The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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Webinar Training Pass
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.
Presentation: Download the presentation
Transcript: Download the transcript
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.
Presentation: Download the presentation
Transcript: Download the transcript
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.
Presentation: Download the presentation
Transcript: Download the transcript
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.
Presentation: Download the presentation
Transcript: Download the transcript
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.
Presentation: Download the presentation
Transcript: Download the transcript
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.
Presentation: Download the presentation
Transcript: Download the transcript
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.
Presentation: Download the presentation
Transcript: Download the transcript
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.
Presentation: Download the presentation
Transcript: Download the transcript
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.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jan Pierre, Principal Consultant, IQVIA
Recorded on: Oct. 20, 2022
Description: Arnold & Porter partner Howard Sklamberg — previously a deputy commissioner for global regulatory operations and policy and director of the office of compliance — with senior associate Abraham Gitterman provide a robust overview of the FDA’s proposed rule and recent guidance documents. They’ll cover:
- What you must know about the regulatory and rulemaking process for the FDA’s proposed rule for wholesale drug distributors (WDD) and third-party logistics providers (3PL) licensing;
- Some of the updated and new requirements for WDD and 3PL licensure, including further clarifications for licensure exemptions;
- The potential implications that this law will have in preempting state and/or local laws; and
- How this proposed rule affects other related DSCSA requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Howard Sklamberg, Partner, Arnold & Porter; and Abraham Gitterman, Senior Associate, Arnold & Porter