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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Webinar Training Pass
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.
- 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
- 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
- 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.
- 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
- 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
- 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
- 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
- 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
- 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