: Electronic submissions expert Antoinette Azevedo explains the technical and organization challenges of complying with the FDA’s eCTD specifications:

• How to avoid a refuse-to-receive when submitting your eCTD;
• Strategies for developing a roadmap for implementing the technical and organization components for eCTD success;
• Real world impact of eCTD format on your CMO and CRO partners; and
• The impact of eCTD on submissions to the rest of the world health authorities.

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Speaker: Antoinette Azevedo, President & CEO, e-SubmissionsSolutions.com

Recorded on: July 17, 2018

Description: FDA official Owen Faris provides a view into FDA’s thinking and activities related to the use of real-world evidence (RWE) and the National Evaluation System for Health Technology (NEST). He discusses:

• Why the FDA is promoting the use of RWE to evaluate medical devices;
• Proof of concept as it applies to using RWE for device evaluation; and
• How RWE and NEST can specifically apply to medical device development.

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Speaker: Owen Faris, Director of the Clinical Trials Program, CDRH

Recorded on: July 11, 2018

Description: Regulatory compliance expert Connie Hoy explains the Medical Device Single Audit Process. She discusses:

• Using the companion document as a preparation guide;
• Ensuring your quality system covers specific country requirements;
• Questions auditors are likely to ask; and
• How the process differs from FDA inspections and ISO audits.

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Speaker: Connie Hoy, President, Hoy & Associates Regulatory Consulting

Recorded on: June 21, 2018

Description: Clinical research compliance experts Jennifer Mallory and Carrie Hanger provide an overview of changes in the Common Rule set to take effect in January 2019. They discuss:

• Broad consent for secondary research;
• Limited and continuing IRB review;
• Exemptions;
• Federalwide assurances; and
• Cooperative research.

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Speakers: Jennifer Mallory and Carrie Hanger, partners, Nelson Mullins Riley & Scarborough

Recorded on: June 20, 2018

Description: Pharmaceutical serialization expert Bill Fletcher discusses emerging trends in serializing drug products, track and trace systems and FDA and global regulation. He covers:

• Child-to-parent aggregation;
• Complexities of the Drug Supply Chain Security Act;
• Traceability based on third-party logistics; and
• Implementing Electronic Product Code Information Services.

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Speaker: Bill Fletcher, Managing Partner, Pharma Logic Solutions LLC