Recorded on: Dec. 15, 2022

Description: Donna Dorozinsky shares a strategy for identifying key parts that represent your study’s unique inspection risks, what you can do now to become more inspection prepared and the key processes you can put into place at study start-up so you’re continually inspection-prepared. You’ll learn:

• How to identify key study activities where inspection risk may exist;
• An approach that allows you to understand your study’s story even if you were not a participant in the management of the study;
• How to identify key processes to put in place at study start-up to ensure that inspection preparation is integral to routine business; and
• Ideas for better inspection preparation.

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Speaker: Donna Dorozinsky, President and CEO, Just in Time GCP

Recorded on: Dec. 14, 2022

Description: This webinar enables you to 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;
• How to construct a statistical approach to comparability; and
• How to assemble the comparability package to comply with FDA requirements.

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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: Dec. 13, 2022

Description: Dennett Kouri and Faviola Michelot detail how to build a regulatory intelligence management system that will enable you to stay ahead of the changes and stay compliant, sharing:

• What regulatory intelligence is and how you can develop and implement it;
• What resources are needed to support regulatory intelligence;
• The new regulatory trends you must have on your radar; and
• How to pursue engaging opportunities with regulators.

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Speakers: Dennett Kouri, Senior Vice President, Edwards Lifesciences; and Faviola Michelot, Senior Director, Edwards Lifesciences

Recorded on: Dec. 1, 2022

Description: Steve Silverman, president of The Silverman Group — and previous director of the Center for Devices and Radiological Health’s (CDRH) Office of Compliance and assistant director of the Center for Drug Evaluation and Research’s (CDER) Office of Compliance — shares how to engage effectively with the FDA. He’ll cover:

• What effective FDA regulatory engagement means as well as misperceptions to be aware of;
• The four essential principles of effective regulatory engagement: informed, trust-based, timely, appropriate;
• The three steps to achieve effective regulatory engagement; and
• How novel issues like digital technology and real-world evidence influence effective regulatory engagement.

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Speaker: Steve Silverman, President, The Silverman Group

Recorded on: Nov. 30, 2022

Description: Take control of compliance and data integrity to accelerate research and development from drug discovery to clinical processes through a unified compliance management solution. Learn how to:

• Unify and connect disparate systems and processes together within your quality and compliance system to mitigate risks and increase efficiencies; and
• Integrate total compliance, quality, and risk management system that will not only replace 10–12-point solutions into one unified solution but also provides a collaborative environment that saves time and speeds up product launches.

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Speakers: Anu Ganguly, Senior Director, Strategic Client Partner, Xybion; and James Castonguay, Assistant Vice President, Product Development, Xybion

Recorded on: Nov. 29, 2022

Description: Effective CAPA implementation needs effective problem communication with team members, clear description of actions and clear goals. Learn how to:

• Communicate corrective actions in a manner to ensure compliance;
• Outline typical CAPA writing problems; and
• Steps to follow to structure effective CAPA’s.

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Speaker: Judith Meritz, Life Sciences Regulatory Consultant, Meritz & Muenz LLP

Recorded on: Nov. 10, 2022

Description: Jessica Ringel sheds light on the changes in user fees, the commitments the FDA’s Center for Devices and Radiological Health (CDRH) has made to the device industry in connection with its performance on marketing applications and related premarket processes — and what that could mean for you — and she’ll discuss what comes next for the unenacted legislation, including:

• How to budget for future marketing applications by understanding the increases in user fees being assessed for device applications;
• CDRH’s timeline commitments so you can better anticipate its marketing application review and the potential effects on timing of new device market launches; and
• When to expect certain guidance documents the FDA has promised to issue over the next few years as part of its MDUFA V commitments, including revisions to the guidance documents on real-world evidence and presubmissions.

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Speaker: Jessica Ringel, Partner, King & Spalding

Recorded on: Nov. 9, 2022

Description: Of counsel Paul Gadiock, who was a former associate center director for policy at the FDA’s Center for Devices and Radiological Health, and associate Olivia Cusimano — both with Wilson Sonsini Goodrich & Rosati — clarify the FDA’s current stance on charging for investigational drugs and devices. And they share:

• The factors to consider when deciding whether to seek cost recovery from participants in different clinical trial phases, such as retaining runway revenue and maintaining adequate recruitment;
• Which investigational drug expenses can be recovered without FDA authorization, which can only be recovered with FDA authorization and which cannot be recovered at all; and
• The documentation requirements for sponsors to receive FDA authorization for cost recovery under the agency’s most recent guidance, Charging for Investigational Drugs Under an IND: Questions and Answers.

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Speakers: Paul Gadiock, Of Counsel, Wilson Sonsini Goodrich & Rosati; and Olivia Cusimano, Associate, Wilson Sonsini Goodrich & Rosati

Recorded on: Nov. 8, 2022

Description: Jessica Greenbaum, counsel in King & Spalding’s FDA and Life Sciences practice and former regulatory counsel in the FDA’s Office of Therapeutic Biologics and Biosimilars, walks you through the potential fate of the remaining provisions so you’ll be ready when — or if — the initiatives of most importance to you finally take effect. She provides:

• An overview of the bare-bones user fee package Congress enacted on Sept. 30, 2022;
• A deeper understanding of the key drug- and biologics-related riders that accompanied the original House and Senate bills, including those related to accelerated approval and diversity in clinical trials; and
• Insight into the potential consequences and impacts of these provisions, including how the proposal to amend the first interchangeable exclusivity provisions could facilitate competition.

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Speaker: Jessica Greenbaum, Counsel, King & Spalding

Recorded on: Nov. 2, 2022

Description: IQVIA principal consultant and former FDA official Jan Pierre reveals how to build a RWE QMS, including insights on:

• What the regulatory landscape looks like for RWE, particularly the FDA’s Quality Framework to support a new drug or device regulatory filing;
• What programmatic changes you must adopt to set up a RWE program;
• The study feasibility process and its relationship to achieving “evidence quality”, including examples of study feasibility parameters; and
• How to identify new RWE-related roles and responsibilities.

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Speaker: Jan Pierre, Principal Consultant, IQVIA