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

 

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.

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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

 

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.

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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

 

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

 

Description: Hoffman LaRoche/Genentech veteran Ken Schiff demonstrates how to use quality risk management principles, electronic data capture and other IT systems to monitor clinical trial sites remotely. Topics include:

• Automatic analysis of existing data that allows continuous risk management;
• Calculating risk priority; and
• Key steps for QRM implementation.

Presentation: Download the presentation

Speaker: Ken Schiff, President and Owner, Quality Risk Management Associates, LLC

 

Description: Consultant Kim Egan explains how the FDA regulates cosmetics and what the agency considers a drug. Topics include:

• GMP requirements;
• Banned and restricted substances; and
• Cosmetics labeling rules.

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Speaker: Kim Egan, Principal, Saltbox Consulting

Description: Attorney Kari Sutherland details important features of an OTC product that FDA guidance recommends should prompt a self-selection study. Sutherland also covers:

• Self-selection study design, objectives and conduct;
• How to conduct label comprehension studies; and
• When to conduct actual use studies.

Presentation: Download the presentation

Speaker: Kari Sutherland, Attorney, Butler, Snow, O’Mara, Stevens & Cannada, PLLC

Description: Industry expert Barbara Immel examines issues with parenteral products in FDA inspections and how to avoid warning letters. Topics include:

• Recent compliance cases;
• FDA inspection ratings; and
• How the FDA conducts drug and biologics inspections.

Presentation: Download the presentation

Speaker: Barbara Immel, President, Immel Resources LLC