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: Nov. 19, 2020
Description: Quality systems expert Dan O’Leary discusses the coming changes to device certification, obtaining a UK Conformity Assessed (UKCA) mark and registering your device with the Medicines and Healthcare products Regulatory Agency (MHRA). Topics include:
- Making sense of the UK conformity assessment bodies;
- The separate rules for Northern Ireland; and
- Some of the planned changes in the UK regulations.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: Nov. 19, 2020
Description: Representatives of Mercy Health discuss the challenges of connecting study teams in multiple states to ensure billing efficiency and compliance. They cover:
- Recent coverage analysis trends;
- Examples and best practices of communication within an organization to ensure study start-up sets the table for compliant billing decisions;
- Importance of coverage analysis utilization by multiple teams within an institution to protect the organization and research participants; and
- Examples of a “living document” that evolves throughout the lifecycle of a clinical trial, including amendments and change requests.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Aubrey Smith and Tiffani Smith, Managers of Business Operations, Mercy Health; Geoffrey Schick, Senior Consultant, WCG Clinical; and Amanda Miller, Manager of Quality and Development, WCG Clinical
Recorded on: Nov. 19, 2020
Description: Pharmacovigilance expert Graeme Ladds discusses best practices around resource reductions, safety reporting, labeling, compliance documents and reporting adverse events. He covers:
- Prioritizing product risks and communicating those risks to regulators during the COVID-19 pandemic;
- Complying with expedited reporting rules during the health crisis;
- Creating world-class SOPs, including those that contain exceptions to accommodate COVID-19 issues; and
- Constructing real-world timelines that take into account compliance requirements around COVID-19.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Graeme Ladds, CEO, PharSafer Associates
Recorded on: Nov. 17, 2020
Description: Clinical trial operations experts Barry Milton, Andy Lawton and Elvin Thalund discuss the concepts of vendor oversight and risk management under ICH E6(R2). They cover:
- The intended purpose of ICH regulations to implement industry best practices;
- How current vendor oversight practices need to evolve to ensure compliance with recent regulatory guidances; and
- How implementing quality-by-design principles can ensure study risk assessment in your vendor oversight – end-to-end.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Barry Milton, Head of Global Program Management, Novartis Institutes for Biomedical Research; Andy Lawton, Consultant, Risk Based Approach Ltd.; and Elvin Thalund, Director of Industry Strategy, Oracle Health Sciences
Recorded on: Nov. 16, 2020
Description: Medical device legal expert Evan Phelps shares the most significant issues that could arise when implementing the FDA guidance on breakthrough devices. He covers:
- The basics of the FDA’s Breakthrough Device Program;
- Program benefits and how the designation will push a device to market earlier;
- FDA criteria to identify breakthrough devices, including specific statutory criteria from Appendix I of the Breakthrough Devices Program Final Guidance; and
- Key elements the FDA uses to review breakthrough device applications.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Evan Phelps, Partner, Amin Talati Wasserman
Recorded on: Nov. 10, 2020
Description: Device quality and regulatory expert Linda Lovett explains how to establish and implement a comprehensive supplier management system using risk management principles. She discusses:
- Setting up a risk-based supplier program that meets quality and regulatory requirements;
- Identifying quality criteria based on supplier risk level (key, custom specification, industry standard and service suppliers);
- Applying risk-based supplier qualifications, auditing and monitoring; and
- Applying examples of supplier quality and risk metrics/key performance indicators.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Linda Lovett, CEO, Lovett Consulting
Recorded on: Nov. 10, 2020
Description: Quality experts Michael Moravia and Tom Barlow discuss updated medical device reporting expectations, including ways to harmonize regulation management strategies across multiple countries and territories. Topics include:
- Global harmonization trends and the overall direction for eMDR and EUDAMED;
- Three data upload strategies for EUDAMED reporting;
- Tools that can help your processes adjust automatically with less probability of error; and
- The harmonization of international reporting terminology, especially around adverse events and country codes.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Michel Moravia, Product Manager of Quality, and Tom Barlow, Strategic Solutions Engineer, ETQ
Recorded on: Oct. 29, 2020
Description: Experts from Greenlight Guru provide insight on industry challenges and barriers to demonstrating closed-loop traceability within a quality management system. They discuss:
- Using purpose-built tools with the latest technologies;
- Optimizing the quality management system for traceability;
- Increasing visibility into relationships withing the quality system; and
- Understanding the impact of change.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Taylor Brown, Senior Medical Device Guru, Tom Rish, Senior Medical Device Guru, and Jason McKibbin, COO, Greenlight Guru
Recorded on: Oct. 29, 2020
Description: A panel of regulatory experts provides tips for evaluating and addressing the new drug patent and exclusivity provisions. They discuss:
- Key resources for drug patent and exclusivity information, including the FDA’s Orange Book and other online CDER resources;
- Key considerations in confirming the duration of patents and exclusivity, such as additive pediatric exclusivity or patent term extensions;
- Timelines and milestones in the patent certification process, including certification to FDA, direct notifications to new drug applications and patent holders and their effect on clearance/approval timelines; and
- Interactions with the drug patent holder when needed, including notifications and rights of reference.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Christina Markus, Partner, King & Spalding, Genevieve Michaux, Partner, King & Spalding, Jessica Ringel, Counsel, King & Spalding, and Quynh Hoang, Consultant, King & Spalding
Recorded on: Oct. 27, 2020
Description: Clinical research operations experts Ken Lownie and Jill Heinz explore the challenges that face sites and a set of strategies to overcome them. They cover:
- An understanding of how ClinOps software fits into the world of the clinical site;
- An example of how one clinical site manager brought in a full range of software solutions successfully; and
- A perspective on the state of the software systems and solutions available today.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Ken Lownie, Head of North American Operations, Agatha Life Sciences, and Jill Heinz, President and Director of Clinical Research, Injury Care Family/ Family Care Research