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

Recorded on: Aug. 8, 2019

Description: FDA staff member Sugato De and regulatory expert Peter Steiger share explain innovative strategies that companies can implement to support smarter, faster approvals. They discuss:

• Which wearables and sensors needs FDA approval;
• How to comply with the FDA’s final guidance on assessing wellness products and how that assessment is determined;
• Why blood pressure monitoring through wearables and sensors represents a new frontier in FDA regulation and should be watched closely by manufacturers; and
• Why the ingestibles category is one of the big new developments in the future of wearables.

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Speakers: Sugato De, Vice President, Technical, PAREXEL; Peter Steiger, Vice President and Chief Scientific Officer, PAREXEL

Recorded on: Aug. 6, 2019

Description: FDA regulatory and life sciences expert Bethany Hills-Grois shares best practices for understanding the current policies and proposed changes to the drug pricing and reimbursement landscape. She discusses:

• How drug pricing policies may impact labeling and promotional activity;
• Practical tips on product data development to align with drug pricing policies;
• The drug pricing and reimbursement framework, including the roles the FDA, CMS and private parties plan; and
• Drug pricing proposals being considered in Congress and those expected to pass before the November elections.

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Speaker: Bethany Hills-Grois, Partner, Morris & Foerster

Recorded on: Aug. 5, 2019

Description: Quality Assurance expert Susan Schniepp shares best practices on regulatory expectations for the prevention of data integrity issues, problem areas for data integrity and strategies for detecting potential data integrity issues in operations. She discusses:

• Recent FDA warning letters citing data integrity;
• Data integrity code of conduct;
• Problem areas where data integrity issues can arise; and
• Strategies for detecting data integrity issues in QC and laboratory, computer systems and manufacturing.

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Speaker: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliances Associates, Inc.

Recorded on: Aug. 1, 2019

Description: Medical device expert Michael Gaba shares best practices to get your software as a medical device (SaMD) product to market faster with the Software Precertification Program. He discusses:

• How to streamline your pre-market review;
• How to leverage information and data obtained during pre-certification; and
• How to establish a more modern and tailored approach toward software integration.

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Speaker: Michael Gaba, Partner, Holland & Knight

Recorded on: July 30, 2019

Description: Legal experts Greg Levine and Kelly Combs shares best practices for understanding the expedited FDA approval programs for drugs and devices, what it takes to qualify and how to secure the benefits to make a difference in the bottom line. They discuss:

• How to explore eligibility criteria;
• How to get clarity on program features and benefits;
• How to discover designation criteria, including data generation requirements; and
• How to understand the designation review process.

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Speakers: Greg Levine, Partner and Co-Chair; Kelly Combs, Partner, Ropes & Gray LLP

Recorded on: July 26, 2019

Description: Compounding expert Karla Palmer shares industry expectations from, and accelerating enforcement of, the FDA’s 2018 Compounding Priorities Plan. She discusses:

• How sections 503A and 503B of the 2013 Drug Quality and Security Act affect compounding pharmacies and outsourcing facilities, and exactly what changes have been made in the draft and final guidances;
• How best to understand what enforcement actions the FDA has taken against compounders to-date and what the future may hold in regard to Warning Letters and 483s;
• What the FDA is looking for right now in compounding inspections; and
• The interplay between FDA and state regulation of outsourcing facilities and compounding pharmacies.

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Speaker: Karla Palmer, Director, Hyman Phelps & McNamara P.C.

Recorded on: July 25, 2019

Description: Cybersecurity expert Norma Krayem shares best practices for working with unchartered regulatory and liability risks and divulges new coping strategies to implement in the rapidly changing global regulatory landscape. She discusses:

• The cybersecurity-triggered changes in the interpretation of HIPPA;
• The DHS cybersecurity initiatives, including the Automated Information Sharing (AIS) program as they pertain to Homeland Security;
• Cybersecurity as an enterprise risk management issue affecting security, risk and privacy functions in device firms; and
• The Cybersecurity Information Sharing Act and the Protected Critical Infrastructure Information (PCII) as potential “safe harbors”.

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Speaker: Norma Krayem, Senior Policy Advisor, Holland & Knight LLP