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.

Presentation: Download the presentation

Transcript: Download the transcript

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.

Presentation: Download the presentation

Transcript: Download the transcript

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.

Presentation: Download the presentation

Transcript: Download the transcript

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.

Presentation: Download the presentation

Transcript: Download the transcript

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.

Presentation: Download the presentation

Transcript: Download the transcript

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.

Presentation: Download the presentation

Transcript: Download the transcript

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.

Presentation: Download the presentation

Transcript: Download the transcript

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.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: June 14, 2018

Description: Quality systems expert Dan O’Leary explains the process of setting and measuring quality objectives to meet regulatory requirements. He discusses:

• Methods an FDA Investigator uses to verify compliance;
• Additional requirements from ISO 13485:2016;
• A description of the three types of metrics; and
• How to use Excel to develop a graphical approach to the metrics.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: June 13, 2018

Description: Acting Associate Director for Regulatory Affairs Tamy Kim explains the Oncology Center of Excellence mission to expedite the development of oncology and hematology medical products and support an integrated approach in the clinical evaluation of drugs, biologics, and devices for the treatment of cancer. She discusses:

• The center’s structure, including where it sits within the agency and how it interacts with other centers;
• Nuances of the regulatory role, such as the formation of clinical review teams for oncology products;
• Elements of OCE research; and
• Examples of OCE outreach, including interactions with professional societies and patient or advocacy groups.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Tamy Kim, Acting Associate Director for Regulatory Affairs in the Oncology Center of Excellence