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: 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
Recorded on: Oct. 19, 2022
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’ll cover:
- FDA guidance and documentation;
- Practicalities of relying on RWD/RWE; and
- Premarket and Postmarket Obligations.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kristin Zielinksi Duggan, Partner, Hogan Lovells; and Sally Gu, Associate, Hogan Lovells
Recorded on: Oct. 18, 2022
Description: Three senior directors with decades of experience at the intersection of quality and technology in the life sciences share how an agile QMS can increase study-based audit efficiency within a pharmaceutical organization and/or a CRO’s compliance framework. You’ll discover:
- How to harmonize integration of quality and compliance;
- How to achieve optimal quality management system efficiency;
- How to achieve study-based audit efficiencies within a compliance framework; and
- How to use audits to drive continuous improvements.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Amy L. Carlson, CQRM Product Manager, Xybion; Anu Ganguly, Senior Director, Strategic Client Partner, Xybion; and Angie Bixler, CQRM Product Manager, Xybion
Recorded on: Oct. 13, 2022
Description: This webinar breaks out the important requirements needed to assure compliance and to help you verify that the practices in place will meet the rigor of inspection readiness and accurate test reporting. Regulations discussed include:
- Organization and personnel requirements;
- Quality assurance (controlled documents and analytical review and release processes);
- Laboratory equipment (design, qualification, calibration, maintenance and periodic reviews);
- Reagents and standards management practices; and
- Test method development, validation [ICH Q2 R1] and transfer (compendial versus in-house).
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tim Fischer, Principal Partner, Great Solutions, LLC
Recorded on: Oct. 12, 2022
Description: Using real-world examples of recent FDA findings, Marion Mays, Just in Time GCP’s Vice President of Inspection Readiness, will share her experiences in supporting numerous sites in preparing for and managing their inspections. She provides specifics on:
- How to overcome your primary inspection-preparedness challenges, including staff who have minimal inspection experience or may not have even been involved in the study;
- Where to focus inspection preparation activities;
- How to mitigate findings and how to speak to issues and compliance; and
- Practical approaches for preparedness, including determining the story of the study, preparing for inspector interviews, and creating a strategy for inspection day.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Marion Mays, Vice President of Inspection Readiness, Just in Time GCP
Recorded on: Oct. 4, 2022
Description: This webinar — presented by current and former FDA officials and an officer in a rare disease advocacy organization — will provide the clarity you need when it comes to your orphan drug products, explaining:
- Why orphan drug development, and transparent, consistent, predictable decisionmaking by the regulators, helps the industry, affected patients and their healthcare providers;
- Recent regulatory decisions and legislative changes regarding orphan drug exclusivity;
- How the FDA interprets statutes and promulgates regulations, and what happens when federal courts/appeals courts determine the agency did not interpret correctly; and
- The Government Accountability Office’s (and others’) recommendations to OOPD to improve decisionmaking, and whether such recommendations have been implemented.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Brian Malkin, Partner, McDermott, Will & Emery; Dr. Karin Hoelzer, Director of Policy and Regulatory Affairs, National Organization for Rare Disorders; and Aaron Friedman, Senior Regulatory Counsel, FDA Office of Orphan Products Development
Recorded on: Sept. 22, 2022
Description: Kristen Grumet, vice president of regulatory compliance at Greenleaf Health, ensures you understand the proposed QMSR, adjust your QMS and reap the benefits of harmonization, explaining:
- The commonalities and differences between ISO 13485:2016 and the FDA’s proposed QMSR;
- The commonalities and differences between how the quality system requirements are enforced by the FDA vs. notified body auditors;
- The history and driving force behind harmonization: why the FDA is changing the QSR now after more than 20 years of successful implementation; and
- The advantages and potential disadvantages of harmonization, such as how the satellite regulations of Part 803 (MDR Reporting) and Part 806 (Corrections and Removals) fit in under ISO 13485:2016 and what happens to the FDA’s Quality Systems Inspection Technique (QSIT) program.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kristen Grumet, Vice President of Regulatory Compliance; Greenleaf Health
Recorded on: Sept. 21, 2022
Description: Three members of King & Spalding’s FDA and Life Sciences practice — two of whom are FDA veterans — use hypotheticals and role play to highlight best practices for sponsors to spot and mitigate high-risk issues related to the integrity of clinical data and its uses before and after product approval, as well as in crisis management, explaining:
- How disruptions brought on by the COVID-19 pandemic opened the door for unintended and deliberate breaches of the development of clinical data;
- Recent trends in FDA warning letters that signal a shift from the agency’s focus during the pandemic to the emerging “new normal” of scrutiny and inspections related to the development of clinical data and its integrity; and
- New modes of FDA enforcement, including those related to sponsor disclosure of clinical results on ClinicalTrials.gov.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Beverly Lorell, MD, Senior Medical and Policy Advisor, King & Spalding; Peter Leininger, Partner, King & Spalding; Mark Brown, Partner, King & Spalding