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
Description: Industry experts Kevin Nelson and Patrick Gallagher use real-world examples of companies currently attempting to demonstrate biosimilarity and demonstrate best practices that allow sponsors to use the FDA's recent draft guidance to improve their chances of getting 351(k) biosimilar applications approved. Topics include:
- How FDA's thinking on the clinical requirements for showing biosimilarity has begun to evolve with the 2014 clinical guidance;
- Preparing an approvable 351(k) application through the use of the Biological Product Development Program; and
- How to use the inter partes review (IPR) process to tackle patent barriers and lessen your patent litigation budget.
Presentation: Download the presentation
Speakers: Kevin Nelson, Partner, and Patrick Gallagher, Associate, Intellectual Property Practice Group, Duane Morris LLP
Description: Drug-naming expert Dr. Susan Proulx addresses industry concerns about FDA drug-naming guidance and discusses best practices for naming drugs to help assure FDA approval. Topics include:
- Pros and cons of relying on computerized searching to identify similarity in proposed names;
- Using simulation testing to predict FDA reaction to a drug name; and
- The need for expert analysis prior to deciding what trademark to choose.
Presentation: Download the presentation
Handout: Download the handout
Speakers: Susan Proulx, PharmD, President, Med-ERRS, Inc.
Description: Using real-life examples, loss control expert Sara Dyson shows how others have handled liability issues related to off-label promotion, explaining what they did right and where they went wrong. Topics include:
- What off-label use and promotion is and how to avoid it;
- Products liability causes of action related to off-label promotion; and
- Two major defenses against liability that are undercut by off-label promotion
Presentation: Download the presentation
Speaker: Sara Dyson, Assistant Vice President of Loss Control, Medmarc Insurance Group
Description: ANDA expert Andy Papas teaches how to achieve first-pass approvals for new generic drug products. Topics include:
- What impact GDUFA is having on today's ANDA applications and how sponsors should be responding;
- How to assure you've adequately addressed bioequivalence requirements ahead of time; and
- Key considerations to address FDA-identified completeness, quality, and bioequivalence issues.
Presentation: Download the presentation
Speaker: Andy Papas, Vice President of Regulatory Affairs at NSF Health Sciences Pharma Biotech
Description: Noted regulatory affairs specialist Cheryl Wagoner explains how to craft 510(k) applications for software-containing devices that will win approval the first time. Topics include:
- What makes your software a medical device?
- How do you define and support Level of Concern determination?
- 11 software-related documentation sections you should include.
Presentation: Download the presentation
Handout: Download the handout
Speaker: Cheryl Wagoner, Principal Consultant/Owner of Wagoner Consulting LLC
Description: Noted serialization authority Bill Fletcher explains how to build a track & trace system that will comply with current and future global regulations without requiring new software or hardware. He discusses:
- Best practices for aligning US requirements with those from other countries, including Brazil, China, the EU and more;
- How to build a steering committee and expanded team that has the proper subject matter experts; and
- Best practices for integrating serialization within existing SOPs.
Presentation: Download the presentation
Speaker: William Fletcher, Managing Partner, Pharma Logic Solutions, LLC
Description: Experts Julie Larsen and Arnold Solomon cover current FDA enforcement and inspection trends, including how to:
- Identify and link current trends to an inspectional readiness program;
- Understand the risk-based approach to preparing SMEs and using simulated inspection scenarios; and
- Answer 10 key questions to determine a manufacturer's state of readiness for inspection.
Presentation: Download the presentation
Speakers: Julie Larsen, Director of Inspection Readiness, BioTeknica; Arnold Solomon, President, FDA Strategic Compliances, LLC
Description: Clinical trials regulatory expert Scott Cunningham discusses compliance issues involved in the federal trial data repository, as well as data disclosure initiatives in the US and EU. He covers:
- The FDA's definition of an "applicable trial;"
- The history and development of Clinicaltrials.gov; and
- Industry concerns.
Presentation: Download the presentation
Speaker: Scott Cunningham, Partner, Covington and Burling LLP
Description: Recall specialists Neil O'Flaherty and Casper (Cap) Uldriks outline the FDA's draft guidance on distinguishing between a device recall and a product enhancement and explain what the agency expects of devicemakers.
Presentation: Download the presentation
Speakers: Neil O'Flaherty, Principal Attorney, and Casper Uldriks, Counsel of Attorneys, OFLW Law
Description: Post-market risk management expert Joe Falvo demonstrates how to integrate best practices throughout the recall process, including:
- Effective SOPs for recalls;
- Techniques to identify correction, removal and withdrawal;
- The steps of notification and acknowledgement audits; and
- Strategies for an effective recall execution.
Presentation: Download the presentation
Speaker: Joe Falvo, Senior Manager: Post Market Risk Management, Ortho Clinical Diagnostics