Recorded on: June 6, 2023

Description: This webinar helps you understand and comply with the FDA’s requirements and avoid common errors so you can maintain your products’ critical quality attributes (CQAs) and bring them to market. You’ll learn:

• FDA requirements for comparability studies for gene and cell therapy products;
• Best practices for risk analysis and mitigation using comparability studies;
• How to design an effective comparability protocol for a gene or cell therapy product; and
• How to construct a statistical approach to comparability.

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Speakers: Scott R. Burger, MD, Principal, Advanced Cell & Gene Therapy; and William E. Janssen, PhD, Principal, WEJ Cell and Gene Therapy Consulting Services

Recorded on: May 25, 2023

Description: Mike Farrell, IT Manager at Illumina, explains how their supplier portal tracks supplier performance, actionable data and empowers suppliers in audits, corrective actions and other critical quality processes. He explains:

• Why Illumina moved away from inefficient, manual supplier processes;
• The benefits of getting the right supplier data at the right time to drive continuous improvement;
• How to drive supplier adoption of a QMS; and
• Best practices and lessons learned when it comes to supplier management.

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Speaker: Mike Farrell, IT Manager, Illumina

Recorded on: May 17, 2023

Description: This webinar provides a refresher of the current regulatory landscape around IVDs and LDTs and how the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) could change it. You will learn about the:

• Current CLIA framework and LDTs
• FDA regulation of IVD tests as medical devices and their regulatory stance towards LDTs
• History and development of the VALID Act and the framework to define and regulate in vitro clinical tests (IVCT)
• Legislative pathways and prospects for the VALID Act to become law and FDA implementation timelines

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Speakers: Michael M. Gaba, FDA Practice Vice Chair, Polsinelli; Colleen Faddick, Health Care Operations Practice Chair, Polsinelli; and Christopher C. Rorick, Senior Policy Advisor, Public Policy Practice Group, Polsinelli

Recorded on: May 11, 2023

Description: Andrew Mackinnon, Martha LaManna, and Mel Mann, discuss the benefits of modern clinical trials that help pharma sponsors and CROs demonstrate greater collaboration, appreciation, and understanding for the roles of patients and sites. They cover:

• Strategies for building empathy and human interaction into the digitized trial process;
• The importance of how best to listen to sites and build trusting relationships;
• How to ease the implementation of clinical trial technology and demonstrate why growing pains are normal during digital change; and
• Best practices from other industries that have successfully gone digital and how the clinical trial industry is headed in the right direction.

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Speakers: Andrew Mackinnon, VP and GM eConsent, Medable; Martia LaManna, Director of Customer Success, Innovative Supply Solutions; and Mel Mann, MBA, M.Ed., Patient Advocate & Advisor, Be The Match

Recorded on: May 10, 2023

Description: FDA regulatory experts Kristin Zielinski Duggan and Sally Gu dig into the FDA’s guidance around RWE as support for regulatory decision-making and detail key examples of how this evidence has been used. They discuss:

• FDA Guidance and Documentation;
• Practicalities of Relying on RWD/RWE; and
• Premarket and Postmarket Obligations.

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Speakers: Kristin Zielinski Duggan, Partner, Hogan Lovells; and Sally Gu, Senior Associate, Hogan Lovells

Recorded on: April 27, 2023

Description: Wayne L. Pines, president of healthcare at APCO Worldwide and former associate commissioner of the FDA — along with a panel of experts — will share what you must know and do to get ahead of the changes. They will look back at the crucial developments of 2022 and what will likely come in 2023 and beyond, including:

• Adoption of new administrative and personnel practices post-pandemic;
• How the new provisions in the user fee legislation will affect your daily business;
• How key personnel changes in the FDA are impacting policy; and
• How CDER, CBER and CDRH are rethinking the R&D process and their own review and approval standards.

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Speakers: Wayne L. Pines, President, Healthcare, APCO Worldwide; Steven A. Grossman, President, HPS Group; Lowell M. Zeta, Partner, Life Sciences and Global Regulatory Practice, Hogan Lovells US LLP; Cathy Burgess, Partner, Alston & Bird LLP; and Nancy Bradish Myers, JD, President, Catalyst Healthcare Consulting, Inc.

Recorded on: April 26, 2023

Description: Michey Landkof and Rosalind Beasley of Dot Compliance describe the transition from paper and file-based systems to automated quality, and the advantages of a cloud quality management system.

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Speakers: Mickey Landkof, general manager and global vice president of sales, and Rosalind Beasley, digital transformation executive at Dot Compliance.

Recorded on: April 20, 2023

Description: Covering traditional health, safety and efficacy concerns, as well as areas like data privacy, identify theft and cybersecurity, this webinar leaves you with the confidence to handle any enforcement situation in medical device development. It covers:

• A comprehensive understanding of how the FDA, DOJ and FTC coordinate their priorities and resources for enforcement actions;
• A review of recent FTC enforcement cases, with a focus on the perils of promoting claims that aren’t supported by science;
• An explanation of the FTC’s health products compliance guidance and other rules; and
• Key updates from the FDA’s guidances on medical device-related cybersecurity.

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Speaker: John Claud, Counsel, Hyman, Phelps & McNamara

Recorded on: April 5, 2023

Description: Sundeep Agarwal discusses ways to make Software as a Medical Device (SaMD) post market risk management less complicated and more systematic for your company. He’ll cover:

• Risk Management in SaMD;
• Risk management core activities;
• Residual risk;
• Benefits risk analysis; and
• Post market risk management sources, planning and controls.

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Speaker: Sundeep Agarwal, Medical Device Expert & Consultant

Recorded on: April 4, 2023

Description: Quality thought leaders Jason Boyd, Veeva, and Alan Maloney, Accenture will share how a strategy for unifying quality across QA, QC, and manufacturing can optimize QC productivity and improve agility in responding to changes. Come away with:

• An understanding of the most impactful levers for optimizing QC;
• Best practices for driving quality transformation initiatives; and
• Success stories from Top Pharma.

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Speakers: Jason Boyd, Sr. Director, Vault LIMS, Veeva Systems; and Alan Maloney, Senior Manager, Accenture