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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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Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
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Webinar Training Pass
REMS 2014
88 minutes
Description: Legal expert Howard Dorfman provides an update on the status of the FDA's REMS requirements and the outlook for 2014. Dorfman discusses:
- Required REMS elements;
- Assessment time frame;
- REMS and the innovator-generic debate; and
- The revised Change Being Effected ("CBE") rule.
Presentation: Download the presentation
Speaker: Howard Dorfman, Vice President and General Counsel, Ferring Pharmaceuticals, Inc.
Description: Regulatory experts Daniel Kracov and Dan Pariser explain the FDA's November 2013 proposal for allowing generic drug manufacturers to use the same process as branded drug manufacturers when updating product labeling. Topics covered include:
- Liability implications for both generic and branded manufacturers;
- Current requirements for updating labeling;
- Process for submitting labeling changes under the proposed rule; and
- Whether legal challenges will delay issuance of a final rule.
Presentation: Download the presentation
Speakers: Daniel Kracov, head of the FDA and healthcare practice at Arnold & Porter LLP, and Dan Pariser, partner and specialist in healthcare product liability, Arnold & Porter LLP
Description: Pharmaceutical security specialists Robert Reznick and Elizabeth Howard share insight on building an anti-counterfeiting/product integrity program, with special focus on China's enforcement activities. They cover:
- Varying definitions of counterfeit drugs;
- U.S. legal issues and actions;
- Using intellectual property laws to combat counterfeiting; and
- How the Internet complicates the problem.
Presentation: Download the presentation
Speakers: Robert Reznick, Partner and Life Sciences Practice Co-Chair, Orrick, Herrington & Sutcliffe, and Elizabeth Howard, Partner and Intellectual Property Litigator, Orrick, Herrington & Sutcliffe
Perfecting Your Company Core Data Sheets
83 minutes
Description: Global drug safety expert Graeme Ladds teaches how to develop and maintain Company Core Data Sheets. Topics include:
- Differences between Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI);
- EU vs. U.S. interpretation of what to include in a CCSI; and
- How and when to add to a CCSI.
Presentation: Download the presentation
Speaker: Graeme Ladds, CEO, PharSafer Associates Ltd.
Metal Impurities in Finished Drug Products
90 minutes
Description: Bristol-Myers Squibb Principal Scientist Nancy Lewen discusses the status of global standards for testing of metals in drug product manufacturing. Lewen covers:
- Problems with current testing methods;
- How to determine what and when to test; and
- Using a risk-based approach to testing.
Presentation: Download the presentation
Speaker: Nancy Lewen, Principal Scientist, Bristol-Myers Squibb
Device Off-Label Promotion
71 minutes
Description: Attorneys and medical device compliance specialists Anne Walsh and Allyson Mullen discuss pitfalls surrounding off-label promotion issues, covering such topics as:
- How the FDA and the Federal Trade Commission share authority over advertising of medical devices;
- Labeling vs. advertising; and
- FDA enforcement tools.
Presentation: Download the presentation
Handout #1: Massager2000
Handout #2: Intradiscal Catheter
Handout #3: Highlights of Promotional Review Policy
Speakers: Anne Walsh, Director, Hyman Phelps and Allyson Mullen, Associate, Hyman Phelps
Cybersecurity Threats to Medical Devices
79 minutes
Description: Axel Wirth, National Healthcare Solutions Analyst for Symantec, brings an expert perspective to the issue of protecting devicemakers’ data from hacking and other cyber threats. Wirth covers:
- The evolution of cyber threats;
- FDA recommendations for medical devices;
- Security systems available to the industry; and
- Resources and references devicemakers can turn to for more information.
Presentation: Download the presentation
Speaker: Axel Wirth, National Healthcare Solutions Analyst, Symantec
Description: Leading clinical trial disclosure expert Scott Cunningham covers recent initiatives and possible changes proposed in both the U.S. and EU. Topics include:
- Congressional action on two bills introduced in 2013 – the Trial and Experimental Studies (TEST) Act and the Clinical Trial Cancer Mission 2020 Act;
- The proposed shift in EMA’s disclosure policy; and
- The FDA’s June 2013 request for comments on its proposal to release de-identified data.
Presentation: Download the presentation
Speaker: Scott Cunningham, Esq, Partner, Covington & Burling LLP
Description: Noted QSR expert Dan O’Leary provides a soup-to-nuts examination of controlling nonconforming product problems to avoid FDA sanctions and recalls. From an in-depth look at QSR requirements to inspection preparation, O’Leary covers:
- The five steps involved in handling nonconformance problems;
- Training personnel to identify and deal with problems;
- Types of disposition of nonconformance problems; and
- Conducting failure investigations.
Presentation: Download the presentation
Handout: Nonconforming Product Checklist
Speaker: Dan O’Leary, President, Ombu Enterprises
ADE? Or ADR?
77 minutes
Description: Top drug development consultant Hoss Dowlat illustrates some of the many pitfalls in new EU pharmacovigilance regulations regarding medication errors using real-world case studies. Dowlat covers:
- Differences between an Adverse Drug Event and an Adverse Drug Reaction and what should be reported in the EU;
- Product design to minimize medication errors;
- Proactive risk assessment guidance from the FDA and the EMA; and
- Setting thresholds for inclusion of ADRs.
Presentation: Download the presentation
Speaker: Dr. Hoss Dowlat, Ph.D., VP-Regulatory Affairs, PharmBio Consulting