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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If you are already a Training Pass member, login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video, click the "Download Presentation" link.
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Webinar Training Pass
Recorded on: Oct. 27, 2020
Description: A panel of clinical trial experts discusses the lack of diversity in clinical trials and ways in which progress can be made to expand inclusiveness. They cover:
- The current state of diversity in FDA-regulated trials;
- Steps toward better outreach to minority and disadvantaged communities;
- Working with local organizations and disease associations to increase minority participation; and
- Achieving greater clinical research literacy and understanding within minority communities.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Lori Abrams, Executive Director of Patient Advocacy and Diversity, WCG Clinical; Ken Getz, Deputy Director and Research Professor, Tufts Center for the Study of Drug Development (CSDD); Zak Smith, Senior Research Analyst, Tufts CSDD; and Jasmine Benger, Associate Director of Research Services, CISCRP
Recorded on: Oct. 22, 2020
Description: Patent attorney Joanna Brougher shares strategies companies can use to develop strong patent portfolios. She discusses:
- How patents and the FDA regulatory process overlap, including during the drug approval process;
- The differences between patent exclusivity and FDA exclusivity;
- Strategies for using exclusivity to build a strong patent portfolio and protect against competitors;
- Potential weaknesses in patents and how FDA exclusivity can help maintain market protection.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Joanna Brougher, Owner and Principal, BioPharma Law Group
Recorded on: Oct. 21, 2020
Description: Regulatory affairs consultant Mary Vater explains how the FDA is modernizing the 510(k) device clearance process. She discusses:
- Implications for companies who choose predicates cleared more than 10 years ago;
- Understanding and using third-party reviewers;
- How the FDA is addressing changing biocompatibility requirements; and
- Issues around reprocessed single-use devices.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Mary Vater, Consultant, Medical Device Academy
Recorded on: Oct. 21, 2020
Description: Regulatory experts Gary Saner and Carolina Wirth discuss opportunities for growing your OTC portfolio and the complicated compliance issues that may arise during that effort. They cover:
- FDA OTC monograph reform;
- Consequences of the COVID-19 pandemic;
- Impact on existing OTC products; and
- Impact on private label distributors.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Gary Saner, Senior Manager, Reed Tech, and Carolina Wirth, Of Counsel, Arnall Golden Gregory
Recorded on: Oct. 20, 2020
Description: FDA regulatory expert Keith Webber explains the FDA’s most important coronavirus-related guidance. He covers:
- GMP manufacturing considerations;
- Supply chain drug and biologics inspections; and
- COVID-19 vaccine guidance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Keith Webber, Senior Associate, Lachman Consultant Services
Recorded on: Oct. 15, 2020
Description: Medical device regulatory expert Dan O’Leary explains the importance of medical device reliability and the tools and methods you need to prove it. He discusses:
- The concept of maintainability;
- Availability as the combination of reliability and maintainability;
- Distinguishing between safety and reliability; and
- The relationship between reliability and warranty cost.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O'Leary, President, Ombu Enterprises
Recorded on: Oct. 14, 2020
Description: Regulatory expert Karla Palmer shares tips on navigating the regulation of outsourcing facilities and compounding activities. She discusses:
- The significant differences between Sections 503A and 503B of the Food, Drug and Cosmetic Act (FDCA);
- The FDA’s position with respect to compounding pharmacies and outsourcing facilities considering drug shortages caused by the COVID-19 pandemic;
- The implications of recent enforcement actions the FDA has taken against compounders; and
- The important interplay between the FDA and states concerning the regulation of outsourcing facilities and compounding pharmacies.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Karla Palmer, Attorney, Hyman, Phelps & McNamara
Recorded on: Oct. 14, 2020
Description: Clinical trial experts Jim Coutcher, Matt Stannard and Qi Li discuss how to use real-world data (RWD) to improve trial recruitment, clinical operations and postmarket surveillance. They cover:
- Approaches to rapid site selection, cohort identification and patient recruitment;
- How to leverage comprehensive, longitudinal patient health records to improve clinical research, health economics and outcomes research, and market access; and
- Where the industry is headed with concepts such as siteless randomized clinical trials, artificial cohorts for comparator arms and the role of RWD in artificial intelligence.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Jim Coutcher, Senior Director/Principal, Global Head of Enriched Studies, Real-World Solutions, IQVIA; Matt Stannard, Life Sciences Adviser, InterSystems; and Qi Li, Physician Executive, InterSystems
Recorded on: Oct. 13, 2020
Description: Quality management experts Bob Mehta and Lou Sanatore explain how a streamlined and precise supplier agreement can improve your time to market. They discuss:
- How to hold suppliers accountable to ensure they meet quality and compliance regulations and company requirements;
- How to demonstrate management and control over suppliers’ compliance during an audit or inspection;
- What criteria to use to create a quality agreement if the law and/or regulatory requirements are not clear; and
- What criteria to use to establish a process for periodic reviews of the quality agreement.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Bob Mehta, Principal Consultant, GMP ISO Expert Services, and Lou Sanatore, Principal Solution Engineer, ComplianceQuest
Recorded on: Oct. 13, 2020
Description: Clinical trial experts Raymond Nomizu and Gail Hinkson discuss the benefits of using electronic data management systems for virtual trial monitoring. They cover:
- Cost savings from remote monitoring;
- Operational challenges of transition to electronic systems; and
- How sponsors can help their sites make the transition.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Raymond Nomizu, Co-Founder and CEO, Clinical Research IO, and Gail Hinkson, CEO, Pinnacle Clinical Research