The Webinar Training Pass

Now get all the training you need – all in one place, and all for one low price!

The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.

PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!

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: Graeme Ladds, CEO of PharSafer Associates Ltd., explains requirements for electronic submission of Individual Case Safety Reports (ICSR), both in Europe and in the U.S., including:
  • Who should report and to whom?
  • What information should be reported;
  • Exemptions for “exceptional circumstances;” and
  • How to report follow-up information.

Presentation: Download presentation

Speaker: Graeme Ladds, CEO, PharSafer Associates Ltd.

Description: Einar Bjornsson, Professer of Gastroenterology and Hepatology at Landspitali University Hospital, explains how to use data capture methods to minimize drug-induced livery injury risks without risking patients. He covers:
  • When DILI is most likely to occur;
  • Drug factors in DILI outcomes;
  • Phase I vs. Phase II reactions; and
  • A comparison of compounds with significant and nonsignificant hepatic metabolism.

Presentation: Download presentation

Speaker: Einar Bjornsson, Professor of Gastroenterology and Hepatology, Landspitali University Hospital

Description: Josh Feldstein of the Center for Applied Value Analysis makes the case for using comparative cost effectiveness (CCE) research and value analytic models to help demonstrate a product’s value to purchasing decisionmakers. Feldstein discusses:
  • Training needed to conduct effective CCE research;
  • Learning from programs already in use in the EU, Canada and Australia;and
  • Integrating medical statistics and health economics to create a value analytic model.

Presentation: Download presentation

Speaker: Josh Feldstein, President, Joint Center for Applied Value Analysis and Principal, MarCom Group International

Description: Attorney Chad Landmon presents strategies for achieving FDA approval of an ANDA by using Paragraph IV certification instead of costly and lengthy patent litigation. Landmon covers such topics as:
  • Understanding the FDA’s bioequivalence requirements;
  • How to craft an ANDA that directly addresses the patent infringement issue; and
  • Strategies for addressing exclusivity grants.

Presentation: Download presentation

Speaker: Chad Landmon Esq., Partner, Axinn Veltrop & Harkrider LLP

Description: Attorneys and FDA inspection specialists Frederick Branding and Cathy Burgess explain how to prepare for the FDA inspection a drugmaker must pass before its NDA is approved.
  • Documents inspectors will request;
  • Information inspectors are not authorized to look at;
  • Agency priorities and what FDA inspectors look for; and
  • Potential post-inspection actions.

Presentation: Download presentation

Speakers: Frederick H. Branding RPh JD, Principal Attorney, Olsson, Frank, Weeda, Terman, Bode and Matz P.C. and Cathy L. Burgess, Partner, Olsson, Frank, Weeda, Terman, Bode and Matz P.C. Health Care Group

Description: Attorney Joan Antokol explains how to ensure the right language is written into a clinical trial agreement indemnification clause to protect the sponsor in the event a malpractice lawsuit is filed. Using case studies and examples of clauses from actual clinical trial agreements, Antokol examines:
  • The impact of the current research landscape on indemnification;
  • IRB and Ethics Committee requirements; and
  • Factors to consider when deciding the scope of indemnification needed for a clinical trial.

Presentation: Download presentation

Speaker: Joan Antokol, Managing Partner, Park Legal LLC

Description: Quality and organization expert Dan O’Leary presents the elements of an integrated complaint management system that functions effectively and meets FDA requirements. O’Leary covers:
  • Mapping the process flow in an integrated complaint management system;
  • Servicing records and reports;
  • Recording and reporting on complaint investigations; and
  • Overlapping reporting requirements for MDRs and Corrections & Removals.

Presentation: Download presentation

Speaker: Dan O’Leary, President, Ombu Enterprises LLC

A World Apart
90 minutes
Description: International compliance experts Steven Datlof and Elisabethann Wright examine the differences between medical device reporting requirements in the EU and the U.S., addressing who needs to report adverse events, when they should be reported and to what authority? Datlof and Wright look at:
  • The differences from the perspectives of manufacturers, user facilities and importers;
  • Premarket and postmarket reporting requirements; and
  • Reporting voluntary recalls and corrections and removals.

Presentation: Download presentation

Speakers: Steven Datlof MD JD, Partner, Hogan Lovells and Elisabethann Wright BL, Partner, Hogan Lovells International

GLP Compliance
69 minutes
Description: GLP compliance expert Anne Maczulak lays out a 10-step strategy for preparing to face FDA inspections, from developing SOPs to conducting mock inspections. Points covered include:
  • Developing a pre-audit assessment plan;
  • Elements of a safety policy; and
  • Roles and responsibilities for staff involved in the inspection.

Presentation: Download presentation

Speaker: Anne Maczulak PhD RQAP-GLP, Principal Consultant, Acorn GLP Consulting

Description: Compliance expert and former FDA investigator Martin Browning presents the EU’s revised rules for managing risks throughout the life of any computerized systems used in a regulated activity, from simple spreadsheets to complex networks. Annex 11, revised in 2011, is the European counterpart to U.S. Part 11 rules for use of electronic systems in manufacturing. Browning explains:
  • The principals and scope of Annex 11;
  • Differences between Annex 11 and Part 11;
  • How the revised rules incorporate standard IT practices; and
  • How they differ from the original Annex 11 provisions that had been in place for nearly 20 years.

Presentation: Download presentation

Handout #1 - Comparison of FDA’s Part 11 and the EU’s Annex 11

Handout #2Verification vs. Validation: FDA’s Expectations and Why The Difference Matters

Speaker: Martin Browning, President and Co-Founder, EduQuest